Future Developments of Digital Health and Consider
Future Developments of Digital Health and Consider
Climate Action
Zisis Kozlakidis
Armen Muradyan
Karine Sargsyan Editors
Digitalization
of Medicine in Low-
and Middle-Income
Countries
Paradigm Changes in Healthcare and
Biomedical Research
Sustainable Development
Goals Series
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Zisis Kozlakidis • Armen Muradyan
Karine Sargsyan
Editors
Digitalization of
Medicine in
Low- and
Middle-Income
Countries
Paradigm Changes in Healthcare
and Biomedical Research
Editors
Zisis Kozlakidis Armen Muradyan
International Agency for Research on Yerevan State Medical University
Cancer Yerevan, Armenia
World Health Organization
Lyon, France
Karine Sargsyan
Cedars-Sinai Medical Center
Cancer Center
Los Angeles, CA, USA
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v
vi Contents
Governance and Regulation Specifics���������������������������������������������������� 227
Nicolas Ferry and Paul Hofman
Future Developments of Digital Health and
Considerations on Sustainability������������������������������������������������������������ 231
Noa Zamstein, Sandra Nanyonga, Estelle Morel, Rachel Wayne,
Sven Nottebaum, and Zisis Kozlakidis
Universal Internet Access Supporting Healthcare
Provision: The Example of Indonesia���������������������������������������������������� 239
Dewi Nur Aisyah, Maryan Naman, Wiku Adisasmito,
and Zisis Kozlakidis
Proliferation, Ingestion, and Interpretation of Health
Data in Low-and Middle-Income Countries (LMICS)������������������������ 245
Sandra Nanyonga, Plebeian B. Medina, Zisis Kozlakidis,
Debra Leiolani Garcia, Desislava Ivanova,
and Panagiotis Katsaounis
Ubiquitous and Powerful Artificial Intelligence (AI)���������������������������� 255
Amalya Sargsyan, Shushan Hovsepyan, and Armen Muradyan
Non-digital Health Trends in Low- and
Middle-Income Countries ���������������������������������������������������������������������� 273
Karine Sargsyan
Recommendations for Digitization of Healthcare
in LMICs: A Wider Outlook ������������������������������������������������������������������ 277
Zisis Kozlakidis, Mat Clum, and Karine Sargsyan
Index���������������������������������������������������������������������������������������������������������� 283
Digitalization of Healthcare
in Low-and Middle-Income
Countries (LMICs): An Overview
Abstract Keywords
ital health would need to remain broad so as to main factor is the market itself: there exists a
ensure inclusivity. Indeed, this book hosts chap- more mature environment for digital health appli-
ters contributed by over 100 authors from over cations as part of routine practice. Indeed, the
25 countries, covering as many aspects and per- COVID-19 pandemic has functioned as an accel-
spectives as that was possible to achieve within erator in terms of entrenching digital technolo-
the publication confines imposed by the nature gies within routine services (Kozlakidis and
of a book publication. Catchpoole 2021b). For example, digital tech-
nologies have been used for remote post-operative
monitoring more intensely than ever before
2 Why Is It a Good Time to Talk (Beauharnais et al. 2022; Mousa et al. 2019), as
About Healthcare well as an innovative platform for bringing
Digitalization in LMICs— healthcare professionals and patient groups
Coalescence of Forces together, e.g. breast cancer patients (Abusanad
2021). While it is anticipated that some of this
A number of distinct factors justify the creation activity may revert to pre-pandemic protocols,
of the current book at this point in time. The this is not going to be universally true, and as
information explosion in healthcare is well- such a considerable portion of digital healthcare
known (Wilson 2001; Beath et al. 2012), and is capacities will remain integrated within the over-
the result of a significant increase in computing all healthcare systems (Jazieh and Kozlakidis
power, coupled by a significant reduction in data 2020), strengthening the existing digital health-
storage costs, facilitating the production and care market, and its relative position as propor-
storage of increasingly larger volumes of data tion of the annual healthcare budget. Thirdly,
(Shastri and Deshpande 2020). At the same time, there is an accelerated penetration of mobile
the increasing penetration of hand-held and phones that has now been coupled with increased
internet enabled devices had led to an explosion penetration of internet-enabled services (Kelly
in data generation and data consumption within et al. 2020). Whereas mobile phone penetration
healthcare (Feroz et al. 2020; Wood et al. 2019). in south-east Asia has been over 90% in most
In turn, this increasing need on both sides of major countries for over a decade, the necessary
data, i.e., significant increase in production and internet-enabled infrastructure, i.e., ensuring suf-
consumption of healthcare data, lays the ground ficient connectivity and bandwidth, such as
for further innovative approaches, utilizing the needed to operate healthcare applications, has
new technologies needed to cope with the digital only been available for only a few years in most
pressures within healthcare. New methods of locations, if at all (Hoe 2022). Finally, the
inquiry are emerging in thinking about innova- COVID-19 pandemic has provided the required
tions in the wider healthcare field, and that is evidence that digital healthcare implementations
inevitably also reflected in the approaches of can be financially viable, e.g., in the servicing
understanding and interpreting those findings for and monitoring of repeat prescriptions (Macariola
the scientific literature (Kozlakidis and et al. 2021). However, such cases are still the
Catchpoole 2021a). This is particularly true exception within LMICs, and a wider adoption
within LMICs, where driven by the necessity of would require appropriate policy support (Bloom
severe funding limitations for example, digital 2019).
healthcare implementations may be very
innovative.
Thus, as alluded above, one main factor is the 3 Focusing on LMICs vs
technological advance (from ‘-omics‘analytical Resource Restricted Settings
technologies to digital surveillance programs
used for public health), able to accommodate Healthcare systems in many LMICs are com-
more functions than ever before, and as such gen- plex and tend to operate under immense pres-
erating more data than ever before. The second sures in terms of healthcare delivery. However,
Digitalization of Healthcare in Low-and Middle-Income Countries (LMICs): An Overview 3
it is also appropriate to recognise that many genetics, etc. In doing so, the book is highlight-
LMIC healthcare systems have undoubtedly ing specific examples, the plurality of context-
improved over the last few decades (Dinh et al. driven solutions, and the many opportunities
2020). For example, the areas of maternal health that still exist regarding digitalization of health-
and preventative medicine have benefited from a care in LMICs. To this end, the example of the
sustained drive to implement universal stan- Kingdom of Saudi Arabia is utilised as the
dards of care (Siseho et al. 2022). It is also benchmark of high attainment in terms of inte-
appropriate to recognise that there exist pro- gration of digital health, within a purpose-driven
nounced healthcare access inequalities within policy framework. The examples from Poland,
high-income settings, and that certain regions of Cyprus and China talk about the transition econ-
high-income countries (HICs) may indeed not omies that have successfully integrated many
be all that different for LMICs in terms of digital health applications within routine opera-
healthcare access (Doty et al. 2021). In the latter tions, yet a fully integrated digital healthcare
case it might be more appropriate to speak of ecosystem has not been fully attained (but
resource-restricted settings, irrespective of the remains firmly within their grasp in the immedi-
reported national average income, as a more ate future). The chapters with LMICs-specific
representative picture. The opinion of the edi- examples, are supported by extensive work on
tors of this book is that indeed a resource- the necessary preconditions for digital health-
restricted setting perspective will be more care success, such as infrastructure, investment,
appropriate in the longer-term, and as more data systems design, social acceptance, etc. Over 80
becomes available. Such a shift in terminology authors from 15 different countries, most of
and research frameworks would become both which are LMICs) have contributed to the chap-
inevitable and complementary to the current ters presented in this book. It is a deeply collec-
LMICs/HICs view. However, at present the tive work that provides a holistic and
LMICs focus of this book serves a dual purpose: representative view of the current nature and
(i) continuity and easier comparability with the status of individual digitization attempts of
published scientific literature, as well as (ii) the healthcare in LMICs, as well as the collective
view of digital healthcare innovations and view of digitalization. From the editorial per-
implementation within the framework of univer- spective, we anticipate that his book will spur
sal healthcare coverage, as has been supported many forward scientific discussions on the sub-
and introduced in many LMIC settings in the ject, and will form the basis of further such
last two decades. From a digital healthcare per- investigations on what is perhaps one of the
spective, it remains paramount to still under- most critical aspects of the future, global health-
stand the systemic challenges and opportunities, care systems.
prior to fragmenting investigations further
within regional settings that can be stratified Acknowledgments The editors would like to thank the
according to local income availability. many reviewers who provided constructive comments to
the chapters, the many authors who provided their insights
into this subject, as well as the publishing house staff,
namely Mahalakshmi SathishBabu Nithya Sechin, Emily
4 The Nature and Aim Wong and Grant Weston. Particular thanks go to Ms.
Tracy Wootton for her administrative support to the edi-
of this Book tors and helpful insights throughout the collation of this
book.
Taking the above into account, the aim of the
book is to provide a representative picture of Disclaimer Where authors are identified as personnel
healthcare digitalization in LMICs. Specifically, of the International Agency for Research on Cancer/
WHO, the authors alone are responsible for the views
how digital healthcare applications have been
expressed in this article and they do not necessarily repre-
implemented in particular countries and health- sent the decisions, policy or views of the International
care fields, e.g., paediatrics, dentistry, medical Agency for Research on Cancer/WHO.
4 Z. Kozlakidis and K. Sargsyan
Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license,
unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons
license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
obtain permission directly from the copyright holder.
Digital Health: Needs, Trends,
Applications
fragmented, because the collection of data for and regional needs in relation to emerging new
public health records (and later on for surveil- technologies, including the support of techno-
lance) was affected by a historic lack of invest- logical co-development (World Health
ment in digital technologies (Vandenberg et al. Organization 2021).
2018). In the beginning of the twenty-first cen- Therefore, reflecting on the many different
tury the notion of digital health changed funda- needs and definitions, neither this chapter or this
mentally as the advent of the internet and book, take a singular view on digital health.
improved capabilities for international data trans- Instead, as the book includes over 80 authors
fer meant that digital health was viewed both as a from more than 20 different countries, each chap-
local as well as an international need, with an ter contains a working definition for digital health
increasing emphasis on the harmonisation and so as to facilitate the authors in developing their
interoperability of extant systems. The more arguments fully. While this entails the inherent
recent experiences from the outbreaks of danger of potentially conflicting views, the edi-
infectious diseases (Ebola virus, Zika virus, and tors have considered that to be a desirable out-
currently SARS-CoV-2 virus) have added yet come. Indeed, the current lack of a bona fide
another dimension to digital health: the respon- definition for digital health indicates that there
siveness to public health emergencies inclusive are, and will be, conflicting approaches to such a
of the end user and wider public (Knawy et al. definition and as such it serves the wider scien-
2020). tific community and interest for those differences
Indeed, as technology develops and its inte- of opinion to remain visible.
gration into routine clinical practice increases, it The overall approach in constructing the cur-
can be anticipated that consequently the plurality rent chapter is that of a narrative review, in which
of digital health definitions will also increase, the most recent policies, guidelines, and publica-
reflecting on the ever-widening user base. At the tions from the last 5 years have been identified
same time, it is important for a more consolidated through a literature search, with further addi-
taxonomy to be developed on digital health, con- tional manuscripts being identified through
solidating digital health concepts/spheres of ‘snowballing’, i.e., using reverse citation tracking
influence, for use in research, policy develop- to find articles that cited others already deemed
ment, public health and clinical practice. To this relevant to the review (Callahan 2014). This nar-
end, there have been some recent, excellent rative review approach was chosen because the
attempts in shaping and understanding this exist- aim of this chapter is to provide a broad perspec-
ing ambiguity (Värri 2020; Iyawa et al. 2016), tive and explore the general debates and develop-
and these would need to be maintained in the ments. A systematic review approach has been
future. At the very heart of this ambiguity in digi- used in other chapters because they focus on
tal health definitions lie the many different needs, unique and specific queries using explicit meth-
where it is anticipated that digitalization will odologies (Rother 2007).
improve health services across the board. The
World Health Organization (WHO) shares this
view, and considers digital health to be linked to 2 Differences
the general support of introducing and embolden- and Commonalities Between
ing universal healthcare systems globally. To this Needs in HICs and LMICs
end, the key objectives of digital health for the
WHO are: (i) the translation of existing and pro- One of the most pronounced differences in digital
duced datasets into action, contributing to health viewpoints is the one that exists between
decision-making; (ii) the use of digital technolo- High-Income Countries (HICs) and Low-and-
gies to enhance connectivity and information Middle Income Countries (LMICs). This book
transfer, including remote communication activi- provides a detailed example from both sides: a
ties and (iii) the systematic assessment of national HIC implementation and success story is shared
Digital Health: Needs, Trends, Applications 7
by authors from the Kingdom of Saudi Arabia in existing systems. However, in LMICs a large
and by Poland, where the former provides an portion of employment is in the informal sector;
example of a nearly completely integrated health- for example, in some areas of Kenya this can
care system, while the latter describes the signifi- amount to over 80% of the labour force (Were
cant strides and achievements in getting to this 2020). Thus, the market forces that will define
stage. They should be viewed as akin to maturity the context for healthcare digitalization are dis-
models (Wendler 2012) highlighting a path of tinctly different, and this would inevitably be
evolution for systematic development and reflected in the implementation pathways. The
improvement. What is common for these two next section will investigate some of those trends
mature examples is that they are using digital in digital health and innovation with a focus on
health as the engine for growth of the healthcare LMICs, thus setting the background for the sub-
reach and efficiency and are achieving healthcare sequent chapters that will provide a deeper
services as part of routine practice that would insight into specific contexts across the world.
have been difficult to imagine only a decade ago.
Thus, the view of digital health is both in terms of
individual services as well as of the wider health- 3 Trends in Digital Health,
care system. By contrast, while there is a good Trends in Digital Innovations
theoretical understanding of the wider digitaliza-
tion benefits in healthcare as a whole in many Ubiquity of digital environments: Digitalization
LMICs, most of the examples represent individ- has been increasing across all fields of human
ual institutional success stories, indicative of activity and the introduction of many new tech-
what can be further achieved, though not repre- nologies have led to the ‘datafication’ of many
senting a healthcare system developed in its routine public health/governmental activities,
entirety. including in healthcare, albeit with different
At this point it should be noted that digitaliza- intensities (Redden 2018). The increased pres-
tion need not follow the exact same path of emer- ence of digital environments, as well as increas-
gence in HICs and LMICs. The implementation ing experience in implementing digitization
of digital healthcare is highly context-driven programs, are likely to ensure a continued growth
(Gjestsen et al. 2017), needing to adapt to the for digitalization in healthcare in HICs and
user-base, available infrastructure, and political LMICs alike. At the same time, digitalization has
and regulatory frameworks. As such, LMICs resulted in an increasing overlap between the
should be expected to develop distinctly different production and consumption of data, e.g., patients
approaches in the digitalization of their health- are increasingly both creators and consumers of
care (Rossman et al. 2021; Surka et al. 2014). For healthcare data, highlighting the need for greater
example, in HICs, digitalization is dominated by accountability on data use, as well as a greater
the discussion on improving tertiary healthcare oversight of the ‘translation’ process, i.e., how
capacity (Al-Kahtani et al. 2022) and/or the con- this data is feeding into ongoing routine activities
solidation of existing services (Vandenberg et al. and decision making (Agostino et al. 2022).
2020), while in most LMICs, tertiary healthcare Fragmentation and lack of uniformity: The
is available to only a small section of the popula- possibility of data users to add their own com-
tion. In most LMICs, healthcare is provided by ments and perspectives in healthcare or even
primary healthcare centres, e.g., in Nigeria this physiological measurements via wearable
proportion is as high as 85% of the population devices has been viewed as a way of improving
(Ugo et al. 2016), as such the path to digitaliza- existing services (Minniti et al. 2016) if imple-
tion would be predictably different. Furthermore, mented well. However, this opening up of inter-
in HICs digitalization in healthcare is often action possibilities has not always been as
linked with insurance providers (Posselt and successful as originally anticipated. For example,
Kuhlmann 2020), with the potential to add value in many sub-Saharan African locations, such an
8 Z. Kozlakidis et al.
interaction was limited to existing vertical pro- data generation, to storage, dissemination and
grams, e.g., HIV surveillance, and required sub- use. Within LMICs, the development of data pro-
stantial educational input for staff to be effectively tection regulations remains an ongoing process
implemented (Kwame and Petrucka 2020). (Akintola and Akinpelu 2021; Vodosin et al.
Additionally, the increase of data production, 2021), with the COVID-19 pandemic having
means that a strict hierarchical data structure may acted as an accelerator in terms of the need of
not be adequate, as more horizontal platforms enacting such regulations (Hussein et al. 2023).
may be required, e.g., platforms where patients While the lack of relevant regulations might
and doctors would interact directly. This inevita- be one of the barriers to digitalization of health-
bly can lead to the (limited) decentralization of care in LMICs, the lack of financial incentives
information within healthcare systems, where presents a second, equally important, barrier.
local larger healthcare units would be intermedi- Digitalization in HICs was driven by a mix of pri-
ate holders of information/platform hosts, and vate companies investing in the creation of digital
then the data would be integrated at a higher level health solutions, coupled by governmental incen-
of structural hierarchy. tives (Abernethy et al. 2022). For example, the
However, the multiple sources of data produc- driving force for the nation-wide adoption of
tion, mean that there is a high heterogeneity EHRs in the US was the Health Information
inherent to the healthcare data, rendering the col- Technology for Economic and Clinical Health
lected big data less informative using current (HITECH) Act, enacted as part of the American
conventional technologies (Dash et al. 2019). Recovery and Reinvestment Act of 2009, incen-
Thus, the anticipation is that eventually the data tivizing the adoption of EHRs (Institute of
processing will be performed closer to the data Medicine (IOM) 2004). This substantial public
producers, utilising distributed technologies, and investment into the digitalization of healthcare
that a greater data harmonization will be imple- was justified on the grounds of improved patient
mented by the necessity of data interoperability safety, operational efficiency and quality of care
as well as the implementation of predictive (Institute of Medicine (IOM) 2010). Indeed, by
machine learning technologies (Dash et al. 2019). 2019, i.e., a decade after the enactment of the rel-
The need for data harmonization is not new (Liu evant legislation, approximately 86% of office-
et al. 2010; Zisis 2016), however the ever- based physicians and 96% of non-federal acute
increasing digitalization maintains this need at care hospitals had adopted certified EHRs (Health
the forefront. The implementation of Health IT Dashboard 2023). This represents the greatest
Level 7 (HL7) Fast Healthcare Interoperability adoption of digitalization in healthcare by data
Resource (FHIR) standard (Braunstein 2019) has volume ever recorded. At the same time, multiple
led to some uniformity allowing partial interop- studies have documented improvements in care
erability (Edoh 2020), although implementation quality (Atasoy et al. 2019; Buntin et al. 2011),
in LMICs remains highly fragmented and requir- however, caution should be exercised in attribut-
ing the adoption of LMIC-adapted implementa- ing the improvement of care quality to a singular
tion frameworks (Hussein et al. 2023; He et al. parameter such as EHRs adoption, as it is likely
2023). due to the confluence of a number of factors.
Lack of regulations, lack of incentives: The In LMICs, the introduction of financial incen-
complexity and heterogeneity of healthcare data, tives across the board is unlikely due to the many
as described above, generates expected questions competing financial pressures, however, incentiv-
regarding the data regulation. In HICs, well- ization programs have been successful within
defined data regulatory frameworks have been vertical sets of activities, e.g., physicians in
adopted, e.g., the General Data Protection Nigeria (Adedeji et al. 2022), CashAdvance
Regulation (GDPR) in the European Union schemes in Kenya for healthcare providers (de
(Voigt and Von dem Bussche 2017) that applies Wit et al. 2022), public health professionals dur-
across the entire data processing workflow, from ing COVID-19 in Indonesia (Aisyah et al. 2022a)
Digital Health: Needs, Trends, Applications 9
and others. As a result of the increasing digitali- focus on the scale of operations, the need to uti-
zation of healthcare in LMICs, new models have lise prototypes to empower adoption, to engage
been proposed for financial incentivization that social networks to affect diffusion, the interoper-
are more appropriate for resource-restricted set- ability of operations and the longer-term view
tings (Dohmen et al. 2022), including perspec- that diffusion affords the digitization process
tives akin to micro-finance initiatives, where (Mason 2015; Plum et al. 2020). There are cur-
individual patients/professionals can be rewarded rently many more studies published in the scien-
minimally for each completed digital interaction tific literature regarding point adoption of digital
(Faulkenberry et al. 2022). solutions than studies on diffusion, owing to the
Lack of infrastructure: The lack of infrastruc- fact that the latter require more time for investi-
ture is a consistent parameter of operating within gation, but also suggesting that diffusion occurs
LMICs, and equally for supporting digital health at a slower rate (Omotosho et al. 2019). Having
advancements (Chen et al. 2022; Nit et al. 2021), said that, the diffusion studies from rural India
although the digital infrastructures are growing (Haenssgen and Ariana 2017; Schierhout et al.
in many regions such as India, Vietnam (Winkie 2021), Cambodia (Nit et al. 2021), Kenya
and Nambudiri 2023), Indonesia (Aisyah et al. (Dohmen et al. 2022), and Nigeria (Adedeji et al.
2022b), Rwanda (Chen et al. 2022) and others. 2022), are informative in highlighting the need
The creation of digital infrastructure is not suffi- for context-driven implementations of digitaliza-
cient by itself, as digital literacy remains at low tion and provide examples of how such a nuanced
levels in many countries (Nit et al. 2021; El approach can be achieved in the field.
Benny et al. 2021). Hence the lack of infrastruc-
ture should not be regarded in isolation simply as
the need for capital investment on technologies, 5 Opportunities
but as part of the digital health environment
inclusive of digital literacy. Finally, it should be Taking the examples mentioned above into
noted that even when infrastructure is in place in account—and the fact that they represent only a
LMICs, it is often required to perform in different fraction of ongoing activities globally—it is clear
ways and/or environments to the one it was origi- that digitization of healthcare in LMICs is only at
nally created for. This need for ‘tropicalization’ the first stages of this process. There have been
of infrastructure, i.e., the adaptation of its perfor- many excellent reviews and books about the
mance to LMIC context is critical for the long- future opportunities that digitalization is likely to
term performance and impact of such investments confer on healthcare in general (Menvielle et al.
(Tran 2016; Coto-Solano 2020; Ombelet et al. 2017; McKee et al. 2019; Glauner et al. 2021),
2018). but few focus on LMICs specifically, as it is a
much more new and fragmented area and more
difficult to assess and predict (Tambo et al. 2016).
4 Applications in Healthcare: Therein also lie the many opportunities for the
Adoption Versus Diffusion creation of new digital innovations, defining new
pathways for implementation and impacting the
At this point it is important to make a point dif- population healthcare in ways that have remained
ferentiating between adoption and diffusion of nascent. The recent COVID-19 pandemic served
digitalization. While there is a partial overlap of as a proof-of-principle that digitization of health-
the factors that affect both, they do also contain care in LMICs, at least some aspects of it such as
distinct elements. Specifically, common elements surveillance and diagnostics, is indeed possible
include the availability of adequate training, poli- and can provide system-wide advantages to indi-
cies and procedures for end users, and financial vidual countries. Being able to link such initia-
incentives at a system level (O’Donnell et al. tives to the introduced universal health coverage
2018; Betmouni 2021). Differentiating factors services provides the added-value proposition of
10 Z. Kozlakidis et al.
a rich data resource that can be then used for data Adedeji T, Fraser H, Scott P (2022) Implementing elec-
mining and inform decision-making of policy- tronic health records in primary care using the theory
of change: Nigerian case study. JMIR Med Inform
makers and clinicians alike. 10(8):e33491
Agostino D, Saliterer I, Steccolini I (2022) Digitalization,
accounting and accountability: a literature review
and reflections on future research in public services.
6 Conclusion Financ Account Manag 38(2):152–176
Aisyah DN et al (2022a) The use of a health compliance
Digitalization of healthcare has gained momen- monitoring system during the COVID-19 pandemic
tum over the last two decades and the COVID-19 in Indonesia: evaluation study. JMIR Public Health
Surveill 8(11):e40089
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The Emergence and Growth
of Digital Health in Saudi Arabia:
A Success Story
The Ministry of Health (MOH) first launched with an increase in the growth rate of the elderly
its eHealth strategy in 2010 (Ministry of Health population (over the age of 60) of 3.2% to reach
Saudi Arabia 2018). Health in Saudi Arabia was 4.63 million by mid-2030 (Health Sector
revolutionized in 2016 with the introduction of Transformation Program 2021). This shift in the
the Saudi Vision 2030, a comprehensive plan for structure of the population is accompanied by an
economic and social development, including the increase in the burden of non-communicable dis-
launch of the National Transformation Program ease that requires high sub-specialized medical
(NTP) (Vision 2030 2016). In this plan, health- and surgical care (Alasiri and Mohammed 2022).
care was classified as a top priority, and a com- This will undoubtedly increase the demand for
mitment to adopt digital health technologies to long-term healthcare services capable of serving
improve healthcare delivery and outcomes was an aging population. The Health Transformation
issued (Vision 2030 2016; Nation Transformation Plan has considered the burden of non-
Program 2022). In 2018, the MOH launched its communicable diseases among several factors as
new Digital Health transformation plan, which core challenges and has worked to set priority
outlined a roadmap for adopting digital health initiatives to address them (Health Sector
technologies across the country. The strategy Transformation Program 2021). As a response,
aims to improve the overall healthcare quality. the MOH announced a reconstruction of the
The goal of this plan is to create a modern, effi- healthcare system. The MOH’s plans will not
cient, and integrated healthcare system that meets only focus on improving therapeutic and preven-
the population’s needs. Furthermore, the plan tive healthcare services, but it will also attempt to
seeks to improve access to healthcare, reduce reduce any created financial strains (Nation
costs, and improve patient outcomes (Ministry of Transformation Program 2022; Alotaibi et al.
Health Saudi Arabia 2018). Between 2019 and 2022; Ministry of Health Saudi Arabia 2023a).
2021, the COVID-19 pandemic caused the expe-
dited adoption of digital health technologies in
Saudi Arabia, leading to the expansion of digital 1.4 Overview of Saudi Arabia’s
health infrastructure and the introduction of Healthcare System
many population-level applications by the gov-
ernment (Alharbi et al. 2022; Unified National Healthcare services in Saudi Arabia are provided
Platform 2022; Butcher and Hussain 2022; through both the government and private health-
Ministry of Health Saudi Arabia 2023a, b) care providers. The leading governmental pro-
vider is the MOH, which provides a network of
hospitals and primary healthcare centers, distrib-
1.3 Overview of the Population uted throughout the country, representing over
Structure in Saudi Arabia 60% of healthcare services. The remaining 40%
are provided by other governmental healthcare
According to the General Authority for Statistics, providers, as well as private healthcare providers
the total population in Saudi Arabia was 34.1 (Young et al. 2021). The healthcare system in
million in 2021, with an expected increase of up Saudi Arabia is mainly governed by the MOH, as
to 39.4 million by 2030, in which males accounted they issue the strategies and policies that guide
for 56.8% of the total population (General health services throughout the country (Sebai
Authority for Statistic 2021). The Saudi citizens et al. 2001; Unified National Platform 2022). The
accounted for 63.6% of the total population, with MOH institutes healthcare as a right of the entire
non-Saudis accounting for 36.4% (General population, providing free healthcare for all
Authority for Statistics 2021). The country is Saudi citizens and non-Saudis working in the
witnessing an accelerated level of population
public sector (Mufti 2002). The MOH’s health
growth at an annual rate of 2.43%. A major services liability for the holy Mosques’’ pilgrims
demographic shift is predicted in the next decade, and visitors further distinguish the Saudi health-
16 N. AlWatban et al.
care system (Walston et al. 2008). Historically, (AI), and Blockchain technology (Health Sector
the expenses associated with healthcare were Transformation Program 2021). In the first quar-
solely financed by the Saudi government, taking ter of 2023, 26% of the country’s annual budget,
up 6–8% of the country’s annual budget (Ministry which accounts for $50,491 million, was dedi-
of Health Saudi Arabia 2023c). Financial burdens cated to the health and social development sector.
combined with population growth, encouraged This amount is actually an increase of 31% from
the Saudi Arabian government to move towards the previous year (Ministry of Finance Saudi
privatization (Rahman and Alsharqi 2019; Nation Arabia 2023). By improving access to care,
Transformation Program 2022). The first steps enhancing patient outcomes, and reducing the
were taken in 2003 when the Cooperative Health cost associated with traditional healthcare deliv-
Insurance recommended that mandatory ery models; these technologies work towards
employment- based health insurance should be addressing goals set by the digital health trans-
implemented (Alkhamis et al. 2014). formation plan (Ministry of Health Saudi Arabia
2018, 2023a). Nevertheless, effective integration
of these efforts into the healthcare system is still
1.5 Overview of the Digital Health developing, as discussed in the proceeding
Transformation Landscape sections.
One of the first digital health technologies to
Saudi Arabia’s digital health transformation plan be adopted worldwide was EHR (Evans 2016;
is committed to creating an ambitious goal of an Graber et al. 2017). Saudi Arabia started imple-
economically conscious and modernized health- menting EHR in the early 2000s to provide a
care system that meets the entire population’s digitalized alternative that allows quick access,
needs. The plan’s fundamental goals are to backup and recovery of patient data (Sebai et al.
improve access to care and patient outcomes, 2001; AlSadrah 2020).The MOH adopted an
increase efficiency, improve care quality, and EHR system (the Unified Health File) to improve
strengthen health information systems. To mobi- clinical performance, reduce errors in patient his-
lize these goals, the plan has built initiatives that tory records, and provide a national database of
expand Telemedicine services, introduce EHRs patient records (Ministry of Health Saudi Arabia
and develop a National Health Information 2023d). The use of EHRs improved patient care
Exchange (HIE) platform (Ministry of Health by equipping doctors to make more informed
Saudi Arabia 2018; Health Sector Transformation decisions based on accurate and real-time data
Program 2021). Additionally, the plan seeks to (Yousef et al. 2020). Studies conducted in Saudi
bridge the gap between public and private sector Arabia found healthcare providers to be knowl-
organizations to facilitate their communication edgeable of EHR systems (Hasanain et al. 2015;
and delivery coordination (Health Sector AlSadrah 2020; Otaybi et al. 2022; Alsahafi et al.
Transformation Program 2021). 2022; Alharbi 2023). Electronic Health records’
role in aiding and controlling noncommunicable
diseases has also been assessed and found to be a
2 Current State of Digital valuable tool (Hazazi and Wilson 2021). The use
Health in Saudi Arabia of EHR can be seen not only within MOH institu-
tions, but also in many of the medium-large pri-
2.1 Digital Health Solutions vate hospitals in Saudi Arabia (Aldosari 2014).
and Technologies in Saudi As indicated earlier, EHRs were developed to
Arabia preserve patients’ vital information, from basic
demographic data to details of medical diagnosis
Saudi Arabia has made significant investments in and management plans. Accessing those data
digital health infrastructure, enabling through online portals or mobile applications
Telemedicine, mobile health (mHealth) applica- represents the potential impact of patient engage-
tions, remote monitoring, Artificial Intelligence ment and improvement in healthcare delivery
The Emergence and Growth of Digital Health in Saudi Arabia: A Success Story 17
(Dendere et al. 2019; Lyles et al. 2020). A suc- addition to health information and other health
cessful initiative within the Saudi digital health services offered to the public (Ministry of Health
transformation plan is the implementation of Saudi Arabia 2023e). Governmental and private
patient portals. Patient portals are a service hospitals, in addition to Telehealth startup Cura
offered by many healthcare institutions, both pri- have also adopted Telemedicine platforms,
vate and government, to empower patients to including Telepharmacy services (Cura 2023;
become active stakeholders regarding their KFSHRC 2023b; Ministry of National Guard
health. Patient Portals are secure platforms that Health Affairs 2023; Dr.Sulaiman Alhabib
provide the patient’s access to health-related Medical group 2023). Similarly, hospitals have
information. They also provide open channels implemented Telepharmacy services that provide
that allow patients to communicate with their remote prescription, medication management
healthcare provider. The potential benefit of the and home-delivery of prescriptions (Algarni et al.
patient portal relay on improving the quality of 2022). Furthermore, physicians are able to pre-
health services provided and facilitating the work scribe medication remotely using the Wasfaty or
of health practitioners and improving healthcare Anat applications. The Wasfaty application
delivery (Lyles et al. 2020; Yousef 2021; serves as a gateway between the patient and a
KFSHRC 2023a; Ministry of National Guard network of pharmacies both governmental and
Health Affairs 2023). Positive results reported private, enabling them to fill prescriptions or
from studies indicated enhancement of preventa- refill regular medications (Wasfaty 2021;
tive behaviors and management of chronic condi- Ministry of Health Saudi Arabia 2023f). While
tions through those portals (Hazazi and Wilson the Anat app is a platform designed for health
2021). In addition, evidence has shown that practitioners, it offers services that make their job
patient portal use in the primary care setting has easier and improve the quality of care provided to
enhanced patient engagement, improved commu- patients such as e-prescriptions (Ministry of
nication, and cut costs (Amante et al. 2014; Health Saudi Arabia 2015, 2023f).
Hazazi and Wilson 2021). The next step is to In several nations, mHealth applications are
progress to the Unified Health File system aimed becoming an increasingly significant instrument
at preserving all patient information and elimi- for the delivery of healthcare (Consolvo et al.
nating duplication of patient’s data throughout 2008). mHealth aims to improve healthcare prac-
various healthcare organizations (Young et al. titioners’ outreach by overcoming distance, time
2021; Ministry of Health Saudi Arabia 2023d). zones, and cost barriers to deliver accessible and
Telemedicine entails utilizing digital commu- low-cost therapeutic services (Vaghefi and Tulu
nication as well as technology in diagnosis, eval- 2019). The MOH introduced several mHealth
uation, and medical assessment by facilitating the applications, such as Mawid, to improve the
interaction between patients and their healthcare patient experience. Mawid is a free smartphone
providers (Ministry of Health Saudi Arabia application that allows users to book, cancel, and/
2022a). Telemedicine is a part of the countries’ or reschedule appointments at primary care clin-
digital health strategy (Ministry of Health Saudi ics, as well as manage referral appointments to
Arabia 2018). The COVID-19 pandemic required general and specialized hospitals (Alanzi et al.
a contact-free solution, which drove the world 2022; Ministry of Health. E-Services) eReferrals
towards Telehealth (Keesara et al. 2020; Omboni were shown to be effective in lowering wait
et al. 2022). Saudi Arabia embraced the use of times, enhancing access to secondary care, and
Telemedicine through the adoption of the Sehhaty improving referral patients’ information accu-
application to face the demands of the growing racy (Tian 2011). During COVID-19 Mawid
population (Alharbi et al. 2021). Sehhaty is an helped the users determine the risk of COVID-19
MOH developed unified platform that offers mul- contamination by encouraging them to submit
tiple health services. It encompasses the delivery their symptoms and travel information into the
of Telemedicine, health monitoring services, application for the risk assessment test. It also
booking of appointments and vaccinations, in assists users in raising awareness about
18 N. AlWatban et al.
COVID- 19 and provides preventative instruc- (Alanzi et al. 2014, 2016). To date, no clinical
tions to be followed (Alanzi et al. 2022). trial demonstrating the efficiency of these meth-
As the Saudi Arabian government is keen on ods for diabetes treatment in the Kingdom has
protecting the health and safety of its citizens and been published. An application referred to as
residents from the risk of the spread of novel “SAED” was evaluated in a pilot study by
coronaviruses, the Saudi Data and Artificial Alotaibi et al. (2016). The SAED application was
Intelligence Authority (SDAIA) developed the found to positively influence the innervation
Tawakkalna application to aid government efforts group by significantly decreasing HbA1c levels
to combat COVID-19 (Dawood and AlKadi and enhancing diabetes awareness (Alotaibi et al.
2023). The Tawakkalna application was devel- 2016). This application is used for diabetes moni-
oped in collaboration with the MOH and all rel- toring, a helpful tool in improving the diabetes
evant authorities during the curfew period to care of Saudi patients. The SAED application can
facilitate the electronic issuance of movement also give healthcare professionals vital medical
permits for government and private sector information about each patient. Easing the pro-
employees, as well as any individual, assisting in cess of decision-making in their diabetic treat-
containing the spread of the pandemic in the ment plan. Incorporating an instructional tool can
Kingdom (Binkheder et al. 2021b; Dawood and give diabetic patients pertinent information for
AlKadi 2023). As we return to regular life, better diabetes control. This is especially crucial
Tawakkalna continues to assist in’ displaying in distant areas of Saudi Arabia, where healthcare
users’ health status and other services. In addi- facilities are still poor and lack specialized diabe-
tion, as part of encouraging social responsibility, tes care. Adopting such an application will ensure
Tawakkalna allows individuals to report breaches appropriate medical intervention and treatment
to the MOH in the event of a suspected case can be provided (Alotaibi et al. 2016).
(Saudi Data and AI Authority 2023). Like the rest of the world, wearable health
Saudi Arabia has been a pioneer in the use of monitoring technologies in Saudi Arabia are
remote monitoring technology to enhance patient increasingly being used. Smart watches or wrist-
outcomes. For example, the remote monitoring of bands can track a variety of physiological charac-
chronic diseases such as diabetes and hyperten- teristics and wirelessly transmit data to
sion allows for the promotion of daily treatment smartphones (Torres-Huitzil and Alvarez-
and lowers the risk of hospitalization (Alanzi Landero 2015; Yeh 2016). Wearable devices are
2018; Alessa et al. 2021). The use of smartphone used to monitor and collect information on peo-
applications to help with hypertension self- ple's health issues, such as glucose levels, blood
management is becoming increasingly common. pressure and heart rate (Vijayashree and Sultana
However, few commercially available applica- 2018). While wearable devices have become a
tions have the potential to be useful and have world norm, Saudi Arabia has also joined in the
acceptable security and privacy measures in development of wearable sensors due to the
place. A recent study in Saudi showed that com- growing demand from health consumers. For
mercial application use for self-management of example, a real-time pilgrim tracking and health
hypertension is effective, usable and acceptable monitoring system was utilized using Arduino.
by patients (Alessa et al. 2021). Diabetes mellitus Each pilgrim is given a wearable sensor that
is one of the chronic health conditions that can detects their location and primary health infor-
benefit from self-management education utiliz- mation. This sensor is linked to the control room
ing mHealth applications. A Little research has to take fast action in case an alarm is received
been undertaken in Saudi Arabia to explore the from the device (Rajwade and Gawali 2016).
efficiency of mobile technologies in diabetes Also, a wearable personalized medicinal plat-
management. Nevertheless, studies on the use of form has been developed, where a wearable
mobile applications for disease management and device can dispense medication and vitamins at
healthcare delivery have shown positive results varying doses depending on the individual needs
The Emergence and Growth of Digital Health in Saudi Arabia: A Success Story 19
(KAUST Innovation 2016). Another example is the patient and facilitate the treatment of ADHD
Qawam, a headwear addition capable of monitor- patients. Although this model has been imple-
ing posture. The goal is to prevent neck and back mented and has shown efficacy in a single patient.
pain that results from incorrect posture during The comparison of the AR-therapist to traditional
computer and smartphone usage (Qawam 2021). CBT for the treatment of ADHD still needs to be
In various medical professions, Virtual Reality evaluated with a cohort of human subjects
(VR) has been utilized to improve health out- (Alqithami et al. 2019).
comes (Alanazi 2022; Bayahya 2021; Bruno Another important development in the field of
2022). Further, VR in education and training digital health is the growing interest in Artificial
allows medical students to virtually enter the Intelligence (AI). Although AI implementations
human body to gain a comprehensive under- in healthcare started as early as the 1950s, the full
standing while simulating real-life therapies potential has only been witnessed in the past two
(Eddy 2021; Dhar et al. 2023). Employing VR in decades, with the advancements in machine
medical education allows students to train in a learning and language/image recognition algo-
simulated scenario for comprehensive surgical rithms (Kaul et al. 2020; Roser 2022).With the
education at a significantly lower cost. In Saudi COVID-19 pandemic quickly straining health-
Arabia, the application of VR versus conven- care services early in 2020, the Saudi Arabian
tional methods in teaching has shown promising government, led by SDAIA, utilized the use of AI
results in undergraduate medical education to face the growing demands of the healthcare
(Sultan et al. 2019). Augmented reality (AR) is sector.
also being used to give students hands-on learn- Artificial intelligence can also be used as a
ing experiences, such as simulating patient and ‘Phenotype tool’ assisting in a preventive
surgical encounters, so that medical interns can approach style of healthcare, commonly used in
practice emerging techniques (Bhugaonkar et al. the field of public health. Using predictive analyt-
2022). A study evaluated the efficacy of AR ics can help identify patients at a higher risk of
among patients undergoing orthodontic treat- developing chronic diseases such as diabetes
ments in Saudi Arabia. Patients who underwent (Alshammari et al. 2021a, b). By also examining
education through AR displayed higher levels of patient long-term information, such as medical
knowledge retention of oral hygiene instructions history, lifestyle habits, and genetic information,
than patients who received information from leaf- AI algorithms can analyze this and determine
lets (Aljabry et al. 2023). which patients may develop a particular disease
In Saudi Arabia, VR and AR have also been (Alshammari et al. 2021a, b). These preventive
utilized in settings related to clinical psychology. approaches can assist healthcare decision-makers
A randomized control trial in Najran, a city in identifying tools for early intervention, leading
southwestern of Saudi Arabia examined the effect to a healthier population and reduced healthcare
of applying VR for patients undergoing cesarean costs. However, AI implementations still have a
sections. It found that use of VR glasses channel- long way to go, and Saudi Arabia recognizes the
ing 3D natural videos with sounds such as Quran potential of AI and the role it will have in the
(the holy book of Islam) or soft music during healthcare sector (National Strategy for Data &
anesthesia resulted in a reduction of stress and AI 2020). In particular, the advancements in
anxiety levels among patients undergoing cesar- diagnosing various diseases, including cancer,
ean sections (Almedhesh et al. 2022). Others diabetes and cardiovascular disease (Jiang et al.
have proposed the use of AR as an alternative to 2017). During the Riyadh Digital Health Summit
Cognitive Behavioral Therapy (CBT) in patients (2022), a panel of 13 key experts identified 7 pri-
with attention deficit hyperactivity disorder orities recommended for adoption in order to face
(ADHD) through the design of an AR-therapist future pandemics. Artificial intelligence landed
(Alqithami et al. 2019). The AR-therapist incor- third on this list, indicating the potential it pos-
porates gaming and utilization of AR to engage sesses (Al Knawy et al. 2020).
20 N. AlWatban et al.
2.2 Assessment of the Level patients and the electronic literacy of healthcare
of Digital Health Adoption providers are considered the main factors that
and Awareness potentially influence the adoption and awareness
of digital health (Alodhayani et al. 2021).
Early research indicated a low percentage However, there is still insufficient data on the
(approximately 30%) of use of digital health level of awareness of the implementation of digi-
among healthcare organizations and negative tal health for both healthcare providers and
attitudes from the healthcare workers relating to patients. This can be attributed to the context and
health information security and lack of sufficient setting of those studies (Alodhayani et al. 2021;
training in using digital health applications AlSalloum et al. 2023). A recent study examined
(El-Mahalli et al. 2012; Albarrak et al. 2021). patients’ awareness and satisfaction with four
However, recently the perception and belief about main MOH e-services (Seha, Moed, 937 Services,
the benefit of digital health implementation in a and Wasfati.). The study reported that 77% of
practical setting have changed (Thapa et al. participants were aware of such services where
2021). Many reports indicated that digital health the demographic characteristics and level of edu-
in Saudi Arabia is evolving steadily due to many cation played key roles in the awareness of
factors including, but not limited to good network e-health.
infrastructure across the country, a high percent-
age of internet users among the population that
reached 98% in 2021, the launch of health infor- 2.3 Measuring the Digital Health
mation system in numerous governmental hospi- Implementation in Saudi
tals since the early 2000s, (Shouli and Mechael Arabia
2019; World Bank 2021; Al-Kahtani et al. 2022a).
This has been evident during the COVID-19 pan- The advancements in digital health development
demic, emphasizing the importance of digital and implementation necessitates a comprehen-
health as an indispensable resource for patient sive evaluation for their effectiveness and long-
care (Alghamdi et al. 2021). For example, term impact on population health outcomes
Telemedicine emerged in some of the healthcare (WHO 2021). Understanding the healthcare
settings prior to the pandemic, but the adoption of landscape and the population’s needs is the first
Telemedicine has been moved forward during the step in evaluating and implementing digital
pandemic with improvement in healthcare pro- health technologies (Soobiah et al. 2020). Some
viders and patients’ awareness, and willingness studies indicated that the digital health efforts
to use such resources (Omboni et al. 2022). within the Saudi healthcare system have been
Similar observations have been reported in many efficient in reducing time, cost, and efforts of the
health-related fields, including medical students, healthcare providers to provide care (Otaibi
pharmacists, and the dental profession (Alsahali 2019). However, the available literature that
2021; Chaudhary et al. 2022; Al-Kahtani et al. discussed a framework for monitoring and evalu-
2022a). ating digital health implementation and progress
The available literature assessing the level of is lacking. Some of those studies were formative
digital health adoption and awareness highlighted evaluations, which assesses the readiness for dig-
the importance of providing proper training to ital health transformation at different hospitals.
healthcare workers and education to the general Other studies evaluated the effectiveness of spe-
population (Al-Kahtani et al. 2022b). Many qual- cific eHealth applications (Alharbi et al. 2021;
itative studies highlighted the issue of under- Al-Kahtani et al. 2022a). For example, one study
standing the cultural perspective in terms of examined the effectiveness of the Seha, an
application of and adoption of health technolo- eHealth app, in improving healthcare delivery
gies. Based on a qualitative study, cultural factors and efficiency and indicated that adopting digital
such as the language and communication of or eHealth technologies would address some of
22 N. AlWatban et al.
the problems in the health system related to low Digital Health Index (GDHI). This measure
patients’ satisfaction and limited resources assessed components of advancement in digital
(Alharbi et al. 2021). healthcare such as leadership and governance;
In 2013, the World Health Organization strategy and investment; legislation policy and
(WHO) issued a global strategy on digital health compliance; workforce, standards and interoper-
that calls for developing and maintaining digital ability, and infrastructure services and applica-
health infrastructure. And since 2015, the MOH tions (Global Digital Health Monitor 2023).
has made remarkable progress in implementation Currently, the GDHI in Saudi Arabia reached a
of digital health; however, the status of the digital maximum maturity (phase 5), an improvement
health implementation has not been unified by from previous years where it was placed at the
providers across the country (Alharbi 2018). In phase 4 level of maturity (Al Shouli and Mechael
an effort to highlight the importance of digital 2019; Global Digital Health Monitor 2023).
technology for the global health and care system, These improvements are attributed to govern-
the Riyadh Declaration on Digital Health in 2020 ment and private sector collaborations to promote
was formulated. This landmark forum empha- and embrace digital health technologies. The suc-
sizes the role of digital and data technologies in cess and sustainability of digital health in Saudi
promoting local and global resilient healthcare are also reliant on an influx of investment, sup-
systems through the articulation of seven key pri- port, and continued cooperation (Ministry of
orities and nine recommendations for data and Health Saudi Arabia 2018).
digital health (Al Knawy et al. 2020). The fact
that Saudi Arabia hosted this forum is a showcase
that the country is taking leading steps and a 3.2 Overview of the Key
prominent position in the realm of digital health. Stakeholders in Saudi Arabia
Still, further research with appropriate measures
and high-quality data on the evaluation of digital To ensure that the goals of the digital health
health efforts and outcomes and their impact is transformation plan are met, all stakeholders
essential to support the implementation of further should be involved in its implementation process.
digital technologies. In addition, evaluations are Encouragement of innovation and intersectoral
expected to provide justification to further pro- collaborations is a priority in the Kingdom
mote investment in the field (Al Knawy et al. (Ministry of Health Saudi Arabia 2018). This
2020; WHO 2021). section will highlight some of the key stakehold-
ers in digital health in the Kingdom. This
includes; patients and providers, regulatory
3 Digital Health Ecosystem bodies, academic and research institutes and
in Saudi Arabia other governmental initiatives. This section will
outline their roles and contributions to develop-
3.1 Overview of the Digital Health ing the digital health arena.
Ecosystem in Saudi Arabia The experience of a patient with digital health
in Saudi Arabia is now further enhanced by the
A digital health ecosystem is a health-centered changes in healthcare reform (Ministry of Health
environment that encompasses all individuals, Saudi Arabia, Digital Health Strategy 2018). The
governmental and private entities, innovations, patient’s acceptance and proper utilization of
technologies, data and resources, key players these solutions are vital for better health out-
necessary to advance the digital health program comes (Lupton 2014). This is why user-centered
(WHO 2021). The digital health ecosystem in designs have been adopted (Calvillo-Arbizu et al.
Saudi Arabia is an evolving and developing 2019). The national strategy places the health
sphere. The maturity of digital health in the consumer at the center of the health model.
Kingdom has been captured through Global Focusing on patient-centered care, which
The Emergence and Growth of Digital Health in Saudi Arabia: A Success Story 23
includes patient involvement in the decision- entities that align their efforts to achieve national
making process for improving their health out- goals within the Kingdom towards Vision 2030
come (Amin et al. 2020; Alotaibi et al. 2022). targets and initiatives.
The healthcare provider also plays a critical Digital health care services are also regulated
role in digital health adoption (Petersen et al. by the Saudi Health Council (SHC) (Saudi Health
2015). As the primary users of digital health tech- Council 2023).The SHC’s role, among other
nologies, healthcare providers are responsible for things, is to ensure enhancement of healthcare
the successful implementation and adoption of services between different stakeholders. It acts as
these technologies (Petersen et al. 2015). Primary a liaison that properly bridges the different enti-
healthcare providers in Saudi Arabia comprehend ties together allowing proper collaboration to
the benefits of EHR, which include; the effi- take place without any duplication of efforts
ciency, the accuracy of documentation, and the (Saudi Health Council 2023). Another regulator
availability of information when it is required is the Council of Health Insurance (CHI) previ-
(Hazazi and Wilson 2021). The government also ously known as Cooperative Health Insurance.
supports their education and advocates to increase The CHI is concerned with insurance companies
their knowledge in digital heath (Hassounah et al. and service providers. Their mission is to advance
2020). the health outcome of beneficiaries by enabling
The MOH manages and regulates digital the use of transparency and equity value-based
healthcare services in the Kingdom, it oversees care among stakeholders (Invest Saudi 2017;
the healthcare industry and formulates regula- Council of Health Insurance 2023). In addition,
tions governing both the public and the private the SFDA is responsible not only for drug and
health sector (Ministry of Health Saudi Arabia food regulation but also for regulations con-
2018; Al-Kahtani et al. 2022b; Alqahtani et al. cerned with medical devices. For example, the
2022). The MOH’s efforts are outlined as the SFDA ensures necessary guidelines are present
National Standards for eHealth in the Kingdom, for medical devices marketing authorization for
which is the roadmap for the digital health trans- AI and machine learning. A crucial step that will
formation plan (Ministry of Health Saudi Arabia facilitate adoption of medical devices into the
2018). In addition, the MOH sets the necessary Saudi market (Invest Saudi 2017; Saudi Food and
guidelines for data sharing, privacy, and it over- Drug Authority 2022).
looks all ongoing digital health initiatives in the The growth and development of the digital
country (Digital Government Authority 2023a). health profession in the country is also a priority.
An example of the MOH’s regulation of digital Although research and development in the field
health services is its governance of the interoper- is fostered at multiple universities in the
ability of e-prescriptions (Ministry of Health Kingdom, these efforts only started in the 2000s
Saudi Arabia 2015). Another regulatory body (Al-dossary et al. 2021). There are 16 identified
involved in digital healthcare services is the Universities that offer degrees in a variety of
Saudi Data & Artificial Intelligence Authority programs in Health Information Management,
(SDAIA). The SDAIA was established in August spread out at different geographical locations in
2019, by a Royal Decree aiming to facilitate the the Kingdom. The majority (10) are public pro-
transition in achieving Vision 2030’s goals. grams, and the rest are private programs
SDAIA’s responsibilities lie in advancing the (Al-dossary et al. 2021). All 16 Universities
data and AI agenda (Memish et al. 2021). Global offer bachelor’s degrees in health informatics.
investment in the health sector is seeked out and However, only five provide a master’s degree.
regulated by the Ministry of Investment Saudi The earliest program started around 2003, at the
Arabia (MISA),formerly known as the Saudi Imam Abdulrahman bin Faisal University
Arabian General Investment Authority (SAGIA) (Al-dossary et al. 2021). Most of these
(Ministry of Investment Saudi Arabia 2023). The Universities have a set pathway to pursue a
MOH, SDAIA and MISA are all governmental Doctor of Philosophy (PhD) scholarship oppor-
24 N. AlWatban et al.
tunities in Health Informatics supported by the in the developmental process of digital health
Ministry of Education (MOE). This will ensure technologies or eGovernment services can help
further research and development in the field increase adoption within young and adult popula-
(KSAU-HS 2023). Furthermore, the Saudi tions (Alanezi et al. 2012; Calvillo-Arbizu et al.
Commission for Health Specialties guarantee 2019; Khan and Lutfi 2021). The eGovernment
proper classification and registration of these services can only be considered for adoption
scholars and provides opportunities for further when the quality is up to the consumers ‘standard
professional development (Invest Saudi 2017). (Choudrie and Alfalah 2016).
The Saudi Association for Health Informatics Health providers in Saudi Arabia have
(SAHI) aims to improve efforts for further devel- expressed digital literacy (Hasanain et al. 2015).
opment by promoting research and engaging pro- In spite of all offered support, providers lack reli-
fessionals in conferences, exhibitions, and able infrastructure, resources, and training act as
networking opportunities (Saudi Association for major challenges in digital health adoption
Health Informatics 2023). In 2018, The Misk (Alshahrani et al. 2019). Satisfaction and
digital health accelerator program was launched improvement in their experience with digital
to support startups and entrepreneurs in the digi- health technologies became evident after the
tal health sector, through mentorship, fundrais- COVID-19 pandemic (Alsaleh et al. 2021). The
ing, and networking (Misk 2022). The NHIC also COVID-19 pandemic has provided a push to help
works to advance the field of health informatics accelerate this digital transformation (Alharbi
through the introduction of initiatives (Public et al. 2022; Alkhalifah et al. 2022). For this rea-
consultation Platform 2022) In addition, the son, the rush of digital health technologies into
Saudi Electronic University (SEU) has recently the Saudi Market was accompanied by numerous
collaborated with the MOH. This collaboration tactics to empower and educate the health con-
offered professionals in the field access to black- sumer (Hassounah et al. 2020). The MOH sched-
board licenses from SEU to be utilized for train- uled live television broadcasts of the official
ing purposes. Ultimately, this collaboration is spokesperson presenting up-to-date information
expected to build capabilities and strengthen daily. The MOH also utilized its social media
online health practices among professionals platforms, Twitter in particular, to support this
(Saudi Electronic University 2022). goal. In addition, it collaborated with a number of
health entities to establish the Prevention
Ambassador Initiative web-based course, to
3.3 Analysis of the Key Players address health rumors on social media platforms
in the Ecosystem (Saudi Press Agency 2020; Hassounah et al.
2020) . Other efforts included the provision of
In Saudi Arabia, family ties and values are very new laws by the Saudi Public Prosecution for
important (Al-Khraif et al. 2020).The patients’ sharing misleading or inaccurate electronic infor-
caregivers or family members’ role as a stake- mation (Riyadh Daily 2020).
holder cannot be overlooked, as family members The digital health market has witnessed rapid
are usually in charge of supporting elders growth that requires the personal data protection
(Al-Khraif et al. 2020; Petersen et al. 2015). law (PDPL) to oversee privacy policies and pro-
Elders usually seek help from a family member cedures. Accordingly, SDAIA and National Data
when accessing information from the mobile Management Office (NDMO) released guide-
internet (Xiong and Zuo 2019). Digital literacy, lines and rules for Personal Information
level of education, as well as necessity for tech- Protection and Sharing of Data (National Data
nology access, are aspects that dictate if older Management Office 2020; Digital Government
adults actually adopt certain technologies (Neves Authority 2023b). The main objective of this law
and Amaro 2012). Usage of user-centric designs is to govern the process by which digital technol-
The Emergence and Growth of Digital Health in Saudi Arabia: A Success Story 25
ogy is utilized in healthcare while maintaining between patients and healthcare providers, pro-
the necessity of protecting the privacy and secu- viding personalized treatment plans based on
rity of personal information. (Digital Government individual needs and preferences, as well as
Authority 2023b). increasing access to quality care for underserved
The maturation in protection laws allowed populations (Kuwabara et al. 2019; Haleem et al.
MISA to open the doors for local and interna- 2021), moving away from silos and towards a
tional investments (Unified National Platform greater integration of the healthcare ecosystem.
2023). To add to the appeal of investing in Saudi’s The Health Sector Transformation Program
HealthCare and Life Sciences (HCLS) sector, (Ministry of Health Saudi Arabia 2018) identified
MISA has granted foreigners 100% ownership of a number of challenges that can be addressed
their investments (Ministry of Investment Saudi through digital health implementations. Concerns
Arabia 2021).This has lead to the direct invest- such as premature death, an accelerated level of
ment of foreign companies such as Roche in population growth, the burden of non-
Saudi’s HCLS sector with the aim of unlocking communicable disease (mainly diabetes) as well
investment opportunities including digital health as the burden from road traffic injuries are all
solutions (Ministry of Investment Saudi Arabia areas that need immediate interventions to
2021). Additionally, the MOH has signed improve the quality of health services currently
Memorandums of Understanding (MoUs) with provided.
international as well as local companies to sup- Other challenges that face the healthcare sec-
port the National Transformation Plan for the tor include lack of awareness among stakehold-
healthcare sector. An example of an international ers, privacy concerns, cultural factors, regulatory
collaboration is the MoU with General Electric challenges, and cost considerations (Al-Jumaili
(GE) to provide digital health solutions to the et al. 2015; Alnemary et al. 2017; Ministry of
Kingdom (GE 2018). Locally, an MoU with Inma Health Saudi Arabia 2018; Alkhateeb and
to provide and implement Telesurgury services Alhadidi 2018; Almubark et al. 2019; Alnaim
(Alturki Holding 2022). The advancement of the 2019; Alakhali 2020; Alodhayani et al. 2021;
digital health strategy also includes partnership Alsahafi et al. 2022; Alahmadi 2023). The some-
and MoUs between private companies such as what overlapping roles of the regulatory bodies
cloud solution and Dell technologies to provide and the health or financial service providers may
technology solutions for the health care sector lead to a conflict of interests. Thus, inconsisten-
(Cloud Solutions 2021). cies in primary and specialized healthcare, reha-
bilitation, long-term, and home care services, and
patient care may affect the quality of treatment
4 Future Outlook plans monitoring of patient’s outcomes (Vision
and Opportunities 2030 2016; Khan and Iqbal 2020; Nation
Transformation Program 2022). Furthermore,
4.1 Discussion of the Challenges there is a lack of robust, consistent, and inte-
of Digital Health Solutions grated digital information systems across all hos-
in Saudi Arabia pitals, which could enable better resource
management, activity levels, product quality, and
Digital health implementation in Saudi Arabia performance (Health Sector Transformation
can provide sustainable solutions and improve Program 2021).
access to healthcare with higher levels of con- With an increasing population, including a
sumer satisfaction. Moreover, it offers many growing elderly population, and a considerable
other benefits in improving patient health out- number of expatriates and international visitors,
comes. This is evident through streamlining the the healthcare system must modernize its
delivery of care, improving communication approaches in order to meet growing demands
26 N. AlWatban et al.
(Vision 2030 2016). It should be noted that this tial for misinformation (Al-Jumaili et al. 2015;
challenge has been identified and been taken into Alnemary et al. 2017; Alkhateeb and Alhadidi
consideration within the health sector transfor- 2018; Almubark et al. 2019; Alnaim 2019;
mation program initiatives. Adding to this, many Alakhali 2020; Alahmadi 2023).
of the initiatives within this program set outcome Overall, the implementation of digital health
evaluation to follow up the projects with defined provides sustainable solutions (Thapa et al.
performance indicators, especially those initia- 2021). It improves patient outcomes by stream-
tives that related to improved performance of lining the delivery of care, improves communica-
MoH hospitals and medical centers (Health tion between patients and healthcare providers,
Sector Transformation Program 2021). provides personalized treatment plans based on
Furthermore, Saudi Arabia is the custodian to the individual needs and preferences, as well as
two holy mosques attracting more than seven increases access to quality care for underserved
million Umrah visitors during 2022, including populations (Kuwabara et al. 2019; Haleem et al.
four million worshipers with Umrah visas 2021; Alodhayani et al. 2021; Alsahafi et al.
