Regulatory approaches to

telemedicine

12 December 2021

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Europe Economics is registered in England No. 3477100. Registered offices at Chancery House, 53-64 Chancery Lane, London WC2A 1QU.
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Contents
Executive Summary..........................................................................................................................................4
1 Introduction.............................................................................................................................................1
1.1 About this study................................................................................................................................1
1.2 Background to telemedicine and this study.......................................................................................1
1.3 Research questions............................................................................................................................3
1.4 Approach to the research..................................................................................................................3
1.5 Structure of the report.......................................................................................................................8
2 Regulatory Context..................................................................................................................................9
2.1 Analytical dimensions informing our approach to the research........................................................9
2.2 Overview of regulatory frameworks in countries examined in this study.......................................10
2.3 Regulating telemedicine in the UK.................................................................................................16
3 Definition of Telemedicine....................................................................................................................19
3.1 Introduction....................................................................................................................................19
3.2 Key findings...................................................................................................................................19
4 Requirements for Healthcare Professionals............................................................................................22
4.1 Licensing and cross-border requirements........................................................................................22
4.2 Requirements and standards for the provision of telemedicine.......................................................24
4.3 Locus of responsibility....................................................................................................................30
4.4 Consequences of non-compliance...................................................................................................31
5 Challenges in Regulating Telemedicine.................................................................................................33
6 Regulating Remote Services in Other Industries....................................................................................34
6.1 Engineering.....................................................................................................................................34
6.2 Surveying........................................................................................................................................34
6.3 Legal advice....................................................................................................................................35
6.4 Summary.........................................................................................................................................36
7 Conclusions............................................................................................................................................38
Appendix 1 — online survey........................................................................................................................40
8 Telemedicine Online Survey..................................................................................................................41
About your organisation........................................................................................................................41
Your organisation and telemedicine.......................................................................................................42
9 Survey Respondents...............................................................................................................................44
10 Online survey responses.........................................................................................................................45
11 Summaries of Key Findings...................................................................................................................48
11.1Definition of telemedicine..............................................................................................................48
11.2Licensing requirements...................................................................................................................48
11.3Requirements for healthcare professionals......................................................................................49

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Executive Summary

Appendix 2 — core countries.......................................................................................................................51

1 Australia.................................................................................................................................................52
1.1 Country level overview...................................................................................................................52
1.2 Medical Board of Australia.............................................................................................................54
1.3 ACRRM (Australian College of Rural and Remote Medicine).......................................................55
1.4 RACGP (The Royal Australian College of General Practitioners)..................................................60
1.5 AMA (Australian Medical Association).........................................................................................63
1.6 The Royal Australasian College of Physicians...............................................................................64
1.7 Australian Health Practitioner Regulation Agency (AHPRA)........................................................66
1.8 Medical Council of New South Wales............................................................................................67
2 Canada...................................................................................................................................................69
2.1 Country level overview...................................................................................................................69
2.2 Federation of Medical Regulatory Authorities of Canada...............................................................69
2.3 College of Physicians and Surgeons of Alberta..............................................................................71
2.4 College of Physicians and Surgeons of British Columbia...............................................................72
2.5 College of Physicians and Surgeons of Newfoundland and Labrador.............................................74
2.6 College of Physicians and Surgeons of Ontario..............................................................................75
2.7 College of Physicians and Surgeons of Saskatchewan....................................................................77
3 Denmark................................................................................................................................................79
3.1 Country level overview...................................................................................................................79
3.2 Danish Health Authority.................................................................................................................80
3.3 National Board of eHealth..............................................................................................................82
3.4 Danish Patient Safety Authority.....................................................................................................82
4 France....................................................................................................................................................83
4.1 Country level overview...................................................................................................................83
4.2 National legal system......................................................................................................................84
4.3 L’Ordre National des Médecins......................................................................................................85
5 New Zealand..........................................................................................................................................88
5.1 Medical Council of New Zealand...................................................................................................88
6 Portugal..................................................................................................................................................90
6.1 Country level overview...................................................................................................................90
6.2 Order 3571/2013 of 6th March 2013...............................................................................................91
6.3 Ordem dos Médicos (Order of Physicians).....................................................................................91
7 Singapore...............................................................................................................................................93
7.1 Country level overview...................................................................................................................93
7.2 Singapore Medical Council.............................................................................................................94
8 United Kingdom....................................................................................................................................96
8.1 Country level overview...................................................................................................................96
8.2 Care Quality Commission...............................................................................................................98

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Executive Summary

8.3 Medicines and Healthcare Products Regulatory Agency................................................................99

8.4 British Medical Association..........................................................................................................100
8.5 General Pharmaceutical Council (GPhC)......................................................................................100
9 United States........................................................................................................................................101
9.1 Country level overview.................................................................................................................101
9.2 Federation of State Medical Boards..............................................................................................102
9.3 American Telemedicine Association............................................................................................107
9.4 State of Maine Board of Licensure in Medicine............................................................................107
9.5 North Carolina Medical Board......................................................................................................108
9.6 Oregon Medical Board..................................................................................................................109
9.7 Washington, DC Board of Medicine.............................................................................................110
9.8 American Academy of Family Physicians....................................................................................111
9.9 National Board of Medical Examiners..........................................................................................112
9.10Medical Board of California.........................................................................................................113
9.11Oklahoma State Board of Medical Licensure and Supervision.....................................................115
Appendix 3 — non-core countries.............................................................................................................117
10 Bhutan..................................................................................................................................................118
10.1Bhutan Medical and Health Council.............................................................................................118
11 Germany..............................................................................................................................................119
11.1German Medical Association........................................................................................................119
12 Indonesia..............................................................................................................................................120
12.1Indonesia Medical Council...........................................................................................................120
13 Ireland..................................................................................................................................................121
13.1Medical Council of Ireland...........................................................................................................121
14 Kenya...................................................................................................................................................123
14.1Kenya Medical Practitioners and Dentists' Board.........................................................................123
15 Poland..................................................................................................................................................124
15.1Polish Supreme Chamber of Physicians and Dentists (Naczelna Izba Lekarska) .........................124
16 South Africa.........................................................................................................................................125
16.1Health Professions Council of South Africa.................................................................................125
17 South Sudan.........................................................................................................................................127
17.1South Sudan General Medical Council.........................................................................................127
18 Sweden.................................................................................................................................................128
18.1The National Board of Health and Welfare...................................................................................128
19 United Arab Emirates..........................................................................................................................130
19.1Dubai Health Authority.................................................................................................................130

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Executive Summary

Executive Summary
Europe Economics has been commissioned by the General Medical Council to review regulatory approaches
to telemedicine around the world. The aim of this work is to understand how various regulators define
telemedicine, what kind of requirements they impose on doctors, and how they deal with the possibility of
doctors from another jurisdiction providing remote medical services to patients.
We adopted a multi-strand approach to the research including desk research, an online survey, and telephone
interviews. Our desk research and interviews focused on a selection of countries where telemedicine
regulation is more developed, i.e. the United States of America, Canada, France, Denmark, Portugal,
Australia, New Zealand, and Singapore. The survey prompted responses from a wider set of regulators and
organisations, however in our analysis we only refer to the survey responses from the core countries (the
remainder of the responses are included in Appendix 1 — online survey and Appendix 3 — non-core
countries).

Definition of telemedicine
In general terms, telemedicine is defined in a similar manner across regulators, i.e. as a medical service
provided remotely via information and communication technology. In addition, some regulators require the
communication to be multi-modal, i.e. not limited to audio-only or text-only interactions. In most cases, it is
understood to occur between a patient and a doctor, but many regulators also acknowledge that it could take
place between doctors (with one regulator limiting the scope of telemedicine to such cases). Moreover, many
regulators recognise that telemedicine could be applied to consultations, diagnosis and treatment. Finally,
many regulators stress that telemedicine should be understood as another way of providing healthcare, rather
than as a distinct medical service in its own right.

Requirements placed on doctors

The requirements placed on doctors practising telemedicine can be categorised into: licensing requirements,
requirements applicable to the provision of telemedicine, and requirements applicable to specific areas of
healthcare.
Licensing requirements in relation to telemedicine are particularly relevant when telemedicine is practised
across jurisdictions. In these cases, the regulators from the USA and many in Canada require a remote doctor
to be licensed or registered with the regulator in the jurisdiction of the patient. While there are some USA
and Canadian jurisdictions where an ‘abbreviated’ licence for telemedicine purposes only can be obtained,
this solution does not appear to be common or popular within those jurisdictions. In Europe, on the other
hand, doctors are generally required to be licensed only with the regulator in their jurisdiction regardless of
where the patient in located. This is perhaps to some extent driven by the EU Directive on electronic
commerce (which is not specific to healthcare itself but mentions public health) which determines the
location of a remote service for regulatory purposes to be in the jurisdiction of the service provider (i.e.
doctor) rather than the service recipient (i.e. patient).
Requirements applicable to the provision of telemedicine usually include: ensuring the same standard of care
as that of face-to-face healthcare; ensuring that telemedicine is an appropriate method of delivering
healthcare; ensuring that sufficient information regarding a patient’s medical history and current condition is
available for diagnosing and/or treating patients; ensuring confidentiality, safety and security of the
exchanged information (sometimes including the technical aspects of it); obtaining a patient’s consent for

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Executive Summary

this method of providing medical services (sometimes paired with a requirement to provide an overview of
what the patient can expect from a tele-consultation or tele-treatment); and confirming a patient’s identity
and maintaining medical records.
A few jurisdictions have also explicitly developed rules around some specific areas of healthcare — such as
remote prescribing of controlled or regulated medications, telepathology, teleradiology and teledermatology.

Regulatory frameworks for telemedicine

The telemedicine requirements applicable to doctors vary in the degree to which they are binding and the
potential repercussions doctors might face as a result of non-compliance. In general, the most indisputable
and binding requirement is to be licensed or registered with the relevant regulator to practise telemedicine. In
the USA for example, it is a criminal offence to practise without such a licence, and thus the repercussions
for non-compliance could — in theory — include legal prosecution (but, for practical reasons, rarely do).
That said, regulators in other countries often do not have the remit to require remote doctors to be registered
with the regulator in the jurisdiction of the patient.
Requirements other than licensing are often less binding and/or harder to enforce. Adherence to those
standards is usually not proactively monitored but rather investigated on a case-by-case basis in response to
complaints. Since a majority (if not all) of the ‘telemedicine’ requirements are in fact consistent with the
requirements applicable to standard healthcare services, the violation of those requirements could be
generally considered not to be specific to telemedicine per se (however, telemedicine might in some
instances make these violations harder to detect).

Specific challenges in the UK

The key types of telemedicine requirements adopted elsewhere in the world appear to mirror the challenges
some of the UK regulators have already observed in the context of remote medical care. In particular, among
the telemedicine-related concerns raised by the Care Quality Commission (CQC) are:
 access to patients’ long-term medical records — which relates to the requirement to ensure that sufficient
information regarding patient’s medical history and current condition is available for diagnosing and/or
treating the patient;
 identification of the patient, including some key characteristics such as age, gender, body weight etc. —
which relates to the requirement to confirm a patient’s identity as well as access to medical records;
 healthcare based on an asynchronous (i.e. not real-time), text-based relationship (e.g. questionnaires or
standardised emails) — which relates, again, to the requirement that sufficient medical information is
obtained before forming a diagnosis or starting treatment, but also to the fact that some regulators do not
consider single-modality communication to fall within the scope of telemedicine;
 requests for confidentiality being potentially abused by patients to avoid sensitive information being
shared between the remote doctor and their primary healthcare provider — which is closely matched by
the concerns of the USA and Canadian regulators that telemedicine increases the risk of patients being
treated in isolation of other healthcare services they receive. This could be mitigated (as some regulators
and organisations from jurisdictions outside North America do) by a requirement to provide telemedicine
only in cases of a pre-established face-to-face relationship between the patient and the doctor, or at least
a physical intermediation from another healthcare professional at the location of the patient.
It is finally worth noting that, even though in some jurisdictions telemedicine has been practised for many
years and appears to be relatively common, the relevant regulation is still evolving as new applications of
telemedicine bring new risks and challenges which regulators aim to address.