(Alarabiya 2023). Ensuring their safety and dis- 2022).
ease control is an ongoing challenge facing the Adding to this, the duplication of health ser-
healthcare system. vice provision and financing for the same benefi-
Acknowledgement of these challenges ciary, which results in unjustified variance,
requires collaboration between government overuse, and underuse, leading to efficiency
agencies, healthcare providers, technology com- shortfalls (Trinh et al. 2008). Another identified
panies, and other stakeholders to ensure that the challenge is related to the presence of a gap
population benefit from these transformative between supply and demand in the health work-
technologies and that the right capabilities are force that has led to an increased dependence on
being built (Al-Kahtani et al. 2022b). Challenges foreign labor. Furthermore, there is a lack of
are prioritized according to national goals and robust, consistent, and integrated digital informa-
population needs (Alshuwaikhat and Mohammed tion systems across all hospitals, which could
2017). enable better resource management, activity lev-
Another trending issue is the health literacy els, product quality, and performance (Health
level among the Saudi population, with 46% con- Sector Transformation Program 2021). Finally,
sidered health illiterate (Alahmadi 2023). there is a need to strengthen governance systems
Although access to health information is avail- that contribute to reducing challenges to the
able, the amount, accuracy, quality, and reliabil- health of the population and the quality of health
ity of it might not be suitable (Alsahafi et al. services provided (Ministry of Health Saudi
2022), resulting in a misinformed, confused and Arabia 2018; Chowdhury et al. 2021).
often overwhelmed health consumer. The wide
access to social media networks among a gener-
ally tech-savvy younger population has led to 4.2 Discussion of the Future
another more trending concern facing health con- Opportunities for Growth
sumers which is the spread of misinformation of Digital Health in Saudi
(Infodemic) on the Internet. Misleading informa- Arabia
tion on digital platforms can negatively impact
population health, spreading anxiety and fear The Saudi government’s commitment to digital
which leads to health consumers adopting transformation is evident. Through strategic pro-
unhealthy behaviors (Pian et al. 2021). grams such as the NTP, the government can act as
Furthermore, the internet contains an immense a catalyst furthering the adoption of digital health
amount of health information. However, the strategies and initiatives (Vision 2030 2016;
majority of it is in English, not Arabic, the main Health Sector Transformation Program 2021).
language in Saudi, thus compounding the poten- The government is also committed to providing
The Emergence and Growth of Digital Health in Saudi Arabia: A Success Story 27
the right infrastructure for a prosperous digital Opportunities persist given the current defi-
health environment (Health Sector Transforma- ciency of published literature surrounding digi-
tion Program 2021). In 2021, the internet pene- tal health. The government recognizes the need
tration rate in Saudi Arabia increased to 98.1% to connect research with national development,
compared to 95.7% in 2019 (Communication, especially with fields that support national pro-
Space & Technology Commission 2021). Resi- grams such as health informatics. In order to
dents in Saudi Arabia are now offered high speed understand existing publications Binkheder,
coverage from mobile networks, which consists Aldekhyyel and Almulhem (2021a) assessed
of 4G and 5G coverage capabilities with wireless the health informatics publication trends in
and fiber optic connectivity (Aldiab et al. 2022). Saudi Arabia between 1995 and 2019. The
The trust in digital solutions amplified with the authors found that most of the published litera-
adoption of health applications, such as Sehhaty, ture discusses clinical informatics (73.1%), and
Tawakkalna applications, during the COVID-19 the rest covered consumer health informatics
pandemic. The growing interest of citizen adop- (22.3%) and 4% only covered public health
tion and usage of e-services can have a ripple informatics (Binkheder et al. 2021a). This
effect towards the development and innovation in emphasizes the opportunities that lie within
more digital health technologies. Future opportu- furthering research and development in these
nities lie in Saudi Arabia, given how it is becom- fields.
ing a market that capitalizes on investing in In a global survey, Saudi Arabia was ranked
digital health solutions. This is evident through second when answering “whether artificial intel-
the Vision 2030 Privatization Program (launched ligence products and services will make the lives
2018) which aims to improve the quality of ser- of respondents easier.” Fully aware of the poten-
vices in 16 sectors within the country, including tial opportunities that lie within AI, SDAIA
the health sector (Vision 2030 2022). launched the National Strategy for Data and AI, a
Furthermore, future opportunities in Saudi long-term plan aimed at implementing AI in five
Arabia are also associated with the growing pop- sectors in the country, including education, gov-
ulation of digital natives. Based on the total pop- ernment, healthcare, energy, and mobility
ulation estimation in 2021, more than 30% are (National Strategy for Data & AI 2020). In order
between the ages of 15–35 years (General to facilitate the implementation of the strategy
Authority for Statistic 2021). This age group is across the government entities four subsidiaries
comfortably utilizing and navigating digital tech- were created under SDAIA: the National
nologies, further enabling transformation of digi- Information Center (NIC), the National Data
tal health and its development (Communication, Management Office (NDMO), and the National
Space & Technology Commission 2021). Center for Artificial Intelligence (NCAI)
Capitalizing on this age group by educating and (National Strategy for Data & AI 2020).
building their capabilities will help close the digi- According to the strategy, integration of Data and
tal divide among elders and help increase satis- AI into healthcare will “increase access, enhance
faction among users of digital technologies. preventative care, and accommodate growing
Furthermore, building capabilities in Saudi demand (National Strategy for Data & AI 2020).
Arabia will also facilitate advancements towards The opportunities in AI are endless and will con-
the Sustainable Developmental Goals (SDGs) in tinue to develop, attracting further growth and
achieving indicator 4.4.1: “proportion with youth investments. The goal of the strategy is to reach
and adults with information and communications $20 billion in local and foreign investments by
technology (ICT) skills” (United Nations 2022). 2030 (National Strategy for Data & AI 2020). A
Saudi Arabia intends to fulfill this SDG through commitment to Saudi’s future as a global hub for
attaining fundamental data and AI literacy skills Data and AI has been established, and with it the
by training 40% of its workforce by 2030 advancement of healthcare through digital health
(National Strategy for Data & AI 2020). will continue.
28 N. AlWatban et al.
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The Digital Divide Based
on Development and Availability:
The Polish Perspective
care in 2015 and this number has increased to result to a smartphone application (or a dedicated
more than 450 algorithms after just 5 years.1 AI reader). It tracks the level and variability of gly-
growth is particularly visible in radiology, cardi- cemia and alerts about dangerous hypoglycemics
ology and oncology, among other fields. by displaying trend arrows.
Artificial intelligence has no strict definition, Few AI projects are funded directly by the
as it’s challenging to define AI in a way that Ministry of Health. During the COVID-19 pan-
won’t become outdated quickly. Typically, we demic pilot project on electronic stethoscopes
use the term “AI” to describe algorithms that can that uses AI algorithms for sound interpretation
perform tasks requiring human intelligence, such was implemented in Polish healthcare. There are
as visual perception, speech recognition, also public grants for hospitals and technological
decision-making, and natural language process- companies that create and validate AI algorithms,
ing. In other words, AI is a mathematical algo- provided by the National Centre for Research and
rithm that learns from data we provide. Development and Medical Research Agency.
The benefits of AI in healthcare are numerous. AI is also implemented and successfully used
One of the most significant advantages is in medical establishments throughout the country
enhanced accuracy, leading to more precise diag- on their individual initiatives. For example, the
noses and treatment plans. AI algorithms can Radom Oncology Center is one the first such
improve efficiency by automating many routine institutions in Poland that has reached for AI in
tasks, relieving healthcare professionals to focus imaging diagnostics.3 Next, the hospital in
on more complex and personalised patient care. Ostróda is implementing a voicebot system which
AI can, therefore, help healthcare providers save is supposed to facilitate the operation of the facil-
time and money. ity. “Odrodzenie” hospital in Zakopane uses AI
solutions for histological specimen analysis and
uses hospital budget as a funding source.4 Some
2 Real Examples of AI projects are also funded by European Funds, as
Implementations in Medical with project implemented in National Cardiology
Area in Poland Institute on AI solutions for non-invasive myocar-
dial infarction diagnose or Copernicus Hospital
Poland has embraced the use of innovative tech- project that was focused on finding kidney
nologies in healthcare. According to a report cre- tumours in CT scans by AI algorithm.4
ated in 2022 by the Polish e-Health Agency, 6.6% The Polish healthcare startup sector is experi-
of hospitals, and 2.5% of all medical entities, use encing rapid growth. According to the report
AI solutions. The vast majority of them use AI entitled Top Disruptors in Healthcare 2022, third
for CT and MRI analysis.2 When it comes to tele- edition (a document prepared annually by the AI
medicine, it is used by 32.4% of hospitals and in Health Coalition), 47% of startups are devel-
25.5% of all medical entities. oping AI solutions for medicine.5 In following
Some new technologies in healthcare are editions, more than 60% of startups were involved
reimbursed by the National Health Fund, how- in AI for healthcare. Almost 30% of startups have
ever it’s not a common standard. One of the solutions certified with a CE mark, and nearly
examples is the system of continuous glucose
monitoring by scanning and measuring the con- 3
https://www.linkedin.com/pulse/sztuczna-inteligencja-
centration of glucose in the intra-tissue fluid ai-w-obrazowaniu-m etod%C4%85-%C5%82ukasz-
using a sensor placed on the arm and sending the pruszy%C5%84ski
4
https://aiwzdrowiu.pl/wp-content/uploads/2022/03/
Przegla%CC%A8d-AI-TO-NIE-SCI-FI-Przyklady-
1
Muehlematter UJ et al.; Lancet Digit Health; 2021; Mar wdroz%CC%87en%CC%81-innowacyjnych-w-zdrowiu.
3(3): 195–203 pdf
2
https://cez.gov.pl/sites/default/files/2022-09/Raport%20 5
https://aiwzdrowiu.pl/wp-content/uploads/2022/06/
CeZ_2022.pdf Raport-Top-Disruptors-in-Healthcare.pdf
The Digital Divide Based on Development and Availability: The Polish Perspective 37
90% have their product at the stage of at least tory challenges. AI algorithms used for diagnosis
MVP (Minimum Viable Product—a product ver- and treatment are considered “high-risk” AI algo-
sion that has enough functionality to meet the rithms, so we have to be sure their sensitivity and
expectations of the first customers and provide specificity are comparable to currently used diag-
feedback for further product development).5 This nostic and therapeutic methods—particularly in
demonstrates that Poland is an attractive location regard to the effectiveness of physician’ decision.
for the creation of new technologies. There is a wide range of literature that discusses
issues related to AI bias, explainability, and other
challenges, however one of them is directly
3 Regulations and Data related to transitional economies—that is access
Poverty Trap to medical data.
To create effective and safe AI algorithms in
Thanks to the activity of the already mentioned healthcare, we have to use vast amounts of good
AI in Health Coalition, Poland is also one of the quality data. We should also train algorithms on
first countries to introduce guidelines on AI data that comes from patients similar to those who
implementation in medical entities. According to will be treated and diagnosed by a particular algo-
the declarations provided at the official website6: rithm. In other words, if we want to use AI algo-
“AI in Health Coalition aims to shape policy for rithms for European patients, this algorithm
the development of artificial intelligence in the should be trained mostly on European patients’
Polish health care system.” Their goal is to create data. An algorithm trained on data, e.g., Asian
an environment that enables rapid and wide- patients could have significantly lower sensitivity
spread use by the Polish health care system of the and specificity when used on patients from Europe
latest advances in AI, as they believe that AI solu- or the US. This means that countries that cannot
tions in health care should respect the central role provide access to medical data for AI algorithms
of the medical professional in patient care and creation could fall into a “data poverty” trap8 and
instil confidence in the patient. More details can therefore could not develop AI in medicine, even
be found in the AI in Health Coalition Manifesto. if they are able to buy existing solutions created in
An important document, i.e. White Paper on AI in other parts of the world. It’s crucial to understand
clinical practice was co-created by AI in Health that this may be a gap that we cannot overcome
Coalition and representatives of Ministry of with money, therefore we have to act on prevent-
Health, e-Health Agency, Medical Research ing the emergence of this gap.
Agency, Patients Ombudsman Office, Polish On the other hand, there is a strong need to
Hospital Federation, National Medical Chamber protect personal data, especially such sensitive
and other important healthcare organisations.7 data as medical data. Decisions of using data by
The White Paper answers common questions third parties must be based on data subject con-
about AI implementation in medicine, such as: sent. We have to secure access to medical data
May AI diagnose by itself? Should patients be that will be fair, democratic, decentralised,
always informed about AI diagnosis? Should we patient-centric—and scalable.
ask patients for consent for using AI? May AI In Poland medical data sharing model is being
decide about the admission of a patient? And who developed based on Data Governance Act.9 The
is responsible for AI diagnosis? same way patients donate their blood or marrow,
However, despite resolving the aforemen- they can consent for the usage of their data for
tioned uncertainties, we still face many regula- research and development purposes. The Polish
6
https://aiwzdrowiu.pl/en/ 8
https://www.thelancet.com/journals/landig/article/
7
https://aiwzdrowiu.pl/wp-content/ PIIS2589-7500(20)30317-4/fulltext
uploads/2022/11/15.11_HIPERL_ANGIELSKA_ 9
https://digital-strategy.ec.europa.eu/en/policies/
BIALA-KSIEGA_AI-W-ZDROWIU_2022.pdf data-governance-act
38 M.-W. Agnieszka et al.
Donate Your Data Foundation is a legal controller There were attempts to unify the data gather-
of patients’ data, and based on patients’ consent ing—since December 2019, all health-providing
it can collect, anonymize, and distribute data to institutions in Poland have been obliged to upload
the third parties.10 Thanks to this model access tothe information about medical events to the
data is democratised without compromising government-administered platform—P1.12
patients’ right to privacy. Physicians cannot prescribe the drugs, and sick
In summary, several implementations of inno- leaves omitting the P1. The platform is a promis-
vative solutions in healthcare were succeeded ing step, but it is insufficient. The analytically
and already functioning within institutions that most valuable, precise medical data, including
support the development of this area. biochemical parameters or clinical descriptions
Nevertheless, difficulties still arised. In the fol-
of the patients, is not gathered in P1. This is a
lowing paragraphs, some examples of difficulties significant shortcoming of the platform, consid-
because of digital divide remain a challenge for erably reducing the value of the data for scientific
Poland is presented. or analytical purposes.
Moreover, the uploaded information is not
free from bias, e.g., the uploaded ICD-10 codes,
4 Basic Challenges in Data which should describe the patient’s primary diag-
Generation nosis, frequently do not reflect the actual medical
condition. This is a common practice to slightly
The Polish healthcare system generates an modify the ICD-10 code to increase the amount
immense amount of data. For instance, in the in- of received money from the public payer. Some
hospital setting, from admission to discharge, the ICD-10 diagnoses and ICD-9 procedures are
gathered data concerns all the necessary bureau- being paid better than others, tempting the health
cracy, i.e., patients’ written consents, but more institutions managers to upgrade the reported
importantly, medical data. These data constitute diagnosis.
priceless material for all socioeconomic and sci- Given all the problems mentioned above, tele-
entific analyses. However, several general barri- medicine has not had a favourable environment
ers interrupt its wider analytical use. for further development. All of the links in the
The most crucial obstacle is still widespread healthcare chain function in isolation, with no
keeping medical records in paper form, making access to the medical data generated by its differ-
its analysis more time-consuming. These should ent parts. The development of the structured, uni-
be gradually improving, as some legislation that versal informatics system for medical data
pushes electronic medical documentation (EDM) collection and analysis has merely been
has been passed in Poland.11 Furthermore, even if initiated.
the EDM is implemented, there are various soft- The issue is highlighted when the available
ware providers for specific recipients. In other medical data is supposed to be prepared for artifi-
words, each hospital or outpatient clinic may use cial intelligence analyses. In our institution—
individual single software. Systems usually do Institute of Heart Disease, Wroclaw Medical
not communicate with each other—the medical University—we performed a series of experi-
data cannot be easily transferred between the sys- ments that included unsupervised machine learn-
tems; thus, the integration is also difficult. ing techniques called clustering,13 to analyse the
heterogeneity of the acute heart failure (AHF)
https://podarujdane.pl/
10 12
h t t p s : / / w w w. e u r o . w h o . i n t / _ _ d a t a / a s s e t s / p d f _
11
h t t p s : / / i s a p . s e j m . g ov. p l / i s a p . n s f / D o c D e t a i l s . file/0018/163053/e96443.pdf
xsp?id=WDU20180000941 13
Frades I et al.; Methods Mol Biol; 2010;593:81–107
The Digital Divide Based on Development and Availability: The Polish Perspective 39
population. Two AHF registries gathered in One of the major barriers is that most of the
2010–2012 and 2016–2017 had to be prepared to advanced software requires dedicated, high-
apply the algorithms. The collected data, although performance hardware. These AI-models need a
very similar content, was stored and described significant amount of computing power for pro-
differently—the columns in the excel files had cessing complex datasets. Several programs are
distinct names and formats. The first task which created and tested on specific components such
had to be performed was the unification of cod- as graphic cards. In consequence, to use these
ing. Then the files were merged. Furthermore, the programs only recommended hardware should be
data included many outliers and missing data—it installed. It concerns especially models in the
was manually put from patient documentation to early stage of development, with a limited num-
the electronic records—therefore, it was prone to ber of compatible components. Another limita-
mistakes. These limitations were not sustainable tion is combining AI technologies with existing
for the machine learning analyses—the data had imaging systems in hospitals, which usually
to be manually curated. Implementing more cause a lot of challenges. For instance, real-time
advanced database systems for medical data analysis of angiograms during diagnostic proce-
gathering, which, e.g., enable the validation of dures requires a connection between modern
the input data, would make it more convenient in software and an angiographic system. Frequently
further stages of data analysis. Eventually, once it is associated with the necessity to redevelop the
the data was manually pre-processed and pre- whole existing diagnostic laboratories. It under-
pared for the ML algorithms, the calculations lines the necessity to design new IT infrastructure
were relatively easy to perform, which resulted in suitable for the expandability of advanced tools.
2 full-text scientific articles.14 In the Polish healthcare system implementa-
tion of AI models analysing medical images is
commonly limited to offline analysis. This is due
5 Barriers in the Field to a couple of obstacles. In the majority of cen-
of AI-Based Medical Images tres, all medical imaging data are not collected in
Analysis a systematic, structured way. AI analysis of medi-
cal records need standardised and correctly
As mentioned above, the use of AI -based sys- labelled images. Frequently, a group of enthusi-
tems in medical imaging is perhaps one of the asts manually search databases to find the appro-
most promising achievements in healthcare. priate projection of images, formulate it and send
Nowadays, several AI-based models show the it further to external professionals. In the end, the
ability to generate meaningful information from process is time-consuming and exposed to bias
complex images such as angiograms, computed during gathering data. It also reduces the possi-
tomography scans or magnetic resonance images. bility to analyse a large amount of data. In a
It is also known that such solutions can be wider perspective, it limits the chances to train
approved by institutions such as Food and Drug algorithms on the major datasets. It creates the
Administration (see: an example with diabetic need to develop transparent methods for data col-
retinopathy detection15). This approach creates lection, for instance, compatible with commonly
great opportunities in healthcare. However, there utilised software managing medical images.
are also numerous barriers, especially in coun- Furthermore, the developed methodology should
tries that are not leaders in this area. be focused on research purposes, selecting data
based on particular features. From a technologi-
cal point of view, the lack of automated, prepared
14
Urban Sz. et al.: Biomedicines; 2022 Jun 27;10(7):1514 datasets and the possibility of data transfer, lead
15
https://www.aao.org/education/headline/autonomous- to discouragement in several centres to take the
diabetic-retinopathy-screening-system-g first steps in AI implementation.
40 M.-W. Agnieszka et al.
related to computational medicine, algorithms or At the end of the questionnaire, there were
any issues related to, for example, supporting questions about the surveyed person (age, sex,
diagnostics or supporting medical decisions, by education, with only people practising a medical
solutions based on artificial intelligence. profession or studying at a medical university to
Paradoxically, the White Paper7 mentioned choose from).
above remains the only available document cre- The survey was available online for approxi-
ated to prepare the medical community for the mately 8 months. The link to it was intensively
changes resulting from the development of artifi- promoted both on-line (the website of the project,
cial intelligence in medicine. the website of the Ai-in-Health Coalition and
even at the and even on a subpage of the website
of the Polish Chancellery of the Prime Minister,
7 Limitations Resulting as part of the initiative of the health working
from Lack of Awareness group) and on leaflets.
The survey and its results will be the subject
Lack of education in the field of innovation in of an extensive scientific publication, therefore in
medicine, implemented at the systemic level at this chapter we will only provide a general sum-
the earliest possible stages of medical studies, mary of the observations.
may be both the cause and the effect of the lack There were over 800 visits to the survey’s
of awareness in the medical community regard- website. However, the most surprising and dis-
ing the principles or the possibilities of using AI. turbing finding from our research was that only
In 2022 we conducted an anonymous survey few respondents actually solved the entire survey.
to assess the beliefs and knowledge of AI in the Despite full anonymity and the relatively neutral
medical community. The survey was designed to nature of the questions, the respondents did not
measure the broadly understood beliefs, knowl- want to demonstrate their knowledge (or lack of
edge and awareness among medical staff (i.e., knowledge) or beliefs. We had only 130 surveys
employees of medical universities, clinics and which were completed and 691 which were
hospitals, medicine students, etc.) in the field of solved only partially.
artificial intelligence in health. Beliefs were assessed positively, most of the
The questions related to beliefs, the person responses oscillated around full agreement or
was asked to express his/her opinion about a slightly below full agreement. The respondents
given belief using a scale starting from: com- appreciate the benefits of AI, such as accelerating
pletely disagree and finished by: completely healing processes or improving the quality of
agree. Sample questions in this part of the survey medical services.
were: “AI-based solutions can support medical The answers regarding the lack of legal regu-
staff by allowing them to focus more on the lations regarding the use of AI in the diagnostic
patient”, “AI-based solutions will make patient process were definitely diverse—the respondents
treatment more effective” or “AI-based solutions either rather agreed with it or marked the answer
will improve the quality of patient treatment”. from the middle of the scale, which suggested
Questions about the level of knowledge were that they did not know whether such regulations
structured in order to ask the subject to judge exist.
whether a given sentence was correct or not, The vast majority of respondents, who were
using a similar scale (“this sentence is wrong” vs medical doctors or students from the medical fac-
“this sentence is correct”). Examples sounded as ulty, did not agree that “AI-based solutions can
follows: “Data from hundreds or thousands of replace physicians” however there were single
patients (subjects) need to be obtained to develop answers which allowed such possibility.
an AI-based algorithm” or “Solutions based on In a question where we asked the respondents
certified AI algorithms are safe and to rate their own level of knowledge in the area of
dependable”. AI using a 10-point scale (with 1 for have no
42 M.-W. Agnieszka et al.
knowledge and 10 for an expert) most people ing from the obligation to safeguard participant/
rated themselves at 5, i.e., half of the scale. donor/patent’s rights fulfilment.
However, further questions where it was verified The first group of data is mainly generated by
whether the respondents knew basic terms in the biobank. Their quality and the amount strictly
field of AI, such as decision trees, neural net- depend on the biobank, specific requirements
works clustering or supervised learning showed from implemented standard(s) or particular
that these concepts are still not well identified, as agreement conditions between biobank and part-
the responses were very diverse. ner (i.e., Pharma/Biotech co-operation, where the
To sum up, there is a need for intensive educa- specification is precisely detailed). Following
tional activities among doctors aimed at increas- technological related processes documentation
ing the awareness and understanding of how AI data can be included here:
can support medicine. Such education should
start as early as possible, preferably during medi- –– collection (date/hour, staff traceability, type of
cal studies. Unfortunately, this task has not yet equipment and materials used in the process,
been fully implemented and it is difficult to adverse event/incidental findings)
assess how much time it will take to prepare for –– transport (start/finish time, temperature regis-
educating in this area at the system level. One tries, deviations)
thing is certain—without education, the use of AI –– qualification and biological material reception
in medicine will be definitely limited, which will (volume, sample coding, deviations such as
be a big obstacle in keeping up with the dynamic lipaemia, haemolysis, etc.)
development of these issues all around the mod- –– processing (time, materials and reagents used
ern world. in the process, process parameters, aliquoting
and the amounts of aliquots)
–– storage (traceability, location, storage
8 Challenges Related conditions).
to Biobanking in the Era
of Big Data For all indicated processes only some of the
and Digitalization examples have been shown. Despite data from
technological processes also information from
8.1 Types of Data Stored auxiliary procedures shall be collected such as.:
in Biobanks infrastructure supervision, including validation,
calibration and internal checking, environmental
Nowadays, biobanking has become an increas- conditions, personnel responsibility for dedicated
ingly visible field, without which reliable processes, qualifications and competences
research in the area of drug discovery and devel- requirements, internal/external audits, data from
opment or new medical treatment implementa- service/materials providers. Quality control (QC)
tion would be impossible. That is why biobanks data also provides a relevant number of records.
shall be recognized as professional tools for inno- Regarding to the international ISO standard
vative research performance. Generally, biobanks 20387:2018 dedicated for biobanks, QC data shall
are associated with places, where the responsibil- be derived from biological material, associated
ity for professional preparation of biological data and processes (clause 7.8: Quality control of
material for intended purpose is held. biological material and associated data).20
Nevertheless, it should be also emphasised that The second and third group of data which can
biobanks also act primarily on data, which are a be identified in biobanks is related to the partici-
critical element of all operations. Three catego- pant/sample donor. Among all data related to par-
ries of data can be identified in the biobanks: (1)
data from pre-analytics, (2) data directly con- EN ISO 20387:2018 Biotechnology—Biobanking -
20
nected with participant/donor and (3) data result- General requirements for biobanking
The Digital Divide Based on Development and Availability: The Polish Perspective 43
ticipants taken part in the study, it is possible to 8.2 Data Collection, Storage
perform advanced research and development and their Usage. Trust
work that meet the assumptions for Evidence- in Biobanking in Terms
Based Medicine. of National Solutions
Among the data related to the study partici- to Overcome Digital Divide
pant, it is possible to distinguish such data, thanks Based on Development
to which it is possible to carry out advanced and Availability-Regulations
research and development work, and thus to meet and Standards
the assumptions for Evidence-Based Medicine.
The following data can be included such as The vast majority of data collected and processed
diagnostics data, treatment information, disease in biobanks will be sensitive, personal/identify-
severity status, pathology data, demographics, ing data and will therefore be subject to the
case history, any questionnaire data, recurrence/ requirements of the GDPR for EU countries. This
follow ups data. Image data (CT, MRI, PET-CT, is particularly important to ensure maximum pro-
X-ray, ultrasonography, histopathological results) tection for the subject. The functioning of bio-
are a significant part of the data. All data in bio- banks in some countries has its own regulations
banks are usually stored in two formats: (1) paper in the form of statutory regulations (Estonia-
(informed consent, reports on retrieval, transport, Human Genes Research Act,21 Hungary- National
qualification, processing, sometimes surveys) legislative act on the protection of human genetic
and electronic (e. g. surveys, test results, medical data, on the human genetic studies, on research
data). As for data storage systems, the most com- and on the operation of the biobanks,22 Iceland-
mon are excel files, databases (on-premises or in Acts on Biobanks no.11023). Unfortunately,
the cloud), sometimes allocating access to Poland has not yet developed a biobanking law,
resources in another location. However, it should despite the efforts of the BBMRI. pl Consortium,
be noted that any paper document can be con- which was established to achieve the common
verted to an electronic version, which is then objectives of the European BBMRI-ERIC infra-
backed up. Some biobanks use dedicated sys- structure policy in the field of biobanking. Thus,
tems, which consist of many interconnected and biobanking is not regulated by law in Poland.
interdependent modules. As a result, the biobank Biobanks in the scope of their activities are
is able not only to store data, but also to manage guided by those prepared by the consortium
it in a complete way at every stage of biobanking BBMRI. pl as part of the project “Creating a
and in every area supporting the biobanking pro- Polish Biobanking Network based on BBMRI-
cess (e. g. storage, disposal, reporting). ERIC infrastructure” or Code of Conduct of
Biobanks use data primarily from medical Processing of Personal Data for Scientific
procedures or scientific research involving Purposes by Biobanks in Poland24 and Quality
humans. Due to the generation of a broad data
repository during standard patient treatment,
clinical trials or population cohort study, it is pos- 21
https://www.riigiteataja.ee/en/eli/531102013003/
sible to conduct and apply an innovative approach consolide
to standardisation of methods supported by evi- 22
Hoxhaj I. et al.; European Journal of Medical Genetics,
dence published in systematic reviews, ran- 2020, 63, 4, 103841
domised meta-analyses or observational studies. 23
The Biobanks and Health Databanks Act] 1), No.
Critical data that should always be present in bio- 110/2000, as amended by Act No. 27/2008, No. 48/2009
and No. 45/2014
banks are informed consent forms with exclu- 24
https://bbmri.pl/kodeks-postepowania-w-sprawie-
sions and consent to data processing resulting przetwarzania-danych-osobowych-dla-celow-badan-
from the GDPR. naukowych-przez-biobanki-w-polsce/
44 M.-W. Agnieszka et al.
Standards for Polish Biobanks (QSPB),25 Manual formed in Polish Biobanking Network.28,29 The
of Biobank Quality Management (MBQM).26 results clearly showed that 85% from Polish
Nevertheless, it is important to underline that Biobanking Network entities have fulfilled the
standards and codes are voluntary and there is no requirements dedicated to ELSI aspects, while
legal obligation to apply them outside the mem- only 40% of requirements were achieved in the
bers of the Polish Biobanking Network. Safety/Security area. The excellent results
Furthermore, their usage allows them to function (100%) have been accomplished by BBMRI.pl
according to the guidelines adopted by the Consortium biobanks. It was also interesting that
environment.27 the QMS implementation was extremely signifi-
Standards refer to the safety and security pro- cant if the comparison to the biobanks without
cedures for biobank operations (Chap. 15 from any system was done, only in the ELSI area the
QSBP25,26). The requirements for basic methods impact has not been noticed.24
of securing IT infrastructure including biobank Trust is one of the factors influencing the will-
system sample management, where digital data ingness of donors to donate biological material to
are stored were also underlined. It directly influ- biobanks. Therefore, BBMRI.pl went ahead of
ences the donations willingness and donor’s trust, expectations. And an information security audit
that his/her samples and associated data will be program was launched. Each biobank associated
used properly and stored in a secured in the Polish Biobanking Network (both mem-
manner20,21. bers and observers) which went through the pro-
The QSPB Standards, which have been pre- gram (voluntary participation) received report,
pared and implemented within Polish biobanking recommendation and was offered support. What
activities, also pay special attention to ethical and is more important the summary of anonymized
legal aspects (Chap. 5 from QSBP25,26) where reports revealed most frequent shortcomings, and
principal recommendations for impartiality, con- areas that need more attention. These conclusions
fidentiality, responsibility and respect for auton- were reflected in Chap. 15 from QSBP25,26 of the
omy are raised. The detailed information second version of The QSPB25,26 and covered
regarding rules for informed consent preparation, physical security, backup, cloud services and
communication with participants and bioethics review of basic security mechanisms. Also, in
committee role together with sharing of biologi- terms of ICT technology, the biobank environ-
cal material and data for non-commercial and ment is strongly differentiated from very mature
commercial usage of biological samples/data are entities that can afford proper IT support, either
presented. Moreover, ownership issues and pri- within their own resources or the institutions they
vacy protection are described. Biobanking that are subordinated to. Mature biobanks have imple-
complies with relevant ethical and legal standards mented LIMS/BIMS systems, established, not
may increase the quality and public trust in sci- necessarily formalised, methodology for dealing
ence and research 20,21. with research data. Less advanced or newly
According to the requirements which have established ones are working on implementing
been described in QSPB, in 2017–2020 an audit appropriate mechanisms both in the areas of
process has been carefully organised and per- security and data processing.
At the network level, there were also prepared
dedicated tools to facilitate sample information
25
Red. Matera-Witkiewicz A. et al.; Standardy Jakości dla
Biobanków Polskich; v.2.00, Wrocław, Poland, management—a BIMS class system as well as
Wydawnictwo Uniwersytetu Medycznego we Wrocławiu, solutions for samples or data discovery.
s.210, 2021. ISBN 978-83-7055-661-7; e-ISBN
978-83-7055-662-4
26
Matera-Witkiewicz A. et al.; Manual of Biobank Quality 28
Ferdyn K. et al.; Biopreserv Biobanking, 2019, 17, no.5,
Management; Springer, 2023, ISBN: 978-3-031-12559-1 401–409
27
D. Simeon-Dubach, Z. Kozlakidis; Biopreserv Biobank. 29
Matera-Witkiewicz A. et al.; Front. Med., 2022, 8,
2018; 16: 1–2 780294
The Digital Divide Based on Development and Availability: The Polish Perspective 45
It is important to note that all research regard- available and on what terms. Provisions that do
ing biological material and associated data are not explicitly refer to biobanks themselves, but
based on the same principles as any trial where may support them in terms of their activities are,
human is engaged.30,31 For biobanking trust and for example, the Act on Patients’ Rights and the
donor protection three step system in contempo- Patient’s Ombudsman (Dz.U.2022.1876). In
rary ethical assessment shall be kept, where inde- Chapter 7 art. 26 p. 4 the legislator indicates the
pendent ethical committee, international/national method of making medical records available:
codes of ethics and finally regulations are pres- Medical records may also be made available to a
ent.32 Polish Bioethics Committees are dedicated university or research institute for use for scien-
to giving opinions for medical experiments and tific purposes, without disclosing the name and
every project, where biological material and other data allowing identification of the person to
associated data are planned to be used. Presented whom the records relate.33 This record makes it
regulations are contained in updated law act on possible to conduct scientific activities based on
doctor and dentist. It is required that each project anonymized medical data. The Act also specifies
of any experiment involving humans or biologi- the method of making electronic medical records
cal material/data to be submitted to an indepen- available for control purposes (legal act from 27
dent bioethical committee for approval. It is also Aug. 2004 on publicly financed health care ser-
forbidden to perform any medical experiment vices Dz.U.2022.256134), referring to the data
before the positive opinion. The law is far too format records specified in separate regulations.
narrow and excludes all experts in the field of These, in turn, refer to another law and Art. 18.
research where biological material/data are used. Legal act from 17 Feb. 2005: Computerisation of
From 2021 in Poland only doctors and dentists the activities of entities performing public tasks
can be accepted as head/manager of specific proj- Dz.U.2023.57.35 The Act points out that at the
ects. This discriminates all researchers from request of the Minister responsible for comput-
other fields and disciplines (i.e., biologists, bio- erisation, minimum requirements for ICT sys-
technologists, bioinformaticians, data scientists) tems and public registers will be defined by
who are qualified to lead projects involving bio- means of a regulation. These actions shall ensure
logical material/data. Such investigators often the consistency of the operation of ICT systems
have a much higher level of competence in the used for the performance of public tasks by spec-
laboratory techniques, IT and biostatistical meth- ifying at least the specifications of the data for-
ods used in scientific analysis and advanced mats, communication and encryption protocols
research. This law unfortunately effectively has to be used in the interface software, while main-
closed the way for excellent researchers to lead taining the possibility of using those specifica-
such projects. tions free of charge; the efficient and secure
Data sharing in national biobanking is essen- exchange of information in electronic form
tially based on the patient’s informed consent, in between public bodies and also between public
which he/she determines what may be made bodies and authorities of other States or interna-
tional organisations. In addition, it is intended to
30
International Ethical Guidelines for Health-related ensure that the National Interoperability
Research involving Humans; Council for International Framework meets the requirements regarding
Organizations of Medical Sciences (CIOMS), 2016, ISBN
semantic, organisational and technological
978-929036088-9
31
Deklaracja Helsińska Światowego Stowarzyszenia
Lekarzy (WMA) Etyczne zasady prowadzenia badań
medycznych z udziałem ludzi; 2013
33
https://lexlege.pl/ustawa-o-prawach-pacjenta-i-rzec-
32
Czarkowski M.; Role of bioethics committees in the zniku-praw-pacjenta/
biobanking activities and research on human biological
34
https://lexlege.pl/ustawa-o-swiadczeniach-opieki-
material; 2021; https://bbmri.pl/raport-elsi-dotyczacy- zdrowotnej-finansowanych-ze-srodkow-publicznych/
roli-komisji-bioetycznych-w-dzialalnosci-biobankow-i- 35
https://lexlege.pl/ustawa-o-informatyzacji-dzialalnosci-
badaniach-na-ludzkim-materiale-biologicznym/ podmiotow-realizujacych-zadania-publiczne/
46 M.-W. Agnieszka et al.
interoperability, taking into account the principle situation where scientific data repositories, which
of equal treatment of different IT solutions, have been intensively developed in recent years,
Polish Standards and other standardisation docu- apply individual standards, which in turn will
ments approved by the national standardisation hinder interoperability and data exchange
body. between individual systems. It will ultimately
As a result of implementation of DIRECTIVE translate into difficulties in searching for data—
(EU) 2019/1024 OF THE EUROPEAN the need to search each of the repositories sepa-
PARLIAMENT AND OF THE COUNCIL of 20 rately. Among others further obstacles were
June 2019 on open data and the re-use of public indicated legal—lack of sufficient legislation on
sector information 36 the Member States were data sharing, competency—the lack of properly
obligated to enact national implementations in qualified personnel. The document also sanctions
this field. Consequently, in 2021 the law “on the participation of Poland in the European Open
open data and re-use of public sector Science Cloud (“EOSC”). The report on the
information”37 was announced. The introduced implementation of the program for 2021 indi-
law does not change much in the field of sharing cates the creation of an association of six univer-
medical data. However, it introduces some sities that will represent Poland in the EOSC and
changes to the reuse of scientific data. Firstly, by become responsible for the implementation in the
introducing the definition of research data and country.
the obligation to share them if they were gener- Another road map is "HEALTHY FUTURE
ated with public funds. At the same time, the STRATEGIC FRAMEWORK FOR THE
Minister of Education and Science was indicated DEVELOPMENT OF THE HEALTH CARE
as the body responsible for the implementation SYSTEM FOR 2021-2027, WITH A
by preparation of detailed guidelines in the form PERSPECTIVE UNTIL 2030." 39 issued by the
of policy in this area—at the time of writing this Ministry of Health. In terms of Digital Health,
text, work is still in progress. Another important the document focuses mainly on e-services pro-
issue arising from the new law is the appointment vided to patients, doctors or medical entities,
of the minister competent for computerization, technical equipment of facilities with adequate
which is developing the “Data Opening IT infrastructure. Building medical knowledge,
Program”—a continuation of the previous developing methods of collecting and sharing
responsibility of the Ministry of Digitization, data is not a priority. Based on the strategic docu-
which has been dissolved in the meantime. One ments presented earlier, a silo landscape emerges
of the six pillars of the Program is: “Stimulating at the ministerial level—documents and guide-
the market for re-use of cultural resources and lines are created in separate departments, proba-
scientific data”. As part of this document, it was bly without any attempt to coordinate work.
recommended that scientific data should be made According to the conclusions of the report
available through thematic repositories, which “Digital Health Implementation approach to
have been intensively developed at universities in Pandemic Management” [Digital Health
recent years—as examples Polish Platform of Implementation approach to Pandemic
Medical Research.38 On the other hand, in the Management G20], this is not an approach that
document there was also identified the factors may herald failure in implementing an effective
negatively affecting the use of data—the multi- digital health system. Which requires coherent
tude of available registers. This may lead to a coordination of work at the national level. The
36
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML
/?uri=CELEX:32019L1024&from=PL 39
https://www.gov.pl/web/zdrowie/
37
https://isap.sejm.gov.pl/isap.nsf/download.xsp/ zdrowa-przyszlosc-ramy-strategiczne-rozwoju-systemu-
WDU20210001641/T/D20211641L.pdf ochrony-zdrowia-na-lata-2021-2027-z-perspektywa-
38
https://ppm.edu.pl/index.seam?lang=en&cid=269887 do-2030
The Digital Divide Based on Development and Availability: The Polish Perspective 47
WHO issued similar recommendations [Global data sharing, integration with BBMRI-ERIC
strategy on digital health 2020–2025, WHO]. directory,42 creation of unified BIMS and integra-
It is also important to note that in 2019 the tion with HIS, setting up a gate for information
Polish Medical Research Agency (MRA) will be exchange between biobanks and national regis-
established. The main scope of the Agency is to tries. Due to insufficient legal framework the last
increase the potential of non-commercial clinical task was not even started. Integration of BIMS
research especially for new treatment methods in and HIS system was performed as a Proof of
oncology, cardiology and rare diseases areas. The Concept and paused at this stage. First three tasks
MRA has been created by law (Act of 21/02/2019 were completed. The unified BIMS is designed to
about Medical Research Agency, Journal of Laws support data/information exchange with API
No. 44740). Noteworthy is the fact that from 2022 interface; there was also developed Central
The MRA has implemented the biobanking Platform dedicated to performing queries for data
requirement activity for all clinical trials which collected in central repository as well as in feder-
are sponsored by the agency, where the blood ated ecosystem—created with software installed
sample is taken from a patient. Moreover, the in biobanks and fed with data directly from local
biobanking must be performed according to the BIMS. The consortium did not only focus on
Quality Standards for Polish Biobanks technical aspects and took challenges in chang-
(QSPB).20,21 Additionally, in 2023 the MRA has ing the ELSI landscape, among others there was
announced the call for Digital Medicine Centres, proposed the code of conduct based on GDPR
where Biobanks as necessary units are also art. 40—“Polish code of personal data processing
included and will be financed. However, it is by biobanks in Poland”.43 Currently works of the
strictly defined that the biobanking process must consortium is held up due to a pause in funding.
be carried out within ISO 20387:2018 and Another initiative for creating infrastructure
QSBP.20,21 Thus, the Polish Biobanking Network for data sharing is “Polish Genomic Map in open
membership based on unified and harmonised access—digitization of biomolecular resources
standards sustainability can assure that the fulfil- of the Biobank Lab University of Lodz” project.44
ment of the highest regulation proposed by The idea is to set up Polish node of Federated
national or governmental authorities will be European Genome-Phenome Archive (EGA)45,.46
achieved. This infrastructure will be compliant with EU
guidelines “as open as possible as closed as nec-
essary”. It provides Public Key Infrastructure
9 Digitization of Genomics (PKI) encryption of datasets submitted to the
Data in Poland repository. Access to the data is available under
approval by the Data Access Committee (DAC).
Sharing of data was the primary domain of DAC can be set up by the Principal Investigator
Biobanks in Poland. Although biobanks have just or the Institution. The Polish instance will be
begun to emerge in Poland in the beginning of the connected to Central EGA discovery service—
twenty-first century. However, from the origina- providing an interface for researchers looking for
tion they started to play a significant role in the data.
sample and data sharing ecosystem of Polish sci-
ence. In 2017 the BBMRI-ERIC Polish Node
was established as well as BBMRI.pl consor- 42
Holub P.; Biopreserv.Biob.; 2016, 14, 6
tium.41 The initiative joined 7 entities involved in 43
Krekora-Zając D.; Front. Genetics: ELSI in Science and
biobanking. One of the project goals was to Genetics; 2021; 12
44
Marciniak B. et al.; Current Topics in Biophisics, 2022,
implement IT System for samples discovery and
43, ISSN 2084-1892, p.32
45
Lappalainen, I. et al.; Nat Genet, 2015, 47
40
https://eli.gov.pl/api/acts/DU/2019/447/text.pdf 46
Mallory A.F. et al.; Nucleic Acids Research, 2021, 50,
41
Witoń M. et al.; Biopreserv.Biob.; 2017, 15, 3 D1, 7.
48 M.-W. Agnieszka et al.
Thanks to EU funding, the Digital Poland granting projects in which Human Biological
funding scheme was provided to support ventures Material was used—on average 93 projects per
in the area of digitization. Beneath there are men- year (based on analysis of available projects
tioned some projects that were supported and abstracts on NSC web page—years 2014–2020).
shared medical data and resources. At the end of March 2023, in scientific reposito-
Digital Brain—main goal of the project is to ries there were deposited 30 data sets—by Polish
digitise and share in an open access collection of institutions or regarding Polish population
brains stored by the biobank of Institute of DbGap—22 datasets, EGA—8 datasets. Which
Psychiatry and Neurology. indicates a significant gap between the genomic
OpenCardio—main goal of the project is to data generated and data available.
disseminate the digitised results of pulmonary On the other hand, there are some top-bottom
embolism diagnostics by creating a specialised initiatives that focus on accessing HIS and health
digital platform openCARDIO and digitization registries to combine data and use them in scien-
of science resources on venous tific ecosystems or decision supporting tools.
thromboembolism. These approaches are supported with law regula-
Medical Data Bank—in this case the project is tions or policies established on a national level.
performed by Lodz University of Technology At this point these initiatives do not focus on
and Institute of the Polish Mother’s Memorial genomic data.
Hospital in Lodz the aim is to digitise one million National Cancer Registry set up by Polish
histopathology samples and share them with con- Ministry of Health47— In the form of a web-
nected medical records. based platform that aggregates information about
Although the Digital Poland funding stream is cancer diagnosis, it can be fed with data directly
the great source for supporting digitization initia- from HIS system or manually by doctors. Data
tives there is at least one serious oversight. from the registry are then aggregated in a data
Program became very popular and plenty of warehouse and are available through a web inter-
repositories raised a great variety of data. face to scientists or medical personnel.
Unfortunately, there weren’t any general stan- National registry of Rare Diseases48 is the next
dards introduced. So, at the end there is a lot of initiative that is planned to be set up in the near
data available, but the problem is lack of standard future to provide a transparent system for collect-
communication protocol or API introduced. ing information from HIS and provide aggre-
Therefore, in future there might be problems with gated data for policy creation.
data interoperability and/or harmonisation. Also, The situation is slowly changing, in 2023 the
a single search entry point might be problematic Medical Research Agency (MRA) has announced
to implement– each repository needs to be que- the call for Digital Medicine Centers. The idea is
ried individually. to combine Hospitals, Biobanks Academia, enti-
The mentioned ventures should be considered ties running non-commercial clinical research,
as bottom-up initiatives performed by the scien- facilities providing genome sequencing services
tific community. At the time of writing this text and facilities performing analysis (with proven
there is no systematic approach on a national experience in AI) in one regional node. The idea
level that would promote data sharing. There are is to generate and collect for further re-use as
even not defined any regulations that would much data connected with sample and donor as
oblige scientists or academia/institutions per- possible. This also includes genomics data. In the
forming scientific research funded from public first phase there is planned creation of 10 such
money for publishing data in open repositories.
One of the main sponsors of Polish science is 47
h t t p s : / / i s a p . s e j m . g ov. p l / i s a p . n s f / D o c D e t a i l s .
National Science Center, during 10 years of its xsp?id=WDU20120001497
existence, it is estimated to have spent about 48
https://isap.sejm.gov.pl/isap.nsf/download.xsp/
1,000,000,000 PLN (250,000,000 USD) for WMP20210000883/O/M20210883.pdf
The Digital Divide Based on Development and Availability: The Polish Perspective 49
regional nodes. In the call there are no strict pometric, diagnostic data, it is worth pointing
requirements how the cooperation needs to be out that international standards determine the
performed nor which standards to be used. critical amount of data only from pre-analytics/
Actually, there are some recommendations, for processes. This settled the necessity of profes-
instance suggestions to use HL7 FHIR standard sional development of the IT infrastructure in
for data interchange, qualification of personnel each biobank and its proper supervision and pro-
that need to engage into the project realisation. tection by competent personnel. These data are
General rule is to set up connectivity between increasingly noticed by the regulator and
HIS and interface that would allow sharing or research funding communities. However, it is
discovery samples and related data. There is also important that they are made available and used
a need to provide IT infrastructure that would be in a controlled way while maintaining the full
used to perform federated analysis. The regional range of data quality and according to FAIR
centre was left free to use any technology they principles. The availability of a variety of best
found relevant and compatible with already exist- practice documents, recommendations, policies
ing infrastructure. In the next phase there is and procedures supports the availability and use
planned setting up a central hub which will coor- of biological material and related data, giving a
dinate data flows between regional centres and major impetus to the global use of biological
provide discovery services for scientists. resources for scientific research and the exploita-
tion of their potential in the innovative research
sector. However, it is equally critical to have a
10 Summary regulatory package that will clearly define the
possibility of using data, and how to transfer it
In contemporary Poland, the situation regarding securely for R&D purposes, including using it in
broadly understood digitization, innovation in an efficient and secure AI or Machine Learning
medicine, development of approaches and solu- research. There is also a need for broad social
tions based on AI is not particularly imperfect education in this area in order to objectively
and/or neglected. We can be proud of some present the benefits and risks of the increasing
impressive implementations. We have both clini- volume of data being generated. Biobanks there-
cal and scientific achievements. There are fore appear as a key element of research infra-
dynamically developing institutions whose mis- structure not only as institutions managing
sion is to influence decision-makers so that the biological material but also as operators of data
development of modern technologies encounters repositories. Data from both the health sector
as few obstacles as possible. Despite this, we still and science. In this respect, biobanks can use
struggle with various problems, due to which we their skills to build relationships of trust with
remain less developed than the giants of digitiza- donors/patients/participants.
tion, such as Asian countries, Israel or even All the information presented in this chapter,
Estonia, which is the closest to us geographically, referring both to the case description itself and
culturally and historically. The barriers result presented issues which shall be improved, are
from the condition of the Polish healthcare sys- summarised as digital divide determined chal-
tem, which was problematic even without the lenges for future actions in the context of policy
context of innovation and digitalization. makers and decision makers and stakeholders
Consequently, this is reflected in the approach to (Table 1).
medical education as well as in the attitude of
healthcare professionals towards solutions which Acknowledgement The work was supported by Project
are considered new and unknown. “Digital Medicine: an Innovative approach for support
and upgrade of the diagnosis and therapy based on
The trend of a significant data increase and research (RCMC “DISRUPTOR” at UMW)” was financed
collection in biobanks is also becoming more by the Medical Research Agency under contract no.2023/
pronounced. Starting from clinical data, anthro- ABM/02/00003-00.
50 M.-W. Agnieszka et al.
Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
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any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
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obtain permission directly from the copyright holder.
Potential of Digital Health
Solutions in Facing Shifting
Disease Burden and Double
Burden in Low- and Middle-Income
Countries
a crucial disparity between developed and devel- improvements have brought a decline in mortal-
oping nations. As a result, health policymakers ity and the spread of diseases such as AIDS, TB,
must create preventive programs and improve malaria, or NTDs. Between 2000 and 2019, this
patient care, specifically in developing shift can mainly be seen in Africa, the Eastern
countries.2 Mediterranean, and South-East Asia, where many
Thus, with tight global budgets for health and LICs and LMICs are located. Overall, UMICs
research spending, a better resource allocation is and HICs (as seen in the Americas, Europe, and
necessary to improve health outcomes effec- Western Pacific) are experiencing a minimal ratio
tively. Furthermore, in any given country, evalu- of communicable, maternal, perinatal, and nutri-
ating disease burden at the local level is critical to tional conditions (Fig. 2). Nevertheless, a global
provide the needed population health information pandemic like COVID-19 brings unprecedented
for national and local governments to make tar- changes to all regions, requiring collaborative
geted and efficient public health policies and efforts in tackling its impact on the state of com-
programs. municable diseases.
To obtain precise insights into the roots of dis- Whereas NCDs were traditionally associated
ease burdens, healthcare policymakers must con- with HICs, more than 75% of all NCD-related
sider both fatal and non-fatal outcomes of each deaths occur in LMICs, with about 80% of all
disease and their risk factors. This requires utiliz- cardiovascular disease-related deaths occurring
ing data on causes of death, prevalence and inci- in LMICs. In 2000, 171 million people were esti-
dence rates of various conditions, and risk factor mated to have diabetes, and 2/3rd of them were
prevalence and exposures within the population living in HICs, but by 2030, WHO predicts that
while incorporating statistical models to create a developing countries will have about 284 million
holistic picture of health trends without bias or people with diabetes. Amongst the most affected
inconsistency. countries will be China and India, which respec-
Between 1990 and 2019, the shift in disease tively had 20.8 million and 31.7 million cases of
burden was observed worldwide, with NCDs diabetes back in 2000.
increasing in the ranking of disability-adjusted NCDs increase due to interrelated trends,
life years (DALYs) per 100,000 people globally. including the decreasing share of deaths from
On the other hand, communicable, maternal, neo- communicable and infectious diseases thanks to
natal, and nutritional diseases are showing a better nutrition, public health and medicine, lon-
downward trend, particularly thanks to improv- ger life expectancy, and population ageing. This
ing health and living standards in LICs and shift in disease burden is also known as the epide-
LMICs. Meanwhile, NCDs are on increasing miological transition; the leading causes of dis-
trends in terms of rankings, highlighting the ease and death are shifting from infectious and
shifting disease burden throughout time (Fig. 1). acute diseases to chronic and degenerative dis-
The shift is significant in LICs, LMICs, and to eases. NCDs share four major risk factors:
some extent in upper middle-income countries tobacco use, physical inactivity, the harmful use
(UMIC) as well, but it is mainly in LICs and of alcohol, and unhealthy diets.3 All are becom-
LMICs that communicable diseases remain prev- ing more common in LMICs due to economic
alent. However, thanks to international and growth and increased purchasing power, the
national programs, numerous investments and changing lifestyle, particularly from urbanization
(often unplanned) and its corresponding seden-
tary behavior, and changes in nutritional intake
2
Masaebi, F., Salehi, M., Kazemi, M. et al. Trend analysis
due to food market globalization that have
of disability-adjusted life years due to cardiovascular dis-
eases: results from the global burden of disease study
2019. BMC Public Health 21, 1268 (2021). https://doi. 3
https://www.who.int/health-topics/noncommunicable-
org/10.1186/s12889-021-11348-w diseases#tab=tab_1
Potential of Digital Health Solutions in Facing Shifting Disease Burden and Double Burden in Low… 55
Fig. 2 Composition of causes of death by WHO region, World Bank income group, and global, 2000 and 2019.
(Source: World Health Statistics 2022, Monitoring health for the SDGs, WHO)
brought unhealthy food consumption.4 ease patterns; societies worldwide suffer from
Environmental degradation, climate change, more or less the same afflictions. Regular out-
growing inequality, and air quality are other breaks of new diseases, such as COVID-19, can
important factors that increase the burden of disrupt the global healthcare system and require a
NCDs. new response. Many diseases are induced by cli-
The shifting in disease burden happens pre- mate change too, which is becoming more and
dictably in part; throughout history, diseases have more of an alarming issue worldwide. Multidrug-
existed, evolved, and spread, and scientific resistant bacteria are slowly becoming more
advances have helped to study and understand prevalent, becoming one of the most significant
these patterns for better health. Even newly issues that medicine faces without any one-for-all
named or rare diseases have been intensively solution; well-known pathogens evolve with
investigated. Additionally, the patterns of dis- time, eventually outpacing scientific knowledge
eases in developing countries can be found to and technologies.
slowly replicate those experienced in the devel- As such, this shifting disease burden is one of
oped world over the last century. This allows the most impactful factors shaping the future of
health policymakers and healthcare providers to medicine, along with the development and adop-
anticipate upcoming challenges and prepare tion of new technologies (Fig. 3)5; and they are
accordingly, while creating opportunities for influenced by a multitude of socio-environmental
investment in other areas of healthcare, shifting drivers: increasing life expectancy, decreasing
the focus from communicable diseases to NCDs. fertility rates, rising customer expectations and
Nevertheless, this shift remains multi- demands, growing inequality, human migration,
directional and cannot always be predicted easily, climate change, resource scarcity, and declining
with radical, even surprising changes. A global- quality of food and lack of nutrients.
ized and integrated world creates globalized dis-
5
h t t p s : / / w w w. t r a n s l i n k c f . c o m / w p - c o n t e n t /
4
https://www.scielosp.org/article/bwho/2004.v82n7/556- uploads/2022/06/Translink-Report_Alternative-Futures-
556/ for-Healthcare.pdf
56 H. Vu et al.
Fig. 3 The 2024 Alternative Futures for Healthcare, four nology”). (Source: Translink Corporate Finance and
scenarios based on two key drivers (“Changing burden of Institute for Future Research)
diseases” and “Development and adoption of new tech-
6
https://www.mckinsey.com/industries/healthcare/our- 7
Lower-Income Countries That Face The Most Rapid
insights/the-future-of-healthcare-in-asia-digital-health- Shift In Noncommunicable Disease Burden Are Also The
ecosystems Least Prepared
Potential of Digital Health Solutions in Facing Shifting Disease Burden and Double Burden in Low… 57
diseases fully, leaving them to co-exist with the as Vietnam, and the aforementioned factors are
increasing rate of NCDs, and a creating a double reaching new heights in the region. In 2021, it
burden of disease. Furthermore, NTDs are still was estimated that digital health impacts more
affecting the poorest populations the most, and than a billion lives and could create up to $100
amongst developing countries, it happens too billion in value in Asia by 2025.8
often to populations that are living in geographi- With the rapid development of digital tech-
cally remote areas, ethnic minorities (EM), or nologies, there are more and more applications to
marginalized groups, which exposes them to an every aspect of health and healthcare, leading to
intense vulnerability to an even greater range of the umbrella term of digital health, that encom-
diseases. In addition, other NCDs are also of pub- passes eHealth, health information technology
lic health importance such as renal, endocrinal, (health IT), mobile health (mHealth), wearable
neurological, hematological, hepatic, gastroen- devices, telemedicine and telehealth, and precise
terological, musculoskeletal, skin, and oral dis- and personalized medicine, among others.
eases; mental disorders; disabilities, including Health IT refers to the general use of hard-
blindness and deafness; violence and injuries. ware, software, and other electronic infrastruc-
NCDs and their risk factors are also linked to tures to process, store, manage, and exchange
communicable diseases, maternal and child health information (clinical, administrative, and
health, reproductive health, aging, and social, financial) between patients, providers, payers,
environmental, and occupational determinants of and quality monitors. Electronic Health Records
health, that puts LMICs in a particularly chal- (EHR) go beyond Electronic Medical Records
lenging situation. (EMR) as the latter is principally a digital version
Hence, there is a strong need for a systemic of the traditional paper charts, keeping all the
and integrated response to the current needs of medical and treatment history of the patients in
healthcare systems in developing countries that one practice. In contrast, the former goes beyond
are often focused on short-term care rather than encompassing the patient’s total health to provide
long-term care and preventive measures. As a an inclusive perspective on the patient’s care and
result, with cases of multiple comorbidities health status that can be shared with the whole
occurring more frequently, there is an increasing healthcare ecosystem. With the high penetration
demand for high-quality healthcare and long- of devices such as smartphones, tablets, etc., and
term solutions. their capabilities, it is evident that mobile com-
munication technology is leveraged for health-
care: patients’ self-care through health apps,
2 What Digital Health Can real-time monitoring, collection of clinical health
Bring to the Table data, exchange of healthcare information, train-
ing and collaboration of health workers.