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Introduction

1 Introduction
2 About this study
Europe Economics has been commissioned by the General Medical Council (GMC) to conduct a review
of approaches to regulating telemedicine around the world. The objective of this review is to contribute to
the development of the GMC's policy in this area. Given the GMC’s role as a regulator of individual
healthcare professionals (i.e. doctors) this study focuses on the types of requirements and standards
applicable to or having implications for healthcare practitioners, rather than the regulation of healthcare
providers (e.g. hospitals, surgeries etc.) or healthcare systems as a whole. 1

3 Background to telemedicine and this study

Treating a patient remotely has varying names such as telemedicine, telehealth, and e-health. The definition
for this type of service varies around the world but most commonly it involves a medical service provided
remotely. The use of telemedicine is made increasingly possible by modern information and communication
technology (ICT), allowing healthcare professionals to communicate with patients and each other at a
distance.
Patients are already utilizing user-friendly medical devices themselves to measure their blood pressure and
other vital signs which are then sent to their doctors. 2 Telemedicine could also utilize high definition video
and sound recordings which allow doctors to zoom in and read the small print on IV bags or listen to a
stethoscope being used by another doctor. 3 In the future, increased capabilities of internet speed, progress in
the area of artificial intelligence and devices such as smartphones, but also wearable technology, are likely to
promote the growth of telemedicine further.4

3.1.1 The role of telemedicine

Telemedicine can offer a streamlined service for both healthcare providers and patients, reducing the time
needed for a consultation. Telemedicine might play a particularly important role in cases where there is no
need for the patient to physically see the doctor (or other medical professional), e.g. for regular, routine
check-ups or continuous monitoring. 5 When used in the right circumstances most patients do not see any
difference in the quality care provided via telemedicine. 6
Telemedicine can also be used to increase access to healthcare in remote areas or areas with a shortage of
healthcare providers (e.g. sub-Saharan Africa or Canada). 7 This application could cover both basic healthcare
and niche or specialised services which are not readily available near the patient’s location. In the latter case,
1
However, where relevant we explore the interactions between providers/systems and individuals’
professional requirements.
2
eVisit “Telemedicine Guide”.
3
Beck, Melinda (2016, June 26) "How Telemedicine Is Transforming Health Care." Wall Street Journal.
4
CDW Healthcare "The History of Telemedicine".
5
For example — in the case of patients in an intensive care unit — doctors can monitor the patient
through video and call in a nurse if the patient needs care. Also, after a surgery, a patient can have follow
up exams and check-ups done using telemedicine.
6
Lewis, Tim (2016, October 2) “The doctor will see you now… on your smartphone.” The Guardian.
7
Glauser, Wendy, Nolan, Michael & Remfry, Andrew (2015, June 25) "Telemedicine on the rise across
Canada." Healthy Debate.
Regulating Remote Services in Other Industries

patients might interact directly with telemedicine practitioners, or nurses and practitioners located where the
patient is located could consult a remote specialist to make a diagnosis or determine the treatment that the
patient needs.8

3.1.2 Telemedicine in the UK and beyond

Telemedicine has become increasingly important in the United Kingdom. Patients can now consult with a
general practitioner using an app that allows them to video-call the doctor. Through the app the general
practitioner can assess the symptoms and even write a prescription. 9 The same idea is being applied to
remote and rural areas, such as Scottish islands, where a GP residing on one island consults a patient in
another island, with the help of a local nurse on the patient’s side. 10 The GP then might prescribe a
medication for an obvious acute condition, or send the patient to the hospital for further examination.
Similarly, general practitioners can consult elderly patients in nursing homes through video calling, and
determine whether an in-person examination is necessary. 11 Emergency services are also experimenting with
the use of telemedicine giving patients the option to video call a health professional. This might be
particularly useful when the wait times for an ambulance are longer and telemedicine could either provide
medical care immediately or quickly deal with cases where people do not actually require urgent help. 12
Remote diagnostics is another example of telemedicine, whereby test results can be sent to diagnostic labs in
other jurisdictions. The UK also markets itself as a destination for remote diagnostics. 13
Another example is the use of telemedicine or broader telehealth services in social care homes. An
established secure video link between a care home and a healthcare provider provides direct access to
medical advice for care home staff and residents. The technology is being piloted in nursing homes in
Bradford, Airedale where 217 homes already have the necessary equipment and links with selected local
hospitals, clinical commissioning groups, community healthcare providers, and numerous GP practices. 14
Telemedicine has also become an important form of healthcare around the world. For example, in Denmark,
telemedicine is specifically targeting patients with Chronic Obstructive Pulmonary Disease (COPD) who
tend to have frequent visits to a clinic. 15 In Singapore telemedicine is used to help patients with physical
therapy — as long as elderly patients are capable of using an electronic tablet, the instructions for the
exercise are given on the tablet and their progress is recorded. 16 France and the United States made a
breakthrough in telehealth in 2001 with the success of the ‘Lindbergh Operation’ which involved doctors in
New York performing surgery on a woman in France via a robot. This was made possible using high
definition communication equipment and a high speed internet connection. 17 Telesurgery (or remote surgery)

8
eVisit “Telemedicine Guide”.
9
Lewis, Tim (2016, October 2) “The doctor will see you now… on your smartphone.” The Guardian.
10
Dawson, Dr Kate (March 1, 2017) “GP’s view: prescribing to remote patients in the Outer Hebrides.”
GMC UK Blog.
11
Gallagher, Paul (2017, Match 30) "GPs will consult nursing home residents using Skype." iNews.
12
Jamieson, Sophie (2017, July 17) "999 callers assessed by Skype instead of being sent ambulance." The
Telegraph.
13
The Department for Health and the Department for Internationa Trade “The UK: your partner for clinical
services” https://www.gov.uk/government/publications/the-uk-your-partner-for-clinical-services/the-uk-
your-partner-for-clinical-services
14
NHS England, "Airedale and partners".
15
Danish Agency for Digitisation Digitaliseringsstyrelsen) (2016, March 17) "Denmark - a frontrunner in
telemedicine in Scandinavia."
16
Senthilingam, Meera and Stevens, Andrew (2016, September 20) "The doctor will not see you now: How
Singapore is pioneering telemedicine." The CNN International Edition.
17
Parsell, D.L. (2001, September 19) "Surgeons in U.S. Perform Operation in France Via Robot." National
Geographic News.

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Regulating Remote Services in Other Industries

is not — yet — widespread but it is gaining attention for its potential for use in locations surgeons cannot
readily access (including, for example, military zones). 18

3.1.3 Potential risks in telemedicine

As telemedicine deals with sensitive issues of personal health, and requires the use of sometimes
sophisticated equipment, it has associated risks that might adversely affect the patient and the quality of
medical service. Among the key concerns are the following:
 verification of the patient’s and practitioner’s identities, practitioner’s licence and patient’s consent;
 referral policies to/from telemedicine doctor and interaction with other doctors, e.g. the patient’s GP;
 privacy, confidentiality and security of personal data and medical records;
 reliability of ICT equipment including network reliability and image quality;
 incorrect diagnosis or treatment, e.g. due to non-physical examination or low-quality images; and
 remote prescription of drugs without either proper examination or access to the patient’s medical history.
This research aims to explore how other regulators seek to mitigate these risks in practice and therefore
inform the development of the GMC’s regulatory approach to telemedicine.

4 Research questions
The key research questions we focus on in this report are:
 frameworks for telemedicine regulation, i.e. who regulates telemedicine, how binding the regulation is,
and what role these regulators play in a wide regulatory context;
 the definition of telemedicine;
 regulation applicable to individual doctors who provide telemedicine services, including the locus of
responsibility and issues associated with compliance;
 issues associated with telemedicine being provided across jurisdictions.
The first two points — i.e. the regulatory framework and definition of telemedicine — provide an important
background that is necessary to interpret the findings on regulating individual doctors. For example, we
might expect different approaches to regulation depending on the key functions of a regulator, and the
overlaps and interactions between its policies and other regulations relevant for telemedicine. With that
background, we can then analyse the issues which are of core interest to the GMC as a regulator of doctors,
i.e. the requirements imposed on doctors who are within the regulator’s mandate, and ways of addressing
issues arising in relation to doctors (and other involved parties) who are not directly within that mandate.

5 Approach to the research

We adopted a multi-strand approach to ensure both breadth and depth to our research: initial desk research
and an online survey allowed us to obtain high-level information for a wide range of regulators, while
telephone interviews and subsequent in-depth desk research provided us with more nuanced insights and
understanding. Our research focused predominantly on organisations whose function is to develop
regulations and/or provide standards for individual practitioners rather than those regulating healthcare
providers or healthcare systems.

18
Smith, Dr. Roger (2015, June 14) "Research In Lag Time Set To Determine The Future Of Telesurgery."
TechCrunch.

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Regulating Remote Services in Other Industries

Figure 1.1: Approach overview

Desk Initial and primary source of

research information

Online Accessing a broad range of

survey stakeholders

Deepening our understanding,

filling the gaps in desk
Interviews research, clarifying survey
responses

Bringing all the

Synthesis reserach strands
together in the report

Source: Europe Economics.

5.1.1 Desk research

Desk research was our primary source of information throughout this project. Initially, it was used to identify
countries where telemedicine is more prominent, and then — within those countries — the regulators and
organisations that are relevant for regulating healthcare practitioners. Countries and regulators that did not
appear to have any telemedicine policies or standards in place were excluded from any further desk research
after this initial review.
There were often several regulators and organisations (potentially) relevant for regulating telemedicine in a
given country, which had two main implications for our work. First, in order to understand the regulation
imposed on healthcare practitioners in its entirety rather in an incomplete, fragmented manner, we examined
the interactions between the regulators/organisation and their respective roles in regulating telemedicine.
This often resulted in the inclusion in our research and stakeholder engagement of several regulators from
the same country. Second, to ensure our research was as efficient as possible, we gave priority to more
‘general’ regulators, i.e. country-wide regulators and regulators covering all medical professions, unless our
research indicated that regional or profession-specific organisations were more relevant for developing
telemedicine policies and standards.

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Regulating Remote Services in Other Industries

Figure 1.2: Desk research

Initial broad ‘sweep’ of regulators and approaches

High-level research across a long-list of countries to identify regulators/organisations potentially
relevant for regulating telemedicine

Selecting core countries of interest

UK, USA, Canada, Australia, New Zealand, Singapore, France, Portugal, and Denmark

Focusing desk research on selected regulators

Giving priortiy to the most general regulators in the medical sector first, rather than organisations
focusing on particular medical professions

Source: Europe Economics.

Our desk research also investigated how individuals providing remote services in the UK are regulated, if at
all, in other sectors such as engineering, legal advice and land surveying. The aim of this strand of our
analysis was to understand whether the types of remote services in other UK sectors could be perceived as
similar to telemedicine services, and thus whether — potentially more developed — regulation in those
sectors could inform the GMC’s views on regulating telemedicine.

5.1.2 Online survey

In addition to the desk research, we developed an online survey 19 for healthcare regulators to gather
information on their role in developing telemedicine policies and standards (including any interactions with
other organisations), type of regulation they have in place or are currently developing, definition of
telemedicine, requirements imposed on healthcare practitioners, and views on telemedicine services provided
across different jurisdictions.20
The survey was distributed by the GMC to International Association of Medical Regulatory Authorities
(IAMRA) members and a number of national healthcare regulators in the GMC’s network.
The main objectives of the survey were, firstly, to reach a wide range of regulators in an efficient manner,
and second to confirm whether our selection of ‘core countries’ and regulators/organisations within those
countries was appropriate.
Indeed, the majority of the responses we received were from the core set of countries. Overall, including
both core and non-core countries, we received 30 responses — 21 of which represent the core countries. As
illustrated in the figure below, 14 out of 21 responses representing the core countries came from the USA
and Canada alone.

19
The survey was developed using Survey Gizmo.
20
See Appendix 1 — online for a full list of questions.

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Regulating Remote Services in Other Industries

Figure 1.3: Survey responses from core countries

Source: Online survey, Europe Economics.