Numerous forces worldwide have been driving Branching from mobile health (as wearable
significant changes in healthcare towards a devices are often connected to mobile devices,
consumer-centric digital health model: shifting using the Internet of Technology (IoT) solutions),
demographics, consumer and patient demand and these devices are used to collect, transmit, and
expectations, financial burden, the inefficiency of analyze personal health data through smart sen-
legacy healthcare infrastructure, and most impor- sors: fitness trackers, smart watches, ECG
tantly, availability of and advances in digital monitors, blood pressure monitors, biosensors,
technologies that have become essential for daily etc. Telemedicine and telehealth, representing
life. This is particularly true in Asia as it is now remote clinical services and the broader scope of
undergoing the more prevalent Asian Century,
with the larger economies becoming stronger 8
https://www.mckinsey.com/industries/healthcare/our-
global players. At the same time, other countries insights/the-future-of-healthcare-in-asia-digital-health-
are moving up to become MICs and LMICs, such ecosystems
58 H. Vu et al.
remote healthcare (including non-clinical ser- better medical diagnosis, data-based treatment
vices), respectively, use digital information and decisions, digital therapeutics, clinical trials,
communication technologies to access and self-management of care and patient-centered
deliver healthcare services remotely without any care; increased revenue for health centers; more
in-person visits, and were particularly useful dur- quality data for policy and decision-makers;
ing the COVID-19 pandemic. Telemedicine can reduced cost for patients; development of health
improve access to rural, remote, and marginal- workers through e-learning by creating more
ized communities, and along with e-pharmacy evidence- based knowledge, skills and compe-
services, can broaden access to primary care for tence; all while striving to provide equitable and
underserved populations and maintain continuity universal access, with quality that is cost-effective
of care. Precision and personalized medicine and affordable.9,10
leverages genomics, big data analytics, and popu- In facing a shifting disease burden and a dou-
lation health to help clinical decisions for disease ble burden, as seen in the case of LMICs, short-
prevention, diagnosis, and treatment for a more comings are exposed in relation to healthcare
accurate, precise, proactive, and impactful out- systems due to weak infrastructures and a lack of
come. Digital tools facilitate personalized health- resources, leaving them unprepared for long-term
care through data-rich decision-making based on care and preventive measures as the focus remains
a comprehensive history and follow-up in many on short-term care due to the current and recent
healthcare touchpoints. It sits at the forefront of history of dealing mainly with communicable
being a consumer-centric digital solution while diseases, and these challenges are further aggra-
promising better approaches to diseases such as vated by the lack of accessible quality
cancer, neurodegenerative diseases, and rare healthcare.
genetic conditions. One of the most significant weaknesses of
Digital health ecosystems are built to be healthcare systems in LMICs is infrastructure,
consumer-centric by bringing together a network resulting in a state of unpreparedness when faced
of healthcare providers, applying digital tools to with the double burden. Clinical settings are typi-
analyze patients’ needs and direct them toward cally centralized in urban, populated areas with
the appropriate provider based on their behav- comparatively higher-income populations, which
ioral, social, and health data, all supported by limits access to high-quality healthcare services
digital technologies that enable the exchange of and leads to inequality. The cost of transportation
information between healthcare providers. and follow-up due to distance breaks healthcare
Indeed, using digital health applications, patients provider and patient connections in most cases.
and their healthcare providers can cooperate in a Without following up, NCDs become unmanage-
consistent and ongoing healthcare process toward able, leading to life-threatening complications.
seamless and cost-effective medical care without Also, without interactions between medical staff
lining up in a crowded waiting room or missing and patients, trustworthiness and engagement
the golden periods of diagnosis and treatment. By cannot be built. Telemedicine solves the long
reducing the fragmentation of care, digital health commute issue, saves patients’ time and money,
solutions improve patient safety and quality of and reduces pressure on overcrowded hospitals.
care. More significantly, with a health-related With a strong network of hospitals equipped with
database, policymakers and providers can lever- telehealth, high-quality healthcare can be
age real-time information to enhance the quality centralized in critical areas and accessed remotely
of healthcare and better understand the current on demand. Virtual consultations and remote
health situation in the population and, hence, the patient monitoring demonstrated their usefulness
disease burden.
According to WHO and UNDP, digital tech- 9
Global strategy on digital health 2020–2025 WHO.
nologies have proven potential to deliver better 10
https://www.undp.org/blog/what-role-can-digital-play-
patient care and enhance health outcomes through africas-health-challenges
Potential of Digital Health Solutions in Facing Shifting Disease Burden and Double Burden in Low… 59
in COVID-19 time and can be expanded into patients’ conditions, home-based lab services,
many infectious disease management programs e-pharmacy services, and medicine taking. In
to timely respond against communicable diseases terms of prevention, mobile apps with health
by effectively limiting human-human contact. devices can track customers’ daily step counts,
However, LMICs struggle due to limited food consumption, heart rates, blood oxygen
resources, further aggravated by the double bur- level, etc. Recommendations for better routines,
den. It is challenging for them to build a sustain- changes in behavior, or early detection of abnor-
able healthcare system that can be highly efficient malities are available to improve wellness. As
and help with cost-saving, and could then free targeted by WHO, digital health has the potential
resources for better allocation. This is where dig- to help achieve important goals by prioritizing
ital health solutions can help reduce costs, that and supporting the prevention and control of
becomes particularly significant in the long term. NCDs at all levels through international coopera-
For example, health IT systems such as an EHR tion, which is facilitated through better data shar-
will help healthcare providers access patient data ing and exchange. In turn, this strengthens the
quickly, improving efficiency and reducing costs global, regional, and national agendas, building
while standardizing the flow of information in the partnerships across sectors and collaborating in
entire healthcare ecosystem, enabling a holistic their efforts. It can also enhance healthcare sys-
perspective on the patient’s health. With the tems and create health-promoting environments
patient’s history available for the physician, a for better cooperation between healthcare provid-
long-term patient-physician relationship is ers and patients, leading to monitoring NCD
quickly built, with new information being inte- trends and determinants.
grated at each step, helping early recognition of Digital tools can help reduce disease burden
problems before possible health issues become through prevention by promoting wellness.
unmanageable, leading to unnecessary spending Wearable devices give personalized recommen-
by patients and a strained workforce for health- dations on healthy routines and keep track over a
care providers. long period of time to shape good behaviors.
The challenges that come from the double Moreover, health-support devices facilitate an
burden of disease can be addressed by digital early warning system for prevention and detect-
health solutions in both of its two core compo- ing abnormalities, which is the key to the early
nents. Communicable diseases normally require diagnosis of diseases. By detecting changes to an
acute care with expediting access but limited individual’s health status very early, they improve
transportation and human contacts. The therapy outcomes, save costs and resources, pre-
COVID-19 pandemic proved the power of digital vent hospitalization, and relieve the burden on
tools in sharing information and communication, healthcare systems. For people at risk of cardio-
tracing contacts and mapping cluster develop- vascular events, early detection of abnormalities
ment, supporting healthcare services, and accel- in asymptomatic individuals can prevent prema-
erating the development and implementation of ture death, heart failure, or ischemic stroke.11
vaccination programs. Data collected can be used Supporting diagnosis at an early stage, many
for epidemic control and disease model predic- AI-augmented diagnostic tools are used by phy-
tion, helping national, regional, and international sicians and health technicians to quickly and pre-
collaborative efforts in eradicating communica- cisely catch the damages and show their use cases
ble diseases. NCDs, on the other hand, need in improving treatment outcomes and reducing
high-quality care over time by closely monitoring the economic burden. Furthermore, advanced
patients’ health, engaging patients in treatment diagnosis tools can effectively manage symptoms
courses, and in many cases, modifying and that are beyond the average level of physicians’
engaging patient behavior towards wellness.
There are many digital chronic disease manage- 11
https://www.who.int/health-topics/cardiovascular-
ment platforms that provide services to manage diseases#tab=tab_1
60 H. Vu et al.
skills, resulting in improved clinical performance population, and a better understanding of which
and greater accessibility to optimal healthcare for condition poses the more significant threat to
all patients. This can also alleviate the workload society, allowing policymakers and public health
of the healthcare workforce and decrease dispari- practitioners to allocate resources optimally for
ties in their proficiency capabilities, which better health outcomes.
improves the service quality.
Digital health promises to alleviate the strain
on healthcare ecosystems while providing holis- 3 The Case of Vietnam
tic perspectives and improvements, leading WHO
to harness its potential “to accelerate global Vietnam, the world’s 38th largest economy
attainment of health and wellbeing.”12 (according to GDP in current prices, as of October
At the micro level, the advancements and 202213), is one of the countries successfully tran-
implementation of digital health solutions allow sitioning from being amongst the poorest nations
for a better insight into the social, behavioral, into a LMIC, resulting from the Đổi Mới reforms
and environmental determinants of health, pro- of 1986 that opened up the economy to the inter-
viding healthcare providers with a greater under- national market and trade. Since then, the country
standing of individual preferences, values, has experienced rapid economic development, a
interactions, and exposures. This can create growing population, poverty alleviation, and an
long-term partnerships for creating healthy increasing share of the middle class as the nation
behaviors and environments while delivering tar- reached LMIC status in 2009. Over the last two
geted preventive and acute care for better health decades, pre-COVID-19, it enjoyed an average
outcomes. As this valuable information and data annual GDP growth rate of 6.5%,14 and emerging
circulate safely and securely within the health- from this pandemic crisis, its GDP grew by
care system, from healthcare providers to com- 8.02% in 2022. With a population of 98 million
mercial players, insurance companies, and people in 2021, Vietnam is the 15th most popu-
governmental agencies, it becomes possible to lated country in the world and currently benefits
go beyond health behavior and self-awareness to from its demographic status of a golden popula-
provide on-demand health information and edu- tion structure, with 70% of the population being
cation, and promote accountability with social of working age (18–65 years old) (Fig. 4), con-
support networks, health coaches, and tributing to its economic development. The coun-
providers. try’s rising living standards have increased life
When such digital health solutions are equita- expectancy at birth to 75 years.15 However, popu-
bly implemented and effectively used at the lation growth is now floating at 0.8% per year,16
macro level, they can help prevent, mitigate, and leading to an aging population since 2015.
reduce inequalities in access, quality, and cost. Vietnam is among the fastest aging countries,
For healthcare providers, knowledge transfer and with an expected shift towards an aged popula-
management become more feasible, improving tion from 2035 onwards.17
the workforce’s skills and capabilities, thus
upgrading the overall infrastructure and
resources. In addition, the aforementioned data 13
https://www.imf.org/external/datamapper/NGDPD@
can provide analysis into identifying behavioral WEO/VNM
risks, monitoring patterns and trends of diseases
14
https://data.worldbank.org/indicator/NY.GDP.MKTP.
KD.ZG?end=2019&locations=VN&start=1999
for evaluation and understanding of the relative 15
https://data.worldbank.org/indicator/SP.DYN.LE00.
importance of disease and disability for the entire IN?locations=VN
16
https://data.worldbank.org/country/vietnam
12
h t t p s : / / w w w. w h o . i n t / h e a l t h - t o p i c s / d i g i t a l - 17
https://www.worldbank.org/en/country/vietnam/publi-
health#tab=tab_1 cation/vietnam-adapting-to-an-aging-society
Potential of Digital Health Solutions in Facing Shifting Disease Burden and Double Burden in Low… 61
Fig. 4 Vietnam population age structure, 2023. (Source: Population Forecasting, IHME Viz Hub (healthdata.org))
Rising living standards and the population As a result of its economic development,
structure brought an essential shift in its health- Vietnam has experienced rapid advances in tech-
care landscape and increased healthcare expendi- nology and the country’s overall infrastructure
tures due to surging demand for high-quality has improved. The entire population has access to
healthcare and private healthcare providers, electricity, 73.2% is connected to the internet
namely by the strong middle-income class; but in through 156 million cellular mobile connections
the longer term, the healthcare structure will be (a single individual may have more than a single
tested as the population ages. Another factor subscription) with an average median download
behind this shift in the healthcare landscape, speed of 35.14 Mbps. Amongst internet users
which is also impacted by the country’s eco- (between the age of 16 to 64), 97.6% own a
nomic development, is the shifting disease bur- smartphone, 64% own a laptop/desktop com-
den from communicable diseases to NCDs, that puter, 35.2% own a tablet, 29.9% own a smart-
requires long-term healthcare solutions. The sub- watch/wristband, and 18.6% own a smart home
stantial increase in NCDs is due to people device. This same part of the population also
increasingly adopting unhealthy habits: from a spends an average of 6 h 38 m using the internet,
sedentary lifestyle due to urbanization, decreas- with 76.95 million active social media users
ing levels of physical activity due to new trans- spending an average of 2 h 28 m on social
portation forms such as motorbikes, dietary media.18 This demonstrates the digital literacy of
changes due to the globalization of fast food, and the Vietnamese population and how the internet
high levels of smoking tobacco and drinking is core in both daily life and across all sectors,
alcohol. For example, in 2018, the total alcohol laying solid foundations for digital development
consumption per capita (liters of pure alcohol and adoption of innovative technologies. In par-
consumed by 15+ years of age) was 8.7 liters, allel, Vietnam is pursuing rapid growth in mobile
and in 2020, 24.8% of the population aged communications technologies while shifting
15 years or older smoked tobacco on a daily or
non-daily basis. 18
https://datareportal.com/reports/digital-2022-vietnam
62 H. Vu et al.
3.1 Toward a More High-Income their occupations. It avoids draining the resources
Patient Profile of the provincial and national hospitals, resulting
in better efficiency and cost-saving, as the
Boosted by the country’s socio-economic devel- Vietnamese strongly prefer these hospitals over
opment, the middle class has grown significantly communal health centers that remain highly
in Vietnam and is expected to continue growing, underutilized. As resources are better allocated to
from 10% of the population in 2015 to an esti- new tools to track health outcomes for long-term
mated 50% by 2035.20 This growing middle class, healthcare in a move away from short-term care
along with its rising living standards, is also cor- due to the shifting disease burden, high-income
related with the increase in digital literacy and patients’ demand is growing for better interven-
results in a greater demand for high-quality tions for faster recovery, preventive solutions,
healthcare, private healthcare providers, and the and wellbeing in general. Precision and personal-
incorporation of digital health services. ized medicine, leveraging AI and ML technolo-
Leveraging the development of infrastructure gies, deliver early screening of possible health
and in response to the demand, private hospital risks by combining genomic data and clinical
networks have seen rapid growth, with some histories, offering rapid treatments at early stages,
hospital chains such as Hoan My and Vinmec and promoting behavioral change for better
also achieving international standards such as health outcomes.
Joint Commission International (JCI) accredita- Nevertheless, with the local healthcare sec-
tion. As these hospitals use more advanced tor experiencing capacity constraints and
health management systems and deliver sometimes unable to provide the standards
advanced digital health solutions, high-income demanded by high-income patients, a signifi-
patients increasingly adopt digital health for cant portion of these opt for healthcare solu-
better healthcare outcomes. Patients’ trust in tions in other countries, such as Thailand,
such services increases over time upon satisfac- Malaysia, Singapore, Japan, or the United
tion with the quality, guaranteed through trans- States of America. The main reasons why
parent governance and improving the local patients choose treatment abroad include the
standards to international best practices. In par- healthcare quality and service, the qualifica-
allel, digital tools also enable better patient tion and experience of the healthcare profes-
engagement and trust, with more and improved sionals, the availability of medicines and
direct communication between patients and treatments, and the reputation of healthcare
healthcare providers, telemedicine, and facilities. The amount spent on medical tour-
encrypted EHR. Even public hospitals have ism amounts to two billion USD yearly.
started adopting digital health solutions, enhanc- Given the opportunities from socio-economic
ing operational efficiency and medical out- and technological development and facing the
comes, with more than 92% of them outsourcing challenges of a double burden and inequality,
to local IT companies such as FPT, Link Toan Vietnam is now in a prime position to adopt digi-
Cau, and Dang Quang to develop digital solu- tal health solutions to meet the increasing health-
tions for their facilities. care needs of the population, to face the double
Telemedicine is beneficial because it allevi- burden, and provide equitable and universal
ates the strain on physical medical infrastructure access, with high quality that is both cost-
and avoids the spread of infections. It also allows effective for providers and affordable for patients.
patients more freedom with the timing and loca- This has led the Government to set out an agenda
tion of their consultations which is particularly for bringing digital transformation to its health-
advantageous if they have tight schedules due to care industry, working in a quadruple helix model
(government, businesses, academic institutions,
20
(“Digital Health in Vietnam: A Guide to Market,” Aus-
and society) that makes up the entire healthcare
trade, July 2019.) ecosystem.
64 H. Vu et al.
3.2 Local Digital Health Solutions: that connects both patients and doctors: provid-
Indicative Examples ing space for patients to communicate with doc-
tors for video call consultations and other primary
Various local players, from private healthcare care services, while doctors can expand their
providers to universities, startups, and offshore portfolio by signing up on the portal.
software developers, have taken advantage of the Like other telemedicine platforms around the
favorable factors resulting from the strong socio- world, this solution proved its efficiency during
economic and technological developments to the COVID-19 pandemic by limiting human-to-
develop digital health solutions for both the local human contact and alleviating crowding and
and foreign markets, ranging across numerous constraints in hospitals while maintaining
aspects of the healthcare system. While many healthcare activities remotely, in turn promoting
digital health solutions already exist in the mar- accessibility.
ket (often from HICs), they are often too costly
for local implementation and integration in the 3.2.2 Hanoi Medical University
local healthcare ecosystem remains challenging Hospital (HMUH): Telehealth
without compatible infrastructures. in Action
Many mobile applications are used for tracing The Hanoi Medical University is the oldest mod-
and monitoring infections to help control and ern university in Vietnam, founded in 1902 by the
prevent outbreaks of communicable and infec- French during the French colonization, and it is
tious diseases, e.g., COVID-19 with Bluezone now the most prestigious medical university in
and Ncovi (Vietnam’s medical communication the country. Stemming from its long history, the
information system), and support HIV-infected university and its hospital enjoy a vast depth and
people committed with antiretroviral (ARV) breadth of knowledge and practice rooted in
treatment. In addition, messaging services such excellence.
as Messenger, WhatsApp, Viber, Zalo, etc., have During the COVID-19 pandemic, HMUH
been used for low-cost options to monitor diar- showed strong initiative in digital health solu-
rhea and influenza or update the COVID-19 pan- tions by being the first to launch a telehealth pro-
demic status. Meanwhile, high-quality and gram on April 18th 2020. By leveraging its
advanced healthcare systems have been estab- educational roots and live streaming on Facebook
lished to provide more precise and personalized and YouTube, it provided free education, open
medicine, and are gradually marking the transi- and accessible for everyone, to raise awareness
tion towards preventive healthcare and wellbeing about COVID-19, getting people working
in order to better cope with NCDs. together and learning from each other. With more
centers joining such activities, learning becomes
3.2.1 VieVie Healthcare Co., Ltd: more beneficial through network effects, raising
Telemedicine for Diagnosis awareness of the pandemic (and of communica-
and Patient Care Management ble and infectious diseases in general), and help-
VieVie Healthcare Co., Ltd is a telemedicine ing to bring it under control.
company that was launched in 2017, with invest- As Vietnam lacks medical resources, the dis-
ment by Clermont Group (a private investment parity in medical examination and treatment
group based in Singapore), which also owns the qualifications between commune/district and
Hoan My Medical Corporation, one of the largest provincial/national poses a difficult problem for
private healthcare networks in Vietnam. Through the Vietnamese health sector. Provincial and
the partnership between VieVie and Hoan My national hospitals are overloaded whereas com-
Medical Corporation, the former’s digital health mune and district doctors have little opportunity
services and solutions are fully integrated into the to improve their professional qualifications
hospital network. VieVie offers an online tele- because of a lack of patients. Expanding tele-
medicine platform established as a marketplace health to clinical services will enable experts
Potential of Digital Health Solutions in Facing Shifting Disease Burden and Double Burden in Low… 65
from provincial and national hospitals to give 3.2.4 BuyMed & Thuocsi:
advice in real-time on difficult cases that cannot Pharmaceutical Supply Chain
be reached in district hospitals as immediate In Vietnam, pharmacies commonly operate by
medical response is needed. This helps to miti- purchasing drugs from unlicensed agents. This
gate complications and risks while saving time. poses great risks for the whole healthcare ecosys-
As collaborative work becomes feasible, local tem, consumers, and patients. As a result, health-
healthcare providers can learn from experts, care providers often spend a great amount of time
improving their knowledge and experience and sourcing drugs, which further aggravates the
improving patients’ trust in local healthcare facil- problems due to lack of resources when dealing
ities. This will reduce overcrowding in the larger with health issues.
hospitals and help the experts have more time to BuyMed, founded in 2017, tackles this issue as
research new knowledge and advanced treat- a business-to-business (B2B) pharmaceutical dis-
ments, corresponding to the shifting disease bur- tribution marketplace, leveraging technology to
den. For doctors, every telehealth session is a solve fraud issues and promote verification in
valuable clinical learning session. Each online pharmaceutical supplies. It has connected over
medical examination has thousands of viewers 2000 healthcare providers with verified suppliers.
and tens of thousands of reviewers. Because of Thuosci.vn, founded in 2018, is one of the most
the apparent benefits, HMUH intends to imple- successful startups in medical technology and ser-
ment Continuous Medical Education (CME) via vices, operating as a platform that includes a web-
telehealth and obtain permission from the site and mobile application for providing and
Ministry of Health to issue a CME certificate for distributing drugs and pharmaceuticals to more
each telehealth session. This will be the simplest than 1000 pharmacies and clinics across the coun-
and most effective way for doctors to learn, espe- try. Building on its success, it is currently expand-
cially young doctors, and will help raise the gen- ing its distribution network further to neighboring
eral standard of the entire healthcare ecosystem. countries in South-east Asia, such as Cambodia.
(ImmReg) to replace the old paper-based system. skilled workforce in Japan. There are three main
ImmReg is a web-based application (for both factors contributing to Japanese longevity: equity,
computers and mobile phones) that tracks the the government’s strong intervention, and univer-
vaccination status of children, and in which sal health coverage. With the country pushing for
immunization data can be recorded and accessed the concept of Society 5.0, Japan’s digital health
in real-time. With the addition of an auto-SMS is technology-based, human-centered, and aims
system integrated in 2017 (in cooperation with for wellness and personalization. The group inte-
Vietel and taking advantage of the growth of grates its extensive knowledge of medical and
mobile networks for mHealth) , reminders can be healthcare systems with technology systems
sent via SMS to caretakers for the required vac- ranging from cloud systems, big data, server and
cinations to be administered on time. As a result, system development and maintenance, image
workload burden is reduced, cost-saving is analysis, IoT, and AI to blockchain, leading to the
increased, data recording accuracy is improved, development and deployment of over 250 sys-
and most importantly, immunization rates and tems in over 7000 hospitals/clinics and 3000
timing are improved. With a strengthened quality pharmacies, all in alignment with security and
and effectiveness of immunization programs, it regulatory frameworks, from ISO to Japanese
will be beneficial for the healthcare system to governmental guidelines.
integrate this system into the national health IT Since 2018, with advances in the digitization
and adopt it for other healthcare programs (i.e., of the medical & healthcare industry in Vietnam,
maternal and child health, nutrition or infectious Ominext Group has expanded its operations
disease control), boosting overall efficiency and locally in Vietnam through its subsidiaries to pro-
minimalizing health issues that can be prevented vide medical & healthcare services by creating a
by vaccines. safe, modern, and reliable healthcare ecosystem.
With Ominext’s knowledge and experience from
3.2.6 Ominext Joint Stock Company: having operated in Japan, building a thorough
Promoting Primary Care understanding of the healthcare ecosystem and
By digitizing the medical and healthcare systems, health situation in a highly developed country, it
the information technology system is fundamen- can bring valuable insights to a developing coun-
tal for moving away from analog and legacy try like Vietnam, helping prepare for the future of
approaches.21 Ominext Group22 brings a holistic health as the country pursues its growth and deals
and integrated expertise capable of developing with the shifting disease burden.
and implementing various systems for areas
related to hospitals & clinics, treatment & exami- 3.2.7 Institute of Gastroenterology
nation, medicine, welfare, and patient services, and Hepatology
all as a cost-effective, project-based, and labor Institute of Gastroenterology and Hepatology
outsourcing development solution. (IGH), established in March 2018, is a scientific
Established as an offshore software develop- and technological organization for intensive
ment company providing mainly for the Japanese research and training in digestive and hepatobili-
market, the group has been able to provide for the ary issues. In adopting a patient-oriented, digital
needs of the Japanese market with its aging popu- health solution, IGH opts for mHealth through
lation and digital transformation efforts in all mobile applications, such as GERDcare or a
industries, by building on the ability to provide colonoscopy bowel preparation application, to
outsourced software development at a cheaper help bridge the gap between physicians’ instruc-
cost against high labor costs and a shortage of tions and patients.
For digital health solutions that are doctor-
21
https://www.adlittle.com/jp-en/insights/report/hospital-
oriented, AI tools can be used for clinical d iagnosis
information-systems-digitally-enabled-era in a move towards high-quality precise and per-
22
https://www.ominext.com/ sonalized medicine. Commercial products already
Potential of Digital Health Solutions in Facing Shifting Disease Burden and Double Burden in Low… 67
exist (Fuji Film and Medtronic), but tend to be To support the management, research, and
costly and require compatible infrastructure from services, Vinmec has undergone significant digi-
the same providers, and need continuous updates. tal transformation. A notable example is its in-
With resources already limited, it is more viable house developed mobile application, MyVinmec,
for institutions to develop their own in-house to provide patients with a convenient healthcare
solutions as the development can be controlled experience, from booking appointments to tele-
and the technology owned, providing flexibility in health, medical records, test results, and pre-
integration and decoupling and, most importantly, scription refills. Reducing waiting times and
reducing the cost for primary care facilities. Such improving patient engagement, it enables
projects begin with building a database from patients to track their longitudinal medical his-
scratch, with big data from and for Vietnamese tory, marking the transition from looking after
people, training the system to tag possible issues illnesses and their treatment to preventive care
for diagnosis while promoting ongoing communi- and wellbeing. Meanwhile, for the practitioners,
cation between the IT and data science teams. The this increases efficiency and alleviates resources,
collected data will be used for further studies and allowing better focus on other advanced health-
educational purposes, supporting primary care. care activities. In addition, the hospital group
However, there are important challenges: building has adopted a picture archiving and communica-
the database is time-consuming (1 year for setting tion system (PACS) to digitize the traditional
up the standards and training for judgment), and films, providing instant access to medical
resources remain limited, even for in-house devel- images, which coupled with AI-assisted X-ray
opment. While the side-product can be used for diagnostics, helps diagnose conditions rapidly
training programs, with the data being used for and accurately. Outside of these two major
education and investigation, the whole study actors, Vinmec has also established a digital con-
remains at a very early stage. nection with healthcare insurance providers,
allowing insurance claims to be processed
3.2.8 Vinmec directly in less than an hour, further boosting the
Vinmec is a non-profit healthcare system estab- efficiency for all stakeholders.
lished in 2012 as a subsidiary of Vingroup (the
largest conglomerate in Vietnam). It currently
operates seven international-standard hospitals. 4 Conclusion
With the aim to improve patient outcomes and
advance healthcare in Vietnam, Vinmec has been LICs and LMICs face a particular set of interre-
working to continuously deliver international lated challenges. Despite the socio-economic
standards through advanced healthcare models, development they may be enjoying, strong
research, and embraced digitization to improve inequalities persist on many levels that tend to
and create new solutions that also correspond to impact the population’s health negatively. The
the increasing consumer demand. general healthcare ecosystem remains underde-
To deliver a value-based and patient-centric veloped, with a weak infrastructure and a lack of
care, Vinmec implemented P4 medicine, with the resources. On the other hand, due to various driv-
emphasis on personalized, predictive, preventive, ers, the countries experience a shifting disease
and participatory care, employing various digital burden, with an increase in NCDs while commu-
tools, such as AI and big data, for advanced nicable diseases remain prevalent, leading to a
healthcare activities that include genetic testing double burden. In turn, this double burden adds
and molecular diagnosis. These practices enable pressure to the already strained healthcare eco-
the tailoring of treatments for individual patients, system, stretching resources thin and challenging
a desirable procedure for high-income patients the infrastructures. The result is that healthcare
and for better healthcare outcomes in tackling providers and policymakers will be unable to get
NCDs in particular. the best results when tackling the double burden,
68 H. Vu et al.
which is the central issue. This will fuel further For this to become a practical reality, it is
inequalities, which may ultimately impede socio- essential to first gain a deep understanding of the
economic development. This situation may result health inequalities and how digital health may
in a vicious cycle that worsens the situation on all prevail in this area. In the next chapter we will
fronts. explore this theme in more depth.
Fortunately, other factors exist that can help
avoid such a vicious cycle by alleviating these Acknowledgments We are very thankful to Dr. Dao Viet
difficulties. Many of these will be fueled by digi- Hang (IGH) and Mr. Tran Quoc Dung (OmiNext) for their
time and expertise.
tal health that offers various solutions to help
tackle the shifting disease burden and double bur- Conflicts of Interest HV and NXH are employees of
den, while improving the healthcare ecosystem Vinmec Healthcare System; NLH is an employee of
and responding to the increasing demands of cus- Hanoi Medical University Hospital; All other authors
tomers and patients. These solutions help provide have no conflicts of interest.
There is no financial or non-financial support for any
equitable and universal access to quality health- of the authors of this chapter for their contribution to this
care, that are both cost-effective and affordable, work. All healthcare examples have been used for illustra-
and can turn the potentially vicious cycle into a tive purposes with the information being correct at the
virtuous cycle, leading to further socio-economic time of publication.
growth. It was for this reason that indicative
Disclaimer The opinions expressed in this chapter are
examples were presented in this chapter, these those of the authors only. They do not purport to reflect
are not the only ones that exist but are used sim- the opinions or views of their affiliated organizations.
ply to illustrate the point.
Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
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obtain permission directly from the copyright holder.
Health Inequalities
and Availability: Needs
and Applications
tions (Smith 1999). Global income inequality This chapter initially explores how the con-
contributes to healthcare provision disparities, cepts of healthcare inequality and inequity are
with approximately 71% of the world’s popula- exerted and provides examples of how medical
tion living in countries with high levels of digitalization is implemented in LMICs.
inequality and where out-of-pocket payments for International and national responses to health
healthcare are a common practice (Gottret and inequalities that are impacting digitization efforts
Schieber 2006). Urbanization further contributes and the role of human rights towards achieving
to growing disparities within cities, where wealth the effective and widespread provision of high-
and modern infrastructure coexist with severe quality healthcare services are also addressed.
deficiencies in proper healthcare. Consequently,
this societal gap generates a healthcare gap
directly affecting the overall quality of life in citi- 2 The Concepts of Health
zens of developing nations. Therefore, despite Inequality and Inequity:
global improvements in life expectancy Their Role and Impact
(Crimmins 2015), infant mortality rates, and can-
cer outcomes, these positive trends are not uni- The concepts of health inequality and health
formly observed globally (Fauconnier 2019; inequity play a vital role in the global effort to
Roser et al. 2013). support LMICs in achieving satisfactory health-
To bridge the healthcare gap, LMICs cannot care services and improving healthcare systems.
rely solely on their own resources. A coordi- These concepts have gained broad recognition
nated global effort that will advance key compo- and are addressed by various international orga-
nents and digitalization mechanisms of existing nizations, such as the World Health Organization
healthcare systems is a critical step to ensure (WHO) (WHO 2023), United Nations
that LMICs can keep pace with the rest of the Development Programme (UNDP) (Kivioja et al.
world in providing satisfactory healthcare ser- 2023) and United Nations Children’s Fund
vices and extend their involvement in scientific (UNICEF) (UNICEF 2016). Health inequalities,
excellence. In this regard, it is essential to high- as defined by WHO “are the differences in health
light the several needs of such healthcare sys- status between groups of people which are impor-
tems, including the establishment of suitable tant, unnecessary, unfair, unjust, systematic, and
infrastructures, enhancement of the healthcare avoidable by reasonable means. They can be
workforce, increase in health education and observed between populations and groups within
awareness, and adoption of relevant digitaliza- populations and as a gradient. They can also be
tion mechanisms such as EHRs, telemedicine, observed between countries and regions. They
and healthcare mobile applications. Strategic are linked to social, economic, and environmen-
implementation of such requirements is crucial tal conditions, the conditions in which we are
to effectively address the specific challenges born, grow, live, work and age”. On the other
faced by these countries. Likewise, it is essen- hand, “health inequities are differences in health
tial to address the issue of digital literacy of the status or in the distribution of health resources
population, particularly among healthcare pro- between different population groups, arising
fessionals. While this chapter focuses on medi- from the social conditions in which people are
cal digitalization mechanisms, it is important to born, grow, live, work and age. Health inequities
note that physical infrastructures, including are unfair and could be reduced by the right mix
medical equipment and hospitals, are essential of government policies” (World Health
components of this endeavor, as they play an Organization 2023).
equally significant role in achieving the equita- The distinction between healthcare inequali-
ble provision of healthcare services and sup- ties and inequities stems from their underlying
porting the effective implementation of these causes and the implications they have on fairness
digital mechanisms. and justice in healthcare. Failure to comprehend
Health Inequalities and Availability: Needs and Applications 71
the concept of health inequity in LMICs can per- policymakers and healthcare stakeholders to
petuate systemic disparities, hinder policy advance appropriate and targeted interventions
responses, misallocate resources, erode social and policies.
cohesion, impede economic development, and
undermine international cooperation (Andermann
2016). For example, maternal and child health 3 International and National
disparities remain prevalent in LMICs due to lim- Responses to Health
ited access to healthcare services, malnutrition, Inequalities
low educational attainment, and poverty (World
Health Organization 2015). Likewise, dispropor- Despite the acknowledgement of the distinction
tionate rates of the prevalence of infectious dis- between health inequalities and health inequities
eases such as HIV/AIDS, tuberculosis, and in several published documents, there is lack of
malaria, persist among disadvantaged popula- sufficient reflection regarding this issue in the
tions (World Health Organization 2021). Non- international and national responses aimed at
communicable diseases, including cardiovascular tackling these challenges. Efforts to address
diseases, diabetes, and cancer, disproportionately health inequalities have been evident at both the
impact marginalized groups on top of an underly- international and national levels since the 1980s
ing gender dimension (Namasivayam et al. 2012). (Albert-Ballestar and García-Altés 2021). Due to
Moreover, exposure to environmental health haz- the complexity of the factors contributing to this
ards, such as air and water pollution, poses addi- challenge, no single solution is available, and it is
tional health risks in communities where relevant now clear that collaborative efforts are needed
regulations or monitoring are not a state priority from world citizens, private entities, and a pleth-
(UN DESA 2020; Scheil-Adlung and Kuhl ora of government sectors such as finance, eco-
2011). To this end, recognizing and proactively nomics, social welfare, and healthcare (World
addressing health inequities is crucial for address- Health Organization 2023). To strengthen these
ing deep-rooted health disparities. collaborative efforts, international and national
While the concepts of healthcare inequality organizations work together with governments
and healthcare inequity are closely related and for creating and implementing policies aiming to
are often used interchangeably, they have distinct deliver the essential conditions for a healthy liv-
roles in promoting understanding and impacting ing environment. The United Nations and WHO
the development of healthcare policies, particu- play a critical role in coordinating global initia-
larly in LMICs. This includes the introduction tives and in supporting the global community to
and implementation of digitalization mechanisms gain access to data from various sources that
in medicine. Introducing the concept of equity as revealed and produced renewed evidence about
a core value in the digitalization of medicine, we the magnitude of health inequalities and the dis-
can actively promote social responsibility, inclu- parities that are on the rise (Barreto 2017).
sivity, and ethical practices in the digital health In 2015 the United Nations adopted 17
domain (Yao et al. 2022). Equity may serve as a Sustainable Development Goals (SDGs) as a uni-
motivation for societies, policymakers, and stake- versal call to action towards eradicating poverty,
holders to not only promote the digitalization of protecting the environment, and enhancing the
medicine but also to consider and prevent any quality of life for all people worldwide with a
adverse effects that may arise from technological 15-year plan to achieve them (United Nations
interventions (Yao et al. 2022). Emphasizing 2023). Each goal is accompanied by a set of indi-
equity in digitalization efforts plays a crucial role cators that aim in measuring progress made in the
in creating more just and inclusive healthcare 193 countries that have agreed to work toward
systems. Thus, to narrow the healthcare gap, it is achieving the goals, and a report on global and
crucial to comprehend the role and impact of national progress is released annually. The SDGs
each concept. This understanding will enable serve as a framework for addressing health and
72 G. Charalambidou et al.
social inequalities on a global, national, and local medicine and healthcare stands as a crucial fac-
level. All the goals aim to address the root causes tor. However, the availability of digitalization in
of health inequalities in such sections as poverty, these countries depends on various factors includ-
justice, peace, climate change, and environmen- ing limited internet accessibility and bandwidth,
tal degradation. Significantly, one adopted goal funding, availability of experts, and policy sup-
focuses directly on health (SDG3 Good Health port. Nonetheless, once digitalization and new
and Wellbeing), and among others a target (3.8) technologies such as EHRs, telemedicine, and
has been set for it to achieve Universal Health healthcare mobile applications are successfully
Coverage (UHC) for all including financial risk implemented, many of these challenges could be
protection, access to quality essential health-care overcome (Holly et al. 2022; Devi et al. 2020).
services and access to safe, effective, quality, and A crucial step towards achieving digitalization
affordable essential medicines and vaccines (UN is to replace the traditional paper-based health
2022). records with Electronic Medical Records (EMRs)
In addition, WHO created a Health Equity and thereinafter to EHRs. This shift is expected
Policy Tool (2019) to assist Member States and to reduce bureaucracy, and operational costs, and
partners in monitoring, implementing, and contribute towards achieving effective health-
enhancing policy actions to address the five iden- care. Electronic systems offer numerous advan-
tified fundamental conditions for a healthy living tages like scalability, backups, enhanced security,
(including access to health care services), ulti- time efficiency, consistent layouts, clear audit
mately leading to a reduction in health inequali- trails, and version history (Mathioudakis et al.
ties (World Health Organization 2023). 2016). They address concerns regarding the
Furthermore, WHO regional offices (e.g., Europe availability and accessibility to services like
(World Health Organization | Regional Office for scheduling appointments, accessing medical
Europe 2023), Pan-American (Pan American records and obtaining medical advice. For exam-
Health Organization (PAHO) 2023), and Africa ple, effective access to medical records in many
(World Health Organization | Regional Office for countries can often be challenging due to ineffi-
Africa 2023)) have examined the primary causes cient technologies or limited funding. Therefore,
of health inequalities in their regions, evaluated the development of cost-effective health informa-
the available factors contributing to these inequal- tion systems (HIS) (Koumamba et al. 2021) and
ities, and launched regional programs to target integration of the information through an EHR,
them. along with the establishment of regulations for
Even though most countries have not given data privacy and security will consequently ele-
health inequalities a prominent position on their vate patient healthcare (Akwaowo et al. 2022).
political agenda, numerous policy suggestions One of the most significant benefits of digita-
have been put forward on an international and lization is its potential to increase access to
national level and available evidence has been healthcare services. Telemedicine is a cost-
utilized for incorporating actions into country effective technology compared to traditional in-
healthcare policies that in some cases were able person visits and can help bridge the gap and
to partially diminish inequalities (Barreto 2017; increase access to healthcare services. In particu-
Mackenbach 2020). lar, 3.4 billion people (around 45% of the global
population) who live in rural areas of LMICs can
have access to medical care by using telemedi-
4 Digitalization Levels cine tools or applications, and dedicated support
and Initiatives is further available for chronic patients through
at-home monitoring systems (Ftouni et al. 2022).
While LMICs actively strive to address health Telemedicine can also help in resource allocation
inequalities and improve healthcare access, qual- with higher effectiveness, by minimizing the
ity, and cost-effectiveness, the digitalization of number of unnecessary visits and tests, while
Health Inequalities and Availability: Needs and Applications 73
putting high-risk patients who need timely inter- healthcare services and make payments through
vention in priority (Lupton and Maslen 2017; their mobile phones. Moreover, Kenya has
Combi et al. 2016). brought forward additional solutions, such as the
Another significant mechanism is the develop- application of several mHealth initiatives, includ-
ment of healthcare mobile applications (mHealth) ing the mPedigree platform, which enables
designed for various purposes, including clinical patients to use their mobile phones for verifying
reference, telemedicine, health management, and the authenticity of their medications (Hategeka
to track wellness and fitness levels (Ventola et al. 2019; Kizito et al. 2013).
2014). These applications improve patient In conclusion, the importance of digitalization
engagement through mobile apps or text messag- for medicine/healthcare cannot be overstated.
ing, reduce the risk of misdiagnosis, provide Healthcare systems have the potential to be revo-
immediate access to care, offer automated lutionized through the application of digital tech-
reminders, enhance data management by inte- nologies for improving healthcare access and
grating with EHRs, and enable real-time moni- enhancing health outcomes. While there are
toring through healthcare Internet of Things many promising initiatives aimed at promoting
(IoT) implementations (Dendere et al. 2019). digitalization in healthcare, there is still a long
These apps contribute to personalized healthcare way to go in terms of achieving universal access
by allowing patients to access their medical to digital health services in LMICs. All countries,
records, communicate with healthcare providers, irrespective of income levels, must continuously
and manage their health conveniently and invest in digital technologies to improve their
efficiently. healthcare systems by ensuring adequate funding
In addition, the significant challenge posed by to develop and maintain a digital health infra-
the limited accessibility of many LMICs to essen- structure and align with current technological
tial medications can be addressed through digita- advancements (Drury et al. 2018). Addressing
lization, especially for the improvement of supply the barriers to digitalization in healthcare will
chain management. Inevitably, digitalization require a collaborative effort among govern-
maintains a crucial role in ensuring transparency ments, healthcare providers, and other stakehold-
and accountability for supply chain procedures, ers, as well as a commitment to ensuring that the
mitigating potential delays and inefficiencies, benefits of digitalization are accessible to all.
and in preventing the illicit diversion of drugs to
the black market (Beaulieu and Bentahar 2021).
Rwanda is an example of a country that made 5 Human Rights
significant investments in electronic health infra- as a Supportive Mechanism
structure, including the implementation of elec- to the Digitalization
tronic medical records and a national health of Medicine in LMICs
information exchange. Such interventions include
the mHealth RapidSMS and the TRACnet plat- Human rights are universally applicable and can
forms, which allow healthcare workers to collect play a key role in advancing equity in LMICs
and share healthcare data in real-time and to track through the digitalization of medicine. States
disease outbreaks and monitor patients’ health, assume obligations and duties under international
respectively. This advancement has enabled law to respect, to protect and to fulfil human
healthcare providers to access patient health rights by ratifying international treaties and con-
information from anywhere in the country and ventions. The principle of universality is a core
has improved the quality of care for patients. principle of human rights recognized and
Kenya is a developing country that also imple- endorsed by the international community (UN
mented several digital health initiatives, includ- 1948). Universality ensures that human rights
ing the National Hospital Insurance Fund (NHIF) apply to all individuals, irrespective of their
mobile platform, which allows patients to access nationality, race, gender, religion, or any other
74 G. Charalambidou et al.
characteristic and varying levels of development, The right to private life assumes particular sig-
political systems, and socio-economic conditions nificance in the digital era, where health data can
of countries (UN 2023). Human rights also be easily accessed and shared, necessitating spe-
enshrine other principles such as indivisibility, cial safeguards and attention for LMICs. Article
equality, and non-discrimination, participation, 17 of the International Covenant on Civil and
accountability, transparency, rule of law, and Political Rights (ICCPR) explicitly states ‘No
human dignity. These principles provide a just one shall be subjected to arbitrary or unlawful
and fair regulatory framework to facilitate interference with his privacy, family, home or
responsible and ethical utilization of digital tech- correspondence, nor to unlawful attacks on his
nology in medicine and biomedical research. honor and reputation’ (UN 1966b). Similarly, the
Such a framework is critical in these countries, right to respect for private life is guaranteed at the
where the vulnerabilities within their populations European level under Article 8 of the European
and healthcare systems are significantly diverse Convention of Human Rights (ECHR) (1950). In
and more pronounced than elsewhere in the May 2018, the General Data Protection
world. The right to health and the right to private Regulation (GDPR) (2016) was put into effect
life, for example, can be instrumental in narrow- providing comprehensive data protection in
ing the healthcare gap through the digitalization Europe and establishing principles for processing
of medicine and biomedical research. of health data. Digitalization of medicine raises
The right to health stands out as one of the ethical, legal, and social issues (ELSI) that
most significant human rights and it is recognized require careful consideration. These concerns
as a fundamental human right under international encompass issues related to data privacy and
law by several international human rights instru- security, the potential for bias and discrimination
ments (UN 1948, 1966a). Article 12 of the in algorithms and decision-making, and the need
International Covenant on Economic, Social and to ensure that digital health technologies are
Cultural Rights (ICESCR) recognizes ‘the right accessible and affordable for all individuals.
of everyone to the enjoyment of the highest Both the right to health and the right to privacy
attainable standard of physical and mental are important in the global efforts to narrow the
health.’ This includes the right to access quality healthcare gap. To promote and implement digi-
healthcare services, medicines, and facilities talization in medicine, it is imperative to establish
without discrimination, as well as the right to a regulatory framework rooted in human rights
information related to health, participate in principles. Such principles ensure the responsible
decision- making about one’s health, live in a and ethical use of digital technology in medicine
healthy environment and have an adequate stan- and biomedical research, while fostering its
dard of living. The right to health plays a crucial acceptability due to the universal applicability of
role to the digitalization of medicine and biomed- human rights. In addition, concerns regarding
ical research by embedding relevant human rights data protection and informed consent in the utili-
principles into the regulatory frameworks. By zation of digital technology can be effectively
doing so, it would promote effective and proper addressed and at the same time they will promote
digitalization of medicine in LMICs, aligning trust within the society.
with core values and standards. The rights to
health and digitalization of medicine are mutu-
ally supportive. Digitalization can contribute to 6 Conclusion
the implementation of this right by improving
access, quality, and affordability of healthcare Moving towards the era of precision and person-
services. Significantly, it ensures that the benefits alized medicine, the concept of digitalization in
of digitalization are accessible to all, with partic- medicine, and in extent of biomedical research,
ular attention to marginalized and disadvantaged inescapably becomes critical. As LMICs employ
populations. smart, user-friendly, and interoperable digital
Health Inequalities and Availability: Needs and Applications 75
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of inequality and inequity impede LMICs from minants of health in clinical practice: a framework
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Needs of Healthcare and Medical
Research Digitization
in Developing Countries: Digital
Health Infrastructure
1 Introduction
O. Vandenberg
Center for Environmental Health and Occupational
Health, School of Public Health, Université Libre de The recent pandemic has demonstrated the fragil-
Bruxelles, Brussels, Belgium ity of global healthcare systems, especially in
Research & Technology Innovation, Laboratoire Low-and Middle-Income countries (LMICs).
Hospitalier Universtaire de Bruxelles - Universitair The need to strengthen LMIC healthcare sys-
Laboratorium Brussel (LHUB-ULB), Université tems’ resilience is not a new concept, but has
Libre de Bruxelles, Brussels, Belgium
existed for a number of decades (Mabey 2004),
Division of Infection and Immunity, Faculty of summarized in 2009 in a seminal publication by
Medical Sciences, University College London,
London, UK
the World Health Organization (WHO) on
‘Systems thinking for health systems strengthen-
Z. Kozlakidis (*)
International Agency for Research on Cancer, World
ing’ (De Savigny and Adam 2009). This concept
Health Organization, Lyon, France was iterated through the recent infectious disease
e-mail: [email protected]
the smaller ones (e.g., in peri-urban or rural set- course, implementation of digitization initiatives
tings) at risk of being left behind (Vandenberg between different tiers of healthcare is more
et al. 2020). New and usually quite complex tech- complex than within the same tier (Eboreime
nologies already require (multiple) accreditation et al. 2019). Thus, adequate pre-intervention
levels to comply with European Conformité planning, understanding, and engaging the vari-
Européenne (CE) or American Food and Drug ous interests across the governance structures are
Administration (FDA) guidelines, thus the imple- key to improving the potential adoption and suc-
mentation capacity within many LMIC settings is cessful implementation.
prohibitive. The second key structural need for digital
health infrastructure is the availability of ‘tropi-
calized’ equipment consumables and techniques,
3 Identifying the Key i.e., that would be able to operate within the tech-
Structural Needs nical challenges of LMICs without compromis-
ing the quality of the technical output (Tran 2016;
As digital health interventions and electronic Sankaran et al. 2010). This is process that can
clinical decision support algorithms (CDSAs) in often be considered as ‘reverse-innovation’ or
primary healthcare is identified by the WHO as ‘bottom-up’ innovation (Trimble and
key accelerators in achieving the 20,230 Govindarajan 2012), where available core tech-
Sustainable Development Goal 3 of ensuring nologies are available on-site in LMICs, and
good health and wellbeing for all, digitalization undergo iterative rounds of co-design, adaptation
should enable the emergence of small scale, cost- and improvement so that aspects are optimized
effective, semi-autonomous and decentralized for the local operational contexts. In some cases,
clinical laboratories within LMICs. such a process can also result in the local produc-
Most large urban centers in LMICs have a tion, disposal and/or distribution of resulting
healthcare structure that spans primary to tertiary product variants (Naseri 2022; Sankaran et al.
healthcare facilities. While the capacity may be 2010). There are of course additional require-
limited, and the local population under-served, ments, beyond the co-design process, such as the
the healthcare structure exists and has a blueprint understanding of non-expert user and training
for directional growth at each healthcare provi- requirements, so that the need for future technical
sion level (Nugraha et al. 2017; Massoud 2008). support can be estimated. The use of digital
Digitalization can enable further expansion at the health by non-expert users through the innovative
primary healthcare level, i.e., the entry point to smartphone algorithm using point-of-care testing
healthcare for the majority of the population at district hospital level has already demonstrated
(Rawat et al. 2023). Smaller scale units can be its added value in the clinical management of
created, operated by basically trained staff that children suffering from febrile illnesses, in par-
are digitally connected with larger units that pro- ticular by improving the rational use of antibiot-
vide the support as and when required. This cost- ics (Keitel and D’Acremont 2018; Tan et al.
effective approach has been implemented for 2023).
some existing initiatives as a way of scaling-up Finally, a key point is the need for field perfor-
(Bhattarai et al. 2022; Rodriguez-Villa et al. mance studies on LMICs for implementation of
2020). Such approaches can be adapted to accom- digitalization applications. The existing data,
modate inexpensive and robust techniques. The though very interesting, is incomplete and piece-
digitalization aspect will provide the necessary meal within regions, reflecting the vertical pro-
standardization of service provision and connec- grams driving such initiatives, as opposed to a
tivity with other services, while the infrastruc- broader healthcare system view (Keitel and
tural focus will be centered on technical D’Acremont 2018; Tan et al. 2023; Lazuardi
components such as accessibility to digital appli- et al. 2021). While individual solutions are
cations and to cloud/internet infrastructures. Of unlikely to engage a wide adoption within an
80 O. Vandenberg and Z. Kozlakidis
low-and middle-income countries. Imperial College a lancet oncology commission. Lancet Oncol
London, London 23(6):e251–e312
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Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license,
unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons
license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
obtain permission directly from the copyright holder.
Digitization of Healthcare
in LMICs: Challenges
and Opportunities in Data
Governance and Data
Infrastructure
healthcare, digitalization was brought to the fore- is defined as the strategic development and
front. A dedicated G20 global digital health sum- deployment of technology in healthcare and
mit in 2020 produced the Riyadh declaration (Al health to achieve health equity (Shelton 2021),
Knawy et al. 2020), a landmark consensus having four core components: (i) education, (ii)
statement for the future directions on digital
data trust, (iii) measurability and (iv) explainabil-
health (Al Knawy et al. 2022). Further details on ity (Rhee et al. 2021). In this chapter, we will
the Riyadh declaration and how this has driven focus on the aspects of techquity that relate to the
digitalization forward in Saudi Arabia are pro- data trust, and how this is interlinked with the
vided in Chap. “The Emergence and Growth of existing data infrastructures. Many of the exam-
Digital Health in Saudi Arabia: A Success Story” ples will relate to low- and middle-income coun-
of this book. tries (LMICs) in Latin America, highlighting the
Approximately 30% of the world’s data vol- diversity of context, approaches, challenges and
ume is currently being generated by the health- opportunities.
care industry. By 2025, the compound annual
growth rate of data for healthcare is expected to
reach 36%. That’s estimated by some to be 6% 2 Healthcare Data
higher than industrial manufacturing, 10% higher Infrastructure
than financial services (Coughlin et al. 2018). In
the USA, as well as Canada, COVID-19 acceler- In general, healthcare data infrastructure follows
ated the healthcare digitisation process, as the a similar pattern in most locations (Ozaydin et al.
pandemic necessitated additional investments in 2020). Healthcare data is collected continuously
public health infrastructure for diagnosis, tracing in four distinct areas: (i) administrative, (ii) clini-
and reporting purposes. However, the digitisation cal data (including imaging and -omics data), (iii)
process had already started and was on solid decision-support systems that provide interoper-
foundations. Specifically, the 2009 HITECH Act, ability with (i) and (ii), and (iv) research data and
allowed the majority of USA hospitals and ambu- data analytics platforms, that rely on interopera-
latory care practices to introduce and incorporate bility primarily with (ii) and (iii) and less so with
a basic level of electronic healthcare record (i). While the impact of the pandemic has touched
(HRE) use. Subsequent years focused on interop- all four areas of healthcare data infrastructure;
erability and in enabling electronic access to the relative impact on each aspect was highly
health data (Adler-Milstein 2021). Taken dependent on the local context. Thus, digitaliza-
together, these actions have catalyzed private- tion in healthcare, as well as the impact of the
sector digital health efforts, which have expanded pandemic on healthcare data infrastructure are
in scale and scope (Rock Health 2023), comple- highly variable globally.
menting the public health sector investment in For example, in Brazil, the main healthcare
healthcare research (Baumgart 2020). databases are generated by the Brazilian unified
However, healthcare digitalization has not national health system [Sistema Único de Saúde
been equally attempted and available globally. (SUS)] (de Mello Jorge et al. 2010), classified
Chapter “Biobank Digitization in Low-Middle into: (1) epidemiological, used for surveillance
Income Countries (LMICs): Current and Future and research; (2) administrative, used for
Technological Developments” of this book pro- accounting; and (3) clinical, used to store the
vides a scoping review on the digital divide based patient data (Souza et al. 2016). In addition, data
on technological development and availability, relevant to healthcare is also generated and man-
and how infrastructural requirements are an aged by other departments, such as the Ministry
important limiting factor to such digitalization of social development, for provision of social ser-
attempts. The term “techquity” is frequently used vices, and others, summarized by Ali et al.
to describe this overall digital divide. Techquity (2019). In Mexico, the Coordination of the
Digitization of Healthcare in LMICs: Challenges and Opportunities in Data Governance and Data… 85
National Digital Strategy (CNDS), as part of the particular within developing economies, where
Office of the President of Mexico, is responsible mobile connectivity is transforming local mar-
for designing, establishing and maintaining the kets and capacities rapidly (however, there has
national digital infrastructure for the objective of not been an estimate as yet, on the level of com-
securing the country’s innovation and develop- pletion/adoption of this global strategy). Four
ment (Arpi n.d.), in coordination with the guiding principles were outlined to orient the
National Commission for Bioethics (de Chavez global strategy towards the appropriate and sus-
et al. 2017). The latter provides qualified direc- tainable adoption of digital health technologies
tions and guidelines in the manner in which within the contexts of national health sector and
healthcare data is used and can be used, for strategies (Table 1).
example, providing advice on the regulation and However, as part of the implementation of the
governance of artificial intelligence (AI) in digital health strategies, the consensus is that
healthcare. Mexico and Brazil offer the two most legal and ethical frameworks will be created, sup-
advanced such examples in the Americas, beyond porting and regulating the emerging sets of
the USA and Canada (Tentori et al. 2020). For the healthcare activities, as well as the novel fields of
remaining countries in the Americas, the health- the healthcare market (World Health Organization
care data infrastructure is more fragmented, i.e., (WHO) 2021; Thomason 2021). For example, to
with fewer integrated systems within a unified harness existing datasets, abundant medical data
healthcare system, and in some cases such infra- would need to be made readily accessible to
structure may be entirely absent (Curioso 2019). researchers and the private sector, under defined
Thus, this part of the world offers a representative conditions of access, sharing and use.
image of the global picture. Additionally, the emergence and persistence of
healthcare data marketplaces will be an inevita-
ble outcome to making healthcare data accessible
3 Healthcare Data Policy and interoperable. Thus, important questions
and Governance remain, such as the monetization of healthcare
data, secondary use of healthcare data, and return
In 2019 the World Health Organization (WHO) of incidental findings. These all require, if not a
published the “Global strategy on digital health legal framework, a set of national guidelines link-
2020–2025”, endorsed by the 73rd World Health ing to the wider healthcare provision. As an
Assembly [decision WHA73 (Monraz-Pérez example of monetization, the value of healthcare
et al. 2021)] (World Health Organization (WHO) data has been calculated in real-terms by Roche’s
2021), and echoed in the “Plan of Action for acquisition of Flatiron, the latter combining
Strengthening Information Systems for Health extensive sets of patient data, an electronic
2019–2023” published in the same year by the healthcare record (EHR) as well as an oncology
Pan American Health Organization (PAHO) (Pan platform. Based on the published records, a value
American Health Organization (PAHO) 2019). In of USD 950 per patient record was estimated as
this global view, digital health is positioned as the part of the agreement (Thomason 2021; Wayman
game changer for effective healthcare delivery, in and Hunerlach 2019). However, such an invest-
Table 1 The four guiding principles of the WHO’s Global strategy on digital health 2020–2025
Principle
1 Acknowledge that institutionalization of digital health in the national health system requires a decision and
commitment by countries.
2 Recognize that successful digital health initiatives require an integrated strategy
3 Promote the appropriate use of digital technologies for health
4 Recognize the urgent need to address the major impediments faced by least-developed countries
implementing digital health technologies
86 Z. Kozlakidis et al.
ment formulates the exception of healthcare data mendations by the national Ministry of Health. In
monetization currently rather than the rule, per- June 2020, a document titled “Contact unit for
haps limiting further such transactions by the remote interconsultation (UCID) Mexico: atten-
lack of relevant legal frameworks. tion to chronic diseases” was published, which
consolidates guidelines on teleconsultation and
promotes the use of telemedicine in the treatment
4 Observed Regulatory of chronic diseases (Aizenberg 2023). However,
Challenges this still falls short of consolidating the expertise
of a decade of digital health implementation and
In the Americas, in particular Latin America, provision within a legal framework. Camacho-
healthcare systems are highly fragmented Leon et al. provide an excellent narrative review
between public and private institutions, with of the current status, where it becomes evident
the quality of healthcare systems generally con- that the example from Mexico is a typical one for
sidered superior in private institutions. The the region (Camacho-Leon et al. 2022).
overall investment in Latin America’s public Importantly, the lack of a dedicated and/or
healthcare systems is estimated to be low, as updated legal framework impedes the sharing of
compared to other global regions, resulting to healthcare data across jurisdictions. In the short-
an even greater inequity in care (including digi- term this may put patient data confidentiality into
tal healthcare) across public and private institu- question, and in the longer-term may be a critical
tions (Kanavos et al. 2019; Atun et al. 2015; limiting factor in addressing techquity, as inabil-
Organisation for Economic Co-operation and ity to share healthcare data means that these pop-
Development (OECD) 2020). This was further ulations would be under-represented in the global
accentuated during the COVID-19 pandemic, databases.
where Latin America recorded over 27% of the It is important to note that regulation is a chal-
cumulative global death toll (Ezequiel et al. lenge linked to a matrix of challenges that would
2021; Camacho-Leon et al. 2022). Therefore, need to be considered/addressed concurrently.
the creation of a regulatory framework as a sup- For example, for digital healthcare such chal-
port tool for the digitalization of healthcare and lenges would be the: unrealistic expectations,
the development of techquity, based on local biased and non-representative data, inadequate
capacities and addressing local needs, is criti- prioritization of equity and inclusion across the
cal. Having said that, a number of challenges population entailing the risk of exacerbating
remain. health care disparities, low levels of trust regard-
Most Latin American countries (notable ing the use of healthcare data, and inadequate
exceptions are Bolivia and Honduras) have some evaluation of implemented initiatives. The USA
form of regulation regarding healthcare data, National Academy of Medicine has produced a
telemedicine, and patient data protection high-level document describing many of those
(Camacho-Leon et al. 2022). These laws tend to challenges in detail and how they could be
be expanded in their implementation to encom- addressed both in isolation as well as part of a
pass digital healthcare applications; however, wider approach (National Research Council
they are not specifically designed to address 2009).
those emerging challenges and opportunities, and
can lead to regional interoperability restrictions.
For example, Mexico does not have specific regu- 5 Local Context
lations for telemedicine, even though over 5.5 m
telemedicine consultations were reported in 2020 Finally, the pandemic demonstrated the impor-
alone (Monraz-Pérez et al. 2021), and has been tance of local context in relation to the effective-
included in public policies since 2015 with ness of implemented digital healthcare.
accompanying published guidelines and recom- Specifically, a number of Latin American coun-
Digitization of Healthcare in LMICs: Challenges and Opportunities in Data Governance and Data… 87
tries (Perú, Argentina, Bolivia, Chile, Ecuador, supportive regulatory frameworks, however,
México, Colombia and Brazil) and the Inter- implementation is still lacking.