The responses submitted by other countries and jurisdictions broadly confirmed that the analysis focusing on
our core countries is likely to provide us with a comprehensive overview of regulatory approaches to
telemedicine.21

5.1.3 Interviews
We conducted 13 telephone interviews with healthcare regulators and other medical organisations from the
UK, the USA, Canada, Australia, New Zealand, and Germany. 22
The aim of the interviews was to fill any gaps in the desk research and/or survey responses, and to explore
certain issues in more detail. The interviews were particularly useful to understand the practical side of
telemedicine and its regulation, including the channels through which patients are exposed to telemedicine
(e.g. via healthcare providers or independently), most common applications of telemedicine (e.g. patient-
doctor consultations, diagnostics, treatment), and issues associated with ensuring compliance (especially
where healthcare is provided across jurisdictions).
Following the desk research, we also conducted a few short interviews with organisations in other UK
sectors (engineering, surveying and legal advice), to better understand how remote services are regulated and
whether any analogies between them and telemedicine could be drawn.

5.1.4 Summary
Across all three strands of our research, we obtained information for 47 healthcare organisations or
legislators, and from four UK organisations in other sectors. Of those 47 healthcare organisations, 38
represent the ‘core’ countries of interest. In the remainder of this report, we only focus on the organisations
from the core countries that also at least made some statements regarding telemedicine (either publicly or as
21
For a full list of respondents see Appendix 1 — online .
22
Federation of State Medical Boards (FSMB), Medical Council of New Zealand, Federation of Medical
Regulatory Authorities of Canada, Australian Health Practitioner Regulation Agency (AHPRA), German
Medical Association, General Pharmaceutical Council, Oklahoma State Board of Medical Licensure and
Supervision, North Carolina Medical Board, College of Physicians and Surgeons of Saskatchewan, Care
Quality Commission (CQC), College of Physicians and Surgeons of British Columbia, College of
Physicians and Surgeons of Ontario, Healthcare Inspectorate Wales.

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Regulating Remote Services in Other Industries

part of our stakeholder engagement programme). There are 36 organisations that satisfy these criteria, as
presented in the table below.
Table 1.1: Organisations representing core countries

Regulator or Desk
Country Organisation Survey Interview
not23 research
Medical Board of Australia Yes 
Australian College of Rural and Remote
No 
Medicine
Royal Australian College of General
No 
Practitioners
Australia Australian Medical Association No 
Royal Australasian College of Physicians No 
Australian Health Practitioner Regulation
Yes   
Agency
Medical Council of New South Wales Yes  
Federation of Medical Regulatory
Not directly   
Authorities of Canada
College of Physicians & Surgeons of Alberta Yes  
College of Physicians & Surgeons of British
Yes   
Columbia
Canada
College of Physicians & Surgeons of
Yes 
Newfoundland and Labrador
College of Physicians & Surgeons of Ontario Yes   
College of Physicians & Surgeons of
Yes   
Saskatchewan
Danish Health Authority Yes 
Denmark National Board of eHealth No 
Danish Patient Safety Authority Yes  
Legislator Law 
France
Council of the National Order of Doctors Yes  
New Zealand Medical Council of New Zealand Yes   
Legislator Law 
Portugal Order of Doctors (European Council of
Yes 
Medical Orders)
Singapore Singapore Medical Council Yes  
Care Quality Commission Yes  
Healthcare Inspectorate Wales Yes  
UK
British Medical Association No 
General Pharmaceutical Council Yes   

23
Alternatively, the organisations included in our research could be professional associations, government
departments or other public bodies developing non-binding standards or factsheets, but not regulation
strictly speaking.

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Regulating Remote Services in Other Industries

Regulator or Desk
Country Organisation Survey Interview
not research
Federation of State Medical Boards Not directly   
American Telemedicine Association No 
American Academy of Family Physicians No  
National Board of Examiners No 
Medical Board of California Yes  
USA State of Maine Board of Licensure in
Yes  
Medicine
North Carolina Medical Board Yes   
Oklahoma State Board of Medical Licensure
Yes   
and Supervision
Oregon Medical Board Yes  
Washington, DC Board of Medicine Yes  
Total 35 21 12
Note: This table only presents organisations from the core countries.
Source: Europe Economics.

6 Structure of the report

The remainder of this report is structured as follows:
 Chapter 7 provides a discussion of the regulatory context for telemedicine — after briefly setting out the
main research questions relevant to this study, we first provide a description of how various
characteristics of the regulatory context could affect the regulation of telemedicine (section 8), and then,
in section 9, we discuss which of those factors are relevant for the countries under consideration in this
report. Finally, in section 10 we provide a short overview of the UK regulatory framework and a
summary of the views on telemedicine among some of the UK regulators and other institutions.
 Chapter 11 provides the key findings regarding the definition of telemedicine in various jurisdictions
outside the UK.
 Chapter 14 provides the key findings regarding the requirements for doctors practising telemedicine.
Specifically, we distinguish between licensing requirements and requirements applicable to the provision
of telemedicine services per se. Given the additional layer of complexity telemedicine creates (e.g. by its
reliance on technology), we also discuss where the locus of responsibility is (section 17). Finally, we
provide a summary of the approaches regulators take to ensure compliance with the relevant
requirements (section 18).
 Chapter 19 briefly summarises some of the challenges in regulating telemedicine.
 Chapter 20 provides a short discussion on the approaches other UK industries take to regulating or
otherwise overseeing the provision of remote services.
 Chapter 25 provides our concluding remarks.
We also include three appendices which provide:
 the questionnaire used in the online survey (Appendix 1 — online );
 all the information relevant for our analysis in the main body of the report (i.e. for the ‘core’ countries of
interest), collected via desk research and via the online survey (Appendix 2 — core countries);
 all the information obtained for all other countries which participated in the survey but which we did not
examine in detail, and thus not included in the main body of the report (Appendix 3 — non-core
countries).

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7 Regulatory Context
In this chapter, we present the analytical dimensions that informed our approach to this study — these
dimensions illustrate how various factors could in principle affect the regulation of telemedicine (section 8).
We explored whether these factors are indeed relevant for regulating telemedicine in our desk research and
fieldwork, the results of which are presented in chapters 11 and 14. In light of the analytical dimensions
presented here, we provide a brief overview of the characteristics of the core countries our analysis focuses
on (section 9). Finally, in section 10, we briefly discuss the views of UK organisations and regulators on
regulating telemedicine.

8 Analytical dimensions informing our approach to the research

In order to better understand and interpret the various requirements and standards, it is useful to first
understand the general types of telemedicine regulation and how different regulatory frameworks might
affect the types of regulation. In particular, the policies are likely to differ depending on regulatory
environment (regulatory frameworks, key functions of various regulators, and the mandate those regulators
have to develop policies or standards), as well as the characteristics of the healthcare system and broader
geographic context.

8.1.1 Regulatory framework

The approach to regulating individual doctors (and other professionals within our research) in the context of
telemedicine is likely to vary depending on whether the regulator oversees just the individual professionals,
or the performance of the healthcare system as a whole (or some part of it). In the former instance, the
regulator might have more detailed requirements for training, qualification and codes of conduct. In the latter
case, the regulator might be interested in the requirements for doctors more in light of how they contribute to
the healthcare system as a whole, for example by setting requirements at a higher level in order to cover a
wider range of individuals from different professions (such as how doctors and nurses should interact in
relation to telemedicine). Professional bodies might have as a primary focus the development of innovative
medical care and as such develop recommendations and standards that seek to promote the use and
development of telemedicine. The context of the regulator/standards-setter will be important in
understanding the rationale for their regulatory requirements and the extent to which these might be relevant
to the GMC.

8.1.2 Regulators’ key functions

Regulators may differ in the specific requirements for health professionals that practise telemedicine (or
other forms of ICT in other industries) depending on their key functions. For example, professional
regulators could be expected to have requirements and procedures spanning functions such as education and
training, standards, setting the scope of practice, and fitness to practise. Systems regulators might have a
different focus, e.g. those relating to care pathways, or interactions with other (healthcare) professionals.

8.1.3 Legal status of regulation

Depending on the regulator’s key functions, but also the wider regulatory context, different pieces of
telemedicine policies, standards, requirements or statements might have varying degrees to which they are

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binding for healthcare practitioners. For example, there could be requirements which are encoded in the
legislation, while others could be in the form of recommendations or non-binding standards. Moreover,
different types of requirements are likely to be characterised by different degrees of enforceability — more
qualitative aspects of telemedicine regulation (e.g. relating to the quality of care) could be harder to monitor
and/or enforce than, for example, the requirements that need to be satisfied in order to become registered
(such as having a relevant qualification).

8.1.4 Healthcare system: public or private

The characteristics of a healthcare system as a whole could influence the evolution and applications of
telemedicine. In particular, a more dynamic and fragmented healthcare system could create different risks
than a centralised one, and therefore might require a different approach to regulating telemedicine. 24
Likewise, there could be differences in how telemedicine is used in practice and what kind of regulatory
tools are available to the relevant authorities in jurisdictions where healthcare is public compared to where it
is private.

8.1.5 Geographic context

Finally, telemedicine and the associated requirements could be to some extent driven by a jurisdiction’s size,
population density, neighbouring jurisdictions etc. For example, large and sparsely populated jurisdictions
might be less concerned with telemedicine being provided across borders but focus more on increasing
access to medical services or on reducing the costs of healthcare within the country.

9 Overview of regulatory frameworks in countries examined in this study

This section provides an overview of how the regulatory environments in the core countries relate to the
dimensions described in the previous section. As elsewhere in the report, we focus on the telemedicine-
related requirements for individual healthcare practitioners adopted by relevant professional bodies or
regulators. More specifically, for each country we summarise:
 whether the healthcare system is predominantly public or private;
 which institutions can regulate individual healthcare practitioners;
 interactions between organisations regulating different areas of healthcare system, different regions
within a country or otherwise involved in developing telemedicine policies;
 what telemedicine regulation and/or policy exists for individual healthcare practitioners; and
 how binding the telemedicine regulation is.

9.1.1 Europe
Denmark
The Danish healthcare system is financed largely with public funds. The Ministry of Health and the Danish
Health Authority are responsible for the overall regulation of the healthcare system and healthcare providers.
The National Board of eHealth (the agency under the Ministry of Health) oversees the healthcare IT strategy
(standards for health registers and systems, electronic medical records, etc.).
The Danish Patient Safety Authority (Styrelsen for Patientsikkerhed, STPS) regulates individual health
professionals, including doctors and health organisations. It issues specialist registrations in 16 different
24
We also note that telemedicine itself might promote fragmentation and market dynamics even in
jurisdictions with public healthcare, and as such change the environment in which the regulator currently
operates (and thus change the nature of the regulation in time).

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healthcare professions and permissions to practise independently for certain professionals. The STPS also
handles complaints about patients’ rights and treatment.
The “Guidance on responsibilities for doctors who use telemedicine” were adopted in 2005 as a legally
binding document for doctors who practise telemedicine. 25
France
The National Authority for Health (Haute Autorité de Santé, HAS) and the National Council of Public
Healthcare (Haut Conseil de la Santé Publique, HCSP) oversee the regulation of healthcare systems and
development of healthcare policy.
France was one of the first countries in the EU to vote in a specific legal framework for telemedicine in
2009, with the implementation of Article 78 of Law 2009-879 and a decree a year later. From a legal point of
view, telemedicine is considered as another type of medical procedure (which adds to and does not replace
existing medical procedures).
The National Order of Doctors (l’Ordre National des Médecins, ONM) is responsible for regulating
individual doctors, including licensing and codes of conduct. The ONM published its telemedicine statement
in 2009 (i.e. around the time the relevant telemedicine legislation was adopted). The statement summarises,
among other things, the responsibilities of the doctor who decides to practise telemedicine. The statement
could be treated as a complementary clarification to the binding legislation. For the present study, we used
the legislation as the only source of telemedicine regulation in France.
Portugal
The Ministry of Health is responsible for healthcare policy-making, planning and regulation. The applicable
telemedicine regulation is codified in national legislation. 26 The law provides a working definition of
telemedicine and establishes general rules of using telemedicine.
The Order of Physicians (Ordem dos Médicos) regulates individual doctors in Portugal. The Order manages
doctors’ licences and applies the disciplinary code, with powers to issue warnings and pursue other
disciplinary actions.