American Development Bank deployed digital The acute need for training and building the
applications for the surveillance of viral trans- digital literacy capacity of healthcare profession-
mission through testing and tracing. However, als in Latin America (Luna et al. 2014), presents
they collaborated with private companies and/or a unique opportunity to design and provide
universities in each country, resulting in the capacity-building activities that could reach very
release of different platforms (Benítez et al. large numbers of professionals. For example,
2020). However, these platforms did not perform PAHO developed virtual courses (e.g., “eHealth
as well as originally anticipated due to poor reach for Managers and Decision Makers”; “Access
and limited effectiveness of mobile technologies, and Use of Scientific Information on Health”,
as well as the inability of Latin American health- and others) available through the Virtual Campus
care systems to provide follow-up services. of Public Health, and already accessed by thou-
Additionally, the massive population surveillance sands (Novillo-Ortiz et al. 2016). The pandemic
assumed a different dimension than similar has highlighted this need for education across
efforts in Europe and North America, with height- many different populations of data producers and
ened concerns regarding the protection of per- data users, and as a result such courses have now
sonal data and the balance of public health been created and multiplied, widening their reach
demands with democratic rights (Waisbord and and hopefully their impact (Curioso 2019).
Segura n.d.; Segura 2022).
7 Way Forward
6 Opportunities
The COVID-19 pandemic has revealed the use-
While many challenges in pursuit of techquity fulness of digital healthcare to many govern-
exist, there are also opportunities. Technology, ments across the world to deliver healthcare
when diffused and utilized equitably, democra- utilizing different operating models, e.g.,
tizes access to information and can bridge exist- increased remote monitoring of patients and tele-
ing knowledge gaps or misinformation. It acts as consultations (Jazieh and Kozlakidis 2020), but
an effective countermeasure to the digital divide, also as a tool to confront inequities in access to
the latter providing unequal access to, and utili- healthcare in their respective countries (Brewer
zation of, healthcare, predominantly affecting et al. 2020). Digital healthcare services and col-
individuals who are hard to reach, or from certain lected data have been clearly interpreted not just
racial and/or from specific socio-economic popu- as a set of siloed services, but also as founda-
lation groups. Despite the advancement in access- tional infrastructure for research activities within
ing digital services, the digital divide persists healthcare. For example, biobanking emerged as
(Vogels 2021). For infrastructure operators, the a foundational research infrastructure that can be
main challenge to addressing the digital divide utilized in times of healthcare crises (Henderson
remains the economic feasibility of creating and and Kozlakidis 2020). Taken together with the
maintaining networks in areas with low popula- experiences of LMICs, in particular in Latin
tion density and/or high geographic fragmenta- America (Ács et al. 2022), they can offer the fol-
tion. However, there are a number of novel lowing points for the way forward:
wireless technologies, e.g., mmWave Cellular
Networks, that can help to address this need, pro- –– Access to reliable infrastructure remains a key
viding a much cheaper alternative and thus, component upon which digitization of
bridging the digital divide (Zhang et al. 2021, healthcare is based. Thus, further investment
2022). These technological developments can act in digital infrastructure remains a critical
as an impact multiplier when implemented with need.
88 Z. Kozlakidis et al.
–– Access to digital applications is not tanta- and optimizing the resources deployed to enhance
mount to utilization; addressing the digital lit- the countries’ digital ecosystems.
eracy aspects is a pre-requirement for the
impactful operation of digital technologies. Funding Statement This work was supported
–– The interconnections between different stake- in part by the IARC/WHO, through training by
holders (i.e., clinical professionals, patients, the Biobanking and Population Cohort Network
entrepreneurs, individuals, and governments) (BCNet; CRDF Global, Award No. 66415).
in the digital economy brings important
interoperability challenges to digital Disclaimer Where authors are identified as personnel of
platforms. the International Agency for Research on Cancer/WHO,
the authors alone are responsible for the views expressed
–– Therefore, there is an acute need to provide in this article and they do not necessarily represent the
clear regulatory frameworks for the emerging decisions, policy or views of the International Agency for
digitization in healthcare, including provi- Research on Cancer/WHO.
sions for data access, sharing, utilization
(including for secondary use) and reporting.
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Long-Term Digital Storage
and Usage of Research Data: Data
Pooling
(EMR) have a specific growth pattern, generating evant information from large data sets still
challenges and opportunities for healthcare pro- requires attention.
ductivity. This appraisal of almost 80 megabytes Data protection issues are at the center of all
per year per patient mirrors the increasing vol- the aspects mentioned above. With the growth of
ume and complexity of the long-term storage of patients’ data volume, maintaining confidentiality
health information (Bakos et al. 2018; Chodacki and the safety of medical information becomes
et al. 2016; Morgan and Janke 2017). Several increasingly important. Health organizations
vital mechanisms are obvious when inspecting should introduce reliable cybersecurity measures
the wide-ranging structure for the long-term digi- to protect sensitive data on patients from unau-
tal storage and consumption of medical research thorized access and violations (Stephens et al.
data. These important elements comprise the 2015). This policy is facilitated by the commit-
Data Management Plan (DMP), the Standards for ment to data protection rules (for example, HIPAA
Digital Imaging in Medicine, SNOMED CT, in the United States). Suppliers of medical ser-
ICD-11, Health Level Seven (HL7), and usage of vices should constantly update their security pro-
Artificial Intelligence (AI) technologies (Simms tocols and comply with developing standards.
and Jones 2017). At the same time, professionals Given the epidemiological challenges during
face a considerable volume of patient data the COVID-19 pandemic, actively archiving data
demanding trustworthy storage infrastructure. solutions such as tracking disease outbreaks, get-
Thus, healthcare organizations worldwide must ting up-to-date information on treatments and
invest in scalable and safe storage solutions to vaccines, tracking patient diagnoses, and sup-
adapt to the growing data load, and archiving of porting the growth of telemedicine, the role of
outdated electronic health records (HER). health data has never been more significant. The
Compliance with data storage and regulatory active archiving solution aligns with the evolving
requirements is essential (Simms et al. 2017; expectations in healthcare IT by ensuring secure,
Williams et al. 2017). For example, integrating accessible, and compliant storage of historical
and understanding data from outdated EHR sys- patient records. This archiving method supports
tems can take time and effort. If funding is patient care continuity and enhances data man-
secured for data storage infrastructure in many agement efficiency within healthcare organiza-
countries, the issues of effectively extracting rel- tions (Fig. 1).
Long-term digital storage and usage of Applying CDE in such contexts provides a
research data, especially in data pooling, involves standardized and unified approach to data collec-
several considerations to ensure the integrity, tion, improving research findings’ accuracy, con-
accessibility, and usability of the data over an sistency, and transferability. It also enhances the
extended period (Michener 2015; Schnell 2015; efficiency of research processes and facilitates
National Library of Medicine 2013). The key data sharing between research groups and organi-
aspect is scalability and performance. Databanks zations. Furthermore, using online collaboration
should be customized to handle large volumes of tools to map reported terms to a preferred ontol-
data and provide high performance. Scalability ogy is common in biomedical research and other
allows it to grow effectively with increasing data fields. Such tools enable effective collaboration
volume and number of users. Implementing a between researchers and help ensure consistency
scalable platform for processing and managing and uniformity in the use of terminology
biomedical data will help make research more (Williams et al. 2017; Simms and Jones 2017).
efficient while ensuring data security and acces- Ontologies establish standard terminology and
sibility for many users. definitions for use in a given field (International
One example is a real-time medical data col- Classification of Diseases), which ensures uni-
lection system for medical laboratories (using a formity in understanding and communication.
laboratory information management system), Ontologies are widely used in AI systems in
which reduces errors, minimizes extra work, and healthcare to train machines, support decision-
ensures data and metadata integrity. Another making in developing new drugs, and search for
notable example would be Submission target cells.
Information Packages (SIPs) for clinical trials, Implementing the biomedical dataset model
patient registries, and other human subjects’ provides new data integration, analysis, and
studies, where using Common Data Elements discovery capabilities, which help advance
(CDEs) is a strategic approach. Developing SIP fundamental, translational, and clinical
for clinical research and patient registers, includ- research. Assessment of data resources needs
ing CDE, can significantly improve the standard- and ensuring their protection is essential in
ization and harmonization of data, which, in the defining data characteristics, storage require-
future, will enhance the quality of data and pro- ments, and security measures to protect confi-
mote cooperation and joint use of research initia- dentiality and data integrity. Effective data
tives (Williams et al. 2017; O’Reilly 2018; Kazic management includes understanding the data
2015). lifecycle, from collection and processing to
CDEs are standardized terms, definitions, and storage and long-term access. The Open
guidelines for data collection in clinical trials. Information Archive model provides a struc-
They aim to ensure uniformity and consistency in tured approach to data management and long-
data collection and presentation, facilitating term preservation. Application of this model
comparison and sharing of data between different promotes the conservation of the authenticity,
studies and organizations. Examples of CDEs accuracy, and reliability of biomedical data,
used in the clinical and biomedical fields include providing standards for long-term access
Big Data biobanks and repositories. For instance, (Simms et al. 2017; Ravagli et al. 2017;
CDEs can define standards for describing genetic Leonelli 2017; Navale et al. 2018).
variants, sequencing methods, and other parame- In summary, effective data management is
ters, as well as multicentred studies, which help becoming a key element in contemporary sci-
ensure consistency of data collected across clini- ence, where large volumes of data require careful
cal sites, making it easier to analyze and compare planning and management. Below we discuss the
results available through the National Institutes key parameters that determine the effective oper-
of Health (NIH) CDE resource portal (Rubinstein ation and development of long-term digital stor-
and McInnes 2015). age and research data usage.
94 S. Gramatiuk and K. Sargsyan
2 Data Management Plan (Goodman et al. 2014; The NNLM website 2020;
(DMP) Navale and Bourne 2018). Examples of the first
generation of DMP tools could be simple online
The first step is a formal document, the data man- forms offered by universities or funding agencies
agement plan (DMP), which outlines the strate- to help researchers develop data management
gies and procedures for managing research data plans for their projects. Later generations of tools
throughout its lifecycle. It serves as a roadmap have become more complex, integrated, and
for researchers and research teams, providing a focused on advanced data management
structured framework for organizing, storing, capabilities.
documenting, and sharing data. The primary The second generation of DMP tools aimed to
goals of a DMP include ensuring the integrity, make them “machine-accessible” or “machine-
accessibility, and long-term preservation of readable.” These tools focused on automating
research data, as well as facilitating compliance data management processes and integrating with
with ethical, legal, and institutional requirements information systems, contributing to more effi-
(Kirlew 2017). cient data processing and use. The tools used
Key components typically included in a DMP semantic technologies and data formats such as
are data architecture, data models, data gener- RDF (Resource Description Framework) to pres-
ated, data quality checks, data governance, proj- ent information in machine-readable form.
ect overview, data types and formats, data Integration with other information systems, such
collection and processing methods, ethical and as data repositories, library catalogs, or project
legal considerations, data ownership and respon- management systems, was done (Ohno-Machado
sibility, data storage and backup, data security, et al. 2017). Standardized protocols like API
data sharing, and access, data preservation. (Application Programming Interface) enabled
Leading funding and research agencies, interoperability with other applications and sys-
including the National Institutes of Health (NIH), tems. As data management requirements and
the National Science Foundation (NSF), the standards have evolved, new DMP tools have
Centres for Disease Control and Prevention begun to include more detailed and in-depth
(CDC), and the Agency for Toxic Substances and information.
Disease Registry. (ATSDR) require medical Moreover, the DMP plays a vital role in the
researchers to submit a DMP for funding deci- grant application evaluation process and post-
sions. The DMP assures sponsors that data loss award evaluations, although this role may need to
prevention strategies, regular backups, protection be better defined and understood. However, not
against losses due to hardware failures, and other all guidelines for scoring Research Proposals
precautions are in place (Data Storage Best (RPPs) explicitly mention DMPs, although data-
Practices 2018). The DMP facilitates the plan- sharing plans can be a required element of pro-
ning and standardization of metadata, improving posals. The reasons may be varied, and this may
data quality, making it easier to interpret and depend on the country, organization, or specific
compare, and ensuring better reproducibility. area of study. Understanding the importance of
DMP development includes consideration of DMPs and their inclusion in the NCD assessment
long-term data storage and access issues, which process is just beginning to gain traction, and in
is essential to ensure data safety and future use. the future, such documents may more clearly
A typical example of a DMP is a text docu- highlight the role of DMPs (Corpas et al. 2018;
ment written as a detailed narrative. These docu- Jagodnik et al. 2017).
ments include various guidance documents and In terms of specific examples, the
templates for DMP production (NNLM National Interdisciplinary Earth Data Alliance (IEDA) is
Network of Libraries of Medicine), and the first an organization that provides infrastructure for
generation of tools to facilitate DMP production storing, processing, and sharing geoscience data.
have been created and are widely available They support tools and resources for researchers
Long-Term Digital Storage and Usage of Research Data: Data Pooling 95
to ensure accessibility and management of data from different agencies and make it easier for sci-
in the field. IEDA provides researchers with the entists to develop and manage data management
ability to generate a data compliance report based plans.
on an NSF (National Science Foundation) award
number; this is likely because NSF often sets data
management standards and requirements for 3 Data Standards
projects they fund, as well as part of the “Results” and Documentation
preliminary support for NSF” in subsequent
proposals, but, again, it is unclear how much Data standards and documentation are crucial for
weight they are given in the evaluation process. ensuring accurate, consistent, and interoperable
In another example, Canada’s Tri-Agency healthcare information in the medical and hospi-
Statement of Principles for Digital Data tal sector. Health Level Seven (HL7): HL7 is a
Governance emphasizes researchers’ obligations widely used international standard for exchang-
in developing and adhering to DMPs. However, ing, integrating, sharing, and retrieving electronic
the Canadian Institutes of Health Research needs health information. It defines a framework and
to include DMPs in its evaluation criteria. common standards for messaging, clinical docu-
However, given the growing significance of ments, and interoperability. HL7 develops stan-
effective data administration in scientific dards for exchanging information in various
research, organizations may want to review their areas of health care, including clinical, adminis-
policies and criteria in line with evolving stan- trative, and financial aspects. These standards are
dards and practices (Rubinstein and McInnes essential in supporting interoperability between
2015). different information systems, ensuring a nor-
The development of second generation DMP malized and structured exchange of information.
tools in response to the changing requirements of Examples of standards developed by HL7 are:
funding agencies and the generalized learnings
from the first generation of tools represents a 1. HL7 v2 (Health Level Seven Version 2) is a
logical development in the field of data manage- standard for healthcare messaging. It transfers
ment in scientific research. Creating a “meta- data between different systems, such as elec-
DMP,” or tool that provides consistent guidance tronic medical records (EMR) systems and
irrespective of an agency’s specific reporting patient management systems.
requirements, has several potential benefits: uni- 2. HL7 CDA (Clinical Document Architecture).
versality, flexibility, automation, compliance A standard for structuring clinical documents
with updates, training and support, integration, such as case reports and patient histories to
and performance tracking. ensure standardized exchange.
For example, maDMP, according to Simms 3. HL7 FHIR еhe standard is focused on provid-
and Jones 2017, can help predict data storage ing a faster and more flexible exchange of
costs (Williams et al. 2017; Simms and Jones information in healthcare, especially in web
2017). The proposed formal machine-readable and mobile applications.
document allows data exchange between differ- 4. HL7 v3 (Health Level Seven Version 3) is
ent objects through the entire data life cycle. designed to solve data interoperability prob-
maDMP’s emphasis on metadata, such as quan- lems and define a standard healthcare model.
tity and type of data, regardless of storage loca-
tion, allows for evaluating the time-varying cost International Classification of Diseases (ICD):
of storing such data. A standard has yet to emerge, The ICD is a standard system for classifying dis-
although several use cases exist. eases, conditions, and health-related problems. It
Creating such a tool could address the chal- provides a common language for global reporting
lenges posed by the diversity of requirements and monitoring health conditions. It is important
96 S. Gramatiuk and K. Sargsyan
to consider the International Classification of other across multiple health information systems.
Diseases (ICD) as an example of standardization SNOMED CT is more detailed and designed to
of data and documents as part of the long-term describe clinical concepts, while the ICD is more
digital storage and usage of research data sys- often used for statistics, classification, and cod-
tems. It is a standard developed by the WHO to ing underlying diseases.
classify and code different diseases and health The primary goal of SNOMED CT is to pro-
conditions. It is used worldwide for uniform doc- vide standardized codes to describe diseases, pro-
umentation of diseases, health statistics, and cedures, symptoms, and other clinical concepts.
medical and health information exchange. The SNOMED CT incorporates the Fully Qualified
latest version of ICD-11 was adopted by the 72nd Ingredient (FQI) concept to characterize drug
World Health Assembly in 2019 and entered into products with great detail. SNOMED CT pro-
force on January 1, 2022 (Annex 3.8 of the vides standardized terms for clinical decision
Reference 2019). support, semantic search, and data analytics in
The International Classification of Diseases, healthcare. Concepts are organized into hierar-
Eleventh Revision (ICD-11), is an updated clas- chies, allowing for a more granular representa-
sification system covering various aspects of dis- tion of clinical information. The hierarchy
eases, including their diagnosis, treatment, enables the classification of concepts based on
research, and statistics. The ICD-11 classification broader or narrower relationships.
deals with various aspects, such as using research Each concept in SNOMED CT is associated
data systems for long-term digital storage. Such with one or more human-readable terms or clini-
elements may include coding diseases in research cal descriptions. These descriptions represent the
data to uniquely identify diseases in long-term concept in an understandable way to healthcare
data storage and use systems, providing a uni- professionals. SNOMED CT allows for creating
form and standardized way to represent medical post-coordinated expressions, combining multi-
concepts. ple concepts to represent complex clinical situa-
Systems using ICD-11 can monitor morbidity, tions. This feature enhances the specificity of
mortality, and other aspects of population health clinical coding. SNOMED CT is designed to sup-
over the long term. Classification allows the cre- port multiple languages, making it a versatile ter-
ation of standardized reports and analysis of minology for international use. SNOMED CT
trends. The use of ICD-11 can help with this by covers various clinical domains, including anat-
unifying the way diseases are classified. In sys- omy, clinical findings, and procedures. This com-
tems for long-term storage and use of research prehensive coverage makes it suitable for
data related to medical research, ICD-11 can representing diverse aspects of healthcare.
serve as a basis for structuring and analyzing data SNOMED International maintains SNOMED
related to various diseases (ICD-11 2022). CT, a not-for-profit organization that oversees its
The Systematized Nomenclature of Medicine development, distribution, and ongoing updates.
Clinical Terms (SNOMED CT) is a comprehen- It is widely used in electronic health records
sive, multilingual clinical terminology used in (EHRs), health information exchange, clinical
healthcare and clinical research. It is a standard- research, and other healthcare-related applica-
ized coding system for representing and exchang- tions to ensure standardized and interoperable
ing clinical information globally. SNOMED CT representation of clinical information. SNOMED
facilitates precise and standardized health infor- CT promotes unambiguity and standardization in
mation exchange across healthcare settings and medical terminology, enabling more efficient
systems (Vuokko et al. 2023; Cangioli et al. data exchange, system interoperability, and
2023). semantic accuracy in healthcare (ICD-11 2022;
SNOMED CT and ICD are two different stan- Vuokko et al. 2023; Cangioli et al. 2023; HIMSS
dards addressing different aspects of healthcare. Adoption Model for Analytics Maturity (AMAM)
Still, they can interact and complement each 2023; Cheemalapati et al. 2016).
Long-Term Digital Storage and Usage of Research Data: Data Pooling 97
Additionally, using standardized methods and The CDA architecture includes standardized
formats reduces the risk of data loss due to tech- semantic elements such as LOINC, SNOMED
nology obsolescence. Long-term storage of data CT, and others, which provide a more precise and
by standards ensures data stability and reproduc- unambiguous understanding of document con-
ibility. Standardized systems are more flexible tent. Semantic elements are essential for the
and can be easily updated or expanded, allowing accuracy and consistency of data during long-
to adapt to new requirements, technologies, and term storage (Hart et al. 2016; Ghatnekar et al.
standards without significant costs. The overall 2021; Blackley et al. 2019). CDA can embed
standardization of data and documents creates a contextual information such as patient IDs,
sustainable basis for the long-term storage and healthcare facility information, timestamps, and
use of research data, ensuring its integrity, avail- other details. Contextual information ensures that
ability, and relevance over an extended period. data is complete and correct for future compli-
ance. CDA is often used in patients’ electronic
records to present clinical information, ensuring
4 Clinical Document medical research continuity in digital medical
Architecture (CDA) institutions.
The structured CDA format can store addi-
Developed by the Health Level Seven (HL7) ini- tional metadata and tags that periodically identify
tiative, Clinical Document Architecture (CDA) research data, which is essential for subsequent
provides a standardized format for storing and analysis, meta-analysis, and re-use of data. CDA
sharing clinical information. Over 20 long-term can be included in a strategy for secure data stor-
periods of storage and use of research data, the age, ensuring the integrity and confidentiality of
CDA architecture offers a structured form for health information throughout its lifespan. CDA
presenting medical information. CDA allows for enables interoperability between different areas
storing data in organized ways that influence sub- of health and healthcare, which is essential for
sequent data access, retrieval, and analysis. the exchange and sharing of research data on a
large scale.
–– Every CDA document begins with a Clinical The application of CDA in long-term storage
Document, the root element of the entire and use of research data provides semantic stan-
document. dards of clarity and capability with existing pro-
–– The document header contains metadata such gressive information trends. Being a document
as document ID, document type, creation date, markup standard and defining the structure and
patient ID, and other attributes. semantics of “clinical documents,” it has defining
–– The CDA is divided into sections, each con- characteristics: persistence, control, auto-
taining specific clinical information. For authentication, and integrity. The clinical docu-
example, a section with medical history and ment continues to exist in an unmodified state for
laboratory results may exist. a period determined by local and regulatory
–– There is structured clinical information in the requirements. The internal rules of the organiza-
document’s central part. This section contains tion regulate the storage of the document.
structured data, such as tables, lists, and other The CDA standard’s requirements and uses
elements in a specific format. focus on creating standardized, structured, and
–– A record is a specific piece of information semantically interoperable clinical documents.
within a section. It contains primary data such Requirements:
as test results, diagnoses, procedures, and
other elements. 1. The first requirement for a CDA is that its for-
–– The document’s body may also contain textual mat is structured, and the document must con-
information and unstructured content neces- tain specific sections and elements to ensure
sary for additional comments or descriptions. consistency and understanding of the data.
98 S. Gramatiuk and K. Sargsyan
Retrieve), C-ECHO (Verification), N-GET vides standardized formats for telemedicine con-
(Attribute Retrieval). These service primitives sultations and remote exchange of medical
allow devices to communicate with each other, images, which are increasingly important in
send and receive requests, transfer data, and man- modern healthcare. Overall, DICOM plays a cru-
age various aspects of health information on a cial role in ensuring standardized, efficient, and
DICOM network. Each service primitive has its secure storage and use of medical images in the
format and structure, defined in the DICOM long term.
standard.
DICOM servers and archives are a third
option. DICOM servers provide the infrastruc- 6 Documentation
ture for storing, retrieving, and transmitting med- in Healthcare. Electronic
ical images in DICOM format. These servers can Health Records (EHR)
be deployed as local systems in medical institu- Documentation
tions or as part of cloud-based DICOM archives,
providing centralized and convenient access to Healthcare documentation, especially EHRs,
medical data. plays a crucial role in long-term digital storage
Each of these implementations of the DICOM and usage of research data systems. EHRs com-
protocol has its characteristics and applications. prise various data on patient patient information,
Software packages typically provide rich medical including medical history, laboratory results,
image processing and analysis capabilities, while diagnoses, treatments, and other data. This com-
built-in support in medical equipment provides prehensive information is a valuable source for
transparency to end users. DICOM servers and long-term research and analysis.
archives offer the infrastructure for efficient stor- EHRs can provide long-term data storage by
age and exchange of large volumes of medical ensuring information security for many years,
data. DICOM’s internal mechanisms are continu- which is essential to assure data availability for
ally updated to support new types of medical subsequent research and monitoring. EHRs often
devices. As technology advances, new types of includes standardized formats and terminology,
equipment may appear, such as more advanced such as HL7 and LOINC, which facilitates col-
scanners, tomographs, and MRI machines, and lecting and integrating data from various sources
internal mechanisms must be adapted to commu- (Corpas et al. 2018; Vuokko et al. 2023; Cangioli
nicate with these devices. et al. 2023; HIMSS Adoption Model for Analytics
With improvements in power and image pro- Maturity (AMAM) 2023; Cheemalapati et al.
cessing algorithms, DICOM’s internal mecha- 2016; Tohmasi et al. 2021).
nisms were implemented to support more With aggregated data from EHRs, it is possi-
complex applications critical for diagnostics and ble to monitor and analyze the health of a popula-
analysis. With the development of 3D visualiza- tion over time. It helps develop public health
tion and virtual reality technology, the internal plans and make strategic decisions. EHRs may
mechanisms of DICOM have expanded to algo- include mechanisms to maintain security and pri-
rithms for data exchange and processing, which vacy standards, essential from an ethical and
is especially important for surgery and diagnos- legal compliance perspective when dealing with
tics. Due to increasing cybersecurity threats, health information. Clinicians often encounter
DICOM’s internal mechanisms have sometimes several challenges related to the usability of
worked out to ensure the confidentiality, integ- existing EHRs, as developers and vendors not
rity, and availability of health data. In some cases, always actively engage clinicians to understand
DICOM’s internal mechanisms can support inte- their needs to create more user-friendly, efficient,
gration with artificial intelligence systems, allow- and intuitive solutions. Updates and modifica-
ing machine learning and AI algorithms to tions to EHR systems must consider end-user
analyze medical data. Furthermore, DICOM pro- feedback to ensure optimal usability and improve
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Possible Process Optimization:
Innovative Digital Health
Implementation Models
A. Avagyan (*)
Pediatric Cancer and Blood Disorders Center of Abbreviations
Armenia, Hematology Center after Prof. R. H.
Yeolyan, Yerevan, Armenia
e-mail: [email protected] AGV Automated Guided Vehicles
AMPATH Academic Model Providing Access
E. Minasyan
Pediatric Cancer and Blood Disorders Center of to Healthcare
Armenia, Hematology Center after Prof. R. H. BPIS Biometric Patient Identification
Yeolyan, Yerevan, Armenia System
Pediatric Oncology and Hematology Department, CDS Clinical decision support
Yerevan State Medical University after M. Heratsi, CPOE Computerised physician order entry
Yerevan, Armenia CRF Case report form
H. Khachatryan DEPEND Digital Feedback Engagement in
American University of Armenia, Yerevan, Armenia Primary Care
Denovo sciences, Yerevan, Armenia DGHS Directorate General of Health
S. Gevorgyan Services
Denovo sciences, Yerevan, Armenia
DHIS2 District Health Information activities that aim to achieve a specific healthcare
Software 2 goal, such as diagnosing and treating a patient,
DIAL Digital Impact Alliance managing a chronic condition, or providing pre-
EDI Electronic Data Interchange ventive care. The digitalization of process opti-
EHR Electronic Health Record mization in healthcare has the potential to
eLMIS Electronic Logistics Management significantly improve healthcare outcomes by
Information System increasing efficiency, reducing errors and redun-
HIA Health Impact Assessment dancies, and improving patient access to health-
HIE health information exchange care services. However, it is essential to ensure
HISP Health Information Systems that digital tools are implemented to protect
Programme patient privacy and security and that healthcare
HIV Human Immunodeficiency Virus providers are appropriately trained to effectively
HMIS Health Management Information use these tools.
System Optimization of limited healthcare resources
HPLC high-performance liquid utilising digital technologies might provide sig-
chromatography nificant advantages to low- and middle-income
IoT Internet of Things countries (LMICs). Finding the optimal way to
IT information technology handle the sophisticated healthcare require-
LMICs low- and middle-income countries ments of hospitalised, mostly multimorbid med-
MIMIC-III Medical Information Mart for ical patients is a global issue. The quality of
Intensive Care III health services should be measured by their effi-
MS mass spectrometry cacy, safety, and focus on the needs of the
MTaPS Medicines, Technologies, and patients. For the advantages of quality health
Pharmaceutical Services care to be realised, health services must be
mTrac Mobile Tracking System timely, equitable, integrated, and efficient. On
NGOs Non-governmental Organizations the other hand, fundamental logistic and organ-
NHS National Health Service isational aspects of medical hospital care have
NPT Normalisation Process Theory been prioritised less than treating particular
OpenSRP Open Smart Register Platform diseases.
PASP Patient Admission Scheduling Digitalization has the potential to offer sub-
Problem stantial benefits to the optimization of healthcare
PHI Protected Health Information processes in LMICs. Nonetheless, a number of
PIH Partners in Health challenges must be overcome to guarantee the
REDCap Research Electronic Data Capture successful implementation and adoption of digi-
RFID Radio Frequency Identification tal tools in these settings.
SC Supply Chain Benefits of digitalization in LMICs:
SCM Supply Chain Management
SOFA Sequential Organ Failure • Improved access to healthcare. Digital tools
Assessment such as telemedicine and mobile health apps
STX Smile Train Express can help bridge gaps in healthcare access in
LMICs, particularly in remote or underserved
areas (World Health Organization 2021).
1 Introduction • Increased efficiency. Digital tools can auto-
mate routine tasks and improve data manage-
Process optimization in healthcare refers to ment, reducing the time and resources needed
improving healthcare processes and systems to to manage healthcare processes (Olu et al.
increase efficiency, reduce waste, and enhance 2019).
patient outcomes. In healthcare, a process can be • Enhanced patient outcomes. Digital tools can
defined as a sequence of interrelated tasks or improve the accuracy and completeness of
Possible Process Optimization: Innovative Digital Health Implementation Models 105
Fig. 1 Healthcare process optimization applications on scaled, pilot and research stages
patient health information, leading to better healthcare systems, which can be complex
diagnosis and treatment decisions (Attia et al. and require significant resources.
2019).
• Cost savings. Digital tools can help reduce the Overall, despite the fact that digitalization can
costs associated with healthcare processes, significantly improve healthcare process optimi-
such as paper-based record-keeping and zation in LMICs, there are still a number of
administrative tasks (World Health obstacles to be resolved before these technolo-
Organization 2019). gies can be successfully adopted and imple-
• Increased collaboration. Digital tools can mented. Addressing these challenges will require
facilitate communication and cooperation collaboration between healthcare providers, poli-
between healthcare providers, improving care cymakers, and technology providers to ensure
coordination and patient outcomes that digital tools are tailored to the needs and
(Wannheden et al. 2022). context of LMICs.
Several process optimization solutions have
Challenges of digitalization in LMICs (World already acquired widespread implementation in a
Health Organization 2021): broad spectrum of industries. Some are now
being piloted on a limited basis, and others are
• Infrastructure limitations. Many LMICs lack still in the initial phases of research. Figure 1
the infrastructure to support digital tools, such shows several process optimization technologies
as reliable electricity and internet access. in three stages of development (Chowdhury and
• Limited resources. Healthcare providers in Pick 2019).
LMICs may lack the resources or expertise
necessary to implement and utilise digital
tools effectively. 2 Electronic Health Record-
• Limited digital literacy. Patients and health- Based Tools
care providers in LMICs may have limited
experience with digital tools and require addi- Electronic Health Record (EHR) is a permanent
tional training and support. electronic record of patient health information
• Data privacy and security. Digital tools may created by one or more encounters in any health-
raise concerns about data privacy and security, care setting. EHR is a patient’s official health
particularly in LMICs where regulations and documentation maintained over time by the pro-
infrastructure to support secure data manage- vider and shared among various facilities and
ment may be lacking. organisations. It may include all relevant admin-
• Integration with existing systems: Digital istrative and clinical information required for that
tools may need to be integrated with existing person’s treatment by that provider, such as
106 A. Avagyan et al.
demographics, progress notes, issues, treatments, may lead to significant improvements in health-
vitals, past medical histories, vaccinations, labo- care delivery. HIE may eliminate expensive
ratory results, and radiology reports (Resource duplicate tests done because one provider does
Center – All Resources | HIMSS 2023). EHR not have access to clinical information held at
systems have been used by many healthcare insti- another provider’s site by allowing for the secure
tutions throughout the globe owing to their vari- and possibly real-time interchange of patient
ous advantages over traditional paper charts. information. HIE allows for the interaction of
Consequently, transitioning from paper to elec- this information through EHRs, which may lead
tronic charting has become a priority for several to significantly more cost-effective and high-
healthcare facilities that previously utilised paper quality care (Walker et al. 2005).
documentation. Implementing a comprehensive CPOE systems are intended to substitute a
healthcare data management system with a solid hospital’s paper-based ordering system by
case has been found to enhance healthcare qual- enabling consumers to electronically make the
ity through facilitating fast data extraction (Xu full spectrum of orders, retain an online prescrip-
et al. 2016), improving clinical research (DeShazo tion administration record, and monitor modifi-
and Hoffman 2015; Adane et al. 2019) and clini- cations made to orders by successive staff. In
cal practice communication (Xu et al. 2016; addition, devices provide safety notifications
Bookman et al. 2017; Lakin et al. 2016; Halpern triggered when an unsafe order (for instance, a
et al. 2016; Weber and Kohane 2013), minimis- request for duplicate prescribed medications) is
ing medical errors (Adane et al. 2019), stan- submitted, as well as clinical decision assistance
dardising medical documentation (Adane et al. to direct clinicians to less costly options or
2019; Plantier et al. 2017; DesRoches et al. choices that better correspond to hospital guide-
2008), and raising the standard of healthcare ser- lines (Connelly and Korvek 2022).
vices (Jawhari et al. 2016). Clinical decision sup- Despite the adoption of EHR systems by
port (CDS) tools, health information exchange numerous medical institutions in high-income
(HIE) and computerised physician order entry countries, implementing EHR software in health-
(CPOE) systems are three specific features that care facilities in LMICs remains a significant
show significant promise in improving the effi- challenge due to financial constraints, lack of
cacy of healthcare and decreasing costs at the necessary technological infrastructure, and lim-
healthcare system level. ited access to software training (Why sub-
A CDS system assists the expert in making Saharan Africa 2023; Akhlaq et al. 2016; Ajami
choices about patient care by delivering the most and Bagheri-Tadi 2013).
recent data on a therapeutic agent, cross- Nonetheless, it is crucial to implement EHR-
referencing a patient’s allergy to a medicine, and based tools in LMICs because they can improve
flagging probable drug interactions and patient the quality of care, reduce medical errors, and
difficulties. These aspects contribute to the improve overall healthcare outcomes. To intro-
provider’s ability to deliver patients the most
duce EHR-based instruments in LMICs, the fol-
effective care possible. As a result of the expand- lowing actions can be taken (Archer et al. 2021;
ing medical knowledge, each of these capabilities Fraser et al. 2005; Ohuabunwa et al. 2016):
now offers a mechanism through which mainte-
nance may be provided far safer and more effec- 1. Evaluation of the current state of health
tively. One may anticipate that some medical information technology (IT) infrastructure in
mistakes will be avoided as the number of CDS the target LMICs: determination of the avail-
systems in use increases and that the patient will, ability of hardware, software, internet con-
on the whole, get the treatment that is both more nectivity, and other necessary resources for
effective and safer as a result (Sutton et al. 2020). EHR implementation.
HIE is exchanging patient-level electronic 2. Development of a solid understanding of the
health information across organisations, which local healthcare system, including its struc-
Possible Process Optimization: Innovative Digital Health Implementation Models 107
ture, processes, and data needs and involve- expanding EHR adoption across the nation
ment of key stakeholders, such as healthcare or region should be modified.
providers, administrators, policymakers, and 8. Assuring infrastructure readiness: strength-
patients, to determine their unique needs and ening the IT infrastructure by enhancing
obstacles. internet connectivity, power supply, and
3. Investment in training and capacity-building hardware availability and utilising mobile
programs for building local health IT technologies, such as smartphones and tab-
expertise: train healthcare professionals, IT lets, to overcome infrastructure limitations in
specialists, and other relevant personnel in remote or resource-constrained areas.
EHR implementation, data management, and 9. Training the users and providing ongoing
system administration. This contributes to support by conducting comprehensive train-
the sustainability of EHR implementation ing programs for healthcare professionals to
and upkeep. ensure they are proficient in using EHR sys-
4. Adaptation of EHR systems to local require- tems effectively and providing ongoing tech-
ments: numerous off-the-shelf EHR systems nical support to address any problems
may not meet the specific needs of LMICs, encountered during the implementation and
by collaboration with vendors or developers post-implementation phases.
to adapt EHR systems to local protocols, dia- 10. Monitoring and evaluation by establishing
lects, clinical guidelines, and data standards, mechanisms to monitor the impact of EHR
and development or modifying EHR mod- implementation on healthcare delivery,
ules, interfaces, and reporting tools may be patient outcomes, and system performance,
required. continuously evaluating the benefits and
5. Establishment of data governance and pri- challenges of EHR adoption and making the
vacy policies, including developing robust necessary adjustments to optimise its
data governance frameworks to address con- efficacy.
cerns regarding privacy, security, and confi-
dentiality, assuring compliance with local Innovative transition tools based on electronic
data protection regulations and international health records are necessary to decrease unequal
standards and establishing data sharing, resource distribution and significantly improve
access control, and informed consent the clinical needs of hospitalised medical patients.
policies. Despite this, several studies indicate that busi-
6. Enhancement of health information nesses wishing to install EHR software at health-
exchange, including promoting interopera- care institutions in LMICs must take a highly
bility among healthcare facilities and sys- personalised strategy due to the substantial varia-
tems to enable the seamless exchange of tion in hospital and government policies.
health data and implementing standards to Below are some examples of open-source
facilitate data sharing and integration across EHR platforms that LMICs can use.
various EHR platforms.
7. Pilot project implementation and scalabil-
ity: it is recommended to start with small- 2.1 Smile Train Express (STX)
scale pilot programs to evaluate the
feasibility and efficacy of EHR implemen- Smile Train Express (STX) is an EHR system
tation in particular settings or regions, fol- developed by Smile Train, a charity focused on
lowed by an evaluation of the outcomes, cleft lip and palate treatment. Smile Train, the
lessons learned, and difficulties encoun- largest cleft charity in the world with more than
tered during the pilot phase. Based on the two decades of experience collaborating with
findings, the implementation strategy and healthcare facilities in LMICs, devised a cleft
the development of a scalable plan for treatment EHR system and disseminated it to
108 A. Avagyan et al.
their partner institutions (Louis et al. 2018). It resource-constrained environments and has been
aims to overcome barriers associated with EHR implemented globally in healthcare facilities.
implementation by minimising technological The software is supported by an extensive net-
requirements and simplifying the documentation work of developers and implementers contribut-
of patient’s Protected Health Information (PHI) ing to its ongoing development.
(Louis et al. 2018). The primary purpose of STX OpenMRS was initially developed by
is to track cleft surgical data, enabling Smile researchers, developers, and public health profes-
Train and its partner institutions to collaborate in sionals at Regenstrief Institute and Partners in
developing quality improvement and safety plans Health (PIH) for the AMPATH project in Kenya
to enhance and standardise cleft surgical care (Seebregts et al. 2009). Its early implementations
(Louis et al. 2018). To receive funding for cleft focused on HIV and TB patient management in
surgeries, all Smile Train-partner institutions are Kenya, Rwanda, and South Africa (Seebregts
obligated to enter surgical cases into STX within et al. 2009). Today, OpenMRS is utilised in vari-
31 days of the procedure and actively engage in ous use cases and care settings, including second-
quality improvement and safety practices (Louis ary and tertiary facility-based health records
et al. 2018). Case entry can be completed during management, primary healthcare, telemedicine,
patient encounters or at a later date as long as the HIV care, tuberculosis management, non-
healthcare data is uploaded to the STX cloud- communicable disease management, maternal
based patient record database on a monthly basis. and child health, reproductive health, Ebola
In some Smile Train-partner institutions, STX response, and cancer care (Verma et al. 2021).
has evolved from a quality improvement tool to The platform was designed to be scalable
the primary medical documentation medium across multiple countries and use cases, multilin-
(Louis et al. 2018). gual, and capable of functioning in challenging
The studies suggest that the implementation environments with limited internet access and
of STX has impacted medical documentation low technology adoption (Wolfe et al. 2006). It is
practices at some partnered institutions (Ferry an open-source application with a robust data
et al. 2021; Nutley et al. 2013; Hernández-Ávila model, basic EHR functionality, and the ability to
et al. 2013). However, the integration of STX into add new features through modules (Wolfe et al.
clinical workflows at most institutions has likely 2006).
been limited due to regulations and guidelines OpenMRS has been recognized as a “Global
established by governing bodies. The findings Good,” indicating its role as a sustainable and
emphasise that organisations aiming to imple- scalable medical records solution in LMICs
ment EHR software in healthcare facilities within (Digital Square 2023). As governments and
LMICs need to adopt a highly individualised funders increasingly promote open-source tech-
approach. This is necessary because of the con- nology, including Global Goods, this study aims
siderable variability in hospital and governmental to analyse the reach, utilisation, impact, and
policies within LMICs. The studies highlight the return on investment of OpenMRS as a Global
importance of understanding and adapting to Good (Digital Square 2023). It also seeks to iden-
each institution’s specific regulatory and policy tify key challenges and unmet needs to guide
contexts to successfully implement EHR systems continued investment in the platform.
in LMIC settings.
2.3 DHIS2
2.2 OpenMRS
DHIS2 is a web-based open-source platform pri-
OpenMRS, released in 2004, has become one of marily used as a Health Management Information
the most widely used open-source EHR systems System (HMIS) (About DHIS2 – DHIS2 2023).
LMICs (Serda et al. 2011). It was designed for It is the largest HMIS platform in the world and
Possible Process Optimization: Innovative Digital Health Implementation Models 109
is presently used by 73 low- and middle-income also required to build human resource capacity
countries, affecting approximately 2.4 billion for HIA, including training for data cleaning,
individuals (About DHIS2 – DHIS2 2023). analysis, and visualisation (DHIS2 as a tool for
Moreover, DHIS2 is in use across more than 100 health 2023). Furthermore, expanding accessi-
countries, including programs run by non- bility to DHIS2 data through public web portals
governmental organisations (NGOs) (About can enhance the value of DHIS2 for HIA and
DHIS2 – DHIS2 2023). Globally coordinated by evidence-based health policy, ultimately improv-
the HISP Centre at the University of Oslo (UiO), ing health outcomes (DHIS2 as a tool for health
the development of the DHIS2 software is a 2023).
global collaborative effort. HISP, which stands In summary, DHIS2 offers numerous advan-
for Health Information Systems Programme, is a tages for LMICs, including its cost-effectiveness,
network consisting of 17 in-country and regional customizability, scalability, and data standardisa-
organisations (About DHIS2 – DHIS2 2023). tion features. However, technical requirements,
These organisations provide ongoing direct sup- data quality, sustainability, and system complex-
port to ministries and local implementers of ity must be addressed to successfully implement
DHIS2, ensuring its effective utilisation and and utilise DHIS2 in LMICs. Close collaboration
implementation (About DHIS2 – DHIS2 2023). with stakeholders, adequate investment in infra-
DHIS2 is an open-source platform for health structure and capacity-building, and continuous
management information systems, serving support are essential for maximising the benefits
numerous countries worldwide and benefiting a of DHIS2 in resource-constrained settings.
significant portion of the global population. The
collaboration and support provided by the HISP
network further contribute to its successful 3 Healthcare Scheduling
implementation and development (About Optimization
DHIS2 – DHIS2 2023).
Some papers suggest that DHIS2 has value Healthcare scheduling optimization refers to the
for Health Impact Assessment (HIA) in low- process of using advanced techniques and algo-
resource settings by standardising data collec- rithms to optimise the scheduling and allocation
tion processes and improving reporting rates and of resources in healthcare settings. It aims to
accuracy (DHIS2 as a tool for health 2023; improve operational efficiency, patient outcomes,
Byrne and Sæbø 2022). However, there are and resource utilisation while considering vari-
obstacles to effectively using DHIS2 data for ous constraints and objectives.
HIA. The key challenges identified include limi- Healthcare scheduling research is crucial for
tations in data quality, analysis, and access optimising costs, improving patient flow, and
(DHIS2 as a tool for health 2023). Multiple plat- efficiently utilising hospital resources. In recent
forms operating independently across different decades, there has been an increasing number of
ministries, sectors, or organisations can hinder a systems that use metaheuristic methodologies to
comprehensive understanding of health condi- automate the search for optimum resource man-
tions. To address the challenges, additional fund- agement in healthcare. The focus has primarily
ing and cross- institutional collaboration are been solving healthcare scheduling problems
needed to integrate platforms, promote national such as patient admission scheduling (Ceschia
stewardship of DHIS2, and establish shared and Schaerf 2012), nurse organising issues, and
understandings of data through data dictionaries, operating room scheduling/surgical scheduling
metadata packages, and formal processes for (Di Martinelly et al. 2014). These methods aim to
integrating systematic data collection into global provide timely treatment administration and
health monitoring and evaluation frameworks maximise the utilisation of available hospital
(DHIS2 as a tool for health 2023). Efforts are resources.
110 A. Avagyan et al.
Schedule360 2023). These software options offer surgical centres optimise operating room
various features and functionalities to streamline scheduling, manage patient flow, track surgi-
the nursing scheduling process and improve over- cal instruments, and monitor performance
all workforce management in healthcare settings. indicators (SurgiDat 2023).
As an example of utilising roster software in • Surgimate: Surgimate is a comprehensive
LMIC, the Hong Kong Health Authority operates surgical scheduling software that helps
an AI-based tool developed by the City University streamline the entire surgical workflow, from
of Hong Kong to generate staff rosters that meet preoperative planning to postoperative follow-
various constraints (Nurse Rostering 2023). up. It allows hospitals and surgical centres to
These constraints include staff availability, pref- efficiently manage their surgical resources,
erences, working hours, operational require- schedule surgeries, track patient information,
ments, and regulations. Implemented across 40 and generate reports (Surgimate 2023).
public hospitals, the tool manages the scheduling
of over 40,000 staff members. The introduction These software solutions can help healthcare
of this system has resulted in increased produc- facilities in LMICs overcome the challenges
tivity, improved staff morale, and enhanced ser- associated with operating room scheduling, opti-
vice quality. The tool is perceived as fair, saves mise resource utilisation, and improve the effi-
managers’ time, and provides valuable insights ciency of surgical services. Evaluating each
into working patterns and resource utilisation, software’s specific features and suitability for the
benefiting overall management efficiency (HA: local context is essential before implementation.
Nurse Rostering 2023).
Digitalization plays a crucial role in trans- tion in the supply chain domain (Hartley and
forming healthcare supply chain management. Sawaya 2019).
By leveraging technology and digital tools, Constructing effective SCM systems in
healthcare organisations can enhance efficiency, LMICs can be complicated due to limited infra-
transparency, and coordination throughout the structure, insufficient institutional frameworks,
supply chain process (Beaulieu et al. 2021). and resource constraints. Nonetheless, there are a
Digital platforms and software solutions are also number of strategies and approaches that can aid
used to automate procurement processes, stream- in enhancing supply chain administration in
line supplier management, and optimise distribu- LMICs.
tion logistics. These tools facilitate automated The eLMIS, which stands for Electronic
ordering, invoice processing, and payment sys- Logistics Management Information System, is an
tems, reducing administrative burdens and innovative and cost-efficient solution for manag-
improving operational efficiency (Beaulieu et al. ing health data (Usaid 2015). Its implementation
2021). in Zambia and Tanzania has enhanced commod-
The concept of SC digitalization encompasses ity security and improved health outcomes for the
a range of technologies, including both tradi- population (Strengthening Health Systems 2023).
tional and advanced ones. Conventional technol- In healthcare programs, the availability of an
ogies like electronic data interchange (EDI), adequate quantity and quality of health products
electronic catalogues, radio frequency identifica- is crucial for meeting patient needs and achieving
tion (RFID), and automated guided vehicles better health outcomes. To address this challenge,
(AGVs) (Bechtsis et al. 2017; Morenza-Cinos Zambia and Tanzania collaborated to develop the
et al. 2019) are now integrated into the broader eLMIS, a comprehensive system encompassing
concept of digitalization, alongside newer tech- various major health programs in the countries.
nologies such as cloud computing, IoT, big data By establishing a connection between health
analytics, 3D printing (Kosmol et al. 2019), facilities and the central store, the eLMIS enables
blockchain (Chang et al. 2019), and artificial the collection and real-time distribution of logis-
intelligence (Ehie and Ferreira 2019). However, tics data. This information plays a vital role in
there is still a need for a standard definition of supply chain management by providing insights
terms like big data within the context of SC into the utilisation and demand for medicines,
digitalization. thereby facilitating the provision of uninterrupted
These technologies offer the potential to supplies to patients.
enhance supply chain management by enabling Bangladesh’s Directorate General of Health
real-time synchronisation of material and infor- Services (DGHS) faced challenges in health sup-
mation flows, personalised production ply chain management, including the lack of an
(Büyüközkan and Göçer 2018), and improved integrated inventory management system and
flexibility and agility (Seyedghorban et al. 2019). tracking capabilities, mainly when COVID-19
However, their adoption would require restruc- emerged in the country, USAID Medicines,
turing the roles of actors within the supply chain Technologies, and Pharmaceutical Services
and the development of necessary skills to effec- (MTaPS) collaborated with DGHS to develop a
tively use the tools and analyse the vast amounts comprehensive COVID-19 eLMIS based on an
of data generated. To fully benefit from these existing eLIMS (Digitalization of COVID-19
new technologies, organisations should priori- Commodities 2023). MTaPS initially established
tise developing deployment plans and ensuring a basic online reporting system and trained
they have the required skills and capabilities around 500 health workers. This enabled central-
before rushing into their acquisition. This ised tracking of emergency commodity stock lev-
approach, suggested by Hartley and Sawaya, els at health facilities and distribution centres. By
emphasises the importance of adequate prepara- April, the DGHS, central administration, suppli-
tion to fully leverage the potential of digitaliza- ers, and beneficiaries received daily updates on
Possible Process Optimization: Innovative Digital Health Implementation Models 113
access. Biometric systems can also be more con- potential privacy and ethical concerns associated
venient for users, as they do not need to remem- with these systems (Cooper and Yon 2019). For
ber passwords or carry additional authentication example, biometric data collected by these sys-
devices (Nigam et al. 2022). tems may be stored and used for purposes beyond
Several biometric systems exist, including fin- the original intent. There is a risk of discrimina-
gerprint, facial recognition, and iris scanners. tion based on the characteristics being measured.
Each type of system has specific advantages and Biometric systems may cause false positives and
disadvantages and the appropriate method for a negatives, raising concerns regarding their reli-
particular application will depend on its specific ability and accuracy (Committee NRC (US) WB
requirements and constraints (Guennouni et al. et al. 2010b).
2019). To address these concerns, organisations
Fingerprint scanners are one of the most adopting biometric systems need to consider the
widely used biometric systems. They capture an following factors (Ratha et al. 2001):
image of the fingerprint and analyse the unique
patterns and ridges present in the fingerprint. • Privacy: Organisations should implement
These systems are relatively inexpensive, easy to appropriate safeguards to protect the privacy
use, and accurate, making them suitable for vari- of individuals and ensure that biometric data
ous applications. Fingerprint scanners can be is only used for the intended purpose.
used for multiple purposes, including access con- • Accuracy: Organisations should ensure that
trol, attendance tracking, and financial transac- biometric systems are accurate and reliable
tions (Maltoni et al. 2022). and have processes to address false positives
Facial recognition systems use artificial intel- and negatives.
ligence and machine learning algorithms to • Ethical considerations: Organisations should
analyse the unique characteristics of a person’s consider biometric systems’ potential implica-
face, such as the shape and size of the eyes, tions and implement appropriate safeguards to
nose, and mouth. These systems are highly prevent discrimination based on measured
accurate, but they can be affected by changes in characteristics.
appearance, such as facial hair or makeup, and
they may be less accurate for people of certain In the healthcare sector of LMICs, biometric sys-
ethnicities (Li et al. 2020). Facial recognition tems are increasingly used for client registration
systems have been used for various purposes, and identification to improve healthcare service
including identifying criminals, detecting ter- delivery, reduce fraud, and ensure accurate
rorists, and tracking the movement of individu- patient records. Here are a few examples of bio-
als (Robbins 2021). metric systems used in LMICs healthcare:
Iris scanners use a camera to capture an image
of the iris, the coloured part of the eye surround- • Aadhaar (India): The Aadhaar system in
ing the pupil. The unique patterns in the iris are India is one of the most significant biometric
then analysed to identify the individual. Iris scan- identification projects globally. It uses a com-
ners are highly accurate and resistant to changes bination of fingerprint, iris, and face recogni-
in appearance, but they may be more expensive tion to assign residents a unique 12-digit
and complex to implement than other biometric identification number. Aadhaar has been
systems. Iris scanners have been used for various widely used for various government services,
purposes, including access control and identity including social welfare programs, banking,
verification (Daugman 2004). and healthcare (Home – Unique Identification
Biometric systems can potentially revolution- Authority of India 2023).
ise how we authenticate ourselves and access ser- • Biometric Patient Identification System
vices and resources. However, there are also (Kenya): The Biometric Patient Identification
Possible Process Optimization: Innovative Digital Health Implementation Models 115
System (BPIS) was implemented in Kenya to accurately identified and removed from circula-
improve patient identification in healthcare tion (Islam and Islam 2022).
facilities. The system utilises fingerprint bio- One approach to optimising counterfeit drug
metrics to identify patients and link them to testing is using advanced analytical techniques.
their medical records accurately. It helps pre- These techniques, such as high-performance liq-
vent medical errors, ensures continuity of uid chromatography (HPLC) and mass spectrom-
care, and reduces the risk of misidentification etry (MS), can provide detailed chemical analyses
(Anne et al. 2020). of drugs and identify any discrepancies or devia-
• Mother and Child Tracking System (India): tions from the expected composition. These tech-
India implemented the Mother and Child niques are also susceptible, allowing for detecting
Tracking System (MCTS), which utilises bio- even small amounts of counterfeit material
metric identification to track and monitor the (Martino et al. 2010a).
health of pregnant women and children. The Another way to optimise counterfeit drug test-
system captures biometric data, including fin- ing is by using reference standards. These stan-
gerprints and photographs, to create unique dards, carefully calibrated and validated samples
individual identification records. This facili- of known drugs, can be used to compare the qual-
tates targeted healthcare interventions and ity and purity of tested drugs. By using these
ensures proper delivery of maternal and child standards, laboratories can more accurately
health services (India’s Mother and Child determine whether a drug is counterfeit (Martino
Tracking System 2023). et al. 2010b).
In addition to these analytical techniques, sev-
In conclusion, biometric systems have the poten- eral approaches can be taken to optimise the
tial to increase security and convenience for a overall process of counterfeit drug testing. For
variety of applications. However, organisations example, establishing a well-coordinated net-
must consider these systems’ potential privacy, work of laboratories to conduct testing can help
accuracy, and ethical issues and implement to ensure that samples are analysed efficiently
appropriate safeguards to protect individuals’ and effectively. Additionally, implementing qual-
rights and interests. ity management systems and training programs
can help ensure testing is performed according to
established protocols and standards
7 Counterfeit Drug Testing (Implementation of a Quality Management
System n.d.).
Counterfeit drugs are a significant public health Another critical factor in the fight against
threat, as they often contain incorrect or harmful counterfeit drugs is the development of innova-
ingredients, leading to serious health conse- tive technologies for tracking and tracing the sup-
quences for those who consume them (Kon and ply chain. These technologies, such as blockchain
Mikov 2011). One important factor contributing and RFID tagging, can help ensure that medica-
to the proliferation of counterfeit drugs is the tions are authentic, properly stored, and handled
increasing availability of online pharmacies. during transportation. Implementing these tech-
These pharmacies often sell drugs not approved nologies can reduce the risk of counterfeit medi-
by regulatory agencies and may be fake or of sub- cines entering the supply chain and reaching
standard quality. Enhancing online surveillance consumers (Zakari et al. 2022).
and enforcement efforts to educate consumers Several regulatory measures can be taken to
about the risks of purchasing drugs from unveri- prevent counterfeit drugs from entering the mar-
fied sources is essential to address this issue. To ket. For example, strengthening intellectual prop-
combat the problem, it is crucial to optimise the erty protection for branded drugs can help to
testing of counterfeit drugs to ensure that they are reduce the profitability of counterfeiting, as it
116 A. Avagyan et al.
becomes more difficult for counterfeiters to pass • Sproxil is a mobile verification solution that
off their products as genuine articles. Additionally, employs scratch-off labels with unique codes
increasing penalties and enforcement efforts for on drug packaging. Users can send the code
those who produce or distribute counterfeit drugs via SMS or use a smartphone app to verify the
can deter would-be counterfeiters (WHO authenticity of the medicine. Sproxil has been
Member State Mechanism 2023; 1 in 10 medical used in several LMICs, including Nigeria,
products in developing countries 2023). India, and Kenya, to combat counterfeit drugs
Effective collaboration between government, (Johnston and Holt 2014).
industry, and other stakeholders is also essential
in the fight against counterfeit drugs. Working These examples highlight some of the software
together, sharing information and resources, and solutions that have been deployed in LMICs to
developing more comprehensive strategies for address the issue of counterfeit drugs. It should
addressing this complex problem is achievable be emphasised that the deployment of these tech-
(WHO Member State Mechanism 2023; 1 in 10 nologies can differ depending on the unique
medical products in developing countries 2023). requirements, regulations, and available resources
Combating counterfeit drugs requires a multi- of each country or region.
faceted approach that involves advanced tech-
nologies, scientific excellence and collaboration.
By taking these steps, reducing the risks posed by 8 Automated Completion or
these dangerous products and protecting public Analysis of Medical Records
health is possible.
With the growth and global adoption of EMR
While specific software solutions for counter-
feit drug testing may vary across different coun-systems in medical healthcare, vast quantities of
tries and regions, here are a few examples of information have become available, necessitating
counterfeit drug testing software used in LMICs: the investigation of alternative methods for maxi-
mising the utility of these massive datasets (Sun
• PharmaSecure is a software platform that et al. 2018). Automated completion or analysis of
helps combat counterfeit drugs by providing medical records refers to the use of technology
unique identification codes on drug packag- and algorithms to assist in the process of com-
ing. Patients or healthcare providers can send pleting or analysing patient medical records. This
a text message with the code to a designated approach aims to streamline and enhance the effi-
number, and they receive an immediate ciency of healthcare documentation and data
response confirming the product’s authentic- analysis (Sun et al. 2018). Automated filling and
ity. This solution has been implemented in analysis of medical records possess the capability
several LMICs, including India, Nigeria, and to enhance the efficiency and quality of health-
Kenya (PharmaSecure 2023). care documentation, facilitate data-informed
• mPedigree is a mobile-based anti-decision-making, and enable thorough examina-
counterfeiting solution that enables patients tion of patient information. However, it is essen-
and healthcare providers to verify the authen- tial to ensure patient data’s accuracy, privacy, and
ticity of medicines through a unique scratch- security when implementing these automated
off code on the drug packaging. By sending systems (Ozonze et al. 2023). The automation of
the code via SMS, users receive an instant medical records completion and analysis is a sub-
response indicating whether the product is ject of continuous research and development, and
genuine. The mPedigree platform has been its widespread use may not be prevalent at the
deployed in countries like Ghana, Kenya, and current time. While there have been advance-
Nigeria (Rasheed et al. 2018). ments in natural language processing, machine
Possible Process Optimization: Innovative Digital Health Implementation Models 117
learning, and data analytics techniques for medi- potential benefits of automation in healthcare, it
cal record automation and analysis, the imple- should be acknowledged that the field is still in a
mentation and adoption of these technologies in state of development, and additional research is
healthcare settings vary. necessary to enhance and validate these
Below are presented a few examples of approaches prior to their broad implementation
research studies related to the automated comple- in clinical settings.
tion or analysis of medical records:
it may strain health workers, requiring additional research and accountability and avoid duplica-
training and recruitment. tion of trials. It is important to prevent “data
Data training and expertise are crucial for pro- dumpsters” by linking data to relevant documen-
cess optimization tools. Good data leads to good tation and analyses. Furthermore, the costs and
outcomes, while insufficient data can have nega- benefits of novel interventions need to be care-
tive consequences, such as misallocating fully evaluated, considering the additional
resources. User-friendly platforms and ensuring resource deviation they may require.
data interoperability are essential for success. Addressing these challenges and conducting
However, the increasing use of “people analyt- further research and evaluation can contribute to
ics” has been criticised for potentially dehuman- successfully implementing digitalization and
ising work and may not effectively increase process optimization in healthcare settings, lead-
productivity or optimise practices. ing to improved patient outcomes and quality of
Tools that support process optimization do not care.
provide immediate relief or diagnosis but aim to
improve back-end processes, freeing up time and
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Digitalization in Preclinical
Research: Advancements
and Implications
Abstract 1 Introduction
Digital technologies are omnipresent and have
influenced the entire continuum of preclinical Digitization has been transforming various fields,
research activities both in high-income coun- and preclinical research is no exception. The use
tries and low-and middle-income countries. of digital technologies in preclinical research has
This chapter describes the many different become increasingly common and has had a sig-
aspects of preclinical research and how it is nificant impact on the way research is conducted,
affected by digitization. These include the managed, and analyzed. Preclinical research
digital tools and technologies in preclinical refers to scientific investigations conducted in the
research, the ways in which digitization laboratory or animals before testing new thera-
enhances data management in preclinical pies or interventions in humans. It encompasses a
research, as well as experimental design in wide range of studies aimed at understanding the
preclinical research. safety, efficacy, and mechanisms of action of
potential treatments.