9.1.2 North America

Canada
The healthcare systems in provinces and territories of Canada rely mostly on funding from the central
government. However, some services are funded through private insurance. In principle, the physician has to
be located in a given province to submit bills to the health system of that province. When the patient and the
doctor are located in different regions, reciprocal arrangements between the Canadian regions allow for
reimbursement of medical costs by the Canadian government.
At the national level, the Federation of Medical Regulatory Authorities of Canada (FMRAC) is responsible
for developing guidelines and policy recommendations. However, the actual legislation is implemented at the
level of provinces and territories that enjoy a large degree of autonomy in regulating their regional healthcare
systems and, more specifically, individual doctors.
The doctors’ regulatory body is typically a regional College of Physicians and Surgeons (CPS), e.g. the CPS
of Ontario. The CPSs are responsible for licensing doctors, developing codes of conduct and standards of

25
The Guidance on responsibilities for doctors who use telemedicine (VEJ No. 9719 of 09/11/2005).
26
Ministry of Health (2013, March 6) "Order No. 3571/2013 Determining that the services and
establishments of the National Health Service (SNS) should intensify the use of information and
communication technologies in order to promote and guarantee the provision of telemedicine services to
users of the National Health Service".

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care, and dealing with complaints against doctors. The doctor has to obtain a licence in at least one region to
be able to practise medicine and, in particular, to be able to offer medical service remotely. The codes of
conduct usually do not have legally binding status but are compulsory for the CPSs’ members and are used
as a reference document in case someone submits a complaint against the doctor.
The FMRAC adopted its telemedicine policy in 2010, which is not a binding document but rather a policy
model for regional regulatory authorities. In turn, the individual CPS adopted their telemedicine policies.
These province or territory-level policies are usually not in the form of binding statutes but — just like
general codes of conduct — are compulsory for doctors as a condition of membership and can be referred to
in disciplinary hearings. Certain CPS adopted their telemedicine policies a few years ago and we understand
from our interviews that they are likely to review or update the policies in the next one or two years
following the development of telemedicine practice and technology (Alberta, Ontario).
United States of America
The USA’s healthcare system is funded largely through employer healthcare insurance plans. More than 50
per cent of employers offer telemedicine benefits as part of their healthcare insurance plans, 27 which explains
the popularity of telemedicine in the USA, especially direct-to-consumer telemedicine.
As in Canada, the USA’s Federation of State Medical Boards (FSMB) has no enforcement power but is an
important provider of policies and statements as well as the terminology used in those documents. There are
70 medical licence boards in the USA, 28 which are, inter alia, responsible for licensing doctors, adopting
policies, codes of conducts and standards of care, as well as for investigating the complaints against doctors.
Most states in the USA have telemedicine policies enacted as part of State legislation (administrative codes).
This may include, but is not limited to, the definition of telemedicine, codes of conduct, etc. In some states,
there is no single legislative document that governs telemedicine practice. In others, only a telemedicine
statement published by the state’s medical board is available. The regulation of telemedicine might not have
legally binding status but is typically compulsory (i.e. as a condition of practising medicine and retaining a
licence) and so applied when investigating a complaint against the doctor. 29
Regulators in both the USA and Canada often stressed the importance of telemedicine as a tool to deliver
healthcare to remote and sparsely populated areas of their jurisdictions. The distances doctors (or patients)
have had to travel before effective communication between two remote locations was possible, appear to be a
crucial driver in the development of telemedicine in North America. Nevertheless, the regulatory approach
might vary depending on the organisation of the healthcare system. For example, in publicly funded systems,
the regulator itself (and other relevant public/ governmental institutions) may be more likely to promote
telemedicine in order to meet patient needs (while maintaining high standard of care) than in the case of a
private healthcare system, where healthcare providers themselves are the key agents in promoting the most
efficient ways of delivering medical services. In the latter case, the role of the regulator might be relatively
more focused on simply ensuring compliance with certain quality standards.

27
We also note that each insurer might --- for practical purposes --- adopt a slightly different definition of
telemedicine depending on which services are covered and reimbursed by them.
28
While there are only 50 states in the USA, some regions have separate boards for osteopathic physicians
(who have the same practice rights as MD physicians).
29
In other words, doctors obtain a licence if they satisfy certain minimum criteria, and then going forward
they are expected to comply with the standards and/or codes of conduct (including those specific to
telemedicine) developed by the relevant regulator. If they do not, an investigation can be started and, if
non-compliance is stark, the license can be revoked. That said, for such a measure the non-compliance
would be associated with more than just neglecting telemedicine-focused requirements.

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9.1.3 Australasia
Australia
The healthcare system in Australia receives mixed financing from both public funds and private insurance.
Most policies and standards for healthcare providers and professionals are developed at the national level.
However, the responsibility for managing and delivering healthcare sits with the governments of the various
Australian states and territories.
The key regulators of individual doctors are the Australian Health Practitioner Regulation Agency (AHPRA)
and the Medical Board of Australia (MBA). The AHPRA acts as an umbrella organisation for 14 National
Boards, according to the regulated professions. The AHPRA develops the national scheme for accreditation
and registration to ensure consistency in the regulation of medical professionals and to bring commonality to
values and processes across professions. The MBA registers medical practitioners and develops standards,
codes and guidelines for them. Complaints can be submitted to the National Health Practitioner Ombudsman.
Several voluntary organisations provide additional standards of conduct and promote interests of doctors,
GPs (general practitioners), or doctors working in rural areas.
In Australia, the preferred term is telehealth rather than telemedicine. The main telehealth policy statement is
the MBA’s guidelines for technology-based consultations. These guidelines complement the general code of
conduct. The guidelines and the code do not have legally binding status; however, they could be used to
assess the doctor’s conduct in case of a complaint.
New Zealand
Similar to Australia, healthcare in New Zealand has a mix of financing from public and private insurance
funds. The Ministry of Health is responsible for the national healthcare policy while the 20 District Health
Boards are responsible for providing and funding public healthcare.
The Medical Council of New Zealand (MCNZ) regulates all medical doctors in the country. It overseas
licencing and registration, and develops standards and codes of conduct for doctors.
As in Australia, the New Zealand regulators prefer the term “telehealth”. The MCNZ revised its statement on
telehealth in 2016 and scheduled the next revision for 2021. 30 The statement on telehealth applies to all
doctors registered with the MCNZ (i.e. effectively all doctors). The MCNZ cannot require foreign doctors to
register with the Council, but it does encourage them to be registered with the council nevertheless.
However, the council introduced a special purpose teleradiology registration for overseas practitioners.
Singapore
Singapore healthcare receives mixed funding from government funds and insurance companies. The core
regulatory organisation is the Ministry of Health of Singapore (MoHS). It is responsible for licensing
medical organisations, clinics, hospitals, laboratories, etc. The MoHS publishes guidelines for medical
organisations, processes licensing applications and conducts inspections. There are seven professional bodies
that cover different types of individual professionals (doctors, nurses, dental practitioners, etc.).
The Singapore Medical Council (SMC) regulates registered medical practitioners in Singapore, including the
registration of doctors and development of standards and codes of conduct.
Regulation of telemedicine is part of guidelines and ethics standards for doctors published by the SMC. The
MoHS has also issued a set of National Telemedicine Guidelines to guide healthcare providers on the safe
and appropriate delivery of healthcare services through the use of telemedicine. As explained in the
Guidelines Summary Card, specific principles laid in the Guidelines might be mandatory, strongly
encouraged or optional as indicated by the words “must”, “should”, and “may” respectively. 31

30
See the end-of-text note in Medical Council of New Zealand (2016) "Statement on telehealth."
31
Ministry of Health Singapore (2015) "National Telemedicine Guidelines".

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9.1.4 Summary
Regulatory context varies from country to country in many ways. Regulators can have different objectives,
scope for imposing binding regulation, and regulatory tools available to them. Indeed our survey illustrated
that the organisations responsible for (at least some aspects of) regulating telemedicine do so through
policies or requirements in different areas such as licensing, setting standards, providing trainings etc. That
said, the most common area where telemedicine-related requirements were developed is ‘standards of work’
(reported by 12 out of 20 respondents).
Figure 2.4: Areas of telemedicine-related requirements

In what areas does your organisation place telemedicine-related requirements on those subject to your
regulation/oversight?
12

10

Note: Sample size: 20. It became subsequently apparent in our later research that respondents who reported ‘Licensing and/or registration’ as one of
the areas in which they place telemedicine-related requirements were unlikely to mean a specific telemedicine-only licence/registration. Where this
was intended, we discuss explicitly in the report.
Source: Online survey, Europe Economics.

Our survey also confirmed that a majority of the jurisdictions with the core set of countries have some form
of formal regulations/policies regarding telemedicine (17 out of 20). That said, as indicated in the overview
of regulatory frameworks above, many of these regulations and policies are likely to be in the form of
standards or guidelines / codes of conduct rather than necessarily legally binding requirements. We discuss
this further in section 18.

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Figure 2.5: Existence and type of telemedicine regulations or policies

Does your o rganisation have specific reg ulations or p olicies relating to telemedicine?

Note: Sample size: 20.

Source: Online survey, Europe Economics.

The survey results also suggest that those jurisdictions which do not have formal telemedicine regulation are
planning to develop such regulation in the near future. Moreover, some of those regulators which already
have telemedicine policies in place are also looking into updating or expanding them (see Figure 2 .6
below).
Figure 2.6: Plans to develop or update existing telemedicine policy

If you do not have a telemedicine regulation or policy in place, do you expect your organisation to
develop such regulation/policy in the near future?

Note: Sample size: 20.

Source: Online survey, Europe Economics.

In the remainder of this report we focus on presenting the regulatory approaches to telemedicine at a
jurisdiction level. This means that in most instances the results could be presented on a national level. The
exceptions are the USA and Canada, where the relevant jurisdictions are states/provinces or territories. 32
While many of the state-/territory-level regulators adopt solutions which are fairly consistent with solutions

32
While Australia has a similar province-based regulatory system, our research focused on nation-wide
regulation which seems to be consistently adopted across various institutions.

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adopted by other states/territories in each country, there are also differences as the state-/territory-level
regulators have full autonomy in developing telemedicine policies and regulations. Therefore, the findings in
the remainder of this report will focus on the following 17 jurisdictions:
 Australia;
 Denmark;
 France;
 New Zealand;
 Portugal;
 Singapore;
 Alberta (Canada);
 British Columbia (Canada);
 Newfoundland and Labrador (Canada);
 Ontario (Canada);
 Saskatchewan (Canada);
 California (USA);
 Maine (USA);
 North Carolina (USA);
 Oklahoma (USA);
 Oregon (USA); and
 Washington (USA).

10 Regulating telemedicine in the UK

In order to understand the context in which regulating telemedicine in the UK takes place, we provide a short
description of the key characteristics of the UK regulatory environment and healthcare system below. In
order to facilitate comparison, we use the same dimensions along which we summarised the regulatory
environment in the other core countries (see section 9 above).
We analyse the views that UK regulators (other than the GMC) and other bodies have on regulating
telemedicine, and in particular in relation to the key research questions this research focuses on.

10.1.1UK regulatory framework

The UK National Healthcare System (NHS) is largely financed with public funds. A small number of private
healthcare providers operate under the supervision of relevant system regulators. Different organisations are
responsible for regulating healthcare providers in the four UK countries:
 Care Quality Commission (CQC) in England,
 Healthcare Improvement Scotland (HIS),
 Healthcare Inspectorate Wales (HIW), and
 Regulation and Quality Improvement Authority in Northern Ireland (RQIA).
With respect to telemedicine, the CQC registers telehealth providers under the regulated activity of ‘transport
services, triage and medical advice provided remotely’. Remote medical advice constitutes a regulated
activity when it meets certain criteria. Being a regulator of healthcare providers, the CQC does not provide
specific requirements for doctors. Other national regulators seem to have no specific telemedicine policies
for healthcare providers (although see on the joint statements below).

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The GMC regulates doctors across the whole of UK. The GMC is responsible for registering UK doctors and
licensing those who wish to practise medicine, but it cannot require doctors outside the UK to register with
the GMC, even if they provide remote medical service to a patient in the UK.
The GMC and the system regulators in Scotland, Wales and Northern Ireland published joint statements on
telemedicine in December 2009. 33 The statements are relatively short and do not represent statutorily binding
regulation for doctors.

10.1.2Regulatory approaches to telemedicine in the UK

As part of our initial desk research, we explored whether other UK regulators and bodies had any public
views, policies or statements regarding telemedicine in general, and our research dimensions in particular.
Our research covered a number of healthcare professional regulators, 34 systems regulators,35 and some
professional associations (most notably the British Medical Association). In many cases, we did not find any
relevant mention of telemedicine on the websites or published documents of those organisations, suggesting
that telemedicine is not an area they actively regulate or distinguish from other healthcare areas. In other
cases, we were able to find documents or sites that mentioned telemedicine, perhaps defined it and discussed
some examples, risks, or best practices, but none that could be considered to actually regulate telemedicine
or have material implications for developing telemedicine regulation for individual doctors.
Nevertheless, we further explored the views among some of the UK organisations. In particular, we
conducted interviews with the CQC, the HIW, and the General Pharmaceutical Council (GPhC) (which also
responded to our online survey).
First, these organisations understood telemedicine in different ways. For the CQC, telemedicine generally
occurs whenever technology is used to provide care services between the doctor and the patient. Overall, the
CQC seems to be of the view that the objective of any regulation in the area of telemedicine should be to
ensure the same quality of care regardless of the modality via which healthcare is provided. For healthcare
providers this implies that they need to ensure that the method of delivering care is safe and effective.
In that sense, in the CQC’s view, standards and policies developed predominantly with face-to-face
interactions in mind might simply require a few adjustments to ensure they are phrased in a way that applies
in the context of telemedicine.
The areas in which the CQC considers telemedicine as potentially creating challenges or risks different to
those in face-to-face interactions are:
 access to patients’ long-term medical records — especially when private healthcare providers are
considered;
 identification of the patient, including some key characteristics such as age, gender, body weight etc. —
this could be particularly challenging when combined with a lack of access to patients’ medical records;
 healthcare based on an asynchronous (not real-time), text-based relationship (e.g. questionnaires or
standardised emails) — the quality and reliability of such forms (and procedures specifying when and
how a follow-up dialogue should be done) varies enormously across providers;
33
General Medical Council "Who we work with. Cross border healthcare – telemedicine." .
34
Including Nursing and Midwifery Council (NMC), Healthcare Professions Council (HCPC), General
Dental Council (GDC), Care Council for Wales, General Chiropractic Council (GCC), General Optical
Council (GOC), General Osteopathic Council (GOsC), General Pharmaceutical Council, Northern Ireland
Social Care Council (NISCC), Police Service of Northern Ireland (PSNI), Scottish Social Services
Council (SSSC), Complementary and Natural Healthcare Council (CNHC), Welsh Institute for Health
and Social Care (WIHSC), and Mary Washington Healthcare (MWHC).
35
Including Professional Standards Authority for Health and Social Care, Care Quality Commission
(CQC), Health and Safety Executive (HSE), Human Fertilisation and Embryology Authority (HFEA),
Medicines and Healthcare Products Regulatory Agency (MHPRA), Medical Schools Council.

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 sharing information between healthcare professionals — for example around 80 per cent of online
pharmacies’ patients take advantage of their right to confidentiality and ask for their medical record not
to be shared with their General Practitioner (GP), which could be viewed as a too literal an interpretation
compared to what the intended application of this right was when originally formulated.
We understand from our interview with the HIW that telemedicine is as yet not common in Wales. The HIW
cited an independent (private) GP offering video consultations as the only example they were aware of.
However, the HIW expects telemedicine to develop in the future. In particular, since Wales has many rural
and remote areas, telemedicine might prove beneficial for people living in those areas. In principle, when
registering healthcare providers who would like to offer telemedicine services, the HIW would expect the
same standards of care as in face-to-face interaction.
The GPhC, on the other hand, is predominantly focused on telemedicine in terms of remote prescribing. The
GPhC is mostly concerned with what happens after the prescription is issued by a doctor, which is a
narrower focus than telemedicine in general. With that caveat in mind, the GPhC’s view is that the general
standards pharmacies have to comply with should also be complied with when prescribed medications are
provided to patients remotely. The Council also noted that pharmacies themselves (i.e. without a doctor)
cannot dispense a medicine based on an online questionnaire, or fulfil a prescription which was written by a
doctor who is not registered with the GMC (or an equivalent regulator in other Member States). While
telemedicine might create challenges for pharmacies to verify prescriptions, in principle, they should
exercise due diligence and, if in doubt, reject dispensing the medicine.

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11 Definition of Telemedicine
12 Introduction
Our working definition of telemedicine at the outset of this study was the provision of medical services and
patient care at a distance, using information and communication technologies (ICT). While this interpretation
of telemedicine is broadly consistent with the definitions adopted by many of the organisations we studied,
there is inevitably some variation in their views on what constitutes telemedicine.
In order to understand the key themes appearing in the definition of telemedicine across countries and
regulators, we distinguish between the following aspects:
 How are telemedicine services provided? What kinds of tools are necessary for a medical service to be
considered a telemedicine service?
 Who is involved in providing and receiving telemedicine services? Is telemedicine taking place between
a patient and a doctor, or does it include a doctor consulting with another doctor with respect to a
patient?
 Where are those involved in providing and receiving telemedicine services geographically located?
 What is telemedicine or what could it be used for? Could it be used for diagnosis and treatment as well
as consultations?
 What are the channels for accessing telemedicine services? Are patients acting independently of their
primary care provider or is telemedicine part of the services offered by their healthcare provider?
This section summarises our understanding of how telemedicine is understood in various jurisdictions, rather
than how it is strictly speaking defined in policies and statements. For example, a definition might explicitly
state that telemedicine could be used for teleradiology, but — at the same time — not mention that it covers
interactions between doctors, even though such an interaction is an almost-automatic implication of the
application of telemedicine to radiology. In such cases — to reflect the actual applications of telemedicine in
a given jurisdiction — we expand the formal definition of telemedicine by its implications in terms of our
analytical dimensions.

13 Key findings
In all jurisdictions the use of information and communication technologies (ICT) is considered an inherent
part of telemedicine. This is in line with our working definition. For most of the analysed organisations the
use of any form of ICT communication would be sufficient for a medical service to be considered
telemedicine, but a few regulators (e.g. the USA regulators in Maine and Oklahoma) noted that a single-
modality communication (such as telephone conversation or email exchange) is not sufficient to be
considered telemedicine. See the example of such definition in Table 3 .2 below.

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Table 3.2: Definition of telemedicine excluding single-modality communication — Maine

“Telemedicine” means the practice of medicine or the rendering of health care services
using electronic audio-visual communications and information technologies or other
means, including interactive audio with asynchronous store-and-forward transmission,
between a licensee in one location and a patient in another location with or without an
intervening health care provider. Telemedicine includes asynchronous store-and-
forward technologies, remote monitoring, and real-time interactive services, including
teleradiology and telepathology. Telemedicine shall not include the provision of
medical services only through an audio-only telephone, e-mail, instant messaging,
facsimile transmission, or U.S. mail or other parcel service, or any combination
thereof.
Source: Main Board of Licensure in Medicine “Telemedicine Standards of Practice”.

For almost all (16) of the jurisdictions telemedicine occurs between a patient and a doctor. In addition to that,
most (10) also implicitly or explicitly acknowledge that consultations between doctors could also be
considered as telemedicine. For a small minority (one jurisdiction in our core set, and one other 36) the
definition of telemedicine is limited to interactions between doctors, and thus does not cover interactions
between patients and doctors.
A large majority of jurisdictions (15) consider that distance between the parties involved in telemedicine is a
defining or otherwise implicit feature of this type of medical service. In all but one case, the definition did
not specify whether the doctor needs to be located in a different jurisdiction or country 37 implying that in
general telemedicine could occur between parties in the same country or even city, but just not in the same
room.
Based on our research we could also say that (either explicitly or implicitly) the scope of telemedicine is
determined by its application. Telemedicine could be most straightforwardly applied to consultations (either
between doctors, or between a doctor and a patient). In addition to that, many jurisdictions seem to
acknowledge that telemedicine could be used for diagnostics (15), and treatment (10). Regarding diagnostics,
we could also distinguish between a ‘final’ diagnosis (e.g. the diagnosis given by a doctor to a patient) —
which was considered to be part of telemedicine by 13 jurisdictions, and an ‘intermediate’ diagnosis (e.g.
consultation on the interpretation of pathology and radiology tests) — which was explicitly mentioned only
by two, but which could be considered as implicit in any jurisdiction where doctor-to-doctor telemedicine
consultations occur. Moreover, many of the documents reviewed and regulators spoken to (e.g. those in the
USA) stressed that telemedicine should be understood as just another way of providing healthcare, rather
than as a distinct medical service in its own right. The table below summarises the definitions across
jurisdictions.

36
Denmark and South Africa, respectively.
37
The exception is Oregon, where telemedicine is narrowly defined as a medical service where the patient
is receiving medical care from a doctor who is based outside Oregon.

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Table 3.3: Definition of telemedicine — summary

Doctor-to- Doctor-to- For For

Jurisdiction ICT Distance
patient doctor diagnostics treatment
Australia    
Denmark     
France      
New Zealand     
Portugal      
Singapore      
Alberta    
British Columbia     
Newfoundland and Labrador     
Ontario   
Saskatchewan      
California     
Maine      
North Carolina   
Oklahoma     
Oregon     
Washington     
Total 17 15 16 10 15 10
Note: Cells with no mark mean the telemedicine regulation does not explicitly mention this issue.
Source: Europe Economics

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Regulating Remote Services in Other Industries

14 Requirements for Healthcare

Professionals
In this chapter we discuss the key requirements imposed on or applicable to healthcare practitioners in
general, and doctors in particular. We distinguish between entry requirements, i.e. the requirements for
registration/licensing that healthcare practitioners need to satisfy before they begin to practise telemedicine
(section 15), and ongoing requirements and standards which should be adhered to when providing
telemedicine services (section 16).
In our discussion of the licensing requirements in section 15, we also cover the issues associated with cases
where telemedicine services are provided across different jurisdictions. Since (at least in the context of
telemedicine) licensing appears to be the strongest regulatory tool available to the organisations included in
our research, and because telemedicine is generally considered not to be materially different from other
medical services, the main approach among our sample to address the possibility of cross-border provision of
telemedicine involves licensing.
We also analyse the implications these requirements and broader regulatory frameworks have for where
ultimate responsibility for patient outcomes lies (section 17).

15 Licensing and cross-border requirements

In all the jurisdictions in our sample a doctor needs to be licensed or registered in order to practise medicine.
In this report we use the terms interchangeably to mean an entry requirement for practising as a doctor. In
this section we provide an overview of how this requirement is applied in the context of telemedicine,
especially when medical services are provided by a doctor based in a different jurisdiction to the patient.

15.1.1Licensing requirements and the location of a medical service

Before discussing the licensing requirements in the context of telemedicine, it is important to distinguish
between two interpretations of where a medical service is occurring when the parties involved are not in the
same location. In principle, the medical service could be deemed to take place in the jurisdiction of the
patient, in the jurisdiction of the doctor providing telemedicine, or in the jurisdiction where the
intermediating company is located (i.e. where the organisation via which telemedicine is provided is
registered).
Based on our research, the USA state-regulators (and most of the Canadian ones) broadly agree that the
relevant jurisdiction is that of the patient, and that doctors must comply with the regulations in the patient’s
jurisdiction. The European Directive on electronic commerce, on the other hand, establishes that the service
provider (i.e. the doctor) should comply with the legal requirements in their jurisdiction rather than with the
requirements in the customer’s (i.e. the patient’s) jurisdiction. 38

38
The Directive states that one of its objectives is protection of public health specifically. Directive
2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of
information society services, in particular electronic commerce, in the Internal Market ('Directive on
electronic commerce').

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This basic distinction to a large extent determines the licensing requirements — in jurisdictions where the
location of a telemedicine service is considered to be in the patient’s jurisdiction a ‘local’ licence is often
required;39 in jurisdictions where telemedicine is considered to take place in the doctor’s jurisdiction the
doctor is only expected to be registered with their regulator and does not need to seek additional licensing
with the regulator in the patient’s jurisdiction.
The rationale behind the USA interpretation is that should anything go wrong, the patient should have
recourse to a regional regulatory body, which could then investigate the complaint on the patient’s behalf. In
our fieldwork, the FMRAC (Canada) also noted that most of the province-/territory-level regulators agree
that the patient’s jurisdiction is the one in which a doctor should be registered, and those that do not require a
local licence, at the very minimum require the practitioner to be registered with at least one Canadian
regulator. The Medical Board of Australia also requires doctors treating patients in Australia to be registered
with the Board regardless of where the doctor is located. This ensures that there is always at least one
regulator which could investigate a patient’s complaint regarding telemedicine service he or she received.
An interesting example in this case is New Zealand, where the Medical Council (MCNZ) does not have the
authority to require doctors from other jurisdictions providing care to patients in New Zealand to be
registered with the MCNZ. As such, its statement on telehealth uses the phrase "you should therefore be
registered with the Council" rather than "you must therefore be registered with the Council". See the exact
formulation in Table 4 .4 below.
Table 4.4: Registration requirement in New Zealand

As a doctor, if you provide care to New Zealand-based patients via telehealth, the
Council holds the view that you are practising medicine within New Zealand and you
should therefore be registered with the Council. When practising telehealth, you will be
subject to the same requirements as doctors registered in and practising in New
Zealand. These include the Medical Council’s competence, conduct and health
procedures and the complaints resolution processes of the office of the Health and
Disability Commissioner. The Council will also notify the appropriate regulatory
authorities in other countries if concerns have been raised about your practice.
Source: MCNZ, Statement on telehealth.