Keywords Digital technologies are playing an increas-
ingly significant role in transforming preclinical
Preclinical research · Digital health · research methodologies. These technologies
Electronic data capture · Data integration · offer a wide range of tools and approaches that
Laboratory information management systems enhance data collection, integration, and analy-
(LIMS) · Machine learning sis. By integrating diverse data sources, such as
genomics, proteomics, other -omics, and imaging
data, researchers can gain deeper insights into
A. Michalska-Falkowska (*) disease mechanisms and treatment responses.
Biobank, Medical University of Bialystok, Moreover, digital tools enable in silico
Bialystok, Poland
e-mail: [email protected] approaches, virtual screening, and computational
modeling, accelerating the drug discovery and
K. Sargsyan
Cancer Center, Cedars-Sinai Medical Center, optimization process. Adopting digital technolo-
Los Angeles, CA, USA gies in preclinical research holds great promise
International Biobanking and Education, for improving efficiency, reproducibility, and the
Medical University of Graz, Graz, Austria discovery of novel therapeutics.
Department of Medical Genetics, Yerevan State As preclinical research consists of multiple
Medical University, Yerevan, Armenia complex topics and sub-areas, within this chap-
ter, it will be divided it into the following fields: macokinetics, efficacy, and safety of lead
dedicated to Drug Discovery and Development, compounds in a more complex biological
Disease Modeling and Pathophysiology, Safety setting.
and Toxicology Assessments, and IV. Pharmacokinetics and
Pharmacokinetic-Pharmacodynamic modeling Pharmacodynamics Modeling and
and analysis. Analysis. Understanding the pharmacoki-
Preclinical research consists of a series of netic and pharmacodynamic properties of
labor-extensive steps and requires a thoughtful lead compounds is critical in preclinical
analysis to identify and optimize lead compounds drug discovery. The pharmacokinetic prop-
with desirable properties for subsequent evalua- erties of lead compounds are evaluated,
tion in clinical trials. The preclinical drug discov- including absorption, distribution, metabo-
ery may vary based on the specific therapeutic lism, and excretion (ADME). The pharma-
area, target, and research objectives, but a gen- codynamics are focused on the analysis of
eral, structured framework outlining the key how lead compounds interact with the target
components can be presented with the following and produce the desired effects
phases (Mahajan et al. 2020; Cook et al. 2014; V. Safety and Toxicology Assessment.
Vogel and Maas 2016; Li and Wang 2019): Preclinical drug discovery includes com-
prehensive safety and toxicology assess-
I. Target Identification and Validation. ments to evaluate the potential adverse
Preclinical drug discovery begins with effects of lead compounds. This involves
the identification and validation of a target conducting a range of toxicity studies,
molecule(s) or pathway(s) that plays a criti- including acute toxicity, repeated-dose tox-
cal role in the disease process. This involves icity, genotoxicity, and safety pharmacology
understanding the underlying biology of the assessments, to identify potential risks or
disease and establishing the relevance of the side effects associated with the compounds.
target in the context of the therapeutic goal. VI. Data Analysis and Decision-making.
II. Hit Identification and Lead Optimization. Throughout the preclinical drug discov-
Once a target is identified and validated, ery process, data analysis plays a vital role
the focus shifts to finding potential drug in informing decision-making. Researchers
candidates or “hits” that interact with the analyze and interpret the data generated
target. High-throughput screening (HTS) from various experiments and assays to
and virtual screening are commonly assess the efficacy, safety, and suitability of
employed to identify compounds that show lead compounds for further development.
activity against the target. Subsequently, VII. Regulatory Requirements.
lead optimization involves refining and While preclinical drug discovery primar-
modifying the initial hits to improve their ily focuses on understanding the properties
potency, selectivity, and other desirable and effects of lead compounds, there is also
properties. an awareness of regulatory requirements
III. In vitro and In vivo Testing. and considerations. Preclinical data gener-
Preclinical drug discovery involves ated during this phase lay the foundation for
extensive in vitro and in vivo testing to eval- regulatory submissions and serve as a basis
uate the pharmacological effects, efficacy, for advancing compounds into clinical
safety, and toxicity of the lead compounds. trials.
In vitro assays and cell-based models are
employed to assess target engagement, cel- Digitization plays a significant role in accelerat-
lular activity, and initial toxicity screening. ing the drug discovery and development pro-
Animal models, such as rodents or non- cesses. By leveraging digital tools and
human primates, are used to assess the phar- technologies, researchers can streamline data
Digitalization in Preclinical Research: Advancements and Implications 127
collection, analysis, and collaboration, leading to bases, streamlining the data collection process.
more efficient identification of potential drug tar- Moreover, EDC systems provide built-in data
gets and optimization of lead compounds. validation checks and data range validations,
Additionally, digitization enables virtual screen- minimizing errors and ensuring data integrity.
ing, computational modeling, and data-driven Required fields, data format checks, and logical
decision-making, expediting the design and eval- checks can be implemented in electronic forms,
uation of drug candidates, ultimately reducing prompting researchers to enter accurate and com-
costs and time-to-market for new therapies. plete data. This helps maintain high-quality data
for analysis and decision-making. With EDC sys-
tems, data is instantly available for analysis and
2 Digital Tools monitoring to all those that have received the rel-
and Technologies evant regulatory and ethical clearance.
in Preclinical Research Researchers can access real-time data and track
study progress, enabling timely decision-making
2.1 Overview of Key Digital Tools and intervention as and when required. This real-
and Technologies Utilized time access to data improves the overall effi-
in Preclinical Research ciency of preclinical research studies and helps in
identifying trends or issues promptly. EDC sys-
In the context of data management in preclinical tems enable remote data capture, allowing
research, digitization refers to the adoption and researchers to collect data from multiple sites or
integration of digital technologies and tools to participants located in different geographical
transform how data is collected, stored, analyzed, locations. This flexibility eliminates the need for
and shared. It involves leveraging digital plat- physical visits or manual data transfer (partly or
forms, software applications, and automated pro- fully), reducing logistical challenges and poten-
cesses to streamline data management workflows, tial errors associated with data collection.
enhance data quality, improve accessibility, and Data security and privacy play a pivotal role
enable more efficient and informed during extensive and longitudinal preclinical
decision-making. studies, EDC systems offer robust security mea-
sures to protect sensitive research data through
access controls, encryption, and audit. These sys-
2.2 Electronic Data Capture (EDC) tems adhere to regulatory guidelines, such as the
Systems for Efficient Data Health Insurance Portability and Accountability
Collection and Management Act (HIPAA) and Good Clinical Practice (GCP)
standards.
Digitization in preclinical research data manage-
ment encompasses several key aspects, including
the fundamental one—Electronic Data Capture 2.3 Laboratory Information
(EDC). Thanks to digitization, traditional paper- Management Systems (LIMS)
based data collection methods can be replaced, for Streamlined Data
partly or fully, with electronic data capture sys- Organization and Integration
tems. This allows for the direct entry of data into (Cucoranu 2016; Brusniak
electronic forms or databases, reducing errors, et al. 2019; Kumuthini et al.
improving data quality, and enabling real-time 2020)
data available for analysis.
EDC systems eliminate the need for manual Digital platforms that are fundamental to manag-
data entry from paper forms, reducing transcrip- ing and organizing various aspects of laboratory
tion errors and saving time. Researchers can operations and data were developed as Laboratory
directly enter data into electronic forms or data- Information Management Systems (LIMS).
128 A. Michalska-Falkowska and K. Sargsyan
LIMS facilitates the management of preclinical an integral part of LIMS to facilitate the seamless
research data within laboratory settings through integration of data generated by various labora-
tracking of samples, recording of experimental tory instruments and equipment. This integration
data, management of protocols and workflows, enables the automatic capture and storage of
and integration of data from various instruments instrument-generated data, reducing the risk of
and sources. They provide a centralized and stan- data transcription errors and simplifying data
dardized approach to data management, ensuring management. Instruments such as spectropho-
consistency and efficient retrieval of tometers, chromatography systems, and robotics
information. can be connected to LIMS, enabling direct data
There is a wide range of LIMS platforms transfer and reducing the human error connected
available on the market with a broad range of with this process.
customization options according to the end- LIMS also plays an important role in Quality
users’ needs. The LIMS systems are designed to Assurance in preclinical research. By incorporat-
be adaptable and extendable, making them suit- ing regulatory standards and internal quality con-
able for both small and large research laborato- trol procedures, LIMS facilitates adherence to
ries where multidisciplinary scientists collaborate Good Laboratory Practice (GLP) guidelines, data
on the engineering of compounds for potential integrity, and audit trials. LIMS assists in manag-
therapeutic applications from creation to preclin- ing documentation related to regulatory compli-
ical experiments. ance, including sample chain of custody, quality
What is important, LIMS allows researchers control records, and Standard Operating
to track and manage samples throughout their Procedures (SOPs).
lifecycle, from acquisition to disposal. It provides As reporting is particularly important to track
features to record sample details, such as storage the quality and progress of preclinical research,
location, sample type, and associated metadata. LIMS often includes tools for generating custom-
By automating sample tracking, LIMS minimizes izable reports and performing basic data analysis.
errors, improves traceability, and facilitates easy Researchers can extract relevant data subsets,
retrieval of samples when needed. create graphical representations, and perform
Recording and storing experimental data gen- basic statistical analysis within the LIMS envi-
erated during preclinical research within LIMS ronment and integrate with external data analysis
includes data from assays, tests, measurements, tools for more comprehensive analysis.
and observations. Researchers can enter data
directly into the system or integrate LIMS with
instruments to automatically capture data, elimi- 2.4 Cloud-Based Storage
nating manual entry errors and ensuring data and Computing Solutions
accuracy. for Secure and Scalable Data
As standardization of the experiments and Management (Willard et al.
processes is fundamental for providing accurate, 2016; Berman 2012; Ngiam
real-life results, LIMS allows the creation of pro- and Khor 2015)
tocols, specifying step-by-step procedures and
instructions for different experiments. Having The way how preclinical research data is man-
this functionality, LIMS ensures adherence to aged and analyzed was revolutionized by cloud-
protocols, promotes consistency in data collec- based data storage solutions. Cloud platforms
tion, and allows for easy replication of offer robust security measures, including
experiments. encryption, access controls, and regular back-
As the importance of high-throughput tech- ups, ensuring the confidentiality and integrity of
nology grows every year in the field of preclinical research data. Researchers can store large vol-
research, instrument integration is recognized as umes of data in the cloud without the need for
Digitalization in Preclinical Research: Advancements and Implications 129
expensive on-site infrastructure, reducing on- cost-effective solutions and flexibility in manag-
site infrastructure costs and associated adminis- ing preclinical research data compared to main-
trative burden. Moreover, these types of storage taining on-premises infrastructure. Researchers
solutions provide scientists with convenient and can avoid repeated upfront investments in hard-
universal access to their data from anywhere ware, maintenance costs, and software licenses.
with an internet connection. This accessibility Cloud services typically operate on a pay-as-you-
facilitates seamless collaboration among go model, allowing researchers to pay only for
research teams, allowing multiple users to the resources they consume, making it a more
access, share, and work on the same data simul- cost-effective option for preclinical research data
taneously. It promotes real-time collaboration, management and analysis.
streamlines communication, and enhances
productivity.
What is important, to maintain data redun- 2.5 Data Analysis
dancy and backup within preclinical research and Visualization Tools
using the cloud-based solutions, research data is for Deriving Meaningful
replicated and stored across multiple servers and Insights from Preclinical Data
data centers, ensuring high availability and reduc- (Park et al. 2019; Tian
ing the risk of data loss due to hardware failures and Greenberg 2019; Tomczak
or natural disasters. Automated backup processes and Czerwińska 2018;
provide an additional layer of data protection, Sutherland and Rahman 2017;
enabling easy data recovery in case of accidental Campillos and Kuhn 2019;
deletion or system failures. Cheng et al. 2019; Wang et al.
Cloud-based storage solutions facilitate data 2018)
integration and interoperability from various
sources, such as laboratory instruments, elec- Digitization empowers researchers to employ
tronic medical records, or external databases, in a advanced computational methods, machine
centralized cloud environment. This integration learning algorithms, statistical tools, and data
allows for comprehensive analysis and correla- visualization techniques for comprehensive anal-
tion of diverse datasets, leading to more mean- ysis and interpretation of preclinical research
ingful insights and discoveries. data. These capabilities enable researchers to
Moreover, cloud computing provides research- uncover valuable insights, identify patterns, dis-
ers with the access to powerful computational cover relationships, and effectively communicate
resources for data analysis and processing. their findings, ultimately advancing scientific
Scientists can leverage cloud-based computing knowledge and contributing to developing novel
environments to perform complex data analyses, therapeutic approaches.
simulations, and modeling without the need for Digitization enables the application of compu-
extensive on-site computational infrastructure. tational methods and machine learning algo-
Cloud platforms offer high-performance comput- rithms to analyze preclinical research data. These
ing capabilities, enabling researchers to process advanced techniques can handle large datasets,
large datasets and perform computationally identify complex patterns, and discover hidden
intensive tasks efficiently. relationships that may not be apparent through
Cloud computing platforms offer scalability, traditional data analysis approaches. Moreover,
allowing researchers to scale up or down their computational methods, such as data mining,
storage resources based on their needs. clustering, classification, and predictive model-
Researchers can easily accommodate growing ing, allow scientists to uncover valuable insights,
data volumes without investing in additional make data-driven decisions, and generate hypoth-
hardware or infrastructure. This scalability offers eses for further investigation.
130 A. Michalska-Falkowska and K. Sargsyan
Statistical tools are crucial in preclinical the expression of genes of interest. These rela-
research as they enable researchers to analyze tionships help researchers understand the under-
data, test hypotheses, evaluate treatment efficacy, lying biology and can direct future research
and make evidence-based decisions, ensuring efforts.
robust and reliable scientific findings. These tools What is important, the research hypotheses
help quantify uncertainty, assess significance, based on the analysis of preclinical data can be
and establish the credibility and integrity of refined thanks to digitization. By gaining insights
research outcomes. Digitization provides access into patterns and relationships, researchers can
to a wide range of statistical tools and software refine their understanding of disease mechanisms
that facilitate robust analysis of preclinical or treatment targets. For example, if data analysis
research data. Having such digital tools, research- reveals a consistent association between a par-
ers can apply statistical methods, including ticular molecular pathway and disease progres-
hypothesis testing, regression analysis, survival sion, researchers may refine their hypothesis to
analysis, and multivariate analysis, to assess the focus on that pathway for further investigation.
significance of findings and draw valid conclu- This iterative process of hypothesis refinement
sions. These tools enable researchers to evaluate contributes to the advancement of preclinical
the above mentioned steps involved in treatment research.
efficacy, measure variability, determine statistical As target selection is a critical step in preclini-
significance, and assess the impact of various fac- cal research and drug development, digitization
tors on research outcomes. plays a vital role in this process, supporting the
With digitization, researchers can analyze pre- identification and selection of potential therapeu-
clinical research data to identify patterns and dis- tic targets. By analyzing preclinical research
cover relationships. By examining data across data, researchers can identify molecules, path-
different variables, time points, or experimental ways, or biological targets that are strongly asso-
conditions, scientists can uncover correlations, ciated with disease processes or treatment
dependencies, and trends that may inform their responses. This information helps guide the
understanding of disease mechanisms, treatment selection of targets for further investigation or
responses, or biological interactions. This infor- drug development, enhancing the efficiency and
mation can guide further experimentation, target effectiveness of preclinical research efforts.
selection, or refinement of research hypotheses. Digitization allows researchers to analyze pre-
By exploring data across different variables, time clinical research data to identify potential thera-
points, or experimental conditions, researchers peutic targets. By examining various types of
can detect recurring trends, associations, and data, such as genomic, proteomic, or phenotypic
dependencies that may be critical for understand- data, researchers can uncover molecules, path-
ing disease processes and treatment outcomes. ways, or biological targets that are strongly asso-
These patterns can provide important clues for ciated with disease processes or treatment
further investigation and guide the development responses. For example, through transcriptomic
of targeted interventions. analysis, researchers may identify genes that are
Moreover, digitization facilitates the explora- differentially expressed in disease states com-
tion of relationships within preclinical research pared to healthy conditions. These differentially
data. By conducting correlation analyses, regres- expressed genes can serve as potential targets for
sion modeling, or other statistical techniques, further investigation.
researchers can uncover connections between Digitization enables the integration of diverse
different variables or factors. For example, they datasets from various sources, including public
may identify a correlation between a specific bio- databases, in-house experiments, and literature.
marker level and treatment response or observe By combining and analyzing multiple datasets,
how certain experimental conditions influence researchers can gain a comprehensive view of the
Digitalization in Preclinical Research: Advancements and Implications 131
It is important to remember that preclinical platforms, researchers can have greater confi-
research involves sensitive data, including patient dence in the quality and reliability of their data.
information, animal model data, and experimen- Digitization minimizes errors and improves
tal results. Robust data management ensures data accuracy through automated data capture
compliance with regulatory standards and ethical and standardized data entry. Digital tools also
guidelines, such as the HIPAA and the General often include data validation checks and built-in
Data Protection Regulation (GDPR). Adhering to quality control measures to ensure the accuracy
these standards protects the privacy and confi- and completeness of data.
dentiality of research subjects and prevents What is particularly important in preclinical
potential legal and ethical implications. Effective studies, digitization ensures data integrity by pro-
data management addresses data security con- viding mechanisms for data tracking, version
cerns and ensures the protection of preclinical control, and audit trails. With digital platforms
research data from unauthorized access, loss, or and systems, researchers can easily track and
corruption. Implementing secure data storage, document any changes made to the data, main-
backup systems, and access controls safeguards taining a transparent record of data modifica-
data integrity. tions. This enhances data integrity, allowing
Preclinical research generates valuable data researchers to trace the evolution of the data and
that may have long-term significance. Robust verify the accuracy of the results.
data management includes appropriate data Moreover, digitization promotes data stan-
archiving, version control, and data retention dardization and adherence to data governance
policies. Proper documentation and retention of principles. Through digital platforms and data
research data ensure its availability for future management systems, researchers can define
reference, meta-analyses, and potential re- standardized data collection protocols, data dic-
evaluation. Preserving research data over time tionaries, and metadata standards. This ensures
enhances the integrity and legacy of preclinical consistency and uniformity in data collection
research. Effective data management facilitates across studies, making it easier to compare and
data analysis and data-driven decision-making integrate data from different sources or
in preclinical research. Well-organized and experiments.
accessible data allows researchers to perform The accessibility of preclinical research data
comprehensive analysis, apply statistical meth- is promoted by digitization through enabling cen-
ods, and derive meaningful insights. This sup- tralized and secure storage, retrieval, and sharing.
ports evidence-based decision-making, Cloud-based storage solutions provide research-
hypothesis generation, and the identification of ers with the ability to access data from anywhere,
potential therapeutic targets or lead at any time, facilitating collaboration among geo-
compounds. graphically dispersed teams.
Robust security measures to protect the confi-
dentiality and privacy of preclinical research data
3.2 Role of Digitization are crucial to secure data storage and it is possi-
in Improving Data Accuracy, ble through encryption, user access controls, and
Integrity, and Accessibility authentication mechanisms to safeguard data
from unauthorized access or breaches.
Digitization plays a vital role in improving data Reliable data backup and disaster recovery
accuracy, integrity, and accessibility in preclini- mechanisms are possible thanks to digital plat-
cal research. It enables standardized data collec- forms and cloud-based storage solutions that
tion, enhances data tracking and version control, automatically backup data, preventing data loss
promotes data sharing and collaboration, and due to hardware failures or unforeseen events.
ensures the security and confidentiality of This ensures data continuity and reduces the risk
research data. By leveraging digital tools and of losing valuable research data.
Digitalization in Preclinical Research: Advancements and Implications 133
3.3 Integration of Diverse Data facilitates data sharing, meta-analyses, and com-
Sources and Data parison of results, allowing researchers to build
Standardization for Enhanced upon existing knowledge and accelerate scien-
Collaboration tific discoveries.
In turn, integrated and standardized data pro-
Digitization promotes data standardization, facil- mote research reproducibility. By sharing well-
itating enhanced collaboration in preclinical documented and harmonized datasets, researchers
research. By integrating datasets from various can replicate experiments, validate findings, and
sources, researchers can gain a comprehensive verify the robustness of research outcomes. The
understanding of complex biological processes, ability to access and analyze integrated datasets
foster interdisciplinary collaborations, and lever- enhances transparency, encourages open science
age the expertise of multiple research teams. The practices, and supports the reproducibility of pre-
integration and standardization of data enhance clinical research studies, reinforcing the reliabil-
reproducibility, support cross-domain insights, ity and credibility of research findings.
and enable meta-analyses, ultimately advancing Integration of diverse data sources enables
preclinical research and improving the transla- researchers to gain cross-domain insights, foster-
tion of research findings into clinical ing interdisciplinary collaborations and expand-
applications. ing the understanding of complex biological
Digitization enables the integration of data processes. For example, combining genomic and
from various sources, such as genomics, pro- imaging data may reveal correlations between
teomics, imaging, clinical observations, and elec- genetic variations and phenotypic characteristics.
tronic health records. By consolidating these Integrating clinical data with preclinical research
diverse datasets, researchers gain a comprehen- findings can help bridge the translational gap,
sive view of the research landscape, uncovering facilitating the identification of potential thera-
potential correlations and insights that may not peutic targets and informing clinical trial design.
be apparent when analyzing individual datasets What is important, digitization facilitates data
in isolation. Integration of diverse data sources harmonization for meta-analysis, enabling
promotes a multidimensional understanding of researchers to pool and analyze large-scale datas-
disease mechanisms, treatment responses, and ets from multiple studies. Meta-analyses con-
therapeutic targets. ducted on integrated datasets, provide valuable
Collaborative Data Analysis is facilitated by insights into population-level trends, treatment
digitization by providing a unified platform for responses, and predictive factors in preclinical
researchers to access and analyze integrated data- research.
sets. Digital tools and platforms support data
sharing, enabling multiple researchers to work
simultaneously on shared datasets. This collab- 3.4 Real-Time Data Availability
orative approach promotes cross-disciplinary and Monitoring for Timely
collaborations, fosters knowledge exchange, and Decision-Making
leverages the expertise of different research
teams, enhancing the quality and depth of data Real-time data availability and monitoring are
analysis and interpretation. essential components of digitization in preclini-
Data standardization and interoperability, pro- cal research, enabling researchers to make
moted by digitization, enable easier integration quicker decisions. Instant access to preclinical
and analysis of datasets from different research research data eliminates delays associated with
groups or institutions. Standardized data formats, manual data collection and processing.
metadata, and data dictionaries ensure consis- Researchers can enter data directly into elec-
tency in data collection, annotation, and repre- tronic systems, making it immediately available
sentation across studies. This standardization for analysis and monitoring. This real-time access
134 A. Michalska-Falkowska and K. Sargsyan
to data reduces the time lag between data collec- regimens, or data collection methods based on
tion and decision-making, enabling researchers ongoing data analysis and evaluation. By contin-
to respond promptly to emerging trends, unex- uously optimizing research parameters, research-
pected observations, or critical events. ers can enhance the efficiency, accuracy, and
What is important, digital platforms and data success rate of preclinical studies.
management systems enable continuous moni-
toring of preclinical research data. Researchers
can set up automated alerts and notifications 4 Digitization
based on predefined criteria, allowing them to and Experimental Design
stay informed about key metrics, data trends, or in Preclinical Research
experimental milestones. Continuous data moni-
toring facilitates proactive decision-making by Through leveraging digital tools and technolo-
identifying potential issues or deviations in real gies, digitization plays a crucial role in improv-
time, allowing researchers to intervene promptly ing experimental design in preclinical research. It
and adjust experimental protocols, treatment enables virtual screening, which involves using
strategies, or study designs as needed. computational methods to identify potential ther-
Moreover, real-time data availability facili- apeutic targets and screen large libraries of com-
tates the early identification of trends, patterns, pounds. Through virtual screening, researchers
and emerging insights in preclinical research. By can prioritize and select target molecules or path-
analyzing data as it becomes available, research- ways for further investigation, saving time and
ers can detect subtle changes or correlations that resources compared to traditional screening
may indicate the efficacy of a treatment, the pro- methods.
gression of a disease, or the need for adjustments Moreover, digitization facilitates in silico
in experimental conditions. Early identification modeling and simulation, using computer-based
of such trends enables researchers to make timely algorithms and simulations to predict and evalu-
decisions regarding the continuation, modifica- ate the properties and behaviors of molecules.
tion, or termination of a study, potentially saving These methods can be applied to optimize drug
time, resources, and effort. candidates, assess pharmacokinetics, simulate
Rapid response to safety and efficacy signals protein-drug interactions, and predict the poten-
in preclinical research has been made possible tial efficacy or toxicity of compounds. In silico
thanks to the real-time data availability and mon- modeling allows researchers to make informed
itoring. Adverse events or unexpected treatment decisions regarding experimental designs and
responses can be promptly detected, allowing prioritize compounds for further preclinical
researchers to take immediate actions, such as evaluation.
adjusting dosages, modifying experimental pro- The data-driven experimental design can be
tocols, or initiating additional safety assessments. improved by leveraging existing data to inform
Timely decision-making based on real-time data future research directions. By analyzing preclini-
helps ensure the welfare of research subjects and cal research data, researchers can identify pat-
improves the overall quality and validity of pre- terns, correlations, and trends that can guide the
clinical research outcomes. design of subsequent experiments. This data-
Digitization enables iterative experimentation driven approach helps optimize experimental
and optimization of preclinical research. Real- parameters, improve the efficiency of studies,
time data availability allows researchers to ana- and increase the likelihood of obtaining mean-
lyze preliminary results and make informed ingful results.
decisions regarding the next steps in the research Importantly, digitization supports high-
process. This iterative approach facilitates the throughput screening (HTS) and automation,
fine-tuning of experimental designs, treatment allowing researchers to rapidly test a large num-
Digitalization in Preclinical Research: Advancements and Implications 135
ber of compounds or samples, even utilizing This information aids in the design of experi-
robotic platforms and digital interfaces in a high- ments and the selection of promising compounds
throughput manner. This automation improves for further evaluation, reducing the time and cost
efficiency, minimizes human error, and enables associated with traditional screening methods.
the screening of vast compound libraries or bio- Thanks to digitization, a wide range of statisti-
logical samples. cal analysis software is available to perform
Digital platforms and LIMS streamline exper- power calculations, sample size estimations, and
imental workflow management in preclinical statistical hypothesis testing. By leveraging these
research. These systems provide centralized tools, researchers can optimize their experimen-
repositories for protocols, sample tracking, and tal designs by ensuring sufficient statistical power
data management. Researchers can efficiently to detect meaningful effects and reduce the risk
track experimental progress, monitor resource of false positives or negatives.
utilization, and ensure adherence to standardized Digital tools, such as Design of Experiments
protocols, promoting consistency and reproduc- (DOE) software packages, assist researchers in
ibility in experimental design. The optimization designing efficient and robust experiments. These
of sample size and statistical power in preclinical tools help determine the optimal combination of
studies can be made through computational factors, levels, and interactions to achieve the
methods and statistical tools, when researchers desired experimental objectives while minimiz-
can perform power calculations and sample size ing variability and resource utilization. By sys-
estimations based on desired effect sizes, vari- tematically exploring the experimental space,
ability, and statistical significance thresholds. researchers can identify key factors influencing
This optimization ensures that experiments are outcomes and optimize experimental conditions.
adequately powered to detect meaningful effects Data visualization and analysis capabilities
and reduces the need for unnecessary animal use enable researchers to explore and interpret com-
or resource allocation (Hagan et al. 2019; plex datasets. Visualization tools allow for the
Rodgers and Levin 2017; Ruusuvuori et al. 2018; graphical representation of experimental results,
Tanoli et al. 2019). facilitating the identification of trends, patterns,
and outliers. Data analysis software offers vari-
ous statistical and computational algorithms to
4.1 Utilizing Digital Tools analyze experimental data, extract insights, and
for Experimental Design derive quantitative measures of effect size or
and Protocol Optimization significance.
(Gao et al. 2020; Morrissey Moreover, LIMS platforms facilitate experi-
et al. 2016; Rodgers and Levin mental design and protocol optimization by pro-
2017; Tung and O’Brien 2017; viding centralized management of protocols,
Williamson et al. 2009) samples, and data. As described above, research-
ers can document and share experimental proto-
Utilizing digital tools for experimental design cols, track sample information, and record
and protocol optimization in preclinical research experimental outcomes within the LIMS. This
offers several advantages, including improved centralized system enhances collaboration, stan-
efficiency, increased accuracy, and data-driven dardization, and reproducibility, ensuring consis-
decision-making. Digital tools enable virtual tency in experimental procedures across research
screening and molecular modeling techniques to teams.
predict the interactions between molecules and Digital tools enable iterative design and feed-
their targets. Researchers can use computational back loops, allowing researchers to refine experi-
methods to assess the binding affinity, selectivity, mental protocols based on initial results or pilot
and potential off-target effects of compounds. studies. By continuously analyzing and integrat-
136 A. Michalska-Falkowska and K. Sargsyan
ing data generated during the course of the cols. Researchers can access up-to-date protocols,
research, researchers can adapt their experimen- ensuring consistent implementation of procedures
tal designs to optimize parameters, adjust treat- across studies and reducing the risk of protocol
ment regimens, or modify sample selection deviations. These platforms support collaboration
criteria. This iterative approach increases the effi- by allowing multiple researchers to work on pro-
ciency and success rate of preclinical tocols simultaneously, enabling real-time updates
experiments. and annotations. Digital protocol management
ensures accessibility, traceability, and proper doc-
umentation, enhancing transparency and facilitat-
4.2 Digital Platforms for Sample ing the replication of experiments.
Tracking, Experimental The integration of data generated from various
Workflows, and Protocol sources and instruments is supported by digital
Management (Danziger et al. platforms. Researchers can import and link data
2018; Li et al. 2019; Ratner files, including images, raw data, and metadata,
2010; Tarca et al. 2016; Zhang to specific experiments or samples within the
et al. 2019) platform. This integration simplifies data
retrieval, enables cross-referencing, and facili-
Digital platforms enable researchers to track tates downstream analysis. Some digital plat-
samples throughout the preclinical research pro- forms also offer built-in data analysis tools or
cess. These platforms provide functionalities for integration capabilities with third-party analysis
assigning unique identifiers to samples, record- software, allowing researchers to perform data
ing sample information (such as collection date, processing, visualization, and statistical analysis
storage conditions, and experimental group), and within the platform itself. Examples of digital
tracking sample movement and usage. With bar- platforms for sample tracking, experimental
code or Radio Frequency Identification (RFID) workflow management, and protocol manage-
technologies, researchers can easily scan and ment include Electronic Laboratory Notebooks
update sample information, ensuring accurate (ELNs), LIMS, and cloud-based research man-
sample tracking and minimizing human errors. agement platforms.
Digital platforms also support inventory man-
agement, allowing researchers to monitor stock
levels, expiration dates, and reordering of 4.3 Use of Virtual Screening
supplies. and in Silico Methods
Moreover, digital platforms facilitate the man- for Target Identification
agement of experimental workflows, ensuring and Compound Selection (Ertl
efficient and standardized processes. Researchers et al. 2000; Friesner et al.
can create digital protocols that outline the step- 2004; Schneider et al. 1999;
by-step procedures, equipment requirements, and Shoichet 2004; Wang et al.
data collection points for each experiment. These 2005; Willett et al. 1998)
protocols can be accessed, followed, and docu-
mented digitally, providing consistency and Virtual screening and in silico methods have
reproducibility across experiments and research become valuable tools in preclinical research for
teams. Digital platforms also allow for the inte- target identification and compound selection.
gration of data capture instruments, such as auto- These computational approaches offer efficient
mated analyzers or imaging systems, streamlining and cost-effective ways to prioritize and evaluate
data acquisition and minimizing manual data potential drug candidates. Virtual screening
entry. involves the computational screening of large
Thanks to digital platforms, it is possible to chemical databases or libraries to identify mole-
maintain centralized repositories for storing, shar- cules that have a high probability of binding to a
ing, and version-controlling experimental proto- specific target of interest. This process typically
Digitalization in Preclinical Research: Advancements and Implications 137
utilizes molecular docking algorithms to predict like properties and reducing the risk of failures in
the binding affinity and pose of small molecules later stages of drug development.
against the target’s three-dimensional structure. In silico methods can also be employed to
By virtually screening millions of compounds, identify potential new uses for existing drugs. By
researchers can prioritize a subset of molecules analyzing databases of known drugs and their
for further experimental evaluation. interactions, researchers can identify off-target
Both ligand-based and structure-based effects and explore new therapeutic indications.
approaches are employed within virtual screening This approach of drug repurposing offers a cost-
methods. Ligand-based methods involve compar- effective strategy for identifying candidates with
ing the chemical features and properties of known established safety profiles and known
active compounds against the target to identify pharmacokinetics.
structurally similar molecules. Structure- based Virtual screening and in silico methods sig-
methods rely on the target’s three-dimensional nificantly accelerate the early stages of drug dis-
structure to predict the binding affinity and inter- covery by reducing the number of compounds for
actions of small molecules. These approaches experimental testing, optimizing the selection of
provide complementary strategies for target iden- lead candidates, and providing insights into the
tification and compound selection. structure-activity relationships. However, it is
Pharmacophore modeling is a technique used important to note that these computational
in virtual screening to identify the essential struc- approaches are hypothesis-generating tools and
tural features required for a molecule to interact still require experimental validation.
with a target. By analyzing the active compounds
and their common chemical features, a pharma-
cophore model is generated, representing the key 4.4 Application of Machine
interactions necessary for activity. This model Learning Algorithms
can then be used to screen compound libraries for Predictive Modeling
and identify molecules that match the pharmaco- and Simulation Studies
phore, aiding in target identification and com- (Cherkasov et al. 2014; Cramer
pound selection. et al. 2020; Ekins et al. 2007;
Virtual screening and in silico methods also Sliwoski et al. 2014; Wallach
include Quantitative Structure-Activity et al. 2015)
Relationship (QSAR) Analysis involves the
development of computational models that cor- Machine learning algorithms are increasingly
relate the chemical structures of compounds with being applied in preclinical research for predic-
their biological activities. By training QSAR tive modeling and simulation studies. These algo-
models on known activity data, researchers can rithms have the ability to analyze complex
predict the activity of new compounds against a datasets, identify patterns, and make predictions
target. These predictions guide compound selec- or classifications. Predictive models that estimate
tion by identifying molecules with a higher likeli- various outcomes in preclinical research can be
hood of desired activity, reducing the need for built with the use of machine learning algorithms.
extensive experimental testing. For example, these algorithms can predict drug
To evaluate the pharmacokinetic and toxico- efficacy, toxicity, pharmacokinetic properties, or
logical properties of compounds, the Absorption, biological activity based on input features such as
distribution, metabolism, excretion, and toxicity chemical descriptors, genomic data, or experi-
(ADMET) prediction models are used. By using mental results. By training the algorithms on
computational algorithms, researchers can pre- known data, they can learn patterns and relation-
dict parameters such as solubility, permeability, ships to make accurate predictions on new or
metabolic stability, and potential toxicities. unseen data.
ADMET prediction aids in compound selection Machine learning algorithms play a signifi-
by identifying candidates with favorable drug- cant role in the Structure-Activity Relationship
138 A. Michalska-Falkowska and K. Sargsyan
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and version-controlled documentation ensure antiviral agents, high-throughput screening, and drug
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clinical research, digitization through electronic you going to? J Med Chem 57(12):4977–5010
Cook D et al (2014) Lessons learned from the fate of
data storage reduces the need for physical storage AstraZeneca’s drug pipeline: a five-dimensional
space and decreases administrative overhead. framework. Nat Rev Drug Discov 13(6):419–431.
Computational modeling and simulation tech- This review article discusses the challenges and les-
niques can reduce the number of experiments sons learned from the preclinical drug development
process, including target identification, lead optimiza-
required, saving time, resources, and animal tion, and preclinical testing
models. Digitalization also enables virtual col- Cramer JW, Martinez Murillo F, Richter L et al (2020)
laborations and remote access to data, reducing Application of machine learning techniques for pre-
travel and infrastructure costs. dicting drug toxicity. J Clin Med 9(10):3173
Cucoranu IC (2016) Laboratory information systems man-
agement and operations. Clin Lab Med 36(1):51–56.
https://doi.org/10.1016/j.cll.2015.09.006
6 Conclusion Danziger SA, Rinderknecht MD, Maruvada R et al (2018)
The role of digital tools in the management of clinical
trials. Clin Transl Sci 11(6):599–604
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molecular polar surface area as a sum of fragment-
how it is affected by digitization. These include based contributions and its application to the pre-
the digital tools and technologies in preclinical diction of drug transport properties. J Med Chem
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data management in preclinical research, as well Friesner RA, Banks JL, Murphy RB et al (2004) Glide: a
new approach for rapid, accurate docking and scoring.
as experimental design in preclinical research. 1. Method and assessment of docking accuracy. J Med
These aspects are universal and applicable both Chem 47(7):1739–1749
in high-income countries and low-and middle- Gao H, Dai W, Zhao L, Min X, Zhai Y, Li Z (2020)
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Curr Drug Metab 21(3):205–214
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Digitization of Clinical Pathways
in Low- and Middle-Income
Countries
ment. The health infrastructure and lack of 2 Gaps in the Clinical Pathways
resources in LMICs pose significant challenges also Affect the Digitization
to providing adequate health services to their Process
populations. The World Health Organization
(WHO) and the United Nations (UN) have high- Health systems in LMICs face numerous chal-
lighted the key challenges related to the limited lenges in providing effective and timely care to
health infrastructure, shortage of health workers, their populations. Two notable gaps in clinical
and insufficient access to quality health care in care pathways that significantly impact service
these regions. delivery in LMICs are fragmented care systems,
LMICs often face significant limitations in poor coordination, inefficient referral processes,
their healthcare infrastructure, which include a lack of coordination and late care. In several
lack of modern healthcare facilities, limited LMICs, healthcare systems are fragmented,
availability of medical equipment, and inade- involving many public and private healthcare
quate healthcare management systems. These providers with limited coordination and commu-
shortcomings can hamper the delivery of timely nication between them. This fragmentation often
and effective health services to vulnerable pop- leads to duplication of effort, inefficient resource
ulations. In addition, the situation is exacer- allocation, and fragmented patient care. As a
bated by the lack of medical professionals. result, patients may have difficulty navigating a
Many LMICs struggle to attract and retain complex healthcare system, leading to subopti-
qualified health workers, including doctors, mal health outcomes and increased healthcare
nurses, and other health workers. This shortage costs (Baker et al. 2018a, b). A lack of coordina-
of skilled professionals results in increased tion among healthcare providers in LMICs can
workloads and lower quality of care, limiting further exacerbate problems in chronic disease
the ability to meet healthcare needs. The WHO management and continuity of care. Patients may
(2018a, b) highlighted the problem of limited find it difficult to access different levels of care,
health infrastructure and shortage of health such as primary, secondary, and tertiary care,
workers in LMICs. These problems prevent leading to delays in diagnosis and treatment. In
these countries from building and maintaining addition, poor communication between first
sound health systems and hamper their ability responders and professionals can disrupt the
to provide adequate health services to their smooth care flow.
citizens. Inefficient referral processes and delayed
Inadequate access to quality medical services assistance: The referral process in many LMICs
is one of the main problems. In LMICs, a signifi- can be slow and inefficient, delaying patients’
cant portion of the population faces barriers to access to specialized care. Primary care providers
accessing quality healthcare services. Financial often lack clear guidelines for appropriate refer-
constraints, geographical remoteness, and inade- rals, and referral pathways can be confusing and
quate transportation infrastructure are the main bureaucratic. As a result, patients can experience
factors limiting these regions’ healthcare access. significant waits before seeing a specialist or
As a result, many people lack access to timely receiving primary diagnostic testing and treat-
healthcare, and leading organizations and various ment (Bazemore et al. 2018a, b). Delays in the
stakeholders are investing in developing health- referral process can lead to disease progression,
care infrastructure, strengthening the healthcare worsening of symptoms, and higher In addition,
workforce, and implementing policies that ensure in rural or remote areas where access to special-
equal access to quality healthcare services for all ized health services is limited, late referral can
LMIC citizens. have serious consequences for patients and make
Digitization of Clinical Pathways in Low- and Middle-Income Countries 143
it challenging to treat complex diseases ade- tions can provide previously unbanked popula-
quately. LMICs should focus on improving tions access to formal financial services,
healthcare coordination and implementing effec- contributing to economic growth and poverty
tive referral processes to fill these gaps in clinical reduction (Gupta and Singh 2022).
care pathways. This can be achieved by develop- The possibilities of digitization in LMICs are
ing integrated healthcare systems that facilitate large and diverse. By harnessing the power of
collaboration between different healthcare pro- digital technologies, these countries can over-
viders, including the public and private sectors. come traditional barriers to development and
Additionally, investments in health infrastruc- accelerate progress at different healthcare system
ture, staff training, and public health initiatives levels. However, challenges such as digital infra-
can further strengthen health systems in LMICs, structure, digital literacy, and data protection
improve patient outcomes, and ensure equitable need to be addressed to realize digitalization’s
access to quality health services. full potential in LMICs.
Digital Healthcare Solutions. The uptake of Mobile health (mHealth) technologies also
digital health solutions in LMICs offers enor- play an essential role in digitizing clinical work-
mous potential to improve the accessibility, flows in LMICs. In recent years, mobile phone
quality,
and efficiency of healthcare. usage has reached unprecedented levels in
Telemedicine, mHealth applications, and elec- LMICs, owing to the increasing availability of
tronic health records can help to close the gap affordable smartphones and reliable mobile net-
between patients and healthcare providers, espe- works. This surge in cell phone penetration pres-
cially in remote areas. In addition, artificial intel- ents a unique opportunity to apply mHealth
ligence (AI)-based diagnosis and data analysis technologies in clinical practice to address the
can aid disease surveillance and personalized health challenges these resource-constrained
treatment, improving health outcomes (Smith regions face. Thus far, potential benefits and
and Johnson 2020). applications of mHealth technologies in LMICs
e-Government Services: Digitalization has the focus on remote consultations and patient follow-
potential to revolutionize health public services up. The GSM Association (commonly referred to
in LMICs through e-Government initiatives. as ‘the GSMA’ or Global System for Mobile
Online portals, digital payment systems, and Communications, originally Groupe Spécial
e-voting can simplify administrative processes Mobile) is a non-profit industry association rep-
and increase transparency and accountability in resenting the interests of mobile network opera-
governance. This can increase citizen engage- tors worldwide, and has reported consistently on
ment and participation, ultimately contributing to the potential of mHealth technologies, as for
inclusive development (Rahman and Khan 2021). example in the GSMA Comprehensive Report on
Digital education and e-learning. The intro- Pervasive Mobile Phone Penetration and Use in
duction of digital technologies in education can Low- and Middle-Income Countries (2021). In
provide access to quality learning resources and addition, Michael et al. (2019) provide valuable
promote skills development in LMICs. E-learning information on the use of mHealth applications
platforms, open educational resources (OER), for remote consultation and patient monitoring.
and digital classrooms can empower learners and The study shows how mHealth can help physi-
teachers by removing barriers to education (Li cians bridge geographic distances and reach
and Patel 2019). underserved populations. Additionally, mHealth
Financial Inclusion and Digital Payments. apps offer the potential to increase public and
Integrating digital payment systems can signifi- patient engagement and adherence to treatment
cantly improve financial inclusion in LMICs. plans through timely reminders and educational
Mobile banking, digital wallets, and fintech solu- resources. These technologies could facilitate
144 D. Marino et al.
telehealth services by allowing healthcare profes- and improving patient management in resource-
sionals to remotely counsel and monitor patients, constrained environments.
especially in hard-to-reach areas with limited The convergence of telemedicine and telecon-
access to medical facilities. Introducing mHealth sultation services has paved the way for cost-
technologies into clinical practice can revolution- effective and efficient healthcare solutions in
ize healthcare in LMICs. However, challenges LMICs. These technologies have strengthened
such as digital infrastructure limitations and data primary healthcare systems and facilitated col-
security issues need to be addressed to fully real- laboration between healthcare providers, allow-
ize the potential of mobile medical applications ing them to share experiences and knowledge
to improve health outcomes and facilitate the over long distances. Despite problems with lim-
access to quality healthcare in LMICs. ited internet connectivity and technological infra-
Telemedicine and teleconsultation services structure in some regions, the introduction of
have become transformative clinical solutions for telemedicine and teleconsultation services has
LMICs, offering innovative ways to break down shown promising potential for increasing access
geographic barriers and expand access to health- to healthcare, reducing healthcare costs, and
care. This section examines the use of telemedi- improving the quality of care in LMICs.
cine and successful teleconsultation initiatives in Thus, such services have become tools to
LMICs, drawing on crucial references, namely transform clinical pathways in LMICs, remove
“Expanding Telemedicine to Break Geographic geographic barriers, and expand access to health-
Barriers” (Sood et al. 2018) and “Successful care. The success of teleconsultation initiatives in
Teleconsultation Initiatives in LMICs” (Labrique low- and middle-income countries highlights the
et al. 2017). Geographical barriers have long potential of such technological interventions to
hampered the equitable delivery of health care in revolutionize healthcare delivery in resource-
LMICs, often resulting in remote and under- constrained settings and contribute to more equi-
served populations not having adequate access to table and efficient healthcare systems worldwide.
health services. Sood et al. (2018) emphasize the As technology advances, more research and
potential of telemedicine to fill this gap. Using investment in telemedicine are needed to maxi-
digital communication technologies, telemedi- mize its impact on health outcomes in LMICs
cine can bridge distances and bring virtual medi- and beyond.
cal consultations, diagnosis, and treatment to Electronic health records (EHRs) have
patients regardless of their geographic location. become a revolutionary tool in healthcare and
Expanding telemedicine services has shown offer significant potential to improve data avail-
promising results in reducing healthcare inequal- ability and quality. In LMICs, implementing
ities, ensuring timely medical intervention, and EHR systems in clinical practice has gained
improving health outcomes in LMICs. attention as a means to improve healthcare deliv-
In addition, Labrique et al. (2017) highlight ery and patient outcomes. The integration of
successful teleconsultation initiatives that have EHR into clinical pathways in LMICs can be
significantly contributed to healthcare delivery seen two landmark studies: Implementation of
in LMICs. These initiatives used mobile tech- EHR Systems to Improve Data Availability and
nology, internet connectivity, and telecommuni- Quality (Rajbhandari et al. 2020) and Successful
cations infrastructure to connect patients in Implementation of E HR in Resource-Constrained
remote areas with skilled health workers in Environments (Fraser et al. 2021).
urban centers or specialized health facilities. Rajbhandari et al. (2020) showed that intro-
Through real-time audio and video consulta- ducing EHR systems in LMICs can significantly
tions, teleconsultation services have simplified improve data availability and quality. By digitiz-
remote diagnosis, medical consultations, and ing medical records and streamlining data man-
treatment plans, optimizing resource allocation agement, electronic health records give healthcare
Digitization of Clinical Pathways in Low- and Middle-Income Countries 145
professionals real-time access to critical patient cesses in LMICs. Healthcare systems in LMICs
information. This accessibility facilitates timely face significant challenges in using technology to
decision-making and enables efficient and per- improve clinical pathways and patient outcomes.
sonalized patient care. In addition, electronic This summary examines critical technical infra-
health records facilitate data standardization, structure and connectivity issues associated with
improving data quality, increasing research clinical pathways, drawing on two key refer-
capacity, and supporting evidence-based prac- ences: “Limited internet connectivity and inade-
tice. Fraser et al. (2021) provided valuable infor- quate network infrastructure” (Vital Wave 2019)
mation on the successful implementation of EHR and “Compatibility issues with existing health-
in resource-constrained environments and high- care systems and technologies” (Tamrat et al.
lighted the feasibility and benefits of implement- 2018).
ing EHR systems in LMICs. The study The 2019 Vital Wave report highlighted the
underscores the importance of addressing issues problem of limited internet connectivity and
such as limited infrastructure, internet connectiv- inadequate network infrastructure in LMICs.
ity, and lack of human resources. Successful This limitation prevents the effective implemen-
implementation of EHR in LMICs requires tai- tation of digital health solutions, telemedicine,
lored solutions that include scalable and cost- and health information exchange systems, which
effective technologies with a focus on ease of use are important components of optimized clinical
and training of healthcare professionals. processes. The lack of reliable internet access
However, implementing digital clinical path- impedes the seamless exchange of patient data,
ways in LMICs is challenging. These issues diagnostic results, and medical records, disrupts
include funding constraints, interoperability, and the continuity of care, and creates problems in
privacy concerns. A lack of financial resources the coordination of complex clinical processes.
can impede the large-scale implementation of In addition, a study by Tamrat et al. from 2018
EHR, thereby impeding the widespread adoption pointed out compatibility issues with existing
of digital clinical pathways. Interoperability healthcare systems and technologies in LMICs.
between different EHR systems and healthcare Integrating new technologies into an established
organizations is critical for effective data sharing healthcare infrastructure can be challenging,
and care delivery, but it can be challenging to often leading to interoperability issues and data
achieve in all healthcare organizations. In addi- silos. This lack of interoperability impedes a
tion, ensuring privacy and data security remains a smooth transition to digital clinical workflows,
priority when moving to digital systems to main- reduces efficiencies, and limits the ability of
tain patient trust and comply with regulatory healthcare professionals to make informed
requirements. decisions.
EHRs offer significant opportunities to Comprehensive strategies and international
improve healthcare in LMICs by improving data collaboration are required to remove these tech-
availability, quality, and overall patient care. The nical barriers to the clinical management of
studies cited in this summary illustrate the bene- LMIC. Building a reliable network infrastructure
fits of introducing EHR into clinical practice and and improving internet connectivity should be a
underscore the need to address challenges for priority to ensure reliable and secure transmis-
successful implementation in resource-sion of patient data. In addition, health policy-
constrained settings. Overcoming these barriers makers and stakeholders need to invest in
will be critical to realizing the major features of interoperable health technologies that seamlessly
EHRs and transforming healthcare in low- and integrate with existing systems. This integration
middle-income countries. can lead to improved coordination of care, data
Technical infrastructure and connectivity sig- sharing, and patient engagement, ultimately con-
nificantly impact the digitization of clinical pro- tributing to improved health outcomes in LMICs.
146 D. Marino et al.
Thus, technical infrastructure and communica- foundly changed the healthcare sector, promising
tions remain key challenges in driving clinical better patient outcomes and more efficient health-
referrals in LMICs. Faced with the impact of lim- care delivery. However, the successful imple-
ited internet access and interoperability issues, mentation of digital clinical pathways in LMICs
healthcare stakeholders can work together on faces significant challenges regarding digital lit-
transformative solutions that prioritize the adop- eracy and user adoption. This summary examines
tion of digital healthcare services, thereby ensur- the impact of these challenges on the implemen-
ing equitable access to quality healthcare for all. tation of digital clinical pathways and possible
Costs and sustainability play an important solutions to address them.
role. Effective implementation of clinical path- Gyau et al. (2020) highlighted the uptake of
ways in LMICs is hampered by the interplay of digital literacy among healthcare professionals
cost and sustainability factors. This summary and patients in LMICs. Limited access to digital
addresses the challenges in achieving optimal tools and technologies can prevent healthcare
patient outcomes in the face of financial con- providers from using digital clinical pathways
straints and the long-term viability of clinical effectively, leading to suboptimal adoption and
pathways in LMICs. Financial constraints and potential resistance to the implementation of
limited resources for technology investments these technologies by healthcare professionals.
have been identified as significant barriers to suc- Additionally, patients’ limited digital literacy
cessfully implementing clinical pathways in may impede their active participation and under-
LMICs (Nelson et al. 2019). Due to tight funding standing of clinical processes, reducing the over-
and limited access to modern healthcare technol- all effectiveness of these interventions.
ogies, LMICs struggle to keep up with the rap- Another obstacle to the widespread adoption
idly changing healthcare landscape. As clinical of digital clinical pathways in LMICs is resis-
pathways are often based on state-of-the-art tance to change and digital skepticism, as Khoja
digital health interventions, financial constraints et al. highlighted (2019). Healthcare systems in
challenge their widespread implementation. these regions often have deep-rooted traditional
Additionally, the long-term sustainability of practices, and any adoption of digital tools can be
digital health interventions is a key issue for met with reluctance and fear. This resistance can
LMICs (Sarker et al. 2020). While these inter- prevent the integration of digital clinical path-
ventions may be promising in the short term, ways into existing healthcare workflows and pre-
maintaining and maintaining such technologies vent them from realizing their full potential to
over long periods becomes a challenge. In many improve patient outcomes.
cases, financial support for initial implementa- Addressing these challenges requires a focus
tions may not cover ongoing maintenance costs, on improving the digital literacy of healthcare
leading to failure and even abandonment of clini- professionals and patients in low- and middle-
cal pathways. Incorporating cost and sustainabil- income countries. Education and training pro-
ity considerations into the design and grams that equip healthcare professionals and
implementation of clinical pathways in LMICs is individuals with the necessary digital skills and
critical to improving health outcomes and knowledge are critical to acceptance and confi-
addressing these countries’ unique challenges. dence in digital clinical pathways. In addition,
By recognizing and overcoming financial con- efforts should be made to increase awareness and
straints and with a long-term vision, countries understanding of the benefits of digital technolo-
with low- and middle-level health care in these gies in healthcare in order to overcome skepti-
regions can move forward. cism and resistance to change. Successful
Digital literacy and user adoption are also implementation of digital clinical pathways in
essential factors in the speed of adoption and LMICs depends on addressing digital literacy
usage. Advances in digital technologies have pro- issues and user acceptance among healthcare
Digitization of Clinical Pathways in Low- and Middle-Income Countries 147
professionals and patients. Improvement can be GSMA (2021) The mobile economy 2021. Retrieved from
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Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
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obtain permission directly from the copyright holder.
Digitalization in Pediatrics in Low-
and Middle-Income Countries:
Rationale and Directions
Sergey Sargsyan
Abstract 1 Introduction
Digital healthcare applications are impacting
all fields of healthcare, including pediatrics Significant achievements and new emerging
and pediatric research. However, the speed at challenges have been observed in child health-
which this is achieved remains highly depen- care in the world over the last decades. In most
dent on the implementation context. countries including low- and middle-income
Pediatricians, family doctors and nurses, as countries (LMICs), child mortality rates have
well as healthcare managers are faced with the gradually decreased. According to the latest esti-
promise and challenges of introducing these mates from the World Health Organization
technologies into routine service. Especially (WHO), the global under-five mortality rate has
in LMICs, many “old” and “new” challenges dropped by approximately 60% from 93 per 1000
have to be met, in the context of digitisation. It live births in 1990 to 38 in 2021 (World Health
is appreciated that in many settings, digital Organization (WHO) 2023). Analysis of the
technologies may help them to reach better kinds of child mortality cases reveals that neona-
results. However, further studies are needed to tal deaths are the most common, even though
highlight the optimal ways for using these mortality rates in children aged 0–28 days have
technologies. gone down, the decrease is less than for the post-
natal period. Worldwide introduction of pneumo-
Keywords coccal vaccines since 2000 (including many
LMICs) has had a significant impact on the pre-
Pediatrics · Digitisation · Low-and middle- vention of this infection and led to a reduction in
income countries (LMIC) · Child develop- mortality caused by it. However, pneumonia is
ment · School health · Neonatal care still one of the leading causes of mortality
accounting for about one out of seven cases,
mainly in LMICs (Liu et al. 2016). Diarrhea is
also a major cause of mortality accounting for
more than half a million deaths annually for chil-
dren in LMICs (Tricarico et al. 2017).
S. Sargsyan (*)
Morbidity and mortality indicators are closely
Institute of Child and Adolescent Health at “Arabkir” related to the children’s nutritional status. In
Medical Centre, Yerevan State Medical University, LMICs, child malnutrition is still among major
Yerevan, Armenia concerns. As an indicator of the “double
burden“of nutrition, overweight and obesity are quality of live for an entire lifetime (Herbert et al.
amongst the newly emerging problems. Globally, 2012).
149 m children under five are estimated to be Thus, despite significant achievements, pedi-
stunted, 45 m are wasted and 39 m are overweight atric systems worldwide, and especially in
(BD 2017 Causes of Death Collaborators 2018). LMICs, are still tackling “old” problems while
Among children aged 5–19 years, the burden of being confronted with “new” issues. To meet
overweight is increasing and there are concerns these challenges, the quality of care in health
regarding the effectiveness of interventions aim- facilities should be improved. The quality of
ing to reduce the prevalence of obesity (Katoch home care, care-seeking practices, and health
2022). behavior of the population should be improved
During the last decades, due to a sum of objec- and adapted to the current needs. Digital tech-
tive and subjective factors, there were significant nologies, already in use in many settings, are one
increases overall in the prevalence of develop- of the tools that can be used to improve child and
mental disabilities, autism spectrum disorders adolescent health. They have the potential to
(ASD), and attention deficit and hyperactivity increase the effectiveness of healthcare delivery,
disorders (ADHD) in children in both developed lead to organizational changes, improve health
(Das et al. 2018) and developing countries information systems and the exchange of these
(Zablotsky et al. 2019). In particular, data from data among stakeholders, support continuous
the large-scale household survey conducted in medical education of staff through easing access
Armenia with the support of UNICEF showed to educational materials, and improve communi-
the prevalence of such conditions in children cation between care-providers and care-takers.
from 0 to 8 years old is as high as 11.6% By using digitalization, nations and communities
(Olusanya et al. 2022). In line with developmen- may achieve significant inputs in promoting
tal problems, other chronic conditions including Universal Health Coverage in LMICs which is
asthma, obesity, and diabetes amongst others, are one of the Sustainable Developments Goals of
becoming increasingly common worldwide. the United Nations (United Nations Sustainable
Some epidemiological studies show that up to Development Goals 2023). This narrative review
1 in 4 children have a chronic disease with preva- focuses on the digitalization in pediatrics in
lence estimates ranging from 10% to 30% LMICs, including specific examples. What prac-
(Ministry of Health, National Statistical Service, tices in digitalization have been adopted in recent
Fund of Armenian Relief. UNICEF 2005). One years and which are on agenda now? The follow-
in fifteen children has multiple chronic condi- ing sections provide a high-level summary by
tions, for instance obesity and/or asthma or dia- field.
betes (Compas et al. 2012).
Key factors related to children’s health out-
comes include social welfare status, education 2 Respiratory Diseases
census and care-seeking practices of the chil-
dren’s families. There are a number of studies As mentioned previously, pneumonias and respi-
and reviews emphasizing the role of home care ratory failure caused by them are still amongst
practices, time of referrals, etc. (Perrin et al. the main causes of mortality in young children.
2007). Health behaviors of school-age children Thirty years ago, the WHO developed guidelines
and adolescents play an important role not only to improve the management of pneumonias that
in their health at this age but also determines their were incorporated into the guidelines on
health status in later life. Unhealthy dietary hab- Integrated Management of Childhood Illnesses in
its, tobacco and drug use, mental health issues, the late 1990s. The guidelines recommended
and other problems originate in school-age and using criteria of fast breathing and chest indraw-
adolescence and often impact health status and ing for early detection of cases of respiratory
Digitalization in Pediatrics in Low- and Middle-Income Countries: Rationale and Directions 151
find the best options to support the children with satisfaction, medication adherence, visit comple-
developmental problems and chronic health tion rates, and disease progression (Shah et al.
conditions. 2021).
It is well known that relevant behavior of the During telemedicine visits, practicality of the
patient can support the management of chronic real-time video Pediatric Gait, Arms, Legs, and
health conditions. The use of digital interventions Spine (v-pGALS) assessment have been used in
may be a more cost-effective and accessible tool the evaluation. The study showed that pGALS
to guide patients. The most promising interven- performed during telemedicine visits was a reli-
tions targeted overweight or obesity through able tool to assess the musculoskeletal system in
exergaming or social media, using web-based children (Kenis-Coskun et al. 2022). In another
cognitive behavioral therapy, and typically using case, telemedicine consultations were provided
behavior change techniques such as feedback, to patients from rural areas that had difficulties to
monitoring, etc. (Brigden et al. 2020) There are access specialized services. The results of this
also targeted studies assessing the effects of study showed that this practice led to an improve-
technology- based interventions on overweight ment in the quality of management of some der-
and obesity treatment in children and a dolescents. matological conditions (Byrom et al. 2016). The
The results of reviews show that functional and cost-effectiveness of therapist-guided, internet-
acceptable technology-based approaches, in delivered cognitive behavioral therapy for chil-
addition to “common” treatment, may enhance dren and adolescents with obsessive-compulsive
weight loss in young populations (Kouvari et al. disorder has been evaluated. The results show
2022). Wireless Body Area Networks (WBANs) that for young people with obsessive-compulsive
that focus on controlling obesity and overweight disorder, a low-cost digital intervention followed
have been developed and have shown to produce by in-person treatment for non-responders was
promising results (Mohammed et al. 2018). cost-effective compared with in-person cognitive
behavior therapy alone (Aspvall et al. 2021).
Overall, it is evident that telemedicine services
5 Health Care Organization complement traditional, in-person health care
and Delivery resulting in a greater impact and improved qual-
ity of care. However, to maximize the potential of
One of the key directions of using digital tech- telemedicine, further research is needed to
nologies in healthcare are video clinical visits. improve its regulations and mechanisms.
The practice of virtual visits increased signifi-
cantly during the COVID-19 pandemics. The
analysis showed that such practices continued 6 School Health
after the pandemics and expanded the capacities
of health systems in many healthcare units world- One of the fields of pediatrics bordering on pub-
wide (Mohammed et al. 2021). lic health is school health. School health is a mix-
The use of telemedicine in pediatrics has also ture of various practices including school nursing,
increased in recent years. One systematic review different programs, health educational activities
analyzed studies where the quality of care and etc. School health is a particularly good option to
care-takers satisfaction was compared with in- reach adolescents and provide care for them.
person visits. The range of conditions included Models for the provision of care in school health
obesity, asthma, type-1 diabetes, and otitis media using opportunities provided by telemedicine
among others. The telemedicine interventions in have been described (North and Dooley 2020). In
all included studies resulted in outcomes that addition, innovative digital health interventions
were comparable to or even better than the out- have been used for assessment, identifying the
comes of control groups. These outcomes were children who are at risk of developing psycho-
related to symptom management, quality of life, logical symptoms and providing support for
Digitalization in Pediatrics in Low- and Middle-Income Countries: Rationale and Directions 153
those most at risk of mental health or related require a systematic review approach.
problems. The results showed that both teachers Additionally, although the subject has often been
and schoolchildren found digital intervention mentioned in the international literature, few
usable and acceptable (Davies et al. 2021). implementation examples have been published.
However, there have been many barriers and fur- This limits the available pool of published manu-
ther research is needed. scripts that can be used throughout. Having said
that, digital health in pediatrics is a relatively new
field and it is developing rapidly. Therefore, this
7 Health Education manuscript provides an overview of a field in its
early stages and should be re-visited in the future
There are many studies that show that child in a more systematic way.
health status is directly related to parental health
literacy. Worldwide, young people and young
parents in particular, obtain health information 9 Conclusions
from the Internet. The outcomes of digital health
interventions on health literacy among parents of What are the conclusions of our brief analysis?
children aged 0–12 years have been assessed Digital health applications will affect every
based on a systematic review of nearly 1500 stud- aspect of pediatric healthcare provision and
ies, (Mörelius et al. 2021). The range of studies research, however, the speed at which this will be
included evaluation of parents’ engagement, the achieved will be highly dependent on the imple-
effect of interventions on parental knowledge and mentation context. Pediatricians, family doctors
health behavior, and the subsequent impact on and nurses, health managers worldwide, espe-
child health outcomes. The review stressed the cially in LMICs, meet many “old” and “new”
potential of digital health interventions to challenges every day. In many LMIC settings,
improve parental knowledge and behavior. digital technologies may help them to reach bet-
ter results. However, further studies are needed to
find the optimal ways for using these
8 Continuous Medical technologies.
Education
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Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license,
unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons
license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
obtain permission directly from the copyright holder.
Digitization in Genetics
and Diagnostics Laboratories
in Armenia
Abstract
1 Introduction
Cancer is the second leading cause of death in
Armenia. Over the past two decades, the coun- The genetics counseling and genetic testing have
try has seen a significant rise in cancer mor- been widely used in Armenia for more than two
bidity and mortality. Additionally, Familial decades (Cazeneuve et al. 1999). The practice of
Mediterranean Fever is the most common medical genetics first concerned hereditary disor-
genetic disorder in Armenia. The current ders common in the Armenian population
chapter presents an overview of the digitisa- (Sarkisian et al. 2005, 2007). Later, genetic test-
tion progress made within Armenia in the last ing and related genetic counseling were applied
decades, and how this is impacting healthcare also for diseases with high genetic predisposition
provision. As a low-and middle-income coun- as well as in precision medicine. Currently, in
try (LMIC), Armenia can set a useful example Armenia with about three million population
for other LMICs with regards to the digitisa- more than 135,000 people have passed different
tion implementation in clinical genetics and genetic or genomic testing, and the number is
diagnostics laboratories. increasing with more than 5000 genetic tests per-
formed annually.
Keywords During this time period the content of genetic
information and its further transfer to end-users,
Armenia · Genetics · Diagnostics · Digital including patients, physicians firstly and society
diagnostics · Low-and middle-income in general, became another challenge which
countries (LMIC) · Familial Mediterranean required the need of active training and increas-
fever ing awareness in genetics (Bagboudarian n.d.),
for the appropriate management of patients and
D. Babikyan (*) genetic disorders as a whole within the country.
Faculty of Public Health, Yerevan State Medical
University, Yerevan, Armenia Meanwhile, digitization in many areas and ser-
vices, including healthcare, raised the importance
Laboratory of Molecular Genetic, Center of Medical
Genetics and Primary Health Care, Yerevan, Armenia of similar changes in genetic services, particu-
larly during the COVID-19 pandemic and
T. Sarkisian
Department of Medical Genetics, Yerevan State because of its related restrictions on population
Medical University, Yerevan, Armenia movement (Sargsyan et al. 2022; Torosyan 2020).
Center of Medical Genetics and Primary Health Care, On the other hand, scarcity of genetic services
Yerevan, Armenia and a very low number of clinical geneticists are
another prerequisite for the development of a new of autoinflammatory disorders patient’s database
model of genetic services with assistance by digi- of the Center of Medical Genetics and Primary
tal technologies, as compared to the classic in- Health Care (based in the capital city of Yerevan)
person visits and time-consuming meetings which is designed to submit, store and analyze a
(taking on average more than 35 min per patient). complex of clinical, genetic, laboratory data of
In addition, several issues also can be patients with autoinflammatory diseases. All
described as secondary contributing factors for information about the tested patients is entered
the digitisation of genetic services. These sec- into the AIDsBuilder central server that includes
ondary contributing factors include, but are not genetic, clinical and laboratory data of patients.
limited to, appropriate genetic information per- However, it has open access only for registered
ception, interpretation and accurate understand- physicians with special access codes who also
ing both by treating physicians and patients; the have access to the anonymized database of other
need for updated national policy and regulations; patients with similar clinics or genotypes for
cost-effectiveness of services and easier financial determination of inheritance patterns in several
administration of allocated costs; societal trans- generations, corrections of doses of relevant
parency while maintaining individual privacy; medicines as well as for templated reporting of
ethnic and religious nuances (due to the geopo- genetic testing. This first digital genetic tool was
litical location of Armenia); and protecting the developed for physicians, incorporating end-user
mental health of patients (Bedirian et al. 2022). feedback, as an emerging digital assistance for
Taken together these present a set of interweaved understanding genetic testing data of autoinflam-
strategic challenges supporting the implementa- matory disorders and for improving patient
tion of a comprehensive digitization framework outcomes.
of genetic services.
2.2 Cancer
2 Current Efforts in Armenia
Cancer is the second cause of death after cardio-
Currently, the digitization of genetic services in vascular disorders in Armenia. Armenia is in the
Armenia is fragmented and concerns only a few global frontline with the mortality rate of differ-
fields of genetic services with different levels of ent types of cancer according to the Globocan
achievements and integration in the health care data. Meantime integration of genomic analysis
system. Here we briefly describe three different in the personalized treatment of cancer patients
cases in use of digital genetic services focused on has driven new challenges for oncologists to bet-
a program for patient clinical and genetic data ter understand molecular bases of cancer and
submission and analysis for physicians, a toolbox genomic data provided after testing (Bedirian
for genetic and/or genomic data at the national et al. 2022; Calvez-Kelm et al. 2011; Moradian
database, and a newly developing genetic toolbox et al. 2021). In recent years, a national cancer
for patients and physicians. registry has been developed in Armenia which
among several other data incorporates genetic
and/or genomic testing reports as well. This web-
2.1 Familial Mediterranean Fever based registry is open for all clinics and laborato-
ries which have access to cancer patients,
Familial Mediterranean Fever is the most com- therefore, the genetic counseling and genetic test-
mon genetic disorder in Armenia and to date over ing data of each patient is submitted to the portal,
50,000 people were tested for this genetic disor- a central national hub of all cancer patients inde-
der (Sarkisian et al. 2005, 2007; Ben-Chetrit pendent of their treatment location. Therefore,
et al. 2015). In this regard a special web-based cancer registry is also serving a comprehensive
program, AIDsBuilder is developed on the basis digital source of delivery of complex medical
Digitization in Genetics and Diagnostics Laboratories in Armenia 159
data of cancer patients which facilitates patient- tests, their results and further management of
centered service delivery, improves the health- patients. At the same time, the Patient’s Office is
care efficacy and eventually, cancer patient an ideal tool to escape from post-test visits of
outcomes. At the same time, the overload of patients who have negative test results and does
genomic data in the clinical oncology workflow not require any further genetic counseling.
is another cause to increase the genetic literacy
among physicians. In this regard, digitally deliv-
ered genetic reports include interpretation of 4 Conclusions
genetic testing results according to current inter-
national guidelines as set by the European Society Armenia is taking the first steps in digitization of
for Medical Oncology (ESMO), the National genetic services and for their incorporation in the
Comprehensive Cancer Network (NCCN), and health care system (Amaryan et al. 2021; Davtyan
the American Society for Clinical Oncology et al. 2019). The adoption of this process will
(ASCO). require development of digital technologies at
national level or in a private sector with help of
artificial intelligence, proof of their clinically
3 Digitization of Genetic evidence-based and economic efficacies. More
Services importantly, for the development of digital
genetic services while restricting personal meet-
Eventually, a more comprehensive approach of ings between patients and physicians, there is a
digitization of genetic services was developed by clear and must-do prerequisite when one needs to
the Center of Medical Genetics and Primary have a patient’s trust-based approach with pri-
Health Care (Amaryan et al. 2021). The Patient’s vacy and data protection and patient-centered
Office is a personal portfolio for each patient and solutions in such a peculiar field of genetic health.
can be co-utilised by the patient and his/her phy-
sician. The Patient’s office is a unique toolbox
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Digitization in Dentistry
and Dental Implantology in Low-
and Middle-Income Countries
Hrach Mikayelyan
Abstract 1 Introduction
The use of digital technology in healthcare
The field of dentistry has undergone a significant
impacts dentistry and dental implantology as
transformation in recent years, with the advent of
well. In high-income countries, digitization is
digitalization and introduction of new technolo-
already transforming the way dental treat-
gies into routine treatment. In high-income set-
ments are planned and executed. However, the
tings, digital technologies have revolutionized
application in Low- and Middle-Income
the way dental treatments are planned and exe-
Countries (LMICs) remains sporadic and lim-
cuted, providing more accurate, efficient, and
ited to specific techniques and/or institutions.
predictable outcomes (Smith 2018a, b; Braun
This chapter explores the current state of digi-
2019). In low and middle-income countries
tization in dentistry and dental implantology
(LMICs), where access to dental care is often
in LMICs, as well as the potential areas of
limited, digitalization remains limited, but has
opportunity for development in the field.
the potential to significantly improve the quality
While there are many potential opportunities
and accessibility of dental treatments (Jones et al.
to still be taken advantage of, digitization in
2020a, b, c).
dentistry and dental implantology in LMICs,
Digitalization in dentistry refers to the use of
require consistent support of infrastructure
digital technologies such as computer-aided
and incentivization of those opportunities for
design and computer-aided manufacturing (CAD/
research and innovation, so that digitization
CAM), cone-beam computed tomography
can become a catalyst for transforming dental
(CBCT), intraoral scanners, and digital radiogra-
care.
phy, among others, to diagnose, plan, and execute
dental treatments (Brown et al. 2019). The scope
Keywords
of digitalization in dentistry is vast and encom-
Digitisation · Low-and middle-income passes a wide range of applications, including but
countries (LMIC) · Dentistry · Dental not limited to restorative dentistry, orthodontics,
implantology · Dental care · Digital imaging oral and maxillofacial surgery, and implant den-
tistry (Johnson 2021).
LMICs face numerous challenges in provid-
ing accessible and affordable dental care to their
populations. These challenges include a shortage
H. Mikayelyan (*) of trained dental professionals, limited financial
Ultradent Clinic, Yerevan, Armenia
resources, and inadequate infrastructure (World there is a severe shortage of oral healthcare pro-
Health Organization 2017). Digitalization has the fessionals (World Health Organization n.d.).
potential to address some of these challenges by According to the WHO, in many LMICs, there is
improving the accuracy, efficiency, and predict- only one dentist per 100,000 population, com-
ability of dental treatments, reducing the need for pared to an average of 10 dentists per 100,000
multiple appointments, and minimizing the risk population in high-income countries (World
of complications (Gupta et al. 2022a, b). Health Organization n.d.). This shortage of oral
Moreover, digitalization can also help to healthcare professionals makes it difficult for
bridge the gap between urban and rural areas by LMICs to provide adequate dental care to their
providing access to high-quality dental care in populations. In addition to the shortage of oral
remote and underserved areas. The use of tele- healthcare professionals, LMICs also face chal-
dentistry, for example, can enable dental profes- lenges related to healthcare infrastructure, financ-
sionals to remotely diagnose and plan treatments ing, and education. The lack of healthcare
for patients in rural or remote areas, reducing the infrastructure and financing limits the availability
need for them to travel long distances to access of basic dental care services, such as preventive
dental care (Lee et al. 2023). care and restorative treatment. Moreover, the lim-
The primary objective of this chapter is to pro- ited education and training opportunities for den-
vide an overview of the current state of digitaliza- tal professionals in LMICs mean that many
tion in dentistry and its potential applications in dentists lack the necessary skills and knowledge
LMICs. The chapter will explore the different to provide advanced dental treatments, such as
digital technologies available for dental treat- dental implantology (World Health Organization
ments, their advantages and limitations, and their n.d.).
potential impact on the accessibility and quality Dental implantology is a complex and
of dental care in LMICs. Moreover, the chapter advanced dental treatment that requires special-
will also discuss the challenges and barriers to ized training, equipment, and materials (Smith
the adoption of digital technologies in LMICs 2018a, b). However, in LMICs, many of these
and provide recommendations for overcoming resources are limited, making it challenging to
these challenges. Finally, the chapter will high- provide dental implant treatment to patients
light the role of digitalization in implant dentistry (Jones et al. 2020a, b, c). The lack of specialized
in LMICs, including the use of guided implant training and education opportunities means that
surgery and digital workflows to improve the many dental professionals in LMICs may not
accuracy and predictability of implant place- have the expertise to perform dental implant sur-
ments. The approach used is that of a narrative gery (Johnson and Brown 2019). Moreover, the
review, based on identified key references, so as cost of dental implant treatment is often prohibi-
to provide a general overview of the subject, tively expensive for many patients in LMICs
without necessarily analyzing a single particular (Nguyen et al. 2021). The high cost of dental
aspect in exhaustive detail. implants, materials, and equipment, combined
with the lack of insurance coverage, means that
many patients cannot afford dental implant treat-
1.1 Overview of Dentistry ment (Gupta et al. 2022a, b).
and Dental Implantology Despite these challenges, there are several ini-
in Low and Middle-Income tiatives underway to improve access to dental
Countries implant treatment in a few locations in LMICs.
For example, some organizations are providing
Oral healthcare challenges in LMICs are multi- training and education opportunities for dental
factorial and complex. The World Health professionals in LMICs, while others are devel-
Organization (WHO) reports that basic dental oping low-cost dental implants and equipment
treatment is not available in many LMICs, and (Johnson and Smith 2023). Additionally, some
Digitization in Dentistry and Dental Implantology in Low- and Middle-Income Countries 163
LMICs are implementing policies and programs sions offer several advantages over traditional
to increase access to dental care services, includ- impression methods, including greater accuracy,
ing dental implant treatment (Ministry of Health faster turnaround time, and reduced discomfort
2021). So, dentistry and dental implantology in for patients (Robinson and Thompson 2021). In
LMICs face unique challenges due to limited LMICs, digital impressions can improve access
resources, inadequate infrastructure, and lack of to dental restorations, as they require fewer office
access to specialized training (Brown et al. 2020). visits and reduce the need for physical impres-
However, with the increasing demand for dental sions (Miller et al. 2018), however only very few
implant treatment in LMICs, there is a need to pilot cases have been published so far in LMICs
address these challenges and improve access to (Shahrul and Rahman 2021).
dental care services for all (World Health Three-dimensional (3D) printing is a rapidly
Organization 2023). emerging technology in dentistry and dental
implantology. 3D printing enables the fabrication
of dental implants, surgical guides, and other
1.2 Digital Imaging dental devices using digital designs (Smith et al.
and Radiology 2021). This technology offers several advantages
over traditional fabrication methods, including
Digital imaging and radiology have revolution- greater accuracy, faster turnaround time, and
ized the way dentists diagnose and treat dental reduced cost (Jones and Brown 2019). In LMICs,
problems (Smith et al. 2018a, b). Digital radiog- 3D printing can help to reduce the cost and time
raphy, cone beam computed tomography required to fabricate dental devices, making them
(CBCT), and magnetic resonance imaging (MRI) more accessible to patients (Wilson et al. 2020).
provide high-quality, detailed images of the oral To date, only a few pilot cases have been pub-
and maxillofacial region, enabling dentists to lished for resource-restricted settings (Ashraf
diagnose and plan treatment more accurately and et al. 2022).
efficiently (Johnson 2020). In LMICs, digital Augmented reality (AR) and virtual reality
imaging and radiology can improve access to (VR) technologies are increasingly being used in
diagnostic services and reduce treatment costs dentistry and dental implantology. These tech-
(Brown and Lee 2019a, b). nologies enable dentists to visualize and plan
Computer-aided design and computer-aided treatments in a three-dimensional virtual envi-
manufacturing (CAD/CAM) systems enable den- ronment, improving treatment accuracy and
tists to design and fabricate dental restorations, patient outcomes (Choi et al. 2022). In LMICs,
such as crowns, bridges, and dentures, using digi- AR and VR technologies can improve access to
tal technologies (Garcia et al. 2021). CAD/CAM specialized training and education opportunities,
systems offer several advantages over traditional enabling dental professionals to acquire the skills
methods, including faster turnaround time, and knowledge required to perform advanced
greater precision, and improved aesthetics (White dental treatments, such as dental implant surgery
and Davis 2017). In LMICs, CAD/CAM systems (Lee and Kim 2023). However, these platforms
can help to reduce the cost and time required to are only incorporated sporadically in educational
fabricate dental restorations, making them more initiatives, and a consistent integration, at scale
accessible to patients (Chen and Patel 2022). and within national training courses has not been
Intraoral scanning and digital impressions are reported for LMICs.
non-invasive, painless methods of capturing a Telemedicine and teleconsultation technolo-
digital impression of a patient’s teeth and gums gies enable dental professionals to provide
(Jones and Smith 2019). Intraoral scanners use remote consultation and treatment services to
light to capture images of the oral cavity, which patients in LMICs. These technologies have the
are then used to create a digital model of the potential to bridge the gap in dental care access
patient’s teeth (Black et al. 2020). Digital impres- by allowing dental professionals to provide spe-
164 H. Mikayelyan
cialized services to patients who would otherwise reducing the risk of surgical errors and improving
have limited access to dental care services (Gupta treatment outcomes (ADA 2020). In LMICs, dig-
et al. 2021a, b). By utilizing telemedicine and ital technologies can increase access to special-
teleconsultation, dental professionals can ized dental implant services and improve
overcome geographic barriers and deliver care treatment outcomes for patients (WHO 2018a,
remotely, improving oral health outcomes in b).
underserved populations (Kumar and Singh Streamlined Workflow and Time Efficiency:
2022). Digital technologies, such as intraoral scanning,
digital impressions, and computer-aided design,
have facilitated a streamlined workflow and
1.3 Benefits of Digitalization reduced treatment time for dental professionals
in LMICs (Smith et al. 2018a, b). By eliminating the need
for physical impressions, digital technologies
Digitalization in dentistry and dental implantol- have significantly reduced the time and cost
ogy offers several benefits for patients, dental required for dental restorations (Chen et al.
professionals, and healthcare systems in LMICs 2020). In LMICs, the adoption of digital tech-
(World Health Organization [WHO] 2018a, b), as nologies has the potential to enhance access to
already observed in high-income settings dental care services by reducing treatment time
(American Dental Association 2021). In this sec- and improving the efficiency of dental profes-
tion, we will discuss some of the most significant sionals (Peters et al. 2019).
benefits of digitalization in LMICs. Patient Education and Engagement: Digital
Enhanced Diagnosis and Treatment Planning technologies, including augmented reality and
is one of the enhancement areas. Digital technol- virtual reality, have empowered dental profes-
ogies, such as digital imaging and radiology, sionals to educate and engage patients in their
intraoral scanning, and computer-aided design treatment (Gupta et al. 2021a, b). By visualizing
(CAD), enable dental professionals to diagnose and explaining treatment plans in a three-
and plan treatment more accurately and effi- dimensional virtual environment, digital technol-
ciently (American Dental Association [ADA] ogies have enhanced patient understanding and
2020). These technologies provide high-quality, engagement (Kuchler et al. 2019). In LMICs, the
detailed images of the oral and maxillofacial utilization of digital technologies has the capac-
region, enabling dental professionals to identify ity to improve patient education and engagement,
dental problems and plan treatment more effec- thereby increasing the likelihood of treatment
tively (Kumar et al. 2019). In LMICs, digital acceptance and enhancing treatment outcomes
technologies can improve access to diagnostic (Jones et al. 2020a, b, c). The integration of digi-
services and reduce the time and cost required for talization in dentistry and dental implantology
treatment planning (WHO 2018a, b). brings numerous benefits for patients, dental pro-
Improved Precision and Outcomes in Dental fessionals, and healthcare systems in LMICs.
Implantology specifically benefits from digital Digital technologies enable more accurate diag-
technology, especially in budget limited settings. nosis and treatment planning, improve treatment
Digital technologies, such as three-dimensional outcomes and precision in dental implantology,
(3D) printing, computer-aided design and streamline workflow, increase time efficiency,
computer- aided manufacturing (CAD/CAM), and enhance patient education and engagement.
and augmented reality, enable dental profession- As digital technologies continue to advance, their
als to perform dental implant surgery with greater potential benefits for LMICs are potentially sub-
precision and accuracy (Schulz et al. 2021). By stantial, and their utilization in dentistry and den-
utilizing these digital tools, dental professionals tal implantology is expected to grow in the future,
can plan treatment in a 3D virtual environment, following the example of other clinical fields
Digitization in Dentistry and Dental Implantology in Low- and Middle-Income Countries 165
where digital tools have been integrated into rou- guidelines governing the use of digital tech-
tine pathways in LMICs, e.g., radiology and nologies in dentistry and implantology (World
pathology. Dental Federatin 2018). Additionally, there
Barriers to Digitalization in LMICs: Despite may be legal barriers to importing digital
the revolutionary impact of digitalization on equipment or materials, which can limit the
dentistry and implantology worldwide, its adop- availability of these technologies in LMICs.
tion in LMICs faces several challenges, as high-
lighted below: While digitalization has the potential to improve
dental care and implantology in LMICs, there are
• Limited Infrastructure and Resources: LMICs significant barriers to adoption. Overcoming
often lack the necessary infrastructure and these challenges will require a concerted effort
resources to support digitalization in dentistry from governments, professional organizations,
and implantology. For example, there may be and industry leaders to address infrastructure,
inadequate internet connectivity, limited financial, training, and regulatory barriers.
access to high-quality imaging equipment,
and insufficient power supply (World Health
Organization 2019). These factors can make it 1.4 Strategies for Successful
difficult to acquire and transmit digital data, Implementation of Digital
which is essential for digital treatment plan- Technologies in LMICs
ning and communication with dental
laboratories. Digital technologies have the potential to revolu-
• Financial Constraints and Affordability: tionize dentistry and implantology; however,
Digital technologies can be expensive to their implementation in LMICs comes with
acquire and maintain, which can pose a sig- unique challenges. To ensure successful imple-
nificant financial burden for dental practices mentation of digital technologies in these set-
and patients in LMICs (Yin et al. 2020). tings, it is crucial to consider the following
Additionally, there may be limited access to strategies:
financing options or insurance coverage for
digital dental procedures (Bukhari et al. 2018). • Collaboration and Partnerships: Collaboration
This can make it challenging for practitioners and partnerships play a pivotal role in the suc-
to invest in digital equipment and for patients cessful implementation of digital technologies
to afford digital treatments. in LMICs (Smith 2020). By fostering collabo-
• Training and Education: Digitalization ration between dental professionals, public
requires specialized training and education health officials, and technology providers, it
that may not be readily available in LMICs. can become possible to tailor digital technolo-
Dental professionals need to be proficient in gies to local needs and challenges. Engaging
using digital imaging and planning software, community organizations and patient groups
as well as in designing and fabricating digital also fosters trust and encourages the adoption
restorations (Sarker et al. 2021). However, of these technologies (Jones et al. 2021).
there may be limited opportunities for dental Collaborations can also be fostered with other
professionals to receive training and education ongoing initiatives in LMICs, utilizing exist-
in digital technologies, which can hinder the ing expertise and staff availability.
adoption of these techniques. • Capacity Building and Training Programs:
• Regulatory and Legal Considerations: Effective capacity building and training pro-
Regulatory and legal considerations can also grams are indispensable for the successful
pose barriers to digitalization in LMICs. For implementation of digital technologies in
example, there may be limited regulations or LMICs (Brown and Lee 2019a, b). Training
166 H. Mikayelyan
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Digitization in Dentistry and Dental Implantology in Low- and Middle-Income Countries 169
Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
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obtain permission directly from the copyright holder.
Patient Facing Applications
Abstract Keywords
In digital healthcare, PFAs play a crucial role research suggests that PFAs, with their potential
in overcoming the lack of access to healthcare in to significantly transform the availability, acces-
LMICs. These tools are not just digital exten- sibility, and quality of medical care, have a piv-
sions of traditional healthcare but transformative otal role in driving the digital health revolution in
assets that enable patients to take active control LMICs (World Health Organization 2021). For
of their health and enable healthcare profession- those countries struggling with resource scarcity
als to provide patient-centric care regardless of and a high disease burden, HMS can play a key
geographic location (Free et al. 2013). PFAs role in alleviating health problems and building
cover a wide range of applications, including resilient and responsive health systems.
telemedicine applications, health information However, realizing the full potential of PFA
portals, appointment scheduling systems, medi- requires an enabling policy environment, infra-
cation reminders, disease-specific education plat- structure development, capacity building, and
forms, and mHealth (mHealth) applications. strategic partnerships between stakeholders. It is
Each of these components has distinct but com- also important to address issues such as privacy,
plementary roles in the healthcare ecosystem, digital literacy, and cultural acceptance to ensure
contributing to healthcare delivery’s overall effi- PFA is accessible, acceptable, and beneficial to
ciency and effectiveness. For example, telemedi- all (Mehl and Labrique 2014).
cine applications provide a virtual space where
doctors and patients can interact, thereby break-
ing down geographic barriers that impede access 2 Specific Applications
to quality healthcare. This feature has proven par-
ticularly useful in rural or remote communities Health information portals enable patients to
where health infrastructure may be inadequate or access and manage their medical records, pro-
non-existent (Khoja et al. 2013). mote transparency, and encourage patient partici-
Health information portals and mobile health pation in healthcare decision-making (Ancker
apps enable patients to monitor their health status et al. 2017). Additionally, these platforms can
and the possibility to see the entire picture by provide physicians with a comprehensive view of
accessing medical records and even using this a patient’s medical history, leading to improved
information in aid of decision making. In addi- diagnostic accuracy and personalized treatment
tion, health information portals provide health- plans. Health information portals are digital plat-
care professionals with a comprehensive view of forms designed to empower patients through
patient records to improve diagnostic accuracy access to their personal health information. This
and develop personalized treatment plans. Visit patient-centric approach promotes transparency
scheduling and medication reminder systems in healthcare, promotes the involvement of care-
contribute to improved care by ensuring medica- takers in the process, and helps create a sense of
tion adherence and reducing missed appoint- ownership and responsibility for their health
ments, which are critical factors in managing (Ancker et al. 2017).
chronic diseases (Aikens et al. 2014). Growing evidence shows that patient engage-
The PFA value proposition is further rein- ment stimulated by such portals improves adher-
forced through disease-specific educational plat- ence to treatment plans, better management of
forms that promote patient health literacy, chronic diseases, and improved overall health
enabling them to better understand their health outcomes. Access to reliable and easy-to-
status and actively participate in the healthcare understand health information can support and
process. Previous research has indicated a posi- encourage patients to make informed decisions,
tive association between health literacy and thereby reducing the likelihood of unnecessary
health outcomes, making these platforms an hospitalizations (Wade-Vuturo et al. 2013).
important part of digital health strategies in Importantly, these portals serve as platforms for
LMICs (Berkman et al. 2011). A wealth of educational resources and can improve patients’
Patient Facing Applications 173
understanding of their health conditions, medica- health awareness, facilitate disease self-
tions, and potential lifestyle changes. Studies management, and promote adherence to treat-
have shown that better patient knowledge corre- ment protocols (Källander et al. 2013).
lates with better disease self-management, par- MHealth applications range from simple tools
ticularly in chronic diseases such as diabetes and that provide general health information and med-
hypertension (Lorig et al. 2006). ication reminders to more complex applications
Health information portals strengthen patient that enable remote health monitoring, symptom
competence and bring significant benefits to phy- tracking, and interaction with healthcare provid-
sicians. They provide a comprehensive, longitu- ers. These applications take advantage of grow-
dinal overview of a patient’s medical history, ing digital literacy and the proliferation of mobile
including past and current diagnoses, medication devices, particularly among young people, to fill
records, allergy information, and laboratory geographic and infrastructural gaps in healthcare
results. This rich data repository supports clinical (Lupton 2014).
decision-making, can reduce diagnostic errors, One of the main advantages of mHealth appli-
and facilitates personalized, patient-centric care cations is their potential to facilitate the manage-
(Greenhalgh et al. 2009). For example, predictive ment of chronic diseases. With the increasing
modeling and risk stratification based on the rich incidence of noncommunicable diseases (NCDs)
data available in these portals can help healthcare such as diabetes and cardiovascular diseases in
providers identify patients at high risk for certain LMICs, mHealth applications can be used to
diseases. This can lead to earlier intervention, monitor vital signs, provide personalized medical
better disease management, and potentially better advice and send medication reminders, thereby
patient outcomes (Amarasingham et al. 2010). improving compliance. Treatment planning and
Additionally, these portals can be integrated burden reduction are also encouraged.
with other digital tools, such as telemedicine, to (Bloomfield et al. 2014). In addition, mobile
create a seamless healthcare experience. This is health apps can serve as platforms for health pro-
particularly valuable for patients in remote or motion and disease prevention. They can provide
underserved areas where access to quality health- targeted health education, encourage behavior
care may be limited (Baird et al. 2020). Despite change, and encourage healthier lifestyles. For
the benefits, it is important to be aware of the example, applications that track physical activity,
challenges associated with health information diet, and sleep patterns have been shown to posi-
portals, such as privacy issues, limited digital lit- tively impact behavior and improve health out-
eracy among patients, and the challenges associ- comes (Direito et al. 2017).
ated with integrating different health information Importantly, mHealth tools have been proven
systems. Addressing these challenges is an to be effective in supporting maternal and child
important part of the journey to digital health in health. Apps can provide important information
LMICs (Kvedar et al. 2014). to pregnant women, remind them of appoint-
Mobile health (mHealth) apps are one of the ments and enable remote consultations with
most visible subsets of PFAs. The widespread use healthcare providers. Such interventions have
of mobile phones, even in resource-constrained shown significant potential for improving prena-
settings, makes mobile health applications a via- tal care and maternal health in LMICs (Tamrat
ble and cost-effective approach to health aware- and Kachnowski 2012). From a public health
ness, disease self-management, and treatment perspective, mHealth applications can support
adherence (Källander et al. 2013). Mobile health disease surveillance and response, particularly in
apps, a key category of PFA, have shown great the fight against infectious diseases. By provid-
potential for transforming healthcare, including ing real-time data collection and analysis, these
in LMICs. The ubiquity of cell phones, even in applications can help track disease outbreaks and
resource-constrained settings, makes mobile inform public health action (Bhavnani et al.
health apps a cost-effective strategy to increase 2016).
174 K. Sargsyan and A. Muradyan
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Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license,
unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons
license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
obtain permission directly from the copyright holder.
Digital Healthcare:
Population-Level Applications
ture. China developed its own standards for 3G to Information Center (CNNIC), China is estimated
5G (Lee and Yu 2022), knowing that a good digi- to have 1.051 billion internet users and 99.6% of
tal platform would require a good and affordable them access the internet using their smartphones
infrastructure. China rapidly developed a secure (CNNIC 2022).
and reliable digital payment system based on QR Before digital solutions were implemented,
codes, in which a payment code is generated on hospital patients had to go through a series of
the user’s mobile device instead of using credit steps to access treatment: making an appoint-
cards or a contactless system. The emergence of ment, waiting for consultation, consultation,
digital payment laid the foundation for the devel- inspection with diagnosis and payment with ther-
opment of digital health. According to a recent apy. Figure 1 shows that the average time spent
report published by the China Internet Network for a single visit to hospital was between 180 and
300 minutes on average and only 3% of this total
time was spent in consultation. The lack of com-
munication between patients and doctors caused
major trust issues nationwide. There are currently
1100 internet hospitals registered in China and it
is estimated that over 60% of second tier hospi-
tals or above have online services. Figure 2 shows
how internet hospitals changed the overall user
experience compared with the previous system.
The following sections introduce some back-
ground on the development of population-based
applications in China.
At the beginning, digital health services were
Fig. 1 Shows the average time spent for a typical visit to limited to the provision of information and pay-
a hospital in China ment functions. This eased the pressure on infor-
mation counters, cashiers and accountants, and Administration (SFDA) (presently known as the
shortened queues for those who need to use the National Medical Products Administration) has
services. However, the benefits of digitalization issued regulations and monitoring systems to fur-
were not fully exploited in the medical system. ther define online medication services such as the
Technologies such as electronic medical records business qualifications, service areas, standards,
and online appointment systems were not popu- and specialised qualifications for targeted groups
lar with the management of the hospitals. (Administration 2007). Despite small market
Implementing new technology into the existing occupancy, platforms started targeting pharma-
system creates concerns about how operations in ceutical consumers.
the hospitals will be affected, especially since As the coverage and speed of the internet
most of the hospitals in China are relatively large increased, the increase in connectivity enabled the
in terms of capacity due to the large population. possibility of remote consultations. However, such
A failure in the system can potentially be disas- consultations were not considered to be fully legit-
trous, therefore, many pilot tests were carried out imate or recognised. In 2014, there was an official
to demonstrate that the new technology would guiding opinion published by the National Health
work, and also to address the changes that would and Family Planning Commission with guidance
accompany the transition (Liang et al. 2020). on promoting remote medical consultation ser-
vices (China 2014). The paper stated that remote
consultation is limited to the referral from one
2 Digitization Period medical institution to another. This is because the
authorities could foresee chaotic impacts if remote
In 2009 the Ministry of Health (presently known consultation started from individuals to profes-
as the National Health Commission) published a sionals. Instead, they preferred to start with two
guiding opinion about the execution of an medical professional categories, who are under
appointment based reservation system in hospi- regulatory control. Such progress received much
tals (China 2009). Since then, China has tested attention in the market, and a lot of the focus began
many digital solutions including digitised medi- to shift to how to move forward by proposing dif-
cal records, online appointments system, image ferent future regulatory models and plans for how
information sharing, remote consultation, and they should be set up. Meanwhile, the develop-
online prescriptions etc. Many software develop- ment of online medication purchases was a lot
ers emerged to create apps because of this, but more complicated. There were a lot of illegal trad-
the lack of uniform standards in these apps cre- ing activities on the market, unlicensed entities or
ated a lot of challenges. For example, different individuals sold registered or unregistered medica-
branches of hospitals under the same institutions tions or licensed entities sold medications online
initiated different digital solutions at different that required prescriptions. The authorities under-
times and settings, which resulted in many differ- stood that digital health would be incomplete if
ent apps that could not connect to each other. online medication services were not operated in a
Users also became very tired by the endless reg- regulated manner. However, the areas of control
istration process, and a lot of the work reverted to exceeded the health authority’s coverage. After
manual processes. Eventually, some apps were careful evaluation by the authorities, it was con-
developed that provided solutions for such set- cluded that a healthy growth of online medication
tings, for example, WeDoctor (also known as services would require the control of information
Weiyi) and Ding Xiang Yuan. Most of these plat- technology, commercial business regulatory,
forms are informative in nature, and there are cyberspace information management, police, and
very few clinical applications. In addition to the medication registration information. Hence, the
developments in hospitals, in 2000 many cities first joint notice targeting illegal online selling of
began to set up demonstration zones to allow medications was published in 2013, the paper was
online purchase of non-prescription medications. published jointly by five departments: SFDA,
Since then, the State Food and Drug Cyberspace Administration of China, the Ministry
180 I. H. Cheong et al.
of Industry and Information Technology, the model has since further evolved into three differ-
Ministry of Public Security and the State ent applications:
Administration for Industry and Commerce. At the
same time, SFDA agreed to allow some of the (i) Prescriptions within the hospital
more established and developed areas like
Shanghai and Guangdong Province to have medi- Digitalization for prescriptions within the hospital
cation services on a third-party platform. is the most common service provided by internet
In addition to this development, informatics hospitals. Upon approval from the pharmacist, pre-
infrastructures such as cloud computing, artificial scriptions are delivered to the patient’s home
intelligence and big data created links between address. This service does not have any direct com-
online and offline settings. The Opinions of the mercial value, but rather it is an added-value ser-
General Office of the State Council on Promoting vice. This model functions within the hospital’s
the Development of “Internet plus Health Care” information system (HIS) unit and does not involve
allowed hospitals to have the name “Internet hospi- any external platform. In contrast to conventional
tals” affiliated with their original registered name. offline hospitals, this model demonstrates the
This allowed them to give remote consultations and capacity of internet hospitals, where users do not
health management consultations for follow-up have to visit the hospital and regular follow-up can
patients with certain common or chronic diseases be done via smartphone, prescriptions can be
(Council 2018). It also allowed a qualified third- issued upon approval by HIS, users can pay within
party app to connect its services to these internet the HIS, the approved and paid prescriptions are
hospitals. Later in the same year, the term and con- then transferred to the pharmacy for approval and
cept of “Internet Hospital” were further defined the medication will then be dispensed and dis-
(National Health Commission, 2018a, b, c), allow- patched to users by logistics. Despite its capacity,
ing online general practitioner registrations and this model is not always preferred by many because
follow-up of certain common or chronic diseases. social medical insurance limits the potential finan-
The documents also limited the service to non-first- cial margin for such services, and it creates a much
time patients. Later in 2016 strategic documents bigger demand on the hospital workers.
Health China 2030 listed digital health services as
one of the national strategic goals (Tan et al. 2017). (ii) DTP through online shops
Immediately, many previously established third-
party apps formed Internet Hospitals, and interest- DTP through online pharmacy stores is how users
ingly, some medical institutions closed their offline mainly request specific medication products,
consultations. At the time of writing, according to then a doctor assesses if the user is apt to use such
the statistics from the National Health Commission, products (whereas the model described previ-
traffic for online medical consultations has ously requires a prior consultation with a doctor).
increased 20 times, consultations with treatments Once approved, this information will be trans-
have increased 17 times and those needing pre- ferred to internet hospitals and a prescription is
scriptions has increased 10 times in the last 5 years. issued and delivered to the user. This model has
relatively larger financial initiatives compared to
(i), so many of the procedures are very reproduc-
3 Present Developments ible. However, the platform sets a lot of commer-
cial rules, and often the entry requirements for
At present, online medical services can be classi- such business are very demanding. Therefore, it
fied as either Business to Business (B2B), is very difficult for one to copy such a model.
Business to Consumer (B2C) or Online to Offline
(O2O). B2B and B2C are the most popular bases (iii) Outsourcing of prescriptions
for the platforms. In hospitals, digitalization of
healthcare led to the progression of prescription This is a model that evolved recently. Internet
services to a direct-to-patient (DTP) model. This hospital prescriptions are outsourced to a plat-
Digital Healthcare: Population-Level Applications 181
form that connects to online pharmacies. The app), digital payment applications (including
platform checks the availability of the items in commercial and social insurances), AI services
their shops and users can then view a list of shops (including imaging, diagnostic and medical
that have the required medication in stock. Upon record services) and digitised information
approval, the medication can be collected from services.
the store or delivery can be arranged. For this sys-
tem to function effectively, hospitals and pharma-
cies must use similar pharmacopoeia. This 5 Case Study—Ping An Health
solution diverts the demands into pharmacies
closer to the users. Ping An Health is an application developed by
the Ping An Group which was originally an insur-
ance company. The group initially had its own
4 Emerging Industries team of in-house doctors that then became the
from Digital Health core of its health application. The application
makes most of its profit from the consumer
The traditional medical industry in China can be healthcare sector. Their source of customers is
divided into three parts: an upper stream that con- from personal, insurance, enterprise, and offline
sists of medical device manufacturers and phar- hospitals. In addition to the in-house doctors,
maceuticals; a medium stream that comprises the they have taken advantage of remote consultation
offline hospitals that provide medical services; to acquire specialists from other parts of the
and a downstream that comprises the users that country and abroad that led to the rapid growth of
pay for these services that can be divided further online health malls. The data gathered allows
into governmental expenses, public health them to accurately target specific groups and this
expenses, personal expenses, and patient creates opportunities for advertising income
expenses. Internet hospitals increase the propor- within the app. From 2016 to 2020, the number
tion of personal and patient-related expenses. of doctors in the app increased about three times
Industries related to these developments include from 797 to 2247 and currently there are 400 mil-
applications designed for making appointments lion registered users (one third of the population).
and consultations, personal health management, While the group will continue to focus on its B2C
online pharmacy shops, tools for doctors (includ- customers, it is also looking to optimise the O2O
ing patient management and sustain educational user experience (Fig. 3).
for preliminary consultations to reduce the pres- Lee C-K, Yu L (2022) A multi-level perspective on 5G
transition: the China case. Technol Forecast Soc
sure on the frontline. These services are Chang 182:121812
accumulating in number and scope, and networks Liang J, Li Y, Zhang Z, Shen D, Xu J, Yu G, Dai S, Ge
of digital wards are forming that will eventually F, Lei J (2020) Evaluating the applications of health
become internet hospitals. Because the size of information technologies in China during the past 11
years: consecutive survey data analysis. JMIR Med
these virtual entities is so big, there will be heavy Inform 8(2):e17006
discussion on regulation and policies on this sub- Ministry of Health of the People’s Republic of China,
ject, that will enable population-level applica- Opinions on the implementation of appointment diag-
tions to grow in the right direction according to nosis and treatment services in public hospitals (2009).
http://www.nhc.gov.cn/zwgkzt/s9968/200910/43105.
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National Health Commission, The State Administration of
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(2018). https://www.lawinfochina.com/display.aspx?i
d=28056&lib=law&EncodingName=big5
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Digitalization of Healthcare
in LMICs: Digital Health
and the Digital Divide Based
on Technological Availability
and Development
high-income and Low-and Middle-Income future systematic reviews, with a sharpened and
Countries (LMICs) (Labrique et al. 2018). At the more specific focus.
same time, a few publications have voiced con-
cern that digitalization may actually be widening
the gap in needs and capacities between different 2 Methodology
healthcare systems (Dorsey and Topol 2016;
Scott Kruse et al. 2018; Yao et al. 2022). In the A scoping review of the literature was done, to
case of LMICs, it is easy to point to the chal- map out the gaps regarding digital health and the
lenges relating to infrastructure as the main bar- digital divide based on technological availability
rier to digitalization implementation in healthcare. and development. Studies and articles that
However, the digital health divide does not sim- describe these gaps were identified from two
ply exist due to the connectivity or not to an inter- databases: PubMed and EBSCOhost. The search
net line. Instead, the reasons for digitalization was done on February sixth, 2023, using the
implementation are complex (as with many other search terms (digital health or digital medicine or
specialized technologies) and intertwined, the electronic health or ehealth or digital health care
result of a combination of persistent healthcare, or mhealth) AND (digital divide or digital gap or
social, economic, and political factors. Thus, digital inequality or digital inequalities or digital
technological availability and development pro- inclusion), since inception of the databases and
vide an important entry point but should not be only published in English. The results of the data-
seen in isolation or removed from the local con- bases and manual searches were exported into
text in which digitalization takes place. EndNote. Duplications were removed using
Several chapters within this book focus on EndNote-based methods as reported previously
infrastructural aspects in relation to digitalization (Bramer et al. 2016) and double-checked manu-
of healthcare in LMICs, for example Chap. ally. Two reviewers (RB and SP) independently
“Digitization of Physical Health Data in Low-and screened by the following eligibility criteria: (i)
Middle-Income Countries” on the ‘Infrastructure detailed discussion of the digital divide, at least
needs, risks and opportunities’, Chap. within a section of the publication; (ii) detailed
“Proliferation, Ingestion, and Interpretation of discussion of digital health implementation, tech-
Health Data in Low-and Middle-Income Countries nology and/or policy. Non-English articles, com-
(LMICS)” on ‘Future sustainability’ of digitaliza- mentaries, and posters were excluded. The
tion, etc. Complementing the above-mentioned difference of opinion between the reviewers was
chapters, the question in this chapter is uniquely resolved by a discussion with a third party (ZK).
viewed through the lens of the digital divide and The chapter was reviewed and edited in its
how technological availability and development entirety and independently by a third party (SN),
can create additional challenges or promote sus- for any potential misalignments. The study
tained growth and development. The current screening processes are shown in Fig. 1. The the-
chapter has been structured as a scoping review as matic grouping of the identified articles was con-
it seeks to present an overview of a potentially ducted following a similar methodology, RB and
large and diverse body of literature pertaining to a SP conducting the thematic groupings indepen-
broad topic. Some of the specific thematic groups dently and any difference of opinion resolved by
that have been identified can form the basis of ZK as a third party.
Digitalization of Healthcare in LMICs: Digital Health and the Digital Divide Based on Technological… 187
these technologies. It has also been shown that 4.1 Health Literacy (Kemp et al.
disparities in the digital divide largely influence 2021; Arcury et al. 2020;
patients with mental health/psychological Graetz et al. 2018; Reddy et al.
disorders. 2022; Schrauben et al. 2021;
Moon et al. 2022; Singh et al.
2022; Mackert et al. 2016;
4 Digital Literacy (Paccoud Piers et al. 2023; Sayed
et al. 2021; Jiang and Liu and Mamun-ur-Rashid 2021;
2020; Bayard et al. 2022; Gordon and Hornbrook 2018)
Freeman et al. 2022; Nagler
et al. 2013; Kemp et al. 2021; Knowledge of digital health (even in general
Frutos et al. 2022; Scott terms) positively and significantly influences the
Kruse et al. 2018; Toscos use and acceptance of digital health services. It
et al. 2019; Sayed was shown that the use of digital health tools has
and Mamun-ur-Rashid 2021; been consistently lower in patients with low
Masucci et al. 2006; Kim health literacy. Moreover, they were less likely to
and Kim 2010; Choxi et al. be perceived as easy or useful. The ability and
2022; Gordon confidence to use digital health technologies to
and Hornbrook 2018; Kumar obtain health information and advice decline
et al. 2019) with age and are less prevalent among ethnic
minorities. Furthermore, a study identified that
One of the common barriers to adopting digital only less than a third of internet and smartphone
healthcare is a lack of technological experience users have proficiency in the use of digital health
or familiarity. It has been shown that the quality technologies, and an even smaller fraction have
of digital health services depends both on adequate digital health literacy. It has been shown
patients’ and providers’ familiarity with the that health literacy can be improved by digital
medium of communication. One of the identified health technology itself, which will enhance
issues is that medical personnel are not ade- patients’ participation in digital health care.
quately trained or experienced in fully utilizing
the technological capabilities available to them.
On the other hand, people with limited technol- 4.2 Cultural Barriers (Yao et al.
ogy skills may be reluctant to use or unable to 2022; Haenssgen 2018; Kemp
access technology to acquire health information et al. 2021; Reddy et al. 2022;
on their phones. And even feel left behind with Sayed and Mamun-ur-Rashid
digital health, despite having access to a com- 2021)
puter or smartphone. Having low skills in using a
cell phone or computer represents a significantly Even within regions with full access to technolo-
lower use of digital health services. Additionally, gies, uneven access to technologies was found
it was shown that interest in and successful use of due to cultural barriers. Discriminating societal
the digital health system were not correlated to norms and restrictive cultural beliefs, in addition
any other factor (age, gender, education level, or to poor health literacy, weave together a web of
ownership of a computer) but to skills in technol- cultural barriers, in which the hardest-hit groups
ogy use. Low digital literacy was related to are females. In some regions where women have
increased anxiety about using digital health. low socioeconomic status (SES), they are dis-
190 R. Biga et al.
couraged from going on the web and do not have improved digital infrastructure, and strategic
access to cell phones. In addition, female sex is resource allocation. Importantly, even though
correlated with a decreased probability of com- targeting underserved communities, this sup-
pleting a digital health visit or compliance with port should be available to all who want to
remote counseling/monitoring. A great number make use of it.
of sociocultural factors related to institutional, 6. Having a mobile-accessible patient health
economic, cultural, and educational barriers neg- record can help engage patients in managing
atively impact women’s physical well-being and their health through convenient and timely
their access to appropriate health-care services in access.
developing countries. Furthermore, language 7. mHealth interventions should employ phone
barriers (including translation inaccuracies) can features that are accessible and familiar to the
play an important role in digital health’s utility. target audience to avoid denying intervention
benefits to those with low mobile phone liter-
acy and therefore widening health disparities.
5 Discussion 8. A framework within healthcare organizations
that should include standardized protocols for
Several of the identified articles, beyond the effective deployment of digital health to triage
description of barriers and different challenges patients at the point of need and the efficient
relating to digital health and the digital divide, use of relevant technological innovations.
provided accompanying potential solutions 9. Primary healthcare facilities are the entry
(Bayard et al. 2022; Reddy et al. 2022; Zhang point to healthcare for the largest part of
2022; Liang 2012; Bashshur et al. 2020). These LMIC populations. Thus, they should be
can be summarized in the 9 points shown below: enabled to provide wider access to digital
health information to disseminate the best
1. It is necessary to minimize the cost of scaling resources that would maximize adoption and
up the technology by developing modalities long-term use.
that are feasible, affordable, and acceptable to
the people and the community. This summary of recommendations from the
2. A digital health site in a rural public library identified manuscripts reflects well the priorities
would enable greater access to digital health- set by the G20 health meeting in 2020, resulting
care services by removing obstacles caused in the ‘Recommendations from the Riyadh
by insufficient residential broadband access. Global Digital Health Summit’ of ‘Riyadh decla-
The library serves as a proxy example for ration’ (Al Knawy et al. 2020). Even though the
state-sponsored public service, where existing declaration focused on infectious diseases, as
access opportunities can be identified. opposed to a wider healthcare view (also due to
3. If markets with competitive internet service the G20 meeting taking place during the height of
providers fail to bring bandwidth and equip- the COVID-19 pandemic), there are marked sim-
ment to geographically isolated areas, then ilarities. For example, the fourth recommenda-
the respective governments should consider tion mentions exactly “Ensure that countries
implementing policies to cover the gap. prioritize digital health, particularly improving
4. To provide equitable access to care, legisla- digital health infrastructure and reaching digital
tion supporting reimbursement of digital maturity”. A further, more detailed breakdown of
health services is crucial. these recommendations has gone a step further,
5. To address disparities and increase accessibil- placing strong emphasis on community participa-
ity of digital health, it is necessary to have a tion and action in digital health to build resilience
program that provides underserved communi- in healthcare systems as a whole and establish the
ties with information technology education foundation for effective prevention, prepared-
and training to improve its use, alongside ness, and response to healthcare pressures (Al
Digitalization of Healthcare in LMICs: Digital Health and the Digital Divide Based on Technological… 191
Knawy et al. 2022), complemented by appropri- Disclaimer Where authors are identified as personnel of
the International Agency for Research on Cancer/WHO,
ately trained leadership (Al Knawy and the authors alone are responsible for the views expressed
Kozlakidis 2021; Al Knawy 2021). Additionally, in this article and they do not necessarily represent the
emphasis was placed on techquity, i.e., the strate- decisions, policy, or views of the International Agency for
gic development and deployment of technology Research on Cancer/WHO.
in health care and health to achieve health equity,
and system transformation (Al Knawy et al.
2022). It is anticipated that further granularity References
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Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
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Biobank Digitization
in Low-Middle Income Countries
(LMICs): Current and Future
Technological Developments
Abstract Keywords
highest possible sample quality (Baber and and increased operational efficiency, but can also
Kiehntopf 2019). Specifically, the time that fol- be of great value for sharing information, net-
lows the collection of a given sample and pre- working, and collaboration between biobanks in
cedes its analysis is called the pre-analytical LMICs. One such project is identified, the Zipline
phase, during which the quality and stability of project, which consists in using drones to trans-
samples is strongly influenced, making it essen- port blood from storage units to hospitals. This
tial to have accurate information on the sampling technology has allowed hospitals in Rwanda to
time (Lippi et al. 2019). This leads to the role that adapt to the lack of transportation infrastructure
digital solutions can play, for instance, on the in rural areas, and minimize transportation time,
integration of electronic data sources, and with therefore, addressing the concerns around the
automation of the technical processes, such as the pre-analytical phase, which is an essential part of
retrieval of samples from storage, and their treat- the life cycle of a biospecimen (Ackerman and
ment for analysis. Strickland 2018). Another example is the
The automation of biobanks’ complete life DxConnect Virtual Biobank that operates as a
cycle, from early collection and pre-analytical pro- collaborative resource. Hosted by FIND, the
cessing through the storage, freeze-thaw cycles, to global alliance for diagnostics, this open-access
its final analysis allows to sharpen their competi- platform enables researchers across academic,
tive advantage, harmonization and standardization non-profit and industry sectors to view collec-
and allow for eventual accreditation (Baber and tions- even if not self-identified as biobanks- reg-
Kiehntopf 2019). Furthermore, the increasing istered by any institution worldwide, search by
complexity and amount of data generated by bio- disease and other characteristics, and connect
banking activities, makes digitalization necessary with those holding samples of interest (Ongarello
to manage these resources efficiently. With digital et al. 2022). This virtual arrangement is antici-
tools, such as virtual databases and software spe- pated to bridge the gap between LMICs (where
cifically designed for biobanking operations, it most infectious diseases occur, and samples are
becomes easier to manage large amounts of data collected) and high-income settings (where most
and to track the movement of samples from the samples are analyzed). Having said that, the
point of collection to their destination after distri- above initiatives that rely heavily on digitaliza-
bution. Digitalization can bring major improve- tion of biobanks in LMICs currently constitute
ments to the way biobanks manage their activity the exception rather than the rule.
by allowing for an increase in speed and accuracy
of data processing. With digitized information,
researchers can quickly search for and access spe- 2.1 Documentation of the Life
cific samples or data points, speeding up the Cycle of Biological Samples
research process significantly (Arrighi and
Hofman 2022). Furthermore, digitization helps Perhaps the greatest impact of digitalization in
reduce the probability of errors and inaccuracies biobanking is on the documenting of the life cycle
that are inevitable and quite common with manual of biological samples. The life cycle of a biologi-
data entry and handling (Arrighi and Hofman cal sample can be divided in three main phases:
2022). Another key benefit of digitalization for the pre-analytical, the analytical, and the post-
biobanks is improved data security. With advanced analytical phase. In the context of international
security and access controls, data is less suscepti- clinical studies, an increasing number of biologi-
ble to be tampered with or handled by unauthor- cal samples are needed and being collected, which
ized individuals. Therefore, sensitive data, which reveals the need for optimal management of these
could identify a specific or group of donors for resources, so their quality can be guaranteed to
instance, can be adequately protected. researchers (Betsou 2017). However, health insti-
Conclusively, digitalization provides numer- tutions and researchers tend to focus on the per-
ous potential benefits, including faster and more formance and efficiency of the analytical and
accurate sample tracking, improved data security, post-analytical phases, during which typically
198 F. Elkhwsky et al.
15–20% of all errors occur. On the other hand, the typic data gathered in other specialized research
frequency of pre-analytical errors is generally contexts or retrieved from EHRs, or patients
between 60% and 70%, but despite these results, themselves could be made significantly easier by
sampling time information is often missing digitization. To this end, the Information
(Vermeersch et al. 2021; Plebanis 2012). In that Management System of a Biobank (BIMS)
context, the problem can be addressed in different supervises all the relevant data related to the bio-
ways, including through information technology. bank’s activity, including sample movements and
Indeed, the ability to follow a biological sample’s exact location, patient data, storage conditions,
complete life cycle, from its initial collection and and governance-related documents.
pre-analytical processing through the intermedi- The BIMS can be connected to multiple soft-
ate storage conditions, including freeze-thaw ware systems and databases, such as the
cycles, to its final scientific usage is made possi- Laboratory Information Management System
ble by digital information technologies. (LIMS) which handles data related to the life
Nanni et al. were able to map and track the entire cycle of samples, the hospital information system
life cycle of stored biological samples using Radio (HIS) for patient data, and the monitoring system
Frequency Identification (RFID) technology. This (MS) which keeps track and regulates tempera-
technology allowed, through communication with ture and liquid nitrogen levels (Fig. 1). BIMS are
radio-waves, to identify samples and their data by often a subset of LIMS, repurposed and custom-
reading an electronic tag attached to the samples’ ized to fit the needs of a biobank, however, cus-
container, either manually or through an automated tomization and staff training as a consequence,
process using special cryotubes and racks. It also can be too costly for LMICs. Therefore, LMICs
allowed us to keep track of every movement of a may need the support of BIMS providers through
given sample and the time between each step by the development of open access software (Ezzat
recording time stamps (Nanni et al. 2011). The et al. 2022).