Within the European Union, on the other hand, telemedicine seems to fall under a broader category of
services provided across borders.40 This implies that for telemedicine, similar to other services, the relevant
jurisdiction is considered to be that at the origin of the service (i.e. where the doctor is) rather than the
location of the consumer/patient.

15.1.2Type of licence
Where a licence for practising telemedicine is required, there is usually no distinction between ‘telemedicine
licence’ and the standard ‘medical licence’, i.e. regardless of whether the doctor provides services remotely
or face-to-face, he or she will be required to have the same licence. This is consistent with the understanding
that telemedicine is just another way of providing the same medical services as are provided face-to-face,
rather than being a different type of medical service in its own right.
That said, there are several jurisdictions where some form of special ‘telemedicine licence’ is available —
i.e. could be used in place of the standard licence as long as the medical services are limited to telemedicine
(and, sometimes, a small number of patients). 41 First, there are a number of USA states which have (or have

39
Here, and elsewhere in this report, by ‘local’ we mean in the jurisdiction of the patient.
40
European Commission (2006, September 26) "Consultation regarding Community action on health
services", SEC (2006) 1195/4.
41
Alternatively, remote doctors could obtain a standard licence if they wished to.

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had) a special licence for telemedicine services only. 42 This special ‘telemedicine licence’ is an abbreviated
licence (e.g. granted at a lesser fee or in a shorter timeframe) available only to physicians providing remote
services. The motivation behind such licences was to improve access to healthcare, especially in more rural
areas with shortages of physicians. That said, the FSMB (USA) notes that this model is not widely used —
partly because other regulatory solutions to cross-state provision of medical services have been developed
subsequently,43 and partly because there are other reasons physicians might want to be fully licensed in the
states where they practise medicine.
Second, one of the province-regulators in Canada noted that — in order not to discourage doctors and
specialists from other Canadian provinces from providing telemedicine services in this province — the
licence cost is linked to the number of patients treated remotely. Specifically, no licence fee would apply if a
doctor treats fewer than 12 patients, a discounted fee would apply to doctors treating between 12 and 52
patients, and a full fee would be charged for those treating more than 52 patients.
Table 4.5: Licensing requirements — summary

Jurisdiction Telemedicine only licence Local licence

Australia  
Denmark  
France  
New Zealand  encouraged
Portugal  
Singapore 
Alberta  
British Columbia  
Newfoundland and Labrador  
Ontario  
Saskatchewan  
California  
Maine  
North Carolina  
Oklahoma  
Oregon  
Washington  
Total 1 9
Note: Here, and elsewhere in this report, by ‘local’ we mean in the jurisdiction of the patient.
Cells with no mark mean the telemedicine regulation does not explicitly mention this issue.
Source: Europe Economics.

16 Requirements and standards for the provision of telemedicine

We distinguish between three main categories of requirements:
 general requirements — applicable to telemedicine services as a whole;
 procedural requirements — relevant for the interaction between patient and doctor itself; and

42
Out of 70 licensing boards in the USA (there are boards for all the 50 states and territories, as well as
separate boards in some states for osteopathic physicians), 15 introduced a special telemedicine license.
None of those 15 boards took part in our stakeholder engagement programme.
43
In particular the Interstate Medical Licensure Compact, which was adopted by 22 state boards. The
Compact licence is almost automatically awarded as long as a doctor satisfies just 9 criteria (see
http://www.imlcc.org/do-i-qualify/). Among other things, the Compact promotes the use of telemedicine
but it is a full medical licence allowing a doctor to practise medicine regardless of whether it is in the
form of telemedicine or face-to-face services. The licence supports licence portability across states and
enables the use of technology in medicine, but, at the same time, the states and state boards are able to
retain control over the local requirements as physicians holding the Compact licence need to adhere to
local state law.

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 specific requirements — which relate to particular applications of telemedicine.

Below, we present our key findings for each of these categories in turn.

16.1.1General requirements
General requirements predominantly focus on establishing when telemedicine may be used. The key general
requirements or standards we identified in our research are listed below. In general these requirements seek
to ensure that telemedicine replicates as far as possible traditional face-to-face care.
 Ensuring the same standard of care is provided via telemedicine as via face-to-face care. This
requirement is consistent with the understanding of telemedicine as just another way of providing
medical service rather than as a distinct service. Out of the 17 jurisdictions in our core sample, 13
explicitly included this requirement in their policies or standards.
 Having access to sufficient information — be it medical records, medical history or other information
provided by the patient or the referring doctor. Since in telemedicine the patient cannot be physically
examined by the doctor, the latter will be more reliant on medical records or other information from the
patient’s history. This requirement — while more specific and thus limited to a particular aspect of
providing medical services — aims to ensure telemedicine is applied in a safe manner, broadly
equivalent to face-to-face services. It is included as part of policies or standards in 9 jurisdictions.
 Assessing the appropriateness of telemedicine. This requirement means that each time a doctor provides
telemedicine services he or she should first determine whether telemedicine is an appropriate way of
providing healthcare in the particular case. ‘Appropriateness’ could also be seen as equivalent to ‘the
same standard of care’ in the sense that the objective of both requirements is to ensure that telemedicine
is not a justification for inferior quality of care. There is only partial overlap between jurisdictions
including this requirement in their standards — of the 7 jurisdictions which included these
‘appropriateness’ requirements, four also mentioned that the standard of care in telemedicine should be
the same as in other medical services. As such, only one regulator did not mention either of the two
requirements explicitly.
 Having an already established relationship with the patient. This requirement limits the applicability of
telemedicine to situations where doctor and patient already have a relationship which was previously
established face-to-face. It could be viewed as the most definitive requirement to ensure that the doctor is
not missing any relevant information necessary to form a diagnosis. Only one jurisdiction in our core set
applies this requirement.44

44
This restriction also applies in Germany (not in our core sample), and one of the organisations in
Australia (not a regulator) also advocated establishing face-to-face relationship before providing medical
services remotely.

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Table 4.6: Telemedicine general requirements — summary

Same standard Having access to Established

Appropriateness of
Jurisdiction of care as face- sufficient relationship
telemedicine
to-face information with patient
Australia  encouraged*
Denmark  
France   
New Zealand   
Portugal  
Singapore   
Alberta
British Columbia 
Newfoundland and Labrador   
Ontario  
Saskatchewan  
California 
Maine   
North Carolina   
Oklahoma  
Oregon  
Washington  
Total 13 9 7 1
Notes: * Encouraged by a medical association, not the regulator.
Cells with no mark mean the telemedicine regulation does not explicitly mention this issue.
Source: Europe Economics.

As different ways of communication become possible (real-time communication at a distance, text-based

communication at a distance and not in real-time etc.) it is important for regulators to define what constitutes
an ‘established patient-doctor relationship’. At one end of the spectrum are jurisdictions (such as Portugal)
which require a face-to-face interaction. At the other end, are those which do not require any form of
interactive communication (e.g. allow telemedicine to be based solely on static standardised forms). Between
those two extremes are regulators which require or encourage some safeguarding measures, such as real-time
communication, or communication with another physician who has a direct face-to-face relationship with the
patient.

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Table 4.7: Establishing patient-doctor relationship — overview of approaches

In Portugal, with the exception of teledermatology (where even the first consultation could be
conducted remotely, but in real-time),
the first consultation must always be on-site, but subsequent consultations, should be
conducted whenever possible in real-time.
Establishing patient-doctor relationship in absence of a face-to-face interaction is one of the key
issues in regulating telemedicine in the USA. The general guidance from the FSMB (USA) says:
Where an existing physician-patient relationship is not present, a physician must take
appropriate steps to establish a physician-patient relationship consistent with the
guidelines identified above, and, while each circumstance is unique, such physician-
patient relationships may be established using telemedicine technologies provided the
standard of care is met.
A specific application of this general rule in Washington emphasise that establishing such
relationship remotely needs to involve real-time communication:
If a physician-patient relationship does not include a prior in-person interaction with a
patient, the physician may use real-time telemedicine to allow a free exchange of
protected health information between the patient and the physician to establish the
physician-patient relationship and perform the patient evaluation.
In British Columbia (Canada), while pre-established relationship is not required, doctors practising
telemedicine are expected to:
communicate with referring and other treating physicians and provide follow-up and
after-hours care as medically appropriate,
which, at least to some extent, mitigates the lack of direct face-to-face interaction between the patient and
the doctor.
In Newfoundland and Labrador and British Columbia (Canada) a stricter approach to establishing
patient-doctor relationship applies in the context of prescribing regulated medicines.
The Royal Australasian College of Physicians — which is not a regulator — states that:
every effort should be made to facilitate the current healthcare provider’s direct
involvement.
Source: Europe Economics.

16.1.2Procedural requirements
Procedural requirements comprise standards that are applicable to the provision of telemedicine services.
These largely relate to the electronic/remote exchange of information, which is a specific feature of
telemedicine. Key issues we identified are:
 Ensuring confidentiality, safety and/or security of the exchanged information. This requirement, while
relevant for all medical services, could be viewed as particularly important for telemedicine where
sensitive information is being exchanged over distances and via third-party software. It was considered
important in 13 jurisdictions.
 Obtaining patients’ consent. This requirement was covered by 11 jurisdictions (including Denmark,
where telemedicine is limited to doctor-to-doctor relationships). Of those 11 jurisdictions, three
(Australia, Portugal, British Columbia) pair this requirement with the requirement to provide the patient
with an overview of what the telemedicine consultation would look like and the specificities of such
consultations. New Zealand also requires the procedural information to be provided to the patient
without the explicit requirement to obtain patient’s consent. In Saskatchewan, only procedural
information is explicitly required.
 Confirming patients’ identity. The fact that the patient-doctor interaction is remote (and bearing in mind
that telephone conversations between a doctor and a patient would generally be considered as part of
telemedicine), telemedicine might also require additional procedures to confirm the patient’s identity.

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Such requirements are listed in five jurisdictions (Australia, France, Singapore, Maine, and North
Carolina).
 Maintaining medical records. This requirement would be generally applicable to any medical service, but
might be particularly important for telemedicine, especially if patients obtain access to telemedicine
independently of their primary healthcare provider (i.e. they need to carry their records with them rather
than these being stored centrally and accessible by all healthcare providers). The requirement for doctors
providing telemedicine to maintain medical records could, at least to some extent, mitigate the risks
associated with fragmented care (i.e. various doctors treating the same patient without a comprehensive
understanding of the patient’s medical history and current treatments) — those records could in principle
be retrieved and shared with the primary healthcare provider if necessary. Eight jurisdictions included
maintaining medical records explicitly as part of their telemedicine standards. Five of those jurisdictions
are in the USA, where private, employer-based healthcare system possibly increases the likelihood of
patients accessing telemedicine independent of other healthcare services they receive. That said, other
jurisdictions have likely assumed that medical record should be maintained for any form of medical
service, and thus have not mentioned this explicitly in the context of telemedicine. 45
 Technical and equipment requirements — overall, 7 jurisdictions explicitly mentioned this aspect of
practicing telemedicine. In all of these cases, the requirements relate mostly to privacy issues, i.e.
ensuring that the technology used does not compromise confidentiality and security of the exchanged
information. A few regulators also mention confirming that the equipment is “fit for purpose”, which, in
turn, could be viewed as a technical counterpart to assessing that telemedicine is an appropriate way of
delivering healthcare in a particular case. For example, in Washington doctors are required to ensure that
the quality of pictures is sufficient to develop a diagnosis. Some regulators advise testing the equipment
prior to using it (e.g. Australia).

45
For example, the College in Saskatchewan noted in the interview that they require all doctors to maintain
medical records and that this is not something specific to telemedicine, and thus not explicitly mentioned
as a telemedicine requirement. As stated, we include only those requirements explicitly mentioned in the
context of telemedicine.

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Table 4.8: Telemedicine procedural requirements — summary

Maintaining Technical and

Confidentiality, Patient’s Procedural Patient’s
medical equipment
safety, security consent information identity
records requirements
Australia      
Denmark   
France   
New Zealand  
Portugal    
Singapore    
Alberta
British Columbia   
Newfoundland and
 
Labrador
Ontario   
Saskatchewan 
California   
Maine     
North Carolina  
Oklahoma   
Oregon 
Washington    
Total 13 11 5 5 8 7
Note: Cells with no mark mean the telemedicine regulation does not explicitly mention this issue.
Source: Europe Economics.

16.1.3Specific requirements
Some jurisdictions also develop telemedicine standards or requirements applicable only to specific areas of
medical practice. The most common area in which such specific standards are included is prescribing
medicines online. Specifically, many of the Canadian and USA jurisdictions explicitly prohibit remote
prescribing in certain circumstances or of certain substances. For example, Maine does not allow prescribing
medication based only on a static, online questionnaire without any form of active interaction (not
necessarily face-to-face) between the patient and the doctor. In Newfoundland and Labrador, and British
Columbia, doctors must not prescribe medical marijuana, narcotics or other controlled or regulated
medications unless they have access to sufficient information or meet certain requirements. These
requirements are embedded in the Colleges’ Standards for Telemedicine, which are binding requirements
reflecting the minimum level of standards expected by the Colleges (as opposed to non-binding guidelines).
Furthermore, New Zealand and Saskatchewan provides specific standards for practising teleradiology or
telepathology, while Portugal has separate requirements relevant for teledermatology. These are all described
or referred to in the Appendix 2 — core countries.

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Table 4.9: Telemedicine specific requirements — summary

Teleradiology,
Jurisdiction Prescribing Teledermatology
telepathology
Australia
Denmark
France
New Zealand 
Portugal 
Singapore
Alberta 
British Columbia 
Newfoundland and Labrador 
Ontario
Saskatchewan  
California
Maine 
North Carolina 
Oklahoma
Oregon
Washington
Total 6 2 1
Note: Cells with no mark mean the telemedicine regulation does not explicitly mention this issue.
Source: Europe Economics.

17 Locus of responsibility
With telemedicine services relying more heavily on technology and equipment, being provided remotely, and
potentially involving more than one doctor or healthcare professional in the patient’s care, the question of
who is ultimately responsible for the diagnosis and treatment could be more complex than that in standard
face-to-face healthcare.
We explored the issue of responsibility predominantly through interviews. In most jurisdictions, it seemed to
be clear that where patient and doctor are in direct contact — regardless of whether the contact is face-to-
face or via communication software — the consulting doctor is ultimately responsible for the diagnosis and
treatment, including any problems.
In cases where the patient is not in direct contact with a doctor — e.g. where the telemedicine consists of a
family physician (the originating doctor) consulting with a specialist — the approach is slightly more varied
across regulators. For instance, the FMRAC (Canada) — while not being a regulator strictly speaking — is
of the view that in general the originating doctor should be considered ultimately responsible for the
outcome. Denmark — where the definition of telemedicine covers only to doctor-doctor consultations —
takes a similar approach, i.e. the doctor who is in direct contact with the patient would be held ultimately
responsible.46
This does not necessarily mean that the specialist to whom the originating doctor refers to is not responsible
for the quality of the service/consultation he or she provides. For example in the case of teleradiology, the
regulator in Saskatchewan said that the tele-radiologist is considered responsible for interpreting the images
(i.e. it is not the responsibility of the referring doctor), but the clinic through which the referring doctor
operates needs to have a medical director who is responsible for ensuring that appropriately qualified
specialists are hired, and thus is indirectly responsible for the quality of the telemedicine services obtained by
the clinic. On the other hand, in North Carolina, the responsibility would be shared between both doctors.
Yet another case would be where a nurse is physically next to the patient who consults a remote doctor. The
Saskatchewan regulator said that its view is that in such a case the nurse should only act within his/her scope

46
This is also true in South Africa, where — similar to Denmark — the definition of telemedicine only
covers doctor-doctor interactions.

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of responsibilities, i.e. Saskatchewan legislation does not permit the remote doctor to delegate to the nurse
action that is not within the nurse’s scope of practice as determined by the nurse’s regulatory body. This also
implies that the nurses are only responsible for things within their competencies, and not the overall outcome
or the doctor’s misdiagnosis, which the nurses are not qualified to verify. This approach could be analogous
to circumstances where other healthcare professionals are engaged in telemedicine but are not the diagnosing
doctor (such as staff in a care home facilitating a consultation between a patient and a doctor).
Table 4.10: Locus of responsibility in robotic procedures — Singapore Medical Council

If you avail your patients of robotic procedures performed by other doctors remotely,
you have only delegated an aspect of care but still retain responsibility for the overall
management of the patients. If you perform robotic surgery on a patient remotely, the
standard of care you are required to provide to the patient is no different than if you
were to perform the operation in person.
Source: Singapore Medical Council, Guideline A6 of the 2016 edition of the ECEG.

18 Consequences of non-compliance
As mentioned in section 9 the requirements discussed above might vary in the degree to which they are
binding and the potential repercussions doctors might face as a result of non-compliance. Based on the
evidence gathered, we consider there to be three general categories of requirements, with varying degrees of
enforcement:
 Requirements imposed by law. These are requirements imposed by law and upheld by regulators.
Violation of these requirements is illegal and a criminal offence. An example could be the legal
requirement to have a licence in order to practise medicine.
 Standards. Standards are imposed by regulators and usually reflect the minimum standards expected in
medical practice. Standards are usually binding and a condition of continued licensing / registration.
Some regulators state that their Standards reflect legal requirements, and that they are enforceable by
law. Therefore a professional not upholding the regulators’ standards may not be acting illegally, but
may be disciplined and struck off the register by the regulator.
 Guidelines and codes of conduct. These are generally considered to be non-binding, and can reflect best
practice.

18.1.1Licensing requirements
In general, the most indisputable and binding requirement is to be licensed or registered to practise with the
relevant regulator.47 In the interviews with the USA and Canadian regulators, it became clear that compliance
with the ‘local’ licensing requirements is generally not a problem. In the USA it is against the law to practise
medicine without a licence, which — combined with the understanding that medical services (including
telemedicine) are occurring where the patient is located — implies that providing telemedicine services to a
patient without the relevant ‘local’ licence is a criminal offence, and thus — if uncovered — could have
serious consequences for the doctor (i.e. criminal proceedings).
Furthermore, doctors providing remote services to patients via healthcare institutions are unlikely to violate
the licensing requirements of that local jurisdiction. First, doctors will need a ‘local’ licence to obtain
benefits from the institution which hires them to provide the remote services. Second, hospitals and other
healthcare providers generally want to avoid the liability associated with employing an unlicensed (remote)
healthcare practitioner. Finally, hospitals have to comply with a number of standards to obtain accreditation
(and receive payment) so they tend to be careful about hiring someone who is unlicensed. So despite the fact
47
Clearly, which practitioners are required to be licensed depend on the regulator’s mandate and/or
national legal framework.

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that healthcare providers are not directly responsible for ensuring all their remote healthcare practitioners
hold appropriate licences, in practice they create additional layer of oversight.
This additional layer of oversight might be effective as a healthcare provider is likely to ensure its remotely
employed doctors hold appropriate licences in advance of employing them (i.e. proactively rather than
retroactively in response to a complaint) and because a healthcare provider would monitor in this way not
only doctors based in the USA but also abroad.
Despite the claims that telemedicine licensing requirements are generally complied with in the USA and
Canada, some regulators admitted that — especially in cases where doctors are based outside the USA and
Canada, respectively — it is virtually impossible for the regulators to know whether those requirements are
always adhered to, i.e. whether doctors practising remotely hold a licence. In both countries, as well as in
New Zealand, the regulators generally adopt a complaint-based approach, which means that they usually
only investigate individual doctors and their registration/licensed status with the relevant regulator in
response to a complaint.
From a practical point of view, several of our interviewees suggested that addressing cases of non-
compliance will vary case-to-case. For example, there might be an escalation process whereby even if the
non-compliance represented an infringement of law (such as a foreign doctor practising telemedicine without
a local licence), the local regulator wouldn’t necessarily initiate criminal proceedings in the first instance but
rather would try to resolve the matter first. One interviewee in the USA noted that in such cases it is often
quicker and more effective to work with the offending doctor and the regulator who has direct jurisdiction
over them (including non-USA regulators) to address the problem, rather than to formally notify appropriate
agencies and attorney generals about the violation of USA law.
The global reach of the Internet means that, regardless of whether a local licence is required or not,
cooperation and collaboration between countries and regulators (which effectively have a national reach at
most) becomes vital in ensuring that technology is safely used in providing medical care. Similarly, the
FSMB argued that educating the public about their rights and responsibilities, and physicians about the
regulation they should adhere to, could go a long way in successful application of telemedicine.

18.1.2Requirements and standards for telemedicine services

Requirements other than licensing can be harder to enforce (this would presumably be a feature of any
medical professional regulation, not just relating to telemedicine). Many of the interviewed regulators
indicated that, although their standards were binding, adherence to those standards is not proactively
monitored but rather investigated on case-by-case basis in response to complaints. Since a majority (if not
all) of the ‘telemedicine’ requirements are in fact consistent with the requirements applicable to standard
healthcare services, the violation of those requirements could be generally considered not to be specific to
telemedicine per se.
When discussing potential repercussions for non-compliance with the requirements and standards relevant
for telemedicine, many regulators stressed once again that these would be heavily case-dependent. If the case
under investigation is the first one for that doctor and/or represents a mild deviation from the standards, the
regulator would normally arrange a meeting with the doctor to discuss the case, explain the regulator’s view,
and provide the doctor with the relevant information for the future practice of telemedicine. More serious or
repeated offenders would normally be violating more than just the relevant telemedicine requirements.

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Regulating Remote Services in Other Industries

19 Challenges in Regulating
Telemedicine
In the interviews we explored the key challenges faced by the regulators. The main concern seemed to be
ensuring the same standard of care in telemedicine as in more traditional medical services. In Australia, one
of the regulators noted that the main challenge of telemedicine is to determine in which cases
teleconsultation is sufficient for a full assessment. (However, in our view this may be analogous to other
aspects of medical regulation in which the regulator must allow the professional sufficient scope to
determine the best methods/treatment etc. — regulators generally stipulate broad principles that professionals
must abide by without specifying details for every area of practice.)
Moreover, as noted by one USA regulator, monitoring the standard of care provided via telemedicine and
identifying/addressing low standards may be more difficult compared to face-to-face services. One reason is
that patients may have lower expectations regarding the quality of telemedicine services than face-to-face
services. Patients often use telemedicine only for specific purposes (e.g. sensitive issues which they find
embarrassing and would prefer not to discuss with their primary care provider), and thus do not expect
comprehensive care. Moreover, patients are often willing to accept lower standards of care if the medical
service is provided immediately. Since the USA regulatory model is predominantly complaint-based if,
because of low expectations, patients do not complain about poor standards of received care, the regulator is
unable to take any action to prevent such situations in the future. This means that the standards of care in
relation to telemedicine may well be lower than for traditional delivery methods due to reduced market
discipline –– certainly the interviewee felt this to be the case but as yet did not have evidence (i.e. in the form
of complaints or other research) to formally back this up.
Some of the Canadian provinces are concerned with the fact that with telemedicine services could be
provided in an isolated, fragmented manner, which could create health risks for the patients. This is most
relevant in cases where patients — due to the sensitive nature of their condition for example — do not agree
for the medical records taken during the tele-consultation to be shared with their primary care provider.
For similar reasons, the regulators in Saskatchewan and British Columbia (Canada) noted that the
“entrepreneurial side of telemedicine” (e.g. online pharmacies, dermatology advice) is where ensuring high
quality and comprehensiveness of healthcare becomes challenging from a regulatory point of view.