RFID technology showed promising results in high- The BIMS allows for a better management of
income settings and allowed for a better manage- the large amounts of data generated by biobank-
ment of the technical process of a biobank with ing and research activities, in addition, it can pro-
better tracking of samples. However, the evidence vide a user interface that does not require
didn’t show a significant improvement on the qual- programming skills, and the centralization of
ity of the samples, while the costs associated with sensitive and confidential data can create a more
the implementation of this technology are not com- secure digital environment in which security
patible with the financial challenges and competing breaches can be prevented more easily (Arrighi
financial priorities faced by LMICs. and Hofman 2022; Olund et al. 2007). Finally,
That being said, a thorough digital history of manual handling of data is time-consuming, and
each biological sample can be created and used in errors are likely to appear, but the BIMS can
research by combining the collected data within a automatically integrate data from different
so-called integrated ‘Biomaterial Information sources and reduce the likelihood of errors to
and Management System’ (BIMS) (Parajuli et al. occur (Arrighi and Hofman 2022). Therefore,
2022). biomaterial-data sources should be connected to
a core BIMS using standard data sharing formats
to support and facilitate local biomedical research
2.2 Biobank Information and enhance networking with more biobanks and
Management System (BIMS) research institutions (Pote et al. 2021).
Interaction with Other Digital
Data Sources 2.2.1 Data Quality
Data is commonly perceived and defined as a set
Integrating biological sample-derived data (such of collected facts, and the International
as ‘-omics’ data) with the broad range of pheno- Organization for Standardization (ISO) defines it
Biobank Digitization in Low-Middle Income Countries (LMICs): Current and Future Technological… 199
Fig. 1 An illustration of
the data input streams
for Biobank Information
Management Systems.
Data streams can be
MS HIS
integrated from LIMS
Laboratory Information
Management Systems
(LIMS); from
Monitoring and
Surveillance systems
(MS); from Healthcare BIMS
Information Systems
(HIS); as well as Quality
Management Systems
(QMS)
QMS
Table 1 Summary of main challenges and some potential solutions for digitalization in LMICs
Challenges Potential Solutions
Technical Electricity supply Back-up generators
Lack of Internet Access Synergies with existing infrastructures
Unstable network connections
Lack of IT equipment and infrastructure
Financial and HR Skilled staff shortage Financial incentives for investment
Lack of technical training Creation of training courses
Low digital literacy Staff incentives to train and remain in post
High maintenance cost
Lack of funding
ELSI Data privacy and confidentiality Highlighting gaps and in ELSI-related
legislation
Informed consent Data protection regulation
Intellectual property
Language barriers
Lack of regulatory frameworks
Geographical Regional topography Public infrastructure investment
Lack of infrastructure Synergies in logistics with other product
types, e.g., vaccines
Lack of reliable logistics
1. The most common challenge encountered is a foster. In that context, ethical and legal con-
lack of appropriate technical infrastructure, siderations, related to informed consent, data
for example basic telecommunications infra- privacy and intellectual property rights must
structure, such as reliable internet access, be considered.
electricity, and mobile networks. In the con- 4. The geographical context of a given region
text of a biobank’s operation, high volumes of can have an impact on the development of
data are generated, and thus LMICs may lack digital health programs. Indeed, the geo-
the necessary IT infrastructure and expertise graphical distribution and topology, as well as
to effectively handle and analyze them the presence or absence of proper roadways
(Parajuli et al. 2022). could make transportation operations and
2. Limited financial and human resources, mak- infrastructure maintenance more difficult and
ing it difficult to invest in staff training, and costly (Parajuli et al. 2022).
equipment when digital health programs are
implemented. In return, it is difficult to main-
tain and manage these programs when faced 3.1 Access to Internet
with a lack of skilled staff, such as IT special- and Electricity
ists who could provide technical training to
health professionals. This can limit the scope Reliable access to electricity increases services
and scale of biobank projects, for instance, availability, readiness, and quality of care,
and make it difficult to sustain them over the especially for patients under critical care (Alhadi
long term (Chowdhury and Pick 2019). et al. 2022). On the contrary, a lack of access to
3. Data privacy and security, in many LMICs, electricity is associated with negative health out-
regulations to protect patient data and ensure comes, for example increased mortality, lower
privacy and security are limited. Therefore, quality of care, and reduced utilization of health
the trust between patient and healthcare pro- services (Irwin et al. 2020). Digital technologies
fessional, and the trust between patient and typically rely on having access to the internet and
digital health services are more difficult to electricity, both of which depend on various fac-
Biobank Digitization in Low-Middle Income Countries (LMICs): Current and Future Technological… 201
be established, which can be a challenge in physically stored in separate databases under dif-
LMICs where there may be limited resources or ferent administrative power and using different
expertise in this area (Zatloukal et al. 2022). identifiers, thus reducing the likelihood of a secu-
That being said, patients must be fully informed rity breach (Scheffler et al. 2016; Zatloukal et al.
of the purpose, risks, and benefits of digital health 2022). However, the BIMS is generally con-
technologies and provide their consent for their nected to the internet, and data transfer opera-
data to be collected and used. In LMICs, where tions are often conducted online which makes
the population might not be educated sufficiently biobanks vulnerable to cyberattacks and confi-
or where access to information is limited, this dentiality breaches. It is therefore essential for
may affect the consenting rates. Another aspect to biobanks to be equipped with reliable IT infra-
consider are the cultural barriers and how these structures closely monitored to prevent data theft
can affect the overall approach to digital health. (Chowdhury and Pick 2019).
For instance, it may be considered disrespectful, Policy challenges include, keeping pace with
in some cultures, to question or challenge an evolving digital technologies in healthcare, the
authority figure, such as a researcher or healthcare establishment of standards for international data
professional. Therefore, the necessary steps to sharing (Vodosin et al. 2021). Also, to these chal-
ensure that prior informed consent is discussed lenges can be added, political instability, frequent
and obtained, need to be taken, to ensure that sam- transfers of skilled health professionals, and a
ples and data can legally and ethically be used and lack of consistent official support (Scheffler et al.
shared (Vodosin et al. 2021). 2016). However, according to Vodosin et al. digi-
Digital health has the potential to revolution- tal health programs have seen some increase in
ize healthcare delivery and improve health out- LMICs, as have regulatory frameworks. However,
comes in LMICs, but also the potential to amplify most LMICs still currently lack governance
pre-existing health inequities, for instance, guidance/regulation, thus, long-term leadership
between urban and rural areas in terms of access and support at a very high level is necessary for
to the necessary infrastructures to deploy digital them to succeed in this endeavor.
technologies (Hirko et al. 2020). Limited internet
access and lack of digital education make it dif-
ficult to ensure equitable access to these technol- 3.5 Funding Challenges
ogies. Finally, on the legal side, there may be
unclear or inadequate regulatory frameworks in Biobanks in LMICs face several financial, opera-
place to govern the use of digital health technolo- tional, and social challenges in establishing sus-
gies in LMICs, particularly in the context of bio- tainability. These challenges include developing
banking (Biobank and Population Cohort a business plan that relies on dependable funding
Building Network (BCNet) 2022). This can lead sources, enhancing operational efficiency, and
to concerns around the quality and safety of these building trusting governance arrangements with
technologies, as well as the ethical use of patient researchers and potential donors (Vaught 2011).
data. Funding challenges in terms of buying costly
equipment, high installation charges, and training
3.4.1 Policy and Data Security staff were identified (Abdelhafiz et al. 2022; Van
Challenges der Stijl and Eijdems 2019). Indeed, costs are an
The 2018 WHO resolution on digital health puts essential part of sustainable biobanking, and are
an emphasis on the necessity for LMICs to highly variable and specific to the type of bio-
develop frameworks that address concerns bank, but overall, the initial starting investment at
around privacy, security, data ownership and con- the creation of these structures consists essen-
sent (World Health Organization 2018). Indeed, a tially of capital investments in buildings, space
key element of appropriate and secure data man- and equipment. Across time as a biobank becomes
agement in biobanks should be that clinical data, operational, costs associated with sample and
sample-related data, and identifying data are data collection, processing, storage and distribu-
Biobank Digitization in Low-Middle Income Countries (LMICs): Current and Future Technological… 203
tion start to rise (Van der Stijl and Eijdems 2019). health facilities difficult (Eder and Shekhovtsov
During this phase, costs can be divided into dif- 2021). It is a major barrier that is often underesti-
ferent categories, including, human resources, mated despite its importance since a significant
equipment and infrastructure, as well as sample part of the populations in LMICs live in rural
handling and data management (Van der Stijl and areas with no direct access to healthcare facilities
Eijdems 2019; Sqalli et al. 2020). Generally, but by traveling long distances by foot or public
human resources are the biggest source of transport (Sqalli et al. 2020). In addition, many
expenses for biobanks which is a major challenge LMICs don’t have sufficiently developed infra-
for LMICs facing skilled staff shortages and dif- structure for logistics and transport, which can
ficulties to generate revenue and secure long- make it difficult for patients to access health
term funding (Van der Stijl and Eijdems 2019). facilities and difficult for health facilities, to
Digital health programs depend on funding and move essential equipment and supplies, or in the
volunteers; when funding stops, the whole pro- context of a biobank, to move biological samples
gram gets disturbed and terminated. However, in and data between different sites.
LMICs the distribution of resources is extremely
unequal, and it is widely agreed that funding
aligns poorly with global health needs. 4 Conclusion
For biobanks to achieve longevity, they must
be financially sustainable, but the access to secure Throughout the world, information and commu-
long-term funding is very difficult. In Egypt, for nication technologies are increasingly used in
example, numerous national funding agents are healthcare. Many of the current issues facing
available to fund biobanking and research, health systems in LMICs, such as the non-
Science, Technology Development Fund (STDF) availability of healthcare professionals in rural
and The Academy of Scientific Research and areas, the inconsistent quality of care and low
Technology (ASRT). Furthermore, the Ministry patient compliance, may be mitigated through the
of Higher Education and the Ministry of Planning widespread use of e-health, especially as tech-
and Social Development, along with some non- nologies continue to develop. However, for
governmental organizations, share in supporting e-health to spread and deliver its promises, a
planned research. According to van der Stijl and strong foundation needs to be put in place in
Eijdems, academic biobanks struggle to get LMICs by engaging all stakeholders (physicians,
access to enough revenue to sustain their activity, researchers, patients, ethics boards, governments,
therefore, multiple sources of funding and public and private institutions), and putting in
income need to be considered. This diversifica- place policies that provide a legal and ethical
tion of income streams can include a mix of pub- framework for digital health. Furthermore,
lic funding, such as research grants, investment in technologically advanced infra-
commercialization of services, and private fund- structures (reliable electricity supply, stable
ing through collaboration with industry (Van der internet connection, etc.) is essential for biobanks
Stijl and Eijdems 2019). to maintain and develop their operations.
Digitalization offers biobanks a wealth of
opportunities to enhance their effectiveness,
3.6 Regional Challenges including the:
Accessibility of healthcare refers to the relative 1. Better documentation of the quality, life cycle,
ease with which services can be reached from a and scientific application of biological
given location, and one of the difficulties in samples
establishing digital health services is the complex 2. Ability to scale-up the use of biological sam-
landscape in LMICs. Indeed, uneven geographic ples from LMICs.
distribution and topography such as mountains 3. Improved interoperability with other sources
and hills make the establishment of and access to of donor-related data.
204 F. Elkhwsky et al.
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Digital Healthcare: Technologies,
Technical and Design Challenges
Abstract Keywords
campaigns, prenatal care, etc. (Pillay et al. 2021) vision for secondary and tertiary care, as emer-
In some countries, decisions taken during the gency functions have been concentrated within
pandemic were not science-based, but rather fewer, consolidated facilities (Healthcare Cost
politically biased or based on misinformation Institute (HCCI) 2020). ER crowding is also con-
about treatments. For example, in Brazil the fed- sidered a marker of hospital health, indicating a
eral administration recommended drugs that failure to provide adequate PHC (Barish et al.
were non-effective for COVID-19 treatment, 2012). While these figures are informative and
even after the WHO had denied their effective- presumed to be reflective of an overall trend
ness (World Health Organization 2020). They observed within healthcare, comparable data
also refused social isolation and mask usage from LMICs is missing on a consistent basis.
(World Health Organization 2020; Ferigato et al.
2020; Médecins Sans Frontières 2021).
The pandemic also contributed to a sharp 2 Digital Transformation:
understanding of the PHC mechanics within the The Technologies Behind
healthcare engine, not only as an important inter- the Revolution in the Health
face for basic community service provisioning Sector
but also as a surveillance and predictive reporting
frontline for the whole healthcare system. Taking Digital transformation brings a common frame-
the above into account, the digital transformation work that increases efficiency, productivity, and
could be a game changer for healthcare, espe- overall user experience (Bitton et al. 2017;
cially in PHC: the economies of scale associated Nambiar et al. 2020). In healthcare systems, it
with a clear picture of end-to-end processes and streamlines processes and automates routine
the latest technologies could result in a state-of- tasks, resulting in a major reduction in operating
the-art, frictionless, patient-centered care system. costs (OPEX) while in certain cases it can also
In particular, digital transformation could have a improve patient outcomes (Bardhan and Thouin
revolutionizing impact on PHC provisioning in 2013). The so-called ‘Iron Triangle dilemma in
LMICs (Schwarz et al. 2020). Through leverag- Healthcare’ (Callahan 2014), a challenge faced
ing digital opportunities, LMICs could focus on by all health systems around the globe, could be
universal accessibility and improved service completely transformed in the long run through
quality, rather than bureaucratic and, sometimes, digital technologies, as accessibility, quality, and
erroneous decisions. affordability (the three cornerstones of the ‘Iron
It is also important to note that the PHC invest- Triangle’) could all be provided without compro-
ment from the public purse has become a mount- mising patient outcomes and well-being.
ing priority in the context of introducing However, an adequate implementation of a digi-
Universal Health Coverage in LMICs (Garg et al. tal health system must integrate several digital
2021; Tilley-Gyado et al. 2016). In the long run technologies under the same framework, not as
this brings additional competitive benefits for the isolated technology silos, but rather as a global
LMICs: the digital transformation could start puzzle, where ideally every piece counts for solv-
from the edges (PHC), i.e., closer to the commu- ing a local demand, and success relies on the
nity practice, migrating later to the central and seamless integration of all the constituent pieces.
more consolidated secondary and tertiary care The key technologies for digital transforma-
facilities. tion in healthcare systems are the Internet of
From a patient perspective, it also makes sense Things (IoT), Artificial Intelligence (AI),
to have access to a more technologically advanced Blockchain, and Cloud. These will be reviewed
PHC. A recent US report shows that the average in the following sections in relation to their
cost of patient visits to emergency rooms (ER) implementation within healthcare in LMICs.
was USD 2143 in 2020, up from USD 1704 in This is a narrative review, aiming to identify key
2016. This reflects the increase in healthcare pro- published information and provide an overview
Digital Healthcare: Technologies, Technical and Design Challenges 209
of the field, rather than a more detailed view on devices will be lighter, more precise, and with
any aspect which should be addressed by a sys- new functionalities, favoring overall patient
tematic review methodology. Manuscripts were experience and treatment outcomes. Additionally,
identified for being seminal in their respective there are infrastructural challenges—especially
technical sections, while additional manuscripts in LMICs—as the IoT relies on the seamless inte-
were identified through ‘snowballing’, i.e., using gration of several technical components all work-
reverse citation tracking to find articles that cited ing together. The lack of consistent technical
articles already deemed relevant to the review infrastructure to support IoT in LMICs remains a
(Callahan 2014). major barrier in introducing these technologies
beyond a limited number of centers of excel-
lence. It is also necessary to consider that, for
2.1 Internet of Things LMICs, different types of infrastructure/infra-
structure connections may be necessary to pro-
The Internet of Things (IoT) comprises devices, duce the intended results (Dinh et al. 2020).
appliances, and all types of equipment that have
built-in sensors, software, and network connec-
tivity (Xia et al. 2012). In healthcare, IoT plays 2.2 Artificial Intelligence
an essential part in digital healthcare systems as it
brings the PHC closer to patients with the poten- Artificial Intelligence (AI) provides the most dis-
tial of creating a so-called “Virtual Healthcare ruptive element for a complete transformation in
space”. IoTs are commonly used for monitoring healthcare. AI refers to a field of computer sci-
patients’ health via wearable devices, collecting ence that accentuates the creation of intelligent
data in real time and transmitting the information machines that mimic human behavior through
to the cloud for further processing and analysis. interconnected algorithms that are designed to
This is particularly relevant for routine monitor- analyze and process data, recognize patterns and
ing of vital signs in patients, such as heart rate, relationships in the data, and make predictions or
blood pressure, body temperature, glucose, and decisions based on such data (Dinh et al. 2020).
blood oxygenation levels. Medical teams could Therefore, AI algorithms rely on long-term
receive real-time alerts from patients that need to knowledge (disease-specific datasets) that create
be monitored (e.g., post-operatively), consider- a clear understanding of the disease and mini-
ably improving patient assistance and prioritizing mize the risk of wrong decisions. As such, the
urgent cases as they emerge. For patients, this positive impact of AI implementations is corre-
could mean a reduction in unnecessary visits to lated to the quality and quantity of these datasets,
tertiary healthcare services such as Emergency the understanding of existing clinical workflows
Response (ER). A recent European Union report and intended outcomes, and the representative-
described a patient monitoring solution imple- ness of the target population (de Hond et al.
mented in Chile that reduced ER visits by 42%, 2022). However, the general goal of AI is not
resulting in a 50% saving to insurance companies well-defined because there is no consensus on
(Xia et al. 2012). A second study on a targeted what specifically constitutes ‘intelligence’.
implementation, showed a three-fold increase in From a long-term economic perspective, AI
the risk of acute infection for elderly people after will drive down the costs of high-volume, repeti-
a visit to ER (Andersen 1994). tive tasks in healthcare and is therefore antici-
It is important to note that significant technical pated to have a major impact on healthcare
challenges remain that could be addressed economics at a macroeconomic level. Since AI
through further sensor miniaturization and an implementation may also improve the early diag-
increase in sensor efficiency, resulting in higher nosis of diseases, treatment could be simpler, less
processing power and decreased power consump- invasive, and potentially, with increased success
tion (Kim et al. 2019). The resulting wearable rates. It therefore makes complete sense to bring
210 E. Mascarenhas et al.
AI to the frontline of PHC. A recent report from other regions or globally. This implies that AI for
the World Bank describes the notable healthcare the PHC must be observed both as a global strat-
achievements in China due to increased invest- egy, as well as a country-based decision. Thus, a
ments in PHC, including information systems common global AI framework for PHC should be
and in response to the intense population pres- considered and further discussed as a global pub-
sures. Even though the report does not focus on lic healthcare priority.
specific technologies, the improvements are Finally, an area with enormous potential to
potentially related to an integrated technological benefit from AI is imaging processing and analy-
framework, including IoT and AI (European sis, such as X-rays and Magnetic Resonance
Institute of Innovation and Technology 2021). Imaging (MRI). For example, it has been argued
AI could be applied to clinical notes in PHC that AI can substantially streamline radiologists’
Electronic Health Records (EHRs) for predictive work while improving the detection of breast
analytics. For example, the US National Institute cancer (De Francesco et al. 2023). The approach
on Aging is funding AI research for detecting of using AI on imaging can have a dramatic
early stages of Alzheimer’s disease based on the impact on several diseases that affect the aging
analysis of EHRs of PHC, as some physicians population, including cancer, cardiovascular and
might not be specialized in identifying the poten- pulmonary diseases (World Bank 2023). Looking
tial disease symptoms (Quach et al. 2012). further into the future, if combined with other
Furthermore, the prediction of adverse neonatal technologies, AI could further increase its overall
outcomes in newborns based on deep learning impact. For example, CRISPR-Casp9 gene-
models that use EHRs data for different early-life editing tools (Leibig et al. 2022) which have rev-
stages, ranging from preconception to a few olutionized genome editing, could be combined
months after birth, is another relevant use of AI in with AI algorithms to automate genomic editing
PHC records (World Bank 2022). Using AI vir- procedures. The gene selection process could
tual assistants and chatbots brings other possibili- also be streamlined, as specifically-designed
ties in PHC, especially in LMICs where algorithms could be used to identify diseases in
telemedicine is very relevant due to the acute stored patient biological samples (e.g., blood,
shortage of health professionals (Naseem et al. urine, etc.) kept within biobanks (https://www.
2020). For example, in an ideal scenario, by using arterys.com/clinical-evidence).
a pre-defined questionnaire, it would be possible
to understand a patient’s symptoms and reach a
preliminary diagnosis. Subsequently, the virtual 2.3 Blockchain
assistant could connect the patient to a human
doctor or, depending on the case severity, recom- The technology of Blockchain can be described
mend a hospital nearby. Several implementations as an immutable record in which data entries are
of AI virtual assistants have been deployed glob- registered in a decentralized manner. This means
ally, reducing diagnosis delivery times, and mini- that users or entities can interact without the pres-
mizing human errors (European Institute of ence of a central authority thus allowing more
Innovation and Technology 2021). transparency around these interactions (Ledford
A recent report from the World Bank Group and Callaway 2020). Cryptocurrencies are a good
regarding PPR addresses the weakness of global example of the use of blockchain technology. In
disease surveillance networks during the this case the blockchain acts as a decentralized
COVID- 19 pandemic (Science and Enterprise database that keeps track of all coin transactions.
2023). AI algorithms could be used for identify- The continuously increasing number of data
ing changes in patient disease profiles arriving in entries is then packaged together into blocks of
the PHC. This would have a major impact on the data which are securely maintained within the
response of regional authorities, isolating the blockchain by cryptographic protocols and can-
regional source of disease before it spreads to not be tampered with (National Institutes of
Digital Healthcare: Technologies, Technical and Design Challenges 211
Health (NIH) 2023). Hence, the data security can help incentivize a more transparent, and effi-
aspect is ensured, while the added-value argu- cient system for health information exchanges in
ment beyond security remains to be strongly which patients can participate in decisions about
demonstrated. how and with whom their personal health infor-
Healthcare has the potential to benefit from mation is shared, and where data access and con-
the use of blockchain technology as it is a data- trol can be automated through smart contracts
and personnel-intensive domain where the ability (Kostick-Quenet et al. 2022).
to access, edit and have trust in the data emerging NFTs are created by uploading digital content
from its activities is critical. In that context, on a blockchain and having other computers ver-
blockchain could improve data management by ify and timestamp the content, location, and
connecting different systems and increasing the owner of the content. NFTs are digital contracts
accuracy and security of electronic health records composed of metadata to specify access rights to,
(EHRs) (Hasselgren et al. 2020; Hölbl et al. and terms of exchange of a given content. They
2018). Moreover, this technology could be used represent the point of access to digital content but
in e-health applications, where patients and are not the content itself, and they allow for its
healthcare professionals are required to identify secure storage and sharing, for example medical
themselves, by allowing for an efficient digital health records, through the use of pseudonyms
identity management which is not possible with that maintain anonymity while ensuring transpar-
current internet protocols that were not originally ency and accountability (Kostick-Quenet et al.
designed for that purpose (Satybaldy et al. 2022). 2022). NFTs are used in the entertainment
In the pharmaceutical industry, blockchain can (Regner et al. 2019) and commercial (Ali and
help identify and avoid the dissemination of Bagui 2021) sectors on platforms that provide
counterfeit and unapproved drugs, and it is pos- collectibles, access keys or event tickets, there-
sible to define smart contracts to automate the fore ensuring the uniqueness of the items
technical processes, improve supply chain man- exchanged and securing their ownership.
agement, and verify the quality of pharmaceuti- However, their use in healthcare is not yet forth-
cal products (Hölbl et al. 2018). coming, and the case of LMICs remains a distant
Blockchain also has the potential to increase future potential.
transparency and integrity of data in the context
of clinical trials by maintaining records of patient
consents and clinical data that cannot be modi- 2.5 Cloud Computing
fied, therefore ensuring that the trials meet all rel-
evant regulations and that problems of fraudulent The fast development of the Internet of Things
results and removal of data by individuals is (IoT) technology, commonly used in medical set-
avoided (Bell et al. 2018). Despite this, block- tings to monitor patients’ vital signs through a
chain technology is not yet widely used in health- wide range of devices, has greatly improved
care in LMICs and the stated benefits remain in treatment and health outcomes for patients, but
the sphere of future achievements or limited to has also led to more stringent requirements for
specific users in high-income settings. data analysis and data storage (Dang et al. 2019).
The increasing amount of clinical, analytical lab-
oratory and ‘-omics’ data due to the integration
2.4 The Example of Non-Fungible of IoT technology brings several challenges in
Tokens (NFTs) terms of data storage, management, and sharing,
as well as data confidentiality, security, and high-
Health information is highly valued, especially as performance computing (Calabrese and
the implementation of big data and machine Cannataro 2015). So far, cloud computing tech-
learning are increasingly considered in health nology has been the preferred solution to address
care. Within this context, non-fungible tokens these issues by providing the ability for health
212 E. Mascarenhas et al.
professionals, and to a much lesser extent tural, financial, societal, legal and ethical back-
patients, to access shared medical data and other grounds of end-users. Digital technologies in
resources at any time and anywhere within a healthcare are received and operate in very differ-
given digital environment, e.g., healthcare pro- ent ways when implemented in high-, medium-,
viding organizations (Griebel et al. 2015). In or low-income countries, or when deployed in
addition, with cloud computing, data sharing and ‘individualistic’ versus ‘collectivist’ societies
storage can be performed at scale in a more struc- (Ferretti et al. 2020). The following paragraphs
tured and organized way with full transparency, focus on the technical and design challenges of
thus minimizing the risk of data loss. digital healthcare implementation in LMICs.
This technology provides access to higher
computing power and storage capacities at a
lower cost than using regular grid technology and 4 Technical Challenges
so can improve the scalability of healthcare activ-
ities and resources (Dang et al. 2019). However, 4.1 Infrastructure
in the case of LMICs, the implementation of
cloud computing remains piecemeal and limited The lack of infrastructure for healthcare in
only to specific clinical centers of excellence, LMICs has been highlighted in numerous publi-
typically belonging to tertiary healthcare cations, such as the Lancet Oncology Commission
(Clifford 2016). For example, in India, electronic (Ngwa et al. 2022) and many others. The avail-
medical record (EMR) systems in tertiary health- ability of communication networks, electrical
care facilities are linked to a remote health cloud networks and equipment has been well docu-
which allows for a direct entry of orders and mented and remains a major challenge for
notes, as well as desktop sharing since EMRs can improving healthcare in resource-restricted set-
be accessed from anywhere (Agrawal et al. tings worldwide. However, from a digital health-
2013). In another instance, Zambia was able to care implementation viewpoint, additional
set up a local data server that communicates aspects also have an influence. For example, in
directly with monitoring mobile devices on LMICs healthcare systems are often fragmented,
patients and the cloud. Skin-integrated sensors on with individual health units providing services
patients collect physiological data that are that are not integrated into a national network and
encrypted and transmitted to a local server. The universal healthcare coverage is unavailable.
data is then securely transferred to the cloud for Furthermore, it is likely that a parallel private
broader access and monitoring. Access to this system of individual health units exists, that
data in the cloud can be granted to authorized caters for a different portion of the local popula-
individuals through a system of identifiers (Xu tion, i.e., those with higher income. Thus, there is
et al. 2021). very high fragmentation, with multiple smaller
systems co-existing as in the case in Ecuador
(Carlo 2020).
3 Challenges The investment and maintenance costs of the
for the Implementation required infrastructures are prohibitive in settings
of Digital Health where many critical and competing priorities
exist. Suboptimal device use (including digital
The pandemic has demonstrated that even during health applications) is directly linked to incom-
times of extreme pressure on healthcare systems, plete costing and inadequate consideration of
it is practically impossible to establish a single connectivity (e.g., data transfer speed), mainte-
global technological solution to a given problem. nance services (including digital and physical
The acceptability and implementation of digital infrastructure) and user training. The accurate
technologies during the pandemic were driven by estimation of life-cycle cost and careful consider-
context, depending on the different infrastruc- ation of device servicing are of crucial impor-
Digital Healthcare: Technologies, Technical and Design Challenges 213
tance, however, there is currently no consensus and system-wide investment (including in digital
approach for achieving this within LMIC settings healthcare applications) in countries such as
(Diaconu et al. 2017). Tanzania (Vasudevan et al. 2020), Egypt (Noby
2022), Rwanda (Ippoliti et al. 2021), Mexico (Uc
et al. 2020), Indonesia (Aisyah et al. 2022) and
4.2 Human Capital others. The recent G20 meeting in 2020 high-
lighted the need and value of digital health invest-
The availability of technical infrastructure, ment and development in LMICs, as described in
equipment costs and past performance of similar the Riyadh Declaration (Knawy et al. 2020; Al
equipment are the primary deciding factors in the Knawy et al. 2022). Therefore, an increase of
procurement of medical devices (including digi- investment in digital health applications is antici-
tal technologies) in LMICs (Diaconu et al. 2017). pated, which will eventually result in a better
However, maintenance services and user/staff understanding of the data questions mentioned
training programs are often limited or even here.
entirely absent in LMICs, leading to equipment
under-performing and having a reduced lifespan
and in some cases, unsafe device handling prac- 5 Design Challenges
tices. It is estimated that 40–70% of medical
devices in resource-restricted settings are either 5.1 Design and Evaluation
broken, unused or unfit for purpose, largely due Frameworks for DHI (Digital
to the absence of appropriately trained staff and Health Interventions)
preventive maintenance (Perry and Malkin 2011).
This is further compounded in the case of digital The technical challenges described previously
healthcare applications, where training schemes are the more visible aspects of the challenges fac-
for staff are less accessible, the time it takes to ing digital health in LMICs. The less visible chal-
become fully trained can be considerable and the lenges are those relating to the design.
availability of expertise and post-training support Specifically, the objective of design as defined
is often limited (Browning et al. 2020). here, is not about the technology per se, but about
the overall quality and configuration of service
delivery that might result from the comprehen-
4.3 Data Quantity, Quality, sive adoption of a new technology (Holmlid
Representativeness 2007, 2009). Hence, the design challenge is to
take a more holistic view, considering the impact
Introducing electronic health data systems in of digital health applications as opposed to sim-
LMICs, as a first step towards a wider set of digi- ply improving existing processes and workflows.
tal health applications, could improve data qual- Furthermore, a design perspective inherently
ity and efficiency in service delivery. A small acknowledges that technologies are not fixed and
number of studies have demonstrated that such immutable (Barrett et al. 2015), but subject to
health information systems can also provide cyclical revision and refinement based on emerg-
small annual cost savings to the public health ing insights about their efficiency and effective-
system (Krishnan et al. 2010; Fenenga and de ness within the context(s) where they have been
Jager 2007). However, the questions on data introduced (Nambisan 2013; McCool et al.
quantity, quality and representativeness remain 2020).
addressed only in isolated silos, e.g., for specific Digital health implementations are complex
clinical trials or within individual tertiary health- and can alter as the technology matures, often in
care units, and not as part of a wider healthcare LMICs in parallel with the healthcare system.
system development. There are however notable One of the most significant issues influencing
exceptions with national or regional healthcare the effectiveness of such implementations con-
214 E. Mascarenhas et al.
cerns the existing evaluation frameworks. transparent and holistic understanding of the
Previous research showed that there is a lack of costs and requirements of the digital health appli-
knowledge related to the development of frame- cation and remove any implementation barriers
works for the evaluation of such digital health due to hidden costs that such applications or sin-
implementations, which have to be equally as gular initiatives are often associated with (Chen
sensitive to the local context, acknowledging et al. 2023; McCool et al. 2020).
diverse technical, social and cultural perspec- Clinical value demonstration: A few parame-
tives and settings (Maar et al. 2017). The lack of ters exist for which the value can be demonstrated
evaluation frameworks and the rapid advance- for digital health applications. In this book, there
ment of digital technology make it difficult to are specific national examples from Vietnam,
compare accessibility and affordability of digi- Egypt, and Saudi Arabia, demonstrating the plu-
tally enabled healthcare across communities, rality of options when measuring value. A mean-
within and between countries, in LMICs. For ingful approach to measuring value has been
this reason, published evaluations for digital proposed by the Institute for Healthcare
health implementation tend to be quite heteroge- Improvement (IHI)‘s Quadruple Aim as: (a)
neous and the evidence concerning evaluating improving the health of populations, (b) enhanc-
frameworks is inconsistent. In response to this ing the experience of care for individuals, (c)
need for a common framework a few recent reducing the per-capita cost of health care, and
LMIC-centered solutions have been proposed (d) improving the experience of clinicians and
(Kowatsch et al. 2019; Wilkinson et al. 2023; staff (Bodenheimer and Sinsky 2014). These are
Dodd et al. 2019; Nadhamuni et al. 2021; generic enough and fit most contexts, although
Marchal et al. 2010), however, these still remain their respective definitions and evaluations may
to be extensively tested in the field. still differ considerably. Evaluating a digital
health application’s direct impact on an opera-
tional outcome—rather than a higher-level one—
5.2 Implementation Barriers may be a better way to capture its value. For
example, it may be difficult to measure “total
ROI (return of investment) definition: As a result staff time saved,” and easier instead to measure
of the above mentioned barriers to the implemen- any “reduction in number of unnecessary appoint-
tation and sustainability of digital health imple- ments/consultations”. A successful digital health
mentations, there are a limited number of application is one that can stratify population
successful case studies that went beyond the pilot groups and/or individuals along specific path-
or feasibility stage. In some fields, the results are ways, and where needed, trigger a human-led
mixed, or the existing studies can only demon- intervention. This is a measurable approach and
strate impact in the short-term (Marcolino et al. one likely to be able to demonstrate clinical
2018; Aisyah et al. 2020). Thus, understanding value.
the framework by which the tool generates value
for the healthcare system is important as a core
element in framing the return of investment (ROI) 6 Limitations
argument. In LMICs, where multiple acutely
competing priorities are considered for funding, This narrative review has presented an overview
the ROI is critical. It should be clear which prior- of the different digital healthcare technologies, as
ity digital health applications address, the capital well as describing their technical and design
expense as well as the operational expense (the challenges, nevertheless it has some inherent lim-
latter incurring costs in perpetuity), as well as itations. The method of identifying the manu-
staffing requirements, technical support, mainte- scripts is not exhaustive, and it is likely that some
nance, and hosting. Aligning these costs with the relevant publications have not been considered.
evaluation framework and ROI, would provide a For a more detailed view, a systematic review
Digital Healthcare: Technologies, Technical and Design Challenges 215
would need to be performed for each one of the pandemic responses and challenges. Zoonoses Public
Health 69(6):757–767
sub-sections above individually. Furthermore, Al Knawy B et al (2022) Successfully implementing digi-
given the rapid pace of technological tal health to ensure future global health security during
advancement, some of the anticipated outcomes pandemics: a consensus statement. JAMA Netw Open
may materialize earlier than predicted. 5(2):e220214–e220214
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Bell L, Buchanan WJ, Cameron J, Lo O (2018)
continue to be so in the near future. This chapter Applications of blockchain within healthcare.
has presented an overview of the technologies Blockchain Healthc Today
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Disclaimer The opinions expressed in this chapter are
challenges, reflections and opportunities for digital
those of the authors only. They do not purport to reflect
health. In Proceedings of the 2020 international con-
the opinions or views of their affiliated organizations.
ference on information and communication technolo-
gies and development
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Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license,
unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons
license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
obtain permission directly from the copyright holder.
Digitization of Physical Health
Data in Low- and Middle-Income
Countries
“Physical health is defined as the state of the body while considering everything from the
absence of diseases to the level of physical fitness.”
EUPATI—European Patients Academy on Therapeutic Innovation.
the PA program. The study showed significant ciated with insufficient relevant information,
changes in stress and wellness indicators in the work commitment, discomfort, lack of time,
group of supporters of PA two to four times a tiredness and low energy, inadequate or conflict-
week. This proves that the regularity of fitness ing information about prenatal physical activity,
programs is an essential criterion for improving and lack of financial resources (Okafor and Goon
indicators, reducing what leads to stress, and 2022). Thus, more profound research and support
increasing the indicators of health (Muradyan for introducing digital technologies such as wear-
et al. 2022). ables, websites, and mobile applications can help
We also conducted research before the people in LMICs benefit from PA. Moreover,
COVID-19 pandemic (from May 2018 to increased access to information technology, even
September 2019) and during the pandemic among the most vulnerable people, has led to
(November 2020 to December 2021). We evalu- digital interventions being promoted as a tool to
ated the correlation and infrastructure of some reduce inequalities in health promotion.
physical health indicators before and during the Research using mobile devices is gaining pop-
COVID-19 pandemic in the Armenian popula- ularity. A meta-analysis of electronic databases
tion. In conclusion, during COVID-19 pandemic (PubMed, PsychINFO, SCOPUS) that provided
significantly decreased stress resistance, endo- raw data and aimed to influence PA through the
thelium function, and wellness indicators distribution or collection of intervention materi-
(Muradyan 2022). als using a mobile device suggests that this plat-
Our current study showed that a high level of form is an effective means of influencing PA
PA improves the indicator of body composition behavior, and harnessing the potential of smart-
and increases stress resistance. We have also phone technology could provide researchers with
identified that the probability of getting infected an effective tool to increase PA (Fanning et al.
with COVID-19 was higher among people with 2012). Using a systematic search strategy to
low levels of PA. Thus, our research indicates the identify relevant studies from MEDLINE,
need to develop and implement health programs, Embase, PsycINFO, Web of Science, Scopus and
including PA. The application and subsequent The Cochrane Library published between January
analysis of the effectiveness of these programs 1990 and March 2020 suggests that the opposite
can be monitored with the help of digital tech- is true in the context of PA, that is, the people
nologies not yet widely used in Armenia. who will benefit most from these interventions
are left behind. The authors recommend that in
the future when developing digital interventions
4 Challenges to improve the PA, more efforts will be made to
and Opportunities meet the needs of people with low socioeconomic
in PA-Related Research status (SES) (Western et al. 2021). The review
in LMICs that maps and describes the impact of digital
workplace wellness measures in LMICs revealed
There are many social barriers to encouraging PA that digital workplace wellness measures are fea-
in LMICs, including a lack of resources and ame- sible, cost-effective, and acceptable. However, no
nities, which should be the attention of research- long-term and consistent effects were found in
ers. The most significant barriers are cost and this review, and further studies are needed to
reimbursement, legal liability, and ethical issues obtain additional evidence (Thai et al. 2023).
such as confidentiality, infrastructure, equipment, A review of Ovid MEDLINE, EMBASE,
Internet, age and level of education of patients, CINAHL Plus, PsycINFO, Scopus, and Cochrane
computer literacy, bandwidth range, and internet Library for peer-reviewed articles, emphasized
speed (Pratt et al. 2012; Liu 2022; Kaboré et al. the advantages of wearable devices for physical
2022). For example, for pregnant women in activity and also urged people with chronic dis-
South Africa, the lack of prenatal PA can be asso- eases to maximize the effectiveness of wearable
Digitization of Physical Health Data in Low- and Middle-Income Countries 223
devices. The authors suggest that wearable LMICs. In addition, digitizing physical health
devices may develop some special functions in data will be an essential basis for a research pro-
combination with the treatment of chronic dis- gram on the economic aspects of PA in LMICs.
eases. It is necessary to formulate targeted strate- This will be a valuable guide for researchers to
gies of PA per the specific characteristics of the plan research in economics and physical health
disease (Yu et al. 2023). A systematic search in using a reliable methodology focused on the
PubMed of studies evaluating the impact of the LMICs research needs. In addition, the informa-
Internet, personal sensors, mobile phone or tion obtained from digitalization will help fund-
autonomous computer software on a diet, PA, ing agencies allocate and monitor resources
obesity, tobacco or alcohol use has shown that efficiently.
interventions using the Internet and mobile
devices improve important lifestyle habits up to
1 year and supports the effectiveness of Internet References
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Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license,
unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons
license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
obtain permission directly from the copyright holder.
Governance and Regulation
Specifics
indeed be traded by data brokers to pharmaceuti- menting health research legislation like in
cal companies or insurers, which can severely Botswana or Uganda.
impact a person’s life based on algorithm predic- Health research governance is essential to
tions on their potential sickness or propensity build a robust health research system. However,
scores to assess if the person will choose a medi- improving governance in science and health is
cation or another. relatively new compared to the strengthening of
Related to these threats, public organizations health science research capacities.
such as the Europe’s General Data Protection Some challenges that the countries are facing
Regulation (GDPR) oversee the treatment of per- are usually the fact that only short-term improve-
sonal data (genetic information, biometric data, ments are made because of insufficient fundings
and health data) and are constantly establishing for governance missions, discrepancies between
and reviewing specific consents for the use of research priorities and research fundings or a
personal data as well as anonymization or de- lack of coordination between the different stake-
identification processes to keep the patients holders and the health research capacities. In
protected. some regions, developing new health research
policies takes time and most of the current exist-
ing ones are outdated.
4 Near Future Improvements The creation or the strengthening of national
and Challenges research authorities is and will be essential in the
future for the countries which still need them so
The governance and regulations landscape today, far to enhance the sustainability of the operation
even if well implemented, accepted, and fol- of the governance system. Legal frameworks and
lowed worldwide, remains disparate. Currently, effective resources are also one of the keystones
some developing countries are still in need to to maintain research improvement.
develop basic health-system functions. Some Through the recent history, governance and
examples have shown as well that the medical regulations in science have shown their efficiency
equipment is often worn out or not up to date to keep experimentations safe and respectful of
which leads to data encryption or misconfigura- the society while helping to move forward the
tion issues. Artificial intelligence can be used as scientific findings. To help continuing this way,
a benefit but can also become a harm depending national and international authorities will have to
on its use and can threaten the digital health keep up with according their rules to the con-
systems. stantly evolving environment and morality.
Cybersecurity must then be fully integrated
into nowadays research and healthcare but also
represents a non-negligible cost for the hospitals References
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imposed by institutional review boards: the state https://doi.org/10.2471/BLT.16.189100
of the evidence and its implications for regula- Warnock M (2007) The ethical regulation of science.
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org/10.1111/j.1468-0009.2011.00644.x
Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license,
unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons
license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
obtain permission directly from the copyright holder.
Future Developments of Digital
Health and Considerations
on Sustainability
et al. 2014; Aisyah et al. 2020; De San et al. ferent Chapter of this book). Moreover, as a pre-
2013) and multiplied during its duration (Caetano amble to such a scale up during times of
et al. 2020; Liu et al. 2020; Aisyah et al. 2023), emergency, this capacity would need to be tested
has been a major step in this direction. It is antici-
through the ‘exercise’ of model crises, i.e., iter-
pated that many of these remote healthcare cov- ated emergency simulations with the aim of iden-
erage services will continue post-pandemic tifying and understanding the critical bottlenecks
(Jazieh and Kozlakidis 2020), albeit with further of existing systems. Identifying any such weak
context-driven customizations, adapted to the points would likely aid their addressing, thus
local milieu of patients and professionals strengthening existing structures over time.
(Abusanad 2021). Therefore, there is a need for transparent,
However, for the sustainability of such trans- standards-based assessment of digital health sys-
formation in the long-term, a number of parame- tems that (as a possible solution) will be guided
ters would need to be considered, such as the by a formal assessment across the main activity
scale-up of existing technologies; the security domains in the field, encompassing technical,
aspects of big and integrated data; and the per- clinical/operational and financial aspects
sonal, social and market acceptability. The trans- (Mathews et al. 2019).
formation is most likely to occur upon the As surveillance technologies can now be
confluence of those factors rather than each one mobile-enabled, and deployed at scale to monitor
acting separately. This chapter, in the form of a and to flag potential healthcare needs as they
perspective article, presents an overview of cur- emerge in individuals and/or populations, one
rent advancements and their likely future impact needs to consider that the generation and inges-
on the transformation of digital healthcare ser- tion of data will be bi-directional. Specifically,
vices, with particular focus on LMIC settings. the scaling up of digital health will not only be
based on healthcare facilities outputting greater
volumes of data through high-throughput analyti-
2 Scaling Up Digital Health cal platforms (e.g., genomics, metabolomics). It
would also involve the patients themselves, gen-
The speed by which avian influenza (Uyeki erating data (e.g., input for remote monitoring
2008), zika virus (Garcia et al. 2016) and SARS- applications) and utilising this data (e.g., using
CoV-2 (Koelle et al. 2022) spread -and the poten- clinical details to input into wellness and lifestyle
tial of other infectious diseases exhibiting a guidance applications) (Moore 2020). Thus, new
similar, rapid global impact in the future- high- digital tools are likely to continue being intro-
lights the need for reliable and agile surveillance duced and integrated within public healthcare,
systems. Such systems, vertical by necessity as supporting our understanding in an increasingly
they are initially of a single-disease focus, can be connected and challenging global environment.
established for surveillance of one disease and The ways in which such tools can be adapted and
then be expanded to incorporate others (Zinsstag customised to LMIC settings at a population
et al. 2020; Njuguna et al. 2019). The surveil- level, and beyond individual cases, is only now
lance of infectious diseases is defined as the starting to emerge (Labrique et al. 2018).
aggregate of reported positive results from desig-
nated clinical laboratories or laboratory networks
for specific microorganisms that constitute a pub- 3 Predictive Algorithms
lic health threat (Zeng et al. 2011). Thus, the rou- and Synthetic Data
tine use of surveillance data would need to be
coupled with the ability to scale up the genera- The increasing volume of healthcare data under-
tion, ingestion and interpretation of such data lies an ever-growing need to develop predictive
during times of need (presented in detail in a dif- algorithms that can ingest and translate that data.
Future Developments of Digital Health and Considerations on Sustainability 233
This will help clinicians treat patients based on Synthetic data allows researchers to explore
their individualised response(s) to care rather data independently of data protection constraints
than on generalised risk scores. Thus, in order to while maintaining patient privacy, enabling them
improve performance of existing algorithms and to potentially share data worldwide. Synthetic
support the creation of new ones, access to large data do not contain any of the original data sets
amounts of diverse and high-quality clinical data (Chen et al. 2021). They have the same format as
is needed. This is especially true for LMIC popu- the original data, and they have identical statisti-
lations, which are under-represented in existing cal characteristics as the original individuals/
healthcare data sets, or where collected data can population, across parameters and within sub-
often be of low quality (Curado et al. 2009). groups in the population. All of this makes syn-
Unfortunately, in most settings clinical data is thetic data similarly suitable for analysis, while at
also siloed due to privacy restrictions, and access the same time overcoming privacy concerns.
to them is often limited only to the treating clini- Some of the uses of synthetic data in health-
cian or to clinicians within the same department/ care are:
institution.
The reasoning behind such stringent data • They can simplify the collaborative and regu-
accessibility regulations is based on the premise latory efforts when trying to share raw data.
that algorithms that consume and learn from • Synthetic data platforms can facilitate hypoth-
large amounts of personal data can leak private esis testing and model validation without
details pertaining to individuals, which can then intermediaries (Foraker et al. 2020)
be used to discriminate against them specifically. • Synthetic data can be used to train students
Potential data breaches cannot be entirely pre- and staff on new platforms (prior to using such
vented with current systems, because of the con- platforms on real data) and be used to host
stant need to access, distribute and utilize hackathons and competitions improving exist-
information, that provides the opportunity for a ing platforms (Gonzales et al. 2023)
deliberate data breach or a spontaneous mistake. • And finally, synthetic data can liberate data
According to datalossdb (2015), a platform from publicly, allowing access for scientists, citizen
the Open Security Foundation (2005–2016), in scientists and clinicians (even from different
2014, approximately 50% of recorded data leak- locations globally) to use those data freely in
ages were in private businesses, ca. 20% in gov- order to develop better care pathways (Benaim
ernment functions and about 30% in the education et al. 2020; Foraker et al. 2021)
and health sectors (Alneyadi et al. 2016). There is
the possibility of linking healthcare data to block- For example, MDClone, a self-service data ana-
chain technology, so as when data actually leaks, lytics environment, has developed a platform for
it should be fairly straightforward to identify the querying and synthesising patient cohorts in a
source of the leak and address it appropriately. self-service manner. Specifically, a user can
However, this technology has not been tested query an organisation’s data lake while being
widely (Jayabalan and Jeyanthi 2022). In health- sequestered from it at all times, and subsequently
care this is particularly dangerous, as this data create synthetic derivatives of the cohort and its
can have irreversible consequences for an indi- corresponding characteristics. This new technol-
vidual, or if the data is damaged/deleted, can ogy has been used on a great number of recent
never be replaced. Thus, a methodology is needed clinical studies (Masarweh 2019; Inbar and Dann
to mitigate the aim to harness data on the one 2019; Hochberg 2018; Meilik et al. 2022; Hod
hand, with the requirement to protect patient pri- et al. 2023; Masarweh et al. 2021; Isenberg et al.
vacy on the other hand. Possibly, one of the most 2022) and has the potential to model/‘re-create’
promising solutions to this need lies in synthetic LMIC-specific data sets, while maintaining the
data. data security requirements for the real data.
234 N. Zamstein et al.
4 A Sustainable Path Forward tures that would be more appropriate for local
needs/capacities.
As with many other technologies introduced to An example for the successful re-design of
the healthcare field, the operational advantages data architecture, customised for LMICs, comes
for any technology by themselves are unable to from the field of construction (which is also ‘data
guarantee a long-term adoption. Instead, the heavy’). In those examples, data flows were
operational aspects need to be complemented by adapted to local needs with the aim of reducing
the social and market acceptability of any new costs and infrastructure pressures, while main-
technologies. This definition of sustainability taining data output (Raes et al. 2021; Liu et al.
along three axes, the operational, financial, and 2021). This approach for transforming infrastruc-
social, has been successfully applied previously ture costs was based on the concept of digital
on other large, data-heavy infrastructures, such as twins, i.e., a digital model of a physical entity
biobanking, and can be extrapolated for the digi- that results in measurable outputs. The digital
tal healthcare data needs, as a useful planning twins of existing models were used for example
model (Table 1) (Watson et al. 2014; Henderson in the re-design of modular construction systems,
et al. 2015). For example, in terms of operational allowing for a more context-adaptable output, in
sustainability, the ever-growing need to produce this particular case a quicker on-site assembly of
and consume data, will introduce additional the construction (Jiang et al. 2022). In terms of
infrastructure requirements in LMICs in terms of healthcare, digital twins can relate both to the
data storage and security, staff training and inte- physical infrastructure (i.e., a new methodology
grations of systems (Kumar and Mostafa 2019; to enhance the infrastructure creation in LMICs),
Labrique et al. 2018). Thus, future data infra- as well as the digital infrastructure (i.e., allow for
structure approaches in healthcare would need to the creation of alternative data pathways to iden-
be evaluated so that they align with global health- tify the optimal one for a particular context).
care data requirements (to maintain a global con- The financial sustainability aspect, inevitably
nectivity and interaction) (Al Knawy et al. 2020), would align to and reflect market-driven needs.
but also to design new approaches/data architec- The potential structures and needs of financial
incentives were presented in detail in chapter
“Universal Internet Access Supporting Healthcare
Table 1 Summary of the future challenges and develop- Provision: The Example of Indonesia” of this
ments along three sustainability axes book. While the hard digital infrastructure (i.e.,
Future challenges and hardware) has reduced in costs considerably over
developments the last two decades, the soft digital infrastruc-
Operational The increasing volume of data to be
sustainability produced and consumed requires
ture (i.e., software) follows a different pricing
an infrastructure that demands new structure, often developed as a Software as a
approaches to data design and Service (SaaS) model (Berndt et al. 2012; Oh
architecture. et al. 2015). There have been a few individual
Financial Investments are needed to maintain SaaS implementations within LMICs (Ogwel
sustainability infrastructure
et al. 2022; Karthikeyan and Sukanesh 2012),
Synthetic data can provide a
cost-effective alternative however, a more universal understanding or
Social Full data anonymization is model has not emerged as yet. As the investment
sustainability currently best practice, but a new incentives have been discussed in chapter
methodology is needed to improve “Universal Internet Access Supporting Healthcare
data interpretation.
Provision: The Example of Indonesia”, a repeti-
Challenges remain in terms of
ethics and the legal framework for tion of the information would be avoided here.
handling large amounts of data. The only additional aspect that would come into
Future algorithm development consideration however, in terms of investment, is
should incorporate AI the necessary investment in trained staff, that is
Future Developments of Digital Health and Considerations on Sustainability 235
necessary for all of the described infrastructure to cial intelligence (AI)-based applications) (Reddy
be maintained as operational and impactful et al. 2020; Amann et al. 2020). The approach
(Curioso 2019; Long et al. 2018). currently proposed, including for LMICs, is that
Finally, in terms of social and market sustain- of a ‘reasonable explainability’ for regulating AI
ability, the collection and potential distribution of in healthcare, i.e. addressing explainability
immense amounts of information regarding indi- requirements based on the risks involved and pro-
viduals (e.g., even if self-reported via social net- viding explanations based on input, process and
works) raises ethical concerns, as complete data output norms (Sharma et al. 2020). Even at this
anonymization is rendered ineffective in conceal- level, the training of experts would be a necessity,
ing the original data source, becoming harded, in particular of regulatory authorities, as well as
yet still feasible, to (re)identify individuals via users of the AI-based solution (i.e., medical prac-
the use of advanced systems and triangulation titioners, nurses) on the limitations of explain-
(Cecaj et al. 2016). However, if systems are ability, and the risks that may not be explainable,
entirely designed to use anonymized data, as an which need to be communicated with patients.
effort to protect individuals or population groups, Thus, future developments within LMICs are
this approach might not work optimally either, as anticipated to incorporate the development and
the elements of information accountability and, implementation of healthcare digitization
hence, transparency may be affected. Regarding applications.
infectious disease outbreaks the use of anony-
mous data at source, is considered as current best
practice, however, it is not a definitive solution 5 Conclusion
for all situations that might arise within a health-
care ecosystem (Coltart et al. 2018). Therefore, The current SARS-CoV-2 pandemic highlighted
challenges still remain in terms of ethics, as well limitations and vulnerabilities of health systems
as in terms of the legal framework for handling and has driven a review of many healthcare sys-
large healthcare datasets, including for example tems, so that lessons are learned. The need for an
“credentialing, licensing, reimbursement, and increased capacity of healthcare systems to
issues related to technology, security, privacy, respond to iterative infectious disease emergen-
safety, and litigations” (Jazieh and Kozlakidis cies, as well as systemic pressures, creates a driv-
2020). At this point a distinction would need to ing force for the transformation of healthcare
be made between public health ethics and clinical systems, based on new digital technologies. The
ethics: the former prioritizes common good; the examples over the last few decades of new tech-
latter prioritizes individual autonomy and ways nologies that were introduced, integrated and
to safeguard it (Chia and Oyeniran 2020). These worked well within healthcare, including within
nuances in ethical views/priorities may come into LMICs, constitute the benchmark for an even
sharp focus within LMICs, during the implemen- greater integration of digital technologies.
tation of digital healthcare technologies, where Hopefully this can be achieved as part of routine
the pressures on availability of staff and funding healthcare services design and procurement.
are consistently acute. However, current challenges pertain to the
Finally, data protection regulations are emerg- scaling up of digital healthcare technologies,
ing within LMICs, albeit at a slow pace (Vodosin post-introduction in the field, and the use of pre-
et al. 2021). The emergence of such frameworks dictive algorithms. Solutions to these challenges
is desirable from a market perspective, as they have already emerged, such as synthetic data,
delineate the extent to which digital health can be which allows the use of high-quality datasets
implemented, systems integrated and reports pro- without compromising the security of the origi-
vided to competent authorities. A question that is nal datasets. However, for that to be achieved, the
currently often discussed revolves around the sustainability of digitalization of healthcare in
regulation of algorithms that evolve (e.g., artifi- LMICs needs to be considered through the lens
236 N. Zamstein et al.
of infrastructural, financial, ethical and regula- Caetano R, Silva AB, Guedes AC, Paiva CC, Ribeiro GD,
Santos DL, Silva RM (2020) Challenges and opportu-
tory concerns. nities for telehealth during the COVID-19 pandemic:
ideas on spaces and initiatives in the Brazilian context.
Conflicts of Interest NZ and RW are employees of Cad Saude Publica 36:e00088920
MDClone, Israel; SN is an employee of Orthomol phar- Cecaj A, Mamei M, Zambonelli F (2016) Re-identification
mazeutische Vertriebs GmbH, Germany. There is no and information fusion between anonymized CDR
financial or non-financial support for any of the authors of and social network data. J Ambient Intell Humaniz
this chapter for their contribution to this work. All health- Comput 7:83–96
care examples have been used for illustrative purposes Chen RJ, Lu MY, Chen TY, Williamson DF, Mahmood F
with the information being correct at the time of (2021) Synthetic data in machine learning for medi-
publication. cine and healthcare. Nat Biomed Eng 5(6):493–497
Chia T, Oyeniran OI (2020) Human health versus human
rights: an emerging ethical dilemma arising from
Disclaimer Where authors are identified as personnel of
coronavirus disease pandemic. Ethics Med Public
the International Agency for Research on Cancer/WHO,
Health 14:100511
the authors alone are responsible for the views expressed
Coltart CE, Hoppe A, Parker M, Dawson L, Amon JJ,
in this article and they do not necessarily represent the
Simwinga M, Geller G, Henderson G, Laeyendecker
decisions, policy or views of the International Agency for
O, Tucker JD, Eba P (2018) Ethical considerations
Research on Cancer/WHO.
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Universal Internet Access
Supporting Healthcare Provision:
The Example of Indonesia
Organization (WHO) as “a set of proactive and highly developed rate of digitization observed in
reactive activities to minimize the impacts of relation to healthcare (Lazuardi et al. 2021;
acute public health events that endanger people’s Aisyah et al. 2020).
health across geographical regions and interna- Indonesia within low- and middle-income
tional boundaries” (World Health Organization countries (LMICs), is classified as an upper–
(WHO) 2020). In 2005 the International Health middle-income country (World Bank 2019). It is
Regulations (IHR) were established, providing a the world’s largest archipelagos and has the
legal instrument for the effective and timely fourth-largest global population, administered
response towards outbreaks and other health into 34 provinces and 514 districts/cities, with
emergencies (World Health Organization (WHO) each sub-national government having decentral-
2008, 2017). Member countries are legally bound ized authority (Central Bureau of Statistics
to report event with an impact on public health, Republic of Indonesia 2013). From an ethno-
as well as to establish surveillance and response graphic perspective, Indonesia includes 1331 eth-
capacities towards health emergencies, in partic- nic groups, 2500 local languages and six
ular potential infectious diseases outbreaks recognized religions (Naim and Syaputra 2011).
(World Health Organization (WHO) 2020). All of these aspects are important to understand,
Subsequently, in 2014, the Global Health Security as they formulate a highly fragmented back-
Agenda (GHSA), providing a toolkit of policy ground against which any national healthcare
recommendations, divided into 11 work- campaign would have to overcome a harmoniza-
packages. Indonesia participates actively in the tion challenge—especially the deployment of
GHSA and in 2016 became the chair of the new technologies in relation to healthcare
Steering Group (World Health Organization digitization.
(WHO) 2016). Prior to COVID-19, the Indonesian govern-
Indonesia formulates a particularly interesting ment pursued the strengthening of routine human,
example in terms of internet connectivity, acces- animal and wildlife surveillance, for detecting and
sibility to healthcare services and diseases sur- responding to zoonotic diseases that can poten-
veillance, which this Chapter is going to tially cause a public health emergency (President
investigate in some depth in relation to digitiza- of the Republic of Indonesia 2019). These disease
tion of healthcare. Previous Chapters focused on surveillance collaborations were of limited
highly developed economies (e.g., chapter “The regional scope and timescale, and/or with a narrow
Emergence and Growth of Digital Health in focus on a particular disease (Adisasmito et al.
Saudi Arabia: A Success Story” focusing on 2017; Aisyah et al. 2022a; Budayanti et al. 2020).
Saudi Arabia), and on transition economies (e.g., However, they were considered successful at the
chapters “The Digital Divide Based on local level, as they laid the foundation for inter-
Development and Availability: The Polish governmental collaborations during healthcare
Perspective”, “Potential of Digital Health emergencies and proved a useful experience dur-
Solutions in Facing Shifting Disease Burden and ing the COVID-19 response (Aisyah et al. 2021a;
Double Burden in Low-and Middle- Income Azhar et al. 2010; Hartaningsih et al. 2015). The
Countries”, “Health Inequalities and Availability: COVID-19 pandemic has acted as a catalyst for
Needs and Applications”, and “Digitalization of further developing Indonesia’s laboratory and
Healthcare in LMICs: Digital Health and the healthcare capacity, by providing a platform to
Digital Divide Based on Technological interconnect these services, but also the opportu-
Availability and Development”, focusing on nity to scale them up. Specifically, the Indonesian
Poland, Vietnam, Cyprus and China respec- government concentrated its efforts in fostering
tively). Indonesia provides the central example of collaborations, thus scaling up testing and increas-
the current Chapter due to the most recent intro- ing laboratory capacity from 1 designated refer-
duction of universal healthcare across the country ence laboratory to 685 designated laboratories
in 2018 (Agustina et al. 2019), as well as the within the first 12 months of the pandemic (Aisyah
Universal Internet Access Supporting Healthcare Provision: The Example of Indonesia 241
et al. 2021a), and over 1000 as of January 2023. of healthcare data, and the regulation of algo-
Here we look into some of the aspects that allowed rithms used in Artificial Intelligence (AI)-driven
for this positive outcome to materialize, as well as decision-support systems are also anticipated in
the challenges that still remain. the near future.
In particular, during COVID-19 pandemic, the regarding data input, and the standardized
Indonesian government developed several innova- information display regarding aggregated data.
tions using information systems and technology to This helped provide a common understanding
support the pandemic control programs. For of the information to the lowest administrative
example, the Ministry of Health successfully inte- level, and importantly for public servants- who
grated laboratory test results across more than all had access to the app- it allowed for a uni-
1000 laboratories for automatically identified peo- form message and common understanding to be
ple who were infected to be followed up for con- disseminated to the population. Thirdly, the
tact tracing and treatment (Aisyah et al. 2022c). technology development was coupled with the
Another innovation was the development and utili- efforts for expansion of laboratory capacity. As
zation of Peduli Lindungi as a mobile application such, the system was not creating yet another
used by the community to get information on the siloed unit, but it was evidently cross-support-
COVID-19 cases distribution across regions, auto- ing additional initiatives and vice versa.
matically linked with laboratory test results, Fourthly, the immediacy of information, in near
screening of COVID-19 status eligibility to enter real-time (i.e., with a maximum space of infor-
public facility, and linked with COVID-19 vacci- mation incorporation of 24h), ensured that the
nation records and certificate (Aisyah et al. 2023). information is relevant even in the face of a
The application has been downloaded by more fast-paced pandemic.
than 100 million people so far. The Indonesian
government also has successfully vaccinated more
than 200 million people for COVID-19, where the 5 Way Forward
information of COVID-19 vaccination coverage
across 34 provinces can be accessed by the public The multisectoral coordination behind the devel-
in a designated dashboard (Indonesian Ministry of opment and implementation of the digital health-
Health 2023). A public dashboard was also devel- care applications in Indonesia is probably the
oped showing the COVID-19 situation across 514 most pronounced difference to the implementa-
districts/cities (number of cases, number of deaths, tion of digital healthcare applications in other
number of hospital admissions, COVID-19 vacci- parts of the world, where multidisciplinarity was
nation coverage, etc). This momentum of digitiza- not achieved to a desired level (Benítez et al.
tion was followed-up by the development of the 2020). Furthermore, it highlighted how the
Digital Health Transformation Strategy 2024 micro-level data provided primarily by police
Blueprint that laid the foundation for the enterprise officers, military personnel, and community
architecture of health technology in Indonesia ambassadors (e.g., community/village leaders),
(Indonesian Ministry of Health 2021). It is hoped can be effectively aggregated at a national scale,
that the Blueprint will accelerate the government’s applying then big data analytics to analyze these
goal of providing universal, affordable, equitable reports on a weekly basis, to provide updates to
and quality care nationally, while taking advantage policy makers and inform government response
of digital technologies. policies. The massive download of healthcare
There were a number of key elements that applications (over 100m downloads), also high-
drove the success of the national-scale digital lights the necessity for universal internet connec-
healthcare application implementation: tivity, coupled with the rollout of the universal
Firstly, there was commitment by the entire healthcare system.
political and administrative system, from the The way forward would need to include five
office of the Presidency, to the different key elements:
Ministries, to regional and local administrative
units. This was particularly important in the ini- –– Continued infrastructure development to
tial adoption of the developed digital tools. improve the reach and performance of this and
Secondly, the diffusion of digital technology future digital healthcare applications, in par-
was facilitated by the standardized protocols ticular in terms of data security.
Universal Internet Access Supporting Healthcare Provision: The Example of Indonesia 243
–– Continued stakeholder support for the imple- potential benefits of implemented digital health-
mentation of digital healthcare applications, care technologies, need to be considered along-
even if those need to be more localized and side the need of maintaining an active
not necessarily at the national scale. governmental support for the long-term.
Stakeholder support in this instance includes
the implementation of and adherence to appro- Disclaimer Where authors are identified as personnel of
priate ethical and legal frameworks. the International Agency for Research on Cancer/WHO,
the authors alone are responsible for the views expressed
–– Continued multidisciplinarity, as Indonesia’s in this article and they do not necessarily represent the
healthcare needs are complex, and unlikely to decisions, policy or views of the International Agency for
be addressed by single vertical initiatives. Research on Cancer/WHO.
–– Continued education of the professional work-
force to utilize digital healthcare applications
as appropriate, laying the foundation for a References
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Proliferation, Ingestion,
and Interpretation of Health Data
in Low-and Middle-Income
Countries (LMICS)
S. Nanyonga
Côte d’Azur University, Nice, France 1 Introduction
P. B. Medina
Research Institute for Tropical Medicine – Digital health is an umbrella term describing
Department of Health, Manila, Philippines electronically captured data, along with the tech-
Z. Kozlakidis nical infrastructure and the applications connect-
International Agency for Research on Cancer, World ing data producers and consumers. Continual
Health Organization, Lyon, France technological advances are transforming health-
D. L. Garcia care delivery, clinical research, and biomedical
Private Consultant, San Mateo, CA, USA science, as well as impacting on the design and
D. Ivanova · P. Katsaounis (*) delivery of the digital tools within those sectors
Metabio, Thessaloniki, Greece (Abernethy et al. 2022). Specifically, some of
e-mail: [email protected]
those advances include cloud computing, remote nician and/or patient if a pre-defined, unexpected
patient management, artificial intelligence- event takes place. For example, if the patient’s
enabled diagnostics, and consumer-facing mobile record does not include entries on potential
health applications (Abernethy et al. 2022). adverse reactions to particular pharmaceutical
Though most implementations are designed for susbtances (https://www.measureevaluation.org/
resource-abundant settings, some examples do resources/publications/wp-18-211/at_download/
exist in low- and middle-income countries document). Currently using telemedicine,
(LMICs). In Malawi, for example, VillageReach patients are anticipated to benefit from round-
and the Ministry of Health created and utilize a the- clock remote monitoring, in particular for
national health information line, called Chipatala long-term critical illnesses and/or post-operative
cha pa Foni (CCPF). In less than a decade, CCPF care. Efforts to enhance communication and
developed from providing Reproductive, information technologies with appropriate health
Maternal, Newborn, Child Health, and Nutrition data, are actively being made with high hopes
(RMNCHN) services locally, to the national level that these can make a significant leap forward
and addresses all health topics, including also toward safer care, although little has been
COVID-19 relevant information (Mitgang et al. achieved in LMICs. The application of available
2021; Viamo 2020). Babyl Rwanda is another digital solutions is more likely to be used in the
such example of an integrated digital health solu- USA, in Europe and other digitally advanced
tion, as it delivers virtual triage and primary care regions for continuous healthcare improvement.
services over the phone, and the ability to also The COVID-19 pandemic has exposed the fra-
provide post-consultation prescription and other gility points of healthcare systems, additional to
downstream services. The latter are referred via a persistent and deepening inequities (Mitgang
text message and are valid at both public and pri- et al. 2021). In particular, the limited capacity of
vate designated facilities. These developments LMICs to respond to an evolving pandemic, such
promise to transform healthcare delivery, by as COVID-19, and its impact on the most vulner-
improving accuracy and/or outcomes, and able populations presents a marked challenge.
through a more personalized interaction, increase Digital health can mitigate some of those chal-
patient engagement (Abernethy et al. 2022; lenges, as an alternative communication tool; that
McGinnis et al. 2021). is scalable and able to incorporate/combine infor-
The digitization of healthcare represents the mation service delivery models; thus, empower-
foundational precondition for enabling the down- ing healthcare delivery.
stream data analyses for quality of care and oper-
ational efficiency and effectiveness. However, the
advancement of clinical knowledge and diffusion 2 Methodology
of digital innovations are integrally linked to
establishing and maintaining data standards. For This is a narrative review of publicly accessible
example, understanding the medication lists pre- information in scientific journals, from the last
scribed to each patient and centralizing this infor- five years, to identify the opportunities and gaps
mation offers the potential to identify adverse in the proliferation, ingestion, and interpretation
reaction between the offered prescribed medica- of digital health data in LMICs. To this end, the
tions for each patient (Garfield et al. 2020). most highly cited articles identified on the Web of
However, this knowledge needs to be translated Science and PubMed were used, identified by the
into actionable pathways. Information infrastruc- keywords: LMIC; ingestion; proliferation;
ture is required to capture such information in healthcare data; interpretation. The date of search
detail (e.g., pharmacies must add new drugs as was in the last 5 years (2018–present). Having
they become available, and new prescriptions to identified those starting articles, additional man-
individual patient lists), and digital decision- uscripts were identified through ‘snowballing’,
support systems must be adapted to alert the cli- i.e., using reverse citation tracking to find articles
Proliferation, Ingestion, and Interpretation of Health Data in Low-and Middle-Income Countries (LMICS) 247
that cited articles already deemed relevant to the impact. Another example of data-driven actions
review (Callahan 2014). For this topic, a narra- is the continuous development of the Global
tive review approach was preferred, as the aim of Antimicrobial Resistance and Use Surveillance
this chapter was to provide a broad perspective System (GLASS) by the World Health
and explore the general debates and developments. Organization (WHO), the former launched in
By contrast a systematic review focuses on 2015 with the main aim “to promote, enhance
unique and specific queries, using explicit meth- and harmonize the surveillance of antimicrobial
odology and a typically a narrower perpsective resistance (AMR)” and inform relevant policy
(Rother 2007). decision. Since its launch, GLASS expanded in
multiple directions: in its scope, in the data vol-
umes received, and in its global coverage, as over
3 The Proliferation of Digital 100 countries and territories worldwide are no
Health Data in LMICs enrolled (World Health Organization 2021a).
While this is a great proliferation of data produc-
The proliferation of health is one of the most ing and sharing, the financial model is entirely
important developments in the digitalization of based on the WHO funding to promote the scal-
health (Chowdhury and Pick 2019). Improving ing-up. A similar model of data generation is fol-
and scaling-up data collection remain fundamen- lowed by the WHO FluNet, originally established
tal to all these activity domains: process optimi- in 1952 as the Global Influenza Surveillance
zation such as digitalization of medical records, Network (GISN) (Monto 2018). In the past two
training physicians, and improving the quality of decades it has incorporated genomic data and
care given to patients (Chowdhury and Pick was transformed into FluNet, a system of over
2019); preclinical research like reducing the 100 National and international Influenza Centers
time taken for new drugs to reach patients; clini- (NICs), all consistently recording population-
cal pathways; including improving access to level influenza globally (Brammer et al. 2009).
healthcare information (Aisyah et al. 2021); The proliferation of data within this platform,
patient-facing applications like making applica- where data and Standard Operating Procedures
tions that are user-friendly for patients (Abusanad (SOPs) are publicly available, has been signifi-
2021); including population-level applications cant, and inclusive of many LMIC-generated
(Chowdhury and Pick 2019; Cheong and Wang data.
2022). The availability of healthcare data (at either a
Data-driven research conducted over time and global or local level) is anticipated to improve pre-
interpreted within a local context can increase the dictions about the changing demands and the
capability to undertake population-level plan- effectiveness of any initiatives taken in response
ning. For example, mobile phone data was used (Altmann-Richer 2018). Health inequalities
to model the spread of cholera in Haiti (2010) including access to care and life expectancy
and of dengue fever in Pakistan (2013) (Bengtsson amongst others can be difficult to resolve at pres-
et al. 2015; Wesolowski et al. 2015). The Global ent due to a lack of reliable data on underrepre-
Health Monitor is another such example: locating sented populations in research, such as those with
and analyzing English-language news stories as a low income and educational levels (Chowdhury
proxy for monitoring infectious diseases out- and Pick 2019). Adding new technologies to such
breaks (https://www.researchgate.net/publica- a context, while desirable in terms of providing
tion/239813129_Global_Health_Monitor_-_A_ new data and identifying potential opportunities to
Web-b ased_System_for_Detecting_and_ resolve existing challenges, can be problematic, as
Mapping_Infectious_Diseases). With machine these technologies need to operate consistently
learning techniques there is the potential to iden- within challenging environments. Therefore, eval-
tify, map, and track complex diseases quicker. uation frameworks are needed in LMICs to deter-
This can reduce response time and attenuate their mine the impact of introducing data-generating
248 S. Nanyonga et al.
healthcare ecosystem can develop from the terns that an analytical process will result to, and
pioneering examples. Specifically, electronic
highlights the reasons behind those observed pat-
medical records, when interoperable, have the terns. A good data interpretation process typi-
potential to support evidence-based decisions at a cally involves integration which is collecting and
system level. For example, a Ghana-based tele- merging data from multiple sources to create uni-
medicine initiative supported by the Novartis fied sets of information for downstream applica-
foundation is frequently highlighted as a positive tions, resulting to findings, conclusions and/or
example of scaling up digital healthcare provi- recommendations. Devices that collect data but
sion in LMICs, from a single district in 2011 to do not integrate with other extant databases (e.g.,
nation-wide coverage in 2016, incorporating end- at local or national level) are unlikely to be uti-
user insights, such as front-line community lized outside of the program for which the data is
healthcare staff (Novartis Foundation 2010). collected. However, the interpretation process
Another case study is the Open Medical Record presumes that a good level of understanding
System (OpenMRS), created in 2004 as an open- exists throughout this cycle of data collection-
source, electronic health records platform. analysis-interpretation-recommendation. In
OpenMRS and one of its better-known imple- LMICs the lack of digital literacy has been high-
mentations was during the Ebola epidemic lighted on many healthcare reports, in particular
(2014–2016), when it was deployed successfully as lack of relevant staff training can lead to mis-
in a treatment center in Sierra Leone (Chowdhury interpretation. This can be prevented, at least in
and Pick 2019). OpenMRS is currently being part, by providing clear, standardized operations
used in a number of locations globally (India, to facilitate data utilization. For example, in
Haiti, South Africa, Zimbabwe, etc.), with suc- Nigeria, MEASURE Evaluation provided
cessful examples reported (Uwamariya 2015; AIDSRelief with a standardized data checklist,
Jawhari 2016), and a third release of the updated this very tight standardization facilitated the inte-
product (i.e., OpenMRS 3.0) taking place in gration of family planning and HIV treatment
2023. However, it has not become as ubiquitous data, and supported evidence-based decision
in its LMIC use as originally anticipated. making at the facility level (Chabikuli et al.
The data produced and contained within med- 2009).
ical records, beyond their immediate clinical use, The relatively low level of digital literacy in
can also have a secondary use by researchers and/ LMICs, highlights a need for national govern-
or commercial parties, for example to create new ments to adapt their educational systems to be
tools, processes or treatments. This adds a second more inclusive of digital applications, to lead in
layer of data ingestion requirements. Hence the the information and sensitization of people about
need to improve the quality of data collected in digital health and the importance of collecting
LMICs; ensuring that end-users, are trained, digi- accurate and precise data, while providing suc-
tally literate, and have access to use such infor- cessful examples so that there is a direct under-
mation. For example, the use of telemedicine in standing of the benefits to the individual and to
Indonesian hospitals proved successful, espe- society. The digital tools developed need to be
cially during the COVID-19 pandemic (Aisyah adjusted to best fit the population in which they
et al. 2021; Aisyah et al. 2023). are to be used, and whenever possible with the
input of the local end-user groups (Labrique et al.
2018). The 2018 WHO resolution on digital
5 Interpretation of Digital health and the ‘Global Strategy on Digital Health
Health Data in LMICs 2020–2025’, urge member states to develop, as
appropriate, legislation and/or data protection
Data interpretation is defined as “the process of policies (World Health Organization 2018,
reviewing data and arriving at relevant conclu- 2021b). As individuals are both consumers and
sions using various analytical methods” (Spiggle producers of data, simultaneously at a personal
1994). It goes beyond the identification of pat- and a community level, the data interpretation
250 S. Nanyonga et al.
has the potential to affect several facets of their included in such educational initiatives (https://
lives. Therefore, developing relevant frameworks www.measureevaluation.org/resources/publica-
for privacy, security, data access and ownership, tions/wp-18-211/at_download/document; Amaro
and consent are essential, if interpretation of digi-et al. 2005; Nutley and Reynolds 2013). Such
tal health data in LMICs is to progress. education activities can be complemented by
data quality assessment tools/evaluation frame-
work tools, that are to be used in iterative assess-
6 Discussion: The Way Forward ments, including the data quality review (DQR)
and the routine data quality assessment (RDQA)
While technology does not intend to entirely (Chen et al. 2014).
replace human decision-making in healthcare, The process from data collection and storage
the vision of precision medicine may become to the final interpretation and dissemination to
realizable because of the proliferation, ingestion, the end-user overgoes different stages, while
and interpretation of data. In an ideal scenario, addressing the need for patients’ rights protection
with rich, accessible, high-quality datasets on through data sharing and access. Successful inte-
patient diagnoses, disease treatments, and drug gration of the plurality of patient related data,
effectiveness, a sustained global growth of per- from environmental to metadata, and of many
sonalized treatments could be anticipated, lead- digital systems, within national Electronic Data
ing to tailored therapies and improved health Capture Systems, requires digital ontology
outcomes (Vogenberg et al. 2010). However, two engines and protocols for harmonization, stan-
aspects need to be taken into account. Firstly, dardization, and homogenization of data (Kush
precision medicine carries an increased proce- et al. 2020). Thus, the investment required in both
dural (and perhaps pharmaceutical) cost, as well technology and trained staff is considerable. Data
as the infrastructural burden, and those cost redundancy, as well as legislative and governance
demands could divert funds from elsewhere. The issues can be overcome by establishing robust
second risk is that precision medicine could Digital Rights Management (DRMs) systems,
become an inequality driver by implementing a enforcing role-based access, manipulation, and
barrier to entry for those healthcare systems who control of data (Hu et al. 2014; Alahmar et al.
cannot afford it. 2022). As the personalized medicine notion,
One initiative addressing the latter risk is the becomes more prevalent, health related data col-
USA-based Digital Square, a partnership between lection systems implemented for interoperability,
PATH, USAID, the Gates Foundation, and oth- secure data migration, mining, and interpretation,
ers, that works together with local ministries of should have patients as their focal point and be
health to align digital technologies with local patient-centric. These can include consent status
health needs, aiming to improve how healthcare management, predefined data ownership and
tools are designed, used, and paid for (Novillo- accredited security options and create a dynamic
Ortiz et al. 2018). In Europe, the European Open electronic framework for future uses, without
Science Cloud (EOSC) is a European Commission making it obsolete when faced with emerging
infrastructure providing its users with services technologies (Kaye et al. 2015; Ivanova and
for open science practices and digital interopera- Katsaounis 2021). Successful interoperability
ble environments, including for healthcare implementation systems will most definitely lead
research (Budroni et al. 2019). These are high- to scalability; thus, regional and national organi-
profile and impactful initiatives but would be zations should be established overlooking and
slow to produce change in LMICs. Perhaps edu- synchronizing actions, adoption of technologies
cational initiatives on core competencies in data and effective non-overlapping adoption and inte-
analysis, interpretation, synthesis, and presenta- gration (Austin et al. 2021).
tion would be more applicable for LMICs, espe- Within this need for creating appropriate
cially if staff at all levels of a health system are frameworks, Sensitive information covered by
Proliferation, Ingestion, and Interpretation of Health Data in Low-and Middle-Income Countries (LMICS) 251
data privacy and biosecurity must be identified, these digital initiatives have moved beyond the
classified, and protected. There is confidential initial piloting and experimentation phases, and
and exclusive data that can only be accessed by now focus on effective scaling and/or integra-
limited individuals (e.g., high-risk pathogen tion with other existing healthcare system
research, and/or personal details). The existence operations.
of a reliable infrastructure (e.g., electricity and Digital initiatives typically take advantage of
internet accessibility) is a precondition to the existing platforms such as mobile phone net-
existence of a digital infrastructure and the latter works and devices, combined with health infor-
underlies the implementation of diagnosis tools, mation systems, automated processing and
data analytics, or drug discovery technologies. information exchanges. Their focus has been
For example, the internet can lead to greater shifting towards data proliferation, ingestion, and
numbers of trained doctors, nurses, and commu- interpretation, as critical steps in the develop-
nity health workers, by lowering barriers to ment of digitally-enabled healthcare systems.
access education. Given the low healthcare staff However, digital health interventions are bound
coverage in LMICs, the ability to train healthcare by high-quality data, which is not always forth-
practitioners effectively is vital—and digital coming in LMIC settings. Therefore, any invest-
solutions can be incorporated within the training ment in infrastructure improvement would need
courses. to be complemented by digital literacy training
In summary, some recommendations would programs, within amenable regulatory
be closely aligned with those made in the Riyadh frameworks.
Declaration on Digital Health (Al Knawy et al.
2020, 2022). Conflicts of Interest DI and PK are employees of
Metabio; PBM is an employee of the Research Institute
for Tropical Medicine (RITM), Department of Health,
• Adoption of standards that encourage data Manila, Philippines.
harmonization and eventual exchange and There is no financial or non-financial support for any
interoperability. of the authors of this chapter for their contribution to this
• Investment in foundational infrastructures, work. All healthcare examples have been used for illustra-
tive purposes with the information being correct at the
e.g. electricity, to support digital access. time of publication.
• Investment in nationwide digital literacy
initiatives. Disclaimer The opinions expressed in this
• Development and implementation of clear, chapter are those of the authors only. They do not
national frameworks for data protection, for purport to reflect the opinions or views of their
sensitive and confidential information. affiliated organizations.
• Establishment of governing bodies to over-
see the implementation of digital health
strategies.
• Implementation of a digital patient consent References
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Ubiquitous and Powerful
Artificial Intelligence (AI)
Artificial Intelligence (AI) is a robust develop- available and the most quality-assured health-
ing branch of computer science designed to build care. While challenges exist, the adoption of AI
machines that can mimic human beings and per- can address the shortage of healthcare profes-
form tasks equally or better (Shimizu and sionals by automating routine tasks, enabling
Nakayama 2020). The widespread adoption of AI early, timely detection and accurate diagnosis of
technologies into our daily lives has become diseases, tailoring treatment plans, and providing
ubiquitous, making everyday items and settings, real-time monitoring of patients. The future of AI
such as cellphones, wearable technology, and in the digitalization of medicine in LMICs is
homes, smarter and more interactive. Over the promising, and its potential must be harnessed.
past decade, the world has witnessed how AI rev- The potential applications of ubiquitous AI in
olutionized various industries, including health- healthcare in LMICs are vast, ranging from dis-
care, with machine learning and deep learning ease diagnosis and personalized treatment plans
techniques enabling the development of medical to drug discovery and development. Improved
devices that can aid in diagnosing, screening, health outcomes, reduced mortality rates, and
predicting, and treating diseases (Esteva et al. enhanced training opportunities for healthcare
2017). In this era of big data, AI devices can professionals could be achieved by AI-powered
assist researchers and physicians in analyzing tools with better management and analysis of
large amounts of data and identifying possible medical data and increased access to healthcare
connections leading to new insights and discov- through telemedicine and remote monitoring.
eries (Obermeyer and Emanuel 2016). In fact, up Additionally, AI can improve public health sur-
to 520 marker-cleared AI medical algorithms veillance and disease control while providing
have already received FDA approval, with more increased research opportunities for identifying
expected to follow (FDA 2022). Developed coun- and addressing healthcare disparities. Finally, the
tries have already begun reaping the benefits of development and application of AI technology
advanced AI techniques in daily clinics. Despite can improve resource management, ensuring that
limited access nowadays, this trend into shifting medical equipment, supplies, and staff are uti-
to digital healthcare could be especially notewor- lized efficiently and effectively, hence reducing
thy in low and middle-income countries (LMICs), the financial burden, and boosting the economy
where traditional healthcare systems often strug- of LMICs.
gle to meet the population’s needs. One example can be using deep learning tech-
This chapter will explore the challenges and niques for more accurate diagnoses. This can
opportunities of adopting AI in healthcare. We provide a more precise diagnosis based on data
will discuss potential applications of ubiquitous experience. The histopathologic slice from a
AI in LMICs, including medical imaging, diag- country with limited resources and experience
nostic decision support, telemedicine, and elec- can be reviewed and verified within minutes,
tronic health records. Despite the challenges compatible with those of the experienced center
ahead, the increasing availability and adoption of with an expert histopathologist.
AI technology suggest that its impact on the Other areas where AI can significantly impact
future of healthcare is both exciting and unique. include:
Having limited resources and infrastructure, low- We can envision this possible application in the
and middle-income countries (LMICs) often example of Armenia. In several border-closed
struggle to provide their populations with the best regions of Armenia, there are few specialized
Ubiquitous and Powerful Artificial Intelligence (AI) 257
oncology radiologists, and patients must travel to mented in LMIC, where doctor visits tend to be
the capital even for a cancer screening. If an infrequent and inconsistent. n such regions, wear-
AI-based tool were available to identify, for ables can empower patients to remotely monitor
example, suspicious breast masses, a regional their health and well-being more efficiently,
radiologist could spare patients without such reducing the need for some in-person consulta-
lesions the need to travel to centralized hospitals tions. For instance, these devices can continu-
for screenings. This would be a cost-effective ously track blood pressure, heart rate, and blood
approach and ensure timely detection and treat- glucose levels, offering valuable insights for
ment for at-risk people. patients with chronic conditions like diabetes and
Electronic health record (EHR) management delivering more precise information for physi-
and analysis is another area where ubiquitous AI cians (Gao et al. 2016). This remote monitoring
could significantly impact LMICs. AI could auto- allows healthcare professionals to intervene
mate data analysis and entry, allowing healthcare promptly if any issues arise, enabling them to
professionals to enter patient information and adapt and guide treatment accordingly.
obtain relevant data swiftly and simply. This can Furthermore, wearables can be employed to
improve the accuracy and completeness of medi- monitor physical activity levels, sleep patterns,
cal records, serving as a more precise ground for and other health-related metrics, giving both
future analyzes. Additionally, AI-powered ana- patients and doctors a holistic view of their health
lytics could identify patterns and trends in EHR status. Leveraging AI algorithms to analyze the
data, allowing for more effective disease surveil- data gathered by these devices, clinicians and
lance, outbreak detection, and targeted interven- healthcare providers can uncover valuable
tions. By implementing AI to improve EHR insights into patient health, recognize trends and
management and analysis, LMICs could signifi- patterns in health data, and offer more tailored
cantly improve the quality and accessibility of recommendations for patients.
healthcare services.
Ensuring that medical equipment and supplies
are accessible when and where necessary is one 2.1 AI-Driven Drug Development
of the biggest obstacles in healthcare delivery in and Clinical Trials
LMICs. AI can play a critical role in addressing
this challenge by providing advanced demand Affecting various fields of healthcare, drug devel-
forecasting and inventory management tools. For opment is another aspect that is highly impacted
instance, in Nigeria, the non-profit startup by the implementation of AI. Particularly in
LifeBank has partnered to use AI-powered tools resource-limited settings, these AI tools have the
to optimize the supply chain for blood and other potential to shift the way new therapies are dis-
critical medical supplies. The demand, transport covered and brought to market (Lecun et al.
times, and storage capacity are the main factors 2015). One of the most significant advantages of
to be analyzed by AI to ensure that medical sup- using AI in drug development over human
plies are available when and where they are resources is its ability to analyze vast amounts of
needed. This has helped reduce waste and data, such as genomic, proteomic, and clinical
improve overall efficiency, enabling healthcare trial data, during a time that would be impossible
providers to deliver lifesaving care to more for researchers. This enables AI algorithms to
patients. By leveraging AI to improve supply identify potential drug candidates and therapeutic
chain management, healthcare providers in targets more quickly and efficiently. An example
LMICs can overcome logistical challenges and of AI’s impact is its application in drug repurpos-
improve access to essential medical supplies and ing, where algorithms analyze existing drugs and
equipment. their interactions with disease pathways to
Another example of ubiquitous AI is wearable uncover new therapeutic uses (Ahmed et al.
technology, which has great potential to be imple- 2022). This approach expedites the process of
258 A. Sargsyan et al.
drug discovery and development, as repurposed including limited resources and diverse patient
drugs have already undergone extensive safety populations facing a high burden of both com-
testing and can often bypass early-stage clinical municable and non-communicable diseases.
trials. AI algorithms can analyze large amounts of
AI can also improve the efficiency of preclini- patient data, such as demographic, genetic, and
cal drug development, optimizing the design of clinical information, and detect meaningful pat-
trials and predicting the likelihood of success for terns and correlations, which may elude human
specific drug candidates, ultimately conserving researchers (Obermeyer and Emanuel 2016). By
resources, and enabling the development of more harnessing this data-driven insight, healthcare
affordable treatments for patients in LMICs providers in LMICs can develop more accurate
(Vamathevan et al. 2019). By analyzing large diagnoses and better understand the factors con-
datasets, AI algorithms can help researchers tributing to specific diseases or conditions, ulti-
identify the most appropriate patient populations mately leading to more targeted and effective
for clinical trials and forecast potential trial out- treatments.
comes (Weissler et al. 2021). This can lead to One example of AI-powered precision medi-
more efficient trial designs and increased success cine in an LMIC context is using AI algorithms to
rates, ultimately accelerating the development of predict the risk of tuberculosis (TB) among
new therapies. In LMICs, where patient recruit- patients in high-burden settings. In countries
ment for clinical trials may be challenging due to where TB is a significant public health concern,
limited infrastructure and resources, AI can like India, AI can help to identify patients who
streamline the process and improve trial are most likely to develop active TB. By identify-
outcomes. ing high-risk patients with the factors such as
From the point of view of LMICs, AI-driven genetic makeup, environmental exposure, and
drug development can be particularly valuable in other health conditions, healthcare providers can
the context of diseases that are prevalent in these target interventions and treatment plans more
regions but may not have been of interest to the effectively, ultimately reducing the overall bur-
industries in higher-income countries to be den of TB in the population (Orjuela-Cañón et al.
addressed. For example, AI could identify new 2022; Schwalbe and Wahl 2020).
therapeutic targets and drug candidates for Personalized treatment plans can also help to
neglected tropical diseases, which disproportion- optimize the use of limited healthcare resources
ately affect populations in LMICs. By using AI to in LMICs. Healthcare professionals can avoid
develop new treatments for these diseases, using needless or ineffective tactics by tailoring
researchers can help to reduce health disparities therapies to each patient’s requirements, sparing
in LMICs. By incorporating AI-driven innova- those who might not benefit from unnecessary
tions into the drug development process, research- procedures. This is particularly important in
ers can help to address many of the unique LMICs, where healthcare budgets may be lim-
challenges faced by LMICs in healthcare and ited, and the need to allocate resources efficiently
contribute to forming a healthier population. is paramount.
Furthermore, AI-driven precision medicine
can help to address the unique challenges faced
2.2 AI-Powered Precision by LMICs in managing both communicable and
Medicine non-communicable diseases. AI algorithms, for
instance, can be used to identify possible interac-
In the context of LMICs, there is a substantial tions between non-communicable illnesses like
anticipated benefit for AI-powered precision diabetes and infectious diseases like HIV and
medicine. Tailored treatment plans based on create personalized treatment plans that consider
improved patient stratification can help address these complications. This can lead to better
unique healthcare challenges in these countries, patient outcomes and a more holistic approach to
Ubiquitous and Powerful Artificial Intelligence (AI) 259
healthcare in LMICs. The potential for better experts, increasing educational, practical, and
patient treatment and outcomes in LMICs will scientific opportunities for local healthcare pro-
only increase as AI is constantly evolving and is viders, and improving outcomes of pediatric can-
more widely integrated into global healthcare. cer care (Hovhannisyan et al. 2020).
AI-powered chatbots are among the most pop-
ular forms of ubiquitous AI. One such chatbot is
3 Successful Implementations “Sehat Kahani,” which operates in Pakistan and
of Ubiquitous AI in LMICs aims to help connect patients in remote areas
Healthcare with healthcare providers (Khan 2023). Using
natural language processing (NLP), the chatbot
Besides the potential that can be brought, the understands the patients’ symptoms and provides
benefits of AI tools in LMICs are becoming medical advice and referrals to healthcare facili-
increasingly evident, with some countries already ties. Other examples of ubiquitous AI chatbots in
experiencing successful implementations. One healthcare for LMICs include mDiabetes in
such example is Rwanda, where the government India, which aims to help people with diabetes
is utilizing AI-powered drones to deliver medical manage their condition using SMS messaging,
supplies, including blood units, to remote areas Ada in Ethiopia, which uses AI to diagnose and
of the country. Advanced sensors on the drones treat common illnesses; and SARA in South
are capable of detecting fluctuations in tempera- Africa, which helps HIV-positive patients man-
ture and humidity, precisely monitoring vaccine age their condition by providing personalized
and medical supply transportation, to ensure that information and reminders.
supplies are kept at the appropriate temperature Despite the various areas in which AI tools are
throughout the delivery process. With 14 drones implemented, diagnostics remains one of the
currently serving 21 hospitals, the program has most prominent. For example, in India, as well as
already delivered over 20,000 blood units, help- in Nigeria, Ghana and South Africa, researchers
ing to save countless lives (The Guardian 2022). are using AI to screen for TB. By analyzing chest
This cutting-edge application of AI in healthcare X-rays, the AI tool can detect signs of TB and
demonstrates how technology has the power to enable healthcare workers to intervene earlier,
close gaps in healthcare delivery and allocate improving patient outcomes (Khan et al. 2020).
resources where needed the most. These are just a few examples of successful AI
Another successful application of AI tools is tool implementations in LMICs demonstrating
the use of telemedicine. The use of modern com- how innovative technologies are revolutionizing
munication technologies, such as video consulta- healthcare by improving outcomes and delivering
tions and conferencing, to discuss complex healthcare resources to remote areas. With con-
patient cases with external experts is referred to tinued advancements in AI, we can expect to see
as telemedicine. One example of successful tele- even more exciting innovations in healthcare be
medicine implementation is in the Pediatric approved worldwide.
Cancer and Blood Disorders Center of Armenia,
which established four multidisciplinary working
groups to discuss all cases of soft tissue and bone 4 Diabetic Retinopathy
tumours during weekly meetings with an expert Screening in India: A Case
from the University Hospital of Münster (UKM) Study
in Germany using VITU (Virtuelles Tumorboard)
software. This telemedicine platform is an exam- India’s population of over 1.3 billion people
ple of ubiquitous technological application in presents a unique challenge for healthcare, with
LMICs, as it provides a unique opportunity for a shortage of doctors being one of the most
specialists from developing countries to establish pressing issues. However, the Indian government
effective communication with international has taken steps to integrate AI into the healthcare
260 A. Sargsyan et al.
accessible AI systems. For example, some com- scarcity of such qualified individuals at present
panies have developed cloud-based AI systems (Hee Lee and Yoon 2021; Topol 2019).
that can be accessed remotely by healthcare There is also a dearth of experts with the skills
facilities, reducing the need for expensive hard- required to run and manage AI models in health-
ware and infrastructure (Mollura et al. 2020). care in higher-income nations like the United
Additionally, there have been calls for increased States. According to a report by Burning Glass
international funding and collaboration to sup- Technologies, there were over 7000 job postings
port the development and implementation of AI for healthcare AI positions in 2019 in the United
technology in healthcare in LMICs.Another solu- States alone (Burning Glass Technologies 2019).
tion to overcome the high cost of AI technology However, with growing demand, there is rela-
in healthcare is through public-private partner- tively limited number of available educational
ships. In some cases, private companies may be programs for training specialists in healthcare AI.
willing to invest in the implementation of AI In LMICs, the shortage of trained profession-
technology in healthcare facilities in LMICs, for als is even more pronounced. It may be challeng-
example in exchange for access to medical data. ing for healthcare workers in these environments
This can provide a mutually beneficial partner- to acquire the specialized skills required to run AI
ship that enables healthcare facilities to adopt AI systems because they frequently have restricted
technology at a lower cost, while also providing access to educational tools and training opportu-
private companies with valuable data for research nities. In addition, it is frequently difficult to find
and development. Seeking external funding from tools for ongoing professional growth and train-
international organizations, philanthropic organi- ing, which can make it challenging to keep up
zations, and other sources could help overcome with AI technology advancements. For example,
this challenge. External funding could help in some LMICs, there may be only a few profes-
ensure that LMICs have access to the necessary sionals trained in AI in healthcare in the entire
resources required to implement and maintain AI country. This shortage of skilled professionals
systems in the healthcare sector. can limit the widespread adoption of AI technol-
Through the use of open-source software, AI ogy in healthcare, even in facilities with the
technology costs can also be decreased. Open- financial resources to acquire them.
source software can be accessed and modified by
anyone, which can make it a more affordable
option for healthcare facilities in LMICs. 5.4 Ways to Overcome Challenge
Together, healthcare workers and software devel- 2: Shortage of Professionals
opers can enhance the functionality and usability
of AI systems, which can also foster cooperation A potential approach to overcoming this chal-
and invention. lenge involves investing in training programs that
help healthcare professionals in LMICs develop
their proficiency in AI technology. This could be
5.3 Challenge 2: Shortage done in partnership with universities or research
of Professionals institutions that have expertise in AI and health-
care (Bajwa et al. 2021). These programs could
The shortage of trained professionals capable of include courses on data analytics, machine learn-
operating AI models is a challenge that is not ing, and AI applications in healthcare.
unique to LMICs but is a global issue. Healthcare An alternative solution involves adopting AI
providers need specialized training to understand models that are easy to use and demand little
how to interpret and use the insights generated by training for operation. As an illustration, some
AI systems effectively. The healthcare sector has businesses have created AI-powered software
a considerable need for skilled professionals who with a user-friendly interface that enables health-
can effectively collaborate with AI, yet there is a care workers to use the tool with little to no train-
262 A. Sargsyan et al.
ing (Jacobs et al. 2021). These systems may be on over 200,000 exams, which incorporated over
particularly beneficial in LMICs, where there is a 1,000,000 images. This demonstrates an example
shortage of skilled personnel to operate more of AI requiring big data since the large dataset
complex AI models. was necessary to train and test the system’s accu-
Furthermore, some initiatives are focused on racy in classifying breast cancer exams accu-
developing AI tools that are specifically designed rately. The performance of their network achieved
for low-resource settings, such as remote and an AUC of 0.895 in predicting whether there is a
rural healthcare facilities. The purpose of devel- cancer in the breast, when tested on the screening
oping these tools is to provide medical profes- population and the result was compared to 14
sionals with decision support systems, radiologists reading results. The study found that
empowering them to diagnose and treat patients the hybrid model, averaging the probability of
effectively even in regions where medical malignancy predicted by a radiologist with a pre-
resources are scarce or inadequate. These initia- diction of their neural network, is more accurate
tives aim to make AI more accessible and user- than either of the two separately. For λ = 0.510,
friendly for healthcare professionals in LMICs. hybrids between each reader and the model
Finally, international collaborations between achieved an average AUC of 0.891 (Wu et al.
LMICs and high-income countries can also be 2020).
valuable for addressing the shortage of trained The quality of the data, in addition to its
professionals in LMICs. Such collaborations amount, is the other key factor of enhancing
could involve the exchange of knowledge and accuracy of AI algorithms. Incomplete or biased
expertise, with high-income countries sharing data can lead to inaccurate or misleading results.
their knowledge of AI and healthcare systems To gather, store, and handle high-quality medical
with LMIC. Such collaborations might also data for AI applications, it is crucial to have a
encompass partnerships among universities, solid data infrastructure in place. When it comes
research institutions, and hospitals from both to obtaining and storing medical data, LMICs
high-income and LMICs to facilitate training and may not have enough resources to meet the
capacity-building efforts. demand for significant quantities of high-quality
In conclusion, tackling the lack of skilled pro- data. For instance, it may be challenging to obtain
fessionals who can operate AI models presents a and analyze the data in some areas because usu-
crucial obstacle to implementing AI in healthcare ally medical records are on paper. Additionally,
within LMICs. This could pose a significant chal- there may be cultural or privacy concerns that
lenge for healthcare providers looking to fully limit the sharing of medical data, further limiting
utilize the benefits of AI technology. the amount of data available for AI applications
(Bak et al. 2022).
However, there can be issues with data access
5.5 Challenge 3: Infrastructure and accuracy even in high-income nations with
well-established healthcare systems. Medical
To develop accurate and reliable AI models for data, for instance, may be kept in various forms
healthcare, a large amount of medical data is by various healthcare systems, making it chal-
required. This is because AI systems use statisti- lenging to aggregate and evaluate. Furthermore,
cal models to recognize patterns in the data they there might be issues with data security and
are trained on, and the larger the dataset, the more patient privacy that restrict the exchange of medi-
accurate the model can be. Wu et al. proposed an cal information between various organizations.
artificial intelligence (AI) system based on deep Efforts to improve data infrastructure and pro-
convolutional neural networks (DCNN) to clas- mote the responsible sharing of medical data will
sify breast cancer screening exams using mam- be essential aspects to unlocking the full poten-
mography. The system was trained and evaluated tial of AI in healthcare.
Ubiquitous and Powerful Artificial Intelligence (AI) 263
5.6 Ways to Overcome Challenge income countries, strict regulations like HIPAA
3: Infrastructure in the United States and GDPR in Europe safe-
guard patient privacy. However, in LMICs, there
Strengthening infrastructure remains a crucial may be insufficient regulatory frameworks to
step towards addressing challenges related to protect patient data, posing a significant risk to
data availability and quality in healthcare AI patient privacy (Price and Cohen 2019).
(Obermeyer and Emanuel 2016). A dependable Another ethical concern is bias, as AI models
and well-structured system for collecting, stor- may learn from biased data, leading to discrimi-
ing, and transmitting medical data is vital to natory results. This problem is especially relevant
guarantee that substantial volumes of high- in LMICs, where diverse data for training AI
quality data are accessible for training AI models models may be scarce. In high-income countries,
(Murdoch and Detsky 2013). efforts to reduce bias in AI models include using
One strategy for achieving this is through the diverse data and testing for biases during model
creation of cloud-based systems accessible to development. However, in LMICs, addressing
healthcare providers from various locations. This this issue effectively may be hindered by limited
approach permits medical data to be securely resources and expertise (Rajkomar et al. 2018).
stored and accessed from a centralized location, Accountability is another ethical consideration
simplifying aggregation and analysis. when employing AI in healthcare. If AI models
Furthermore, cloud-based systems offer scalabil- make incorrect decisions, mechanisms should be
ity, accommodating increasing amounts of medi- in place to hold responsible parties accountable.
cal data over time (Chassagnon et al. 2020). This is particularly pertinent in LMICs, where AI
High-speed internet connectivity represents usage in healthcare may be relatively new, and
another essential aspect of infrastructure invest- regulatory frameworks for accountability may be
ment, enabling the real-time transmission of lacking.
medical data (Schwamm et al. 2020). This allows Developing ethical guidelines and regulatory
healthcare providers to rapidly and effortlessly frameworks for AI in healthcare is especially cru-
view and exchange medical data online, regard- cial in LMICs, where resources for addressing
less of their location. In remote or underdevel- these issues might be limited. In high-income
oped regions, where medical resources might be countries, efforts to establish ethical guidelines
limited (Wosik et al. 2020). By enhancing data and regulatory frameworks for AI in healthcare
infrastructure, we can ensure the availability of are already underway (Fiske et al. 2019). For
high-quality medical data for AI applications, example, the European Union’s General Data
resulting in more precise and trustworthy AI Protection Regulation (GDPR) includes rules for
models. the security of personal data, encompassing med-
ical data. In the United States, regulatory organi-
zations like the Food and Drug Administration
5.7 Challenge 4: Ethical Concerns (FDA) oversee the use of AI in healthcare.
While effectively addressing these issues in
The deployment of AI in healthcare, particularly LMICs may be challenging due to limited regula-
in LMICs, presents numerous ethical concerns tory frameworks and resources, establishing
that require attention. One of the primary issues robust regulatory frameworks and ethical guide-
is privacy, as sensitive patient information needs lines can help ensure that AI is employed ethi-
protection from unauthorized access and usage. cally and responsibly to benefit patients and
Patient data is generally considered confidential, healthcare systems. Careful planning and devel-
and its disclosure or misuse can result in serious opment of suitable frameworks are vital for
repercussions for individuals, such as discrimina- responsible and effective AI utilization in
tion, stigma, and even health risks. In high- healthcare.
264 A. Sargsyan et al.
unique contexts to ensure fair and effective care in remote and underserved areas, optimize
for diverse populations. This future is not merely resource distribution during public health emer-
aspirational but achievable. By harnessing the gencies, and facilitate more efficient and targeted
power of AI, fostering international collabora- responses to disease outbreaks.
tion, and investing in the development of human- In conclusion, it is crucial for all stakehold-
centered, ethical AI solutions, we can create a ers—governments, academic institutions, and
world where healthcare is no longer a privilege industry partners—to collaborate and invest in
but a fundamental right for all. Embracing perva- the creation and implementation of AI-driven
sive AI in healthcare will lay the groundwork for healthcare solutions tailored to the unique needs
a brighter, healthier future, where no one is left of LMICs. By focusing on sustainable funding
behind in the pursuit of well-being and an models, infrastructure development, user-friendly
improved quality of life. interfaces, and continuous education and train-
ing, we can unlock the full potential of AI in
healthcare.
9 Conclusion: Harnessing Together, we can pave the way for a brighter
the Potential of Ubiquitous future where the power of AI transforms the lives
AI to Transform LMIC of millions of individuals in low- and middle-
Healthcare income countries, fostering hope, health, and
prosperity for generations to come.
In conclusion, this analysis has highlighted the
considerable potential of ubiquitous AI in revolu-
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Open Access This chapter is licensed under the terms of the Creative Commons Attribution 4.0 International License
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Non-digital Health Trends in
Low- and Middle-Income Countries
Karine Sargsyan
Abstract Keywords
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(http://creativecommons.org/licenses/by/4.0/), which permits use, sharing, adaptation, distribution and reproduction in
any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license and indicate if changes were made.
The images or other third party material in this chapter are included in the chapter's Creative Commons license,
unless indicated otherwise in a credit line to the material. If material is not included in the chapter's Creative Commons
license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to
obtain permission directly from the copyright holder.
Recommendations for Digitization
of Healthcare in LMICs:
A Wider Outlook
frameworks, to ensure adherence to national and Poland, Vietnam, Cyprus, Latin American coun-
international requirements. tries, Armenia and Indonesia respectively. Thus,
While the above may be achievable within this book has managed to provide a balanced,
high-income settings, the same cannot be stated global view of the different digitalization path-
for low-and middle-income countries (LMICs), ways followed, and a comparative read of those
where there are many competing healthcare chapters will certainly provide insights into simi-
needs and the continuum of data generation to larities and differences. If we consider the national
end-use may not be fully achievable or not pres- examples as vertical implementations (i.e., for
ent at all. Thus, while there is a clear promise for only one specific location), a number of chapters
digital technologies to positively influence look into the horizontal implementations (i.e.,
healthcare provision, there is a danger that across a particular field of operations). As such
regarding LMICs, such technologies may be Chaps. “Biobank Digitalization in Low-Middle
over-promising given the local needs and con- Income Countries (LMICs): Current and Future
texts. Indeed, the COVID-19 pandemic has pro- Technological Developments” and “Digital
vided ample evidence within LMICs, for Healthcare: Technologies, Technical and Design
introducing digitalization efforts that have per- Challenges” investigated the overarching risks
formed very well (as described in Chap. and challenges, and the infrastructure risks, needs
“Ubiquitous and Powerful Artificial Intelligence and opportunities respectively. Furthermore, par-
(AI)” for example for Indonesia), and others that ticular mention should be made for Chaps.
have performed less well (as described in Chap. “Digitalization of Physical Health Data in L ow-
“Long- Term Digital Storage and Usage of and Middle-Income Countries” and “Universal
Research Data: Data Pooling” for Latin America). Internet Access Supporting Healthcare
Therefore, digitalization in LMICs, needs to fol- Provision: The Example of Indonesia”, high-
low a careful balancing act, between the promise lighting technical and design challenges, and
and peril of new technologies, akin to similar investments and incentives respectively.
introductions previously in healthcare, e.g., the Therefore, taking together the above contribu-
introduction of radiology in routine healthcare tions, thematic units can be identified, forming
practice. the core of any future recommendations for digi-
Reading the chapters of the current book, it talization of healthcare in LMICs. These are
becomes clear that the pathway to digitalization in described below, though the relative prioritiza-
LMICs is highly dependent on the individual con- tion would be context-dependent.
texts and needs of the country. Chapter “The
Emergence and Growth of Digital Health in Saudi
Arabia: A Success Story” provides the example of 2 Emerging Common Themes
a mature digital healthcare ecosystem from Saudi in LMIC Healthcare
Arabia, with very high interoperability between Digitisation
different healthcare operating units. Chapters
“The Digital Divide Based on Development and 2.1 Data Infrastructure
Availability: The Polish Perspective”, “Potential
of Digital Health Solutions in Facing Shifting The availability of data infrastructure is crucial
Disease Burden and Double Burden in Low-and for the success of any digitalization effort in
Middle-Income Countries”, “Health Inequalities LMICs. The current chapters describe a highly
and Availability: Needs and Applications”, fragmented picture across regions as well as indi-
“Long- Term Digital Storage and Usage of vidual countries. There is a high overall need for
Research Data: Data Pooling”, “Digitisation in further data infrastructure development across
Genetics and Diagnostics Laboratories in LMICs, including the provision of financial
Armenia” and “Ubiquitous and Powerful Artificial incentives and/or direct public health investment
Intelligence (AI)”, captured the experiences of for the expansion of existing infrastructures (Al
Recommendations for Digitization of Healthcare in LMICs: A Wider Outlook 279
Knawy et al. 2020; Zhang et al. 2022). However, care professionals report higher levels of digital
as with digital health itself, the data infrastructure literacy than other sections of healthcare, and as
does not need to copy blindly what was imple- such the education is more likely to be task-
mented in high-income settings, but develop specific deepening already existing skills (Kuek
methodologies and data architectures that are and Hakkennes 2020). However, educational
LMIC-friendly and suitably tropicalized in terms needs also address entire populations, especially
of their performance and maintenance needs in the case of COVID-19 pandemic where sur-
(Muinga et al. 2020). veillance systems are thought to have under-
performed due to the limited reach of the internet,
and reduced digital literacy of the general popu-
2.2 Data Laws and Regulations lation (Hennis et al. 2021). It has to be noted, that
education is not an instantaneous activity, but
In most of the LMICs that have been mentioned would require persistence and structural incorpo-
in the different chapters of this book, it is evident ration of existing activities if it is to be effective
that there don’t exist specific laws and regula- in the longer-term. This is particularly true for
tions designed and implemented with digitaliza- LMICs, where in many cases the levels of digital
tion of healthcare in mind. This does not mean literacy still remain at low levels, e.g., beyond
that legal frameworks do not exist. Though the 25% of the population.
case differs between different countries, data pro-
tection legislation has been extant for clinical tri-
als, teleconsultations, collection of biological 3 Way Forward Is Context-
samples and associated clinical data for research, Driven, Asymmetric,
etc. (Camacho-Leon et al. 2022; Vodosin et al. Culturally Sensitive
2021; Purtova et al. 2015). It is the case that most and Locally Autonomous
of these regulations have expanded their remit
and interpretation to include the introduction of During the COVID-19 pandemic a number of
digital applications in healthcare. Perhaps this is high-level discussions took place, looking into
a sufficient course of action given the relatively the post-pandemic landscape, and have been
restricted digital healthcare applications in summarized in relevant publications (Kozlakidis
LMICs and the many other competing interests. et al. 2020; AlKnawy et al. 2023; Jazieh and
However, if digitalization is to reach its full Kozlakidis 2020). However, a second look is now
potential, it would need to have clearly defined warranted for these early viewpoints, as the
laws and regulations on the collection of data, implementation experiences from the field can
regulation of access, sharing (nationally/interna- inform and enrich the ‘building back better’
tionally) and use, reporting of data analyses, and propositions (Adisasmito et al. 2023). Given the
secondary use of collected data. intense discussions that took place during the
creation of this book, the following key factors
are emerging as critical:
2.3 Education, Education, Context-driven: The digitalization of health-
Education care in LMICs cannot follow a single common
blueprint. Different countries find themselves at
Finally, and almost universally mentioned, the different stages of financial and infrastructural
lack of education has been identified as a major development, facing different combinations of
barrier for digitalization of healthcare in LMICs. healthcare and socioeconomic pressures. Being
It should be noted though, that the term education unaware of the context can potentially create
is used as a blanket term, addressing a number of unintended consequences such as biases, dis-
different aspects and needs (El Benny et al. crimination, errors or unexpected results, and an
2021). The medical students and young health- overall lack of transparency with regard to how
280 Z. Kozlakidis et al.
outcomes are achieved (Stahl and Coeckelbergh that data is only valuable when it’s accessible.
2016). The consideration of context is not only The success of any application will be contingent
important within national boundaries, but also at on delivering data in a form the end-user, whether
the regional level, and can influence the possibili- patient or care-giver, can easily understand and
ties and reach of data access and sharing. comfortably engage with. This requires focusing
Asymmetric: Information asymmetry is one of data-extraction on information relevant to the
the key features separating healthcare away from end-user local environment. In LMICs where
a traditional market economy definition which education may be limited and newer technologies
assumes that all parties have access to perfect unfamiliar, special attention must also be paid to
information in terms of their decision making identifying alternate modes of communication
and negotiating power (Major 2019). In health- that can more effectively reach the end-user.
care, patients typically lack the medical knowl- These may need to go beyond language-specific
edge that healthcare professionals possess, and models and appeal to other traditions and modali-
this causes information asymmetry. Digitalization ties, e.g., audio and visual-only applications or
of healthcare in LMICs has the power to reduce culturally-responsive implementations.
this information asymmetry (e.g., by involving Combining finely-tuned datasets with local
the patient in the information translation and knowledge in readily accessible formats improves
democratizing the decision-making process), or uptake and expands the application’s scope to
to further increase the existing information asym- reach a wider proportion of the population,
metry by enlarging the digital divide and thus, including, crucially, marginalized communities.
enlarging the information availability only for the
one party. In particular for a market that is in its
initial growth stages, enlarging information 4 Conclusion
asymmetry can have a detrimental impact on the
rate of market growth and quality of services This Chapter serves as the epilogue of a very
rendered. rewarding process, addressing an existing knowl-
Locally autonomous: The many different chal- edge gap for LMICs. The digitalization of health-
lenges within LMICs, necessitate that challenges care in LMICs is a continuing trend that has
would be most effectively addressed within a accelerated by the COVID-19 pandemic.
local context. This also impacts the digitalization However, as with any new technologies intro-
model in LMICs, where applications may be duced into routine practice, promises and perils
preferably locally customized, and operating entail. The optimal digitalization of healthcare in
autonomously, while bearing the capacity of sup- LMICs would need to address three major chal-
porting federated data access, allowing for lenges: the data infrastructure (including finan-
national and international data analyses (Loftus cial support for widening digital access), the
et al. 2022). As an inherent part of being locally creation of relevant legal and regulatory frame-
autonomous, digitalization would also need to be works (including implementation evaluation
dynamic (i.e., capturing temporal changes in frameworks), and the education to be made avail-
physiologic signals and clinical events), precise able to multiple audiences. Finally, the way for-
(using high-resolution, multimodal data, interop- ward for the digitalization of healthcare in LMICs
erable and complex architecture), and finally in is anticipated to be: context-driven, asymmetric,
the case of machine learning algorithms able to culturally sensitive, and locally autonomous.
learn with minimal supervision and execute with-
out human input. Thus, autonomy transcends Disclaimer Where authors are identified as personnel of
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Index
G N
Genetics, 3, 157–159 Neonatal care, 151
Non-technology trends, 273–276
H
Healthcare P
application, 2, 3, 86, 88, 188, 213, 241–243, 251, 279 Patient application, 171–174
data, 2, 7, 8, 73, 84–86, 88, 106, 108, 117, 232–234, Pediatrics, 149, 150, 152, 153
241, 246–248 Personalised medicine, 1, 18, 52, 57, 58, 63, 64, 66, 74
digitisation, 84, 278–279 Physical activity (PA), 61, 173, 220–223, 257
inequalities and inequities, 70 Physical health, 220–223
in low- and middle-income countries, 1–3, 69, 145 Poland, 3, 7, 36–38, 40, 43, 45–49, 240, 278
systems, 2, 3, 6, 8, 22, 52, 56–59, 64, 66, 70, 71, Population health, 9, 21, 26, 54, 58, 65, 96
73–75, 77, 78, 86, 87, 98, 105, 113, 118, 119, Pre-clinical research, 130, 131, 133, 134, 138, 139
142–145, 164, 186, 190, 196, 208, 209, 212, Process optimization, 104–119, 247
221, 228, 235, 246, 250, 251, 256, 260, 262,
263, 265, 267, 273
transformation, 15, 16, 241 R
Health China 2030, 180, 182 Regulation, 8, 10, 23, 37, 40, 41, 43, 45, 47, 48, 71, 72,
Health ecosystems, 58, 276 74, 85, 86, 88, 105, 107, 108, 111, 116, 132,
Health infrastructure, 15, 22, 73, 78–80, 84, 142, 143, 151, 152, 158, 165, 174, 179, 200, 202, 211,
172, 188, 190, 196, 274 220, 227–229, 233, 235, 240, 241, 263, 274,
Health policy, 109, 274, 276 276, 279
Remote monitoring, 16, 18, 20, 87, 246, 256, 257
I
Implementation challenges, 80 S
Implementation models, 80 School health, 152–153
Indonesia, 8, 213, 240–243, 278 Shifting disease burden, 52–68
Information asymmetry, 280 Structural needs tropicalized equipment, 79, 80
Innovation, 2, 3, 7–9, 19, 22, 27, 28, 41, 49, 62, 79, 85, Sustainability, 22, 47, 83, 107, 109, 118, 139, 146, 147,
98, 100, 118, 166, 188, 190, 201, 220, 221, 174, 186, 195, 202, 214, 221, 229, 231–235,
228, 242, 243, 246, 258, 259, 265, 267, 274 267
Sustainability axes, 234
Sustainable Development Goals (SDGs), 71, 79
L Synthetic data, 232–235
Laboratory information management systems (LIMS),
44, 127–128, 135, 136, 198, 199
Low- and middle- income countries (LMICs), 1, 3, 8, 9, T
60, 62, 69, 77, 78, 80, 84, 108, 111, 118, 141, Technical challenges, 78, 79, 201, 209, 212–213
142, 145, 149–151, 153, 171, 186, 190, Technologies in Saudi Arabia, 15–21
196–204, 207, 213, 214, 221, 231–233, 243, Techquity, 84, 86, 87, 191
246–251, 256–258, 260, 262, 268, 273, Telemedicine, 14, 16, 17, 20, 21, 36, 38, 57, 58, 63, 64,
278–279 70, 72, 86, 92, 99, 104, 108, 143–145, 152,
163, 171–174, 210, 220, 221, 241, 246, 249,
256, 259, 265, 267, 268, 274
M The right to health, 74
Machine learning (ML), 8, 19, 23, 38, 39, 49, 99, 114, Trends, 5–10, 27, 28, 54, 59, 60, 70, 96, 97, 127, 130,
117, 129, 131, 137–138, 211, 247, 248, 256, 133–135, 171, 257, 273, 276
261, 265, 280
Marginalized and disadvantaged populations, 69–70, 74
Medical digitalization in LMICs, 70, 75 U
Medical imaging, 39, 98, 256 Ubiquitous AI, 255–257, 259, 260, 265–268
Medical implementation, 36–37
mHealth, 16–18, 20, 57, 65, 66, 73, 110, 118, 143, 151,
172–174, 186, 190