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Regulating Remote Services in Other Industries

20 Regulating Remote Services in

Other Industries
Using ICT for providing services at a distance is not unique to medicine and many other professions such as
financial, legal, or engineering services have benefitted from the ICT development. In this section we review
associate guidance and policies by relevant regulatory bodies and professional associations. More
specifically, we have reviewed the following professions:
 engineering,
 surveying, and
 legal advice.
We base on findings on desk research, a review of relevant professional guidance and interviews with
representatives of professional regulatory bodies.

21 Engineering
The UK’s Engineering Council is the main regulatory body for the engineering profession. We reviewed the
Engineering Council’s Standards48 that define registration process and competence requirements and
Guidance49 that deal with ethics, risk, security, and sustainability. We also held short conversations with the
Engineering Council and the Institution of Engineering and Technology (one of 35 professional bodies for
engineers).50
Examples of remote services range from basic remote IT support, to equipment monitoring and maintenance
services using ICT, and complex technical work involving devices (measurement tools, manipulators, robots,
etc.) controlled by an engineer in another location. Remote engineering might be a preferred option where
there are additional health and safety risks, e.g. nuclear power sites, or for sites that might be difficult to
reach, e.g. underwater works.
There seems to be no recognised definition of remote engineering services. An internet search suggests that
remote services happen when the engineer located in one place uses ICT to work on a technical assignment
or system located elsewhere (with or without support of engineers at the remote site). As with any other
engineering problem, a remote engineering service would involve some degree of problem-specific thinking
and searching for a solution, and in this respect, it would resemble telemedicine.
It also seems that there is no special guidance for providing remote engineering services — all rules and
recommendations apply to remote services as if they were provided on site.

22 Surveying
The Royal Institute of Chartered Surveyors (RICS) is the regulatory professional body for UK-based
surveyors.

48
The Engineering Council "UK Standard for Professional Engineering Competence (UK-SPEC)".
49
The Engineering Council "Guidance.”
50
The Engineering Council "Professional Engineering Institutions."

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Regulating Remote Services in Other Industries

A simple internet search indicates that companies providing remote services tend to use ICT and remotely
controlled devices to survey a building or a plot of land. For example, a client might send photos of the
building to the surveyor who would analyse the quality of construction work and materials used and provide
recommendations on the property value or potential repairs. Another example of remote services would be
the use of video-drones to examine a high building without installing scaffolding or using high-altitude
workers. Similar to certain applications of telemedicine, the quality of remote surveying advice would
depend critically on the quality of images sent by the client or acquired by the drone.
That said, based on the RICS ‘Rules of conduct’ for individual members and firms’, 51 it appears that the
RICS has no definition of remote services nor specific guidance on the providing them.

23 Legal advice
The Solicitors Regulation Authority (SRA) is the regulatory body for solicitors in England and Wales. The
SRA established the SRA Innovate initiative to review and support innovative practices in the legal services
industry, such as online services or one-stop packaging. 52 However, the SRA has made no special regulatory
provisions for remote legal services (e.g. via email, telephone or video conferences) or automated legal
solutions (e.g. online legal packages), in its Principles or the Code of Conduct.
By contrast, the Law Society which is the representative body for solicitors in England and Wales, has
published a practice note on semi-automated online services. 53 The document describes the Law Society's
view of good practice in cases where legal services are provided electronically with little or no human
intervention. We reviewed the practice note and further explored the topic in the interview with them. The
practice notes are not binding or compulsory, rather they represent the view of the Law Society on good
practice. When there is a complaint against a legal professional, the practice note would represent a model
against which the conduct of legal professional would be assessed.
Semi-automated services in the context of legal advice are not simply electronic communication, but refer to
online tools and automated technologies that provide solutions to clients’ legal problems (rather like an
automated decision tree based on algorithms). The automated answer can sometimes be verified by a
solicitor to ensure the key elements of the problem and the risks are properly considered by the tools.
Examples of semi-automated services include automated preparation of legal documents (e.g. wills) or
uncontested online divorces. Our interviewee from the Law Society suggested that semi-automated services
could be as good or in some cases even better than the traditional services (as they can make use of the
wealth of accumulated knowledge) but are also subject to certain risks. These risks are broadly associated
with: (1) identifying the client and the problem, and (2) dealing with the problem itself.
If the remote legal service is provided entirely via a standardised interface, there is a risk of incorrectly
identifying the client’s identity and his legal rights (which could be especially important in case of
vulnerable clients). Therefore, the Law Society recommends some degree of direct personal interaction, to
assess the client’s vulnerability and avoid undue influence or impersonation.
The second type of risk relates to the automated legal solutions. It is important to understand that the semi-
automated services rely on complex decision-trees, and it is not obvious to what extent solicitors need to
verify the path along the decision tree in each case. 54 As semi-automated solutions evolve (potentially taking
51
Royal Institute of Chartered Surveyor (2017) "Rules of conduct." .
52
Solicitors Regulation Authority (2015) “SRA Innovate. Innovation and growth in legal services.”
53
Law Society (2016, June 8) “Semi-automated online services. Practice note” .
54
While our understanding is that there are no legal cases associated with this issue, what could be
expected in practice is that the solicitor — regardless of the methods used — is ultimately responsible for
the advice given to the client; if the advice is poor due to errors in the software used, the solicitor could
sue (or otherwise request compensation from) the software provider while at the same time being sued by
the client.

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Regulating Remote Services in Other Industries

advantage of machine learning) and become virtually impenetrable for individual solicitors, it will become
even more challenging to ensure transparency and to determine accountability. The Law Society is currently
considering what kind of governance processes would be necessary in such cases.
When compared to telemedicine, the requirement of direct interaction between the client and the legal
professional is similar to the discussion around establishing a patient-doctor relationship. Further, the issue
of undue influence or impersonation in the legal profession resembles the issues of informed consent and
patient’s identity in many telemedicine policies. The issue of correct algorithms (and when it is appropriate
to fully rely on them and when a qualified person should monitor the outcome) could in turn be related to
online pharmacies where prescriptions are issued based on a standardised questionnaire.

24 Summary
The use of remote services and formal regulations varies between industries. Most professional regulators do
not have any specific policies relating to the regulation of remote services. By contrast, the Law Society
provides detailed guidance for automated ICT-based services as the legal services, in principle, deal with
complex personal issues and may impact profoundly the client’s quality of life.
With respect to telemedicine, several lessons can be drawn from the (non-)regulation of remote services in
other industries. These are largely a confirmation of requirements already in place in some jurisdictions,
rather than providing new insights into regulatory approaches.
 The lack of a clear definition of tele-services among these regulators suggests that these do not recognise
remoteness and ICT as an additional feature of the profession that requires separate regulation. Rather,
the general consensus is that professionals in these areas should adhere to the same standards of care as
in “face-to-face” services. This may also suggest that these regulators are not as up-to-date with
advances in remote technologies as the industries, although this is not something we can verify.
 The exception is the Law Society which, as a professional body rather than a regulator, may arguably be
more up-to-date with advances in the profession. A lesson here may be that whilst medical professional
bodies may not issue laws and regulations, they may have relevant insights into the potential advances in
telemedicine. Our research for this report did not find any notable coverage of telemedicine by non-
regulator professional bodies, but presumably more informal discussions with these would be valuable
over time.
 The Law Society’s requirement for some direct interaction between the client and the legal professional
can be applied to the telemedicine issue of establishing a patient-doctor relationship before the provision
of telemedicine.
 This is reinforced by the need to verify the client’s identity when offering legal services via a remote
interface, which again is reflected by the issue of patients’ identities and informed consent in the context
of telemedicine.
 The risks entailed in using increasingly sophisticated and technically opaque automated solutions could
be a useful learning point for telemedicine. The greater the use of decision-making algorithms, the less
direct control the doctor has over the outcome. Whilst this is currently most identifiable with online
prescribing using standardised questionnaires, it may extend to other forms of consultation. The Law
Society’s awareness of the risks and cautions around over-reliance on these tools is a valuable lesson,
even though it is still considering how to address this issue.
The table below summarises the use of remote services in the three industries and the available regulation.

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Regulating Remote Services in Other Industries

Table 6.11: Remote services in selected industries

Regulation
Informal Risks / Similar to
Industry Examples Benefits of remote
definition challenges telemedicine?
services
Reduce health
Remote IT
and safety
support;
risks, e.g. Yes, remote service
Engineer at Equipment
nuclear power No-one on site involves ICT and
one site monitoring and
sites to quickly deal problem-specific No special
Engineerin remotely maintenance
Access sites with an thinking and searching regulation or
g controls services using
that might be emergency for a solution; guidance
equipment at ICT;
difficult to situation substitutes for human
another site Complex
reach, e.g. presence
technical work
underwater
using robots
works
Client sends
photos of the
Save
house interior – Yes, remote service
Surveyor time/cost;
surveyor involves ICT,
using ICT to Reach Critical
advises on examination of a No special
assess otherwise dependence on
Surveying house value or specific building and regulation or
condition of a inaccessible quality of
repair; individual advice; guidance
building/plot parts of the images
Video-drone to substitutes for human
of land building or
examine a high presence
area
building/plot of
land
Client’s
identity
verification;
To some extent: client’s
Preparing a Save time on Transparency
identity verification is a
standardised standard and
Semi- similar issue; Law Society’s
document, e.g. solutions; accountability
automated Problem description is practice note
Legal will; Reduce cost; when
legal services similar to making the on semi-
services Online legal Increase automated are
using ICT and diagnosis; automated
advice for an accessibility based on
algorithms Could be viewed as online services
undisputed of legal algorithms too
similar to questionnaire-
divorce services complex for a
based online pharmacies
solicitor to
fully
understand
Source: Europe Economics.

- 37 -
Conclusions

25 Conclusions
Telemedicine is a quickly evolving area of healthcare and, thus, often a challenging one to regulate.
Technological progress creates opportunities for better, cheaper and more accessible medical services, but it
also creates risks (such as inferior standard of care or lack of regulatory oversight in cases of cross-
jurisdiction telemedicine), which are recognised by regulators around the world.
In our research, we found that telemedicine was usually perceived as a means of delivering medical services
rather than a medical service which is distinct from more traditional healthcare. Telemedicine seems to be
defined in broadly similar terms across jurisdictions, i.e. as a medical service provided remotely using ICT. It
is usually interpreted as an interaction between a patient and a doctor, but in many jurisdictions it is
recognised that it could also include consultations and services exchanged between medical professionals (or
even only between the latter). Telemedicine is not necessarily limited to consultations, and might also
include diagnosis and treatment.
There are two general categories of requirements imposed on doctors practising telemedicine: entry
licensing/registration requirements for permission to practise medicine, and ongoing requirements related to
the provision of the telemedicine services themselves. The licensing requirement is the main tool regulators
use to ensure a form of proactive oversight over doctors providing medical services while being located (and
subject to regulation) in both their jurisdiction and in another jurisdiction. It is also the strongest requirement
which might have legal implications if not complied with. However, in cases where doctors practising
telemedicine are outside the regulator’s jurisdiction, this tool is available only to certain regulators, most
notably those in the USA and Canada. In those jurisdictions, the licence requirements for practising
telemedicine are generally the same as the requirements for practising in the traditional face-to-face manner,
but in some cases an abbreviated or cheaper licence is available if used solely for the purpose of
telemedicine, or for a small number of patients.
The remit of European regulators — including the GMC — seems to include only doctors (and other medical
professionals, where relevant) who are physically located in their jurisdictions. This appears to be a material
limitation in terms of overseeing cross-jurisdiction telemedicine services.
Requirements relevant to the provision of telemedicine services themselves are usually in the form of
standards, policies or codes of conduct. While compulsory to adhere to in theory (i.e. as a condition of
maintaining a licence to practise), these requirements are much harder to monitor and enforce. The key
requirements we found in our research relate to:
 ensuring the same standard of care as that of face-to-face healthcare;
 ensuring that telemedicine is an appropriate method of delivering healthcare;
 ensuring that sufficient information regarding patient’s medical history and current condition is available
for diagnosing and/or treating patients;
 ensuring confidentiality, safety and security of the exchanged information;
 obtaining patient’s consent for this method of providing medical services, sometimes paired with a
requirement to provide an overview of what the patient can expect from a tele-consultation or tele-
treatment; and
 confirming a patient’s identity and maintaining medical records.
The key types of telemedicine requirements adopted elsewhere in the world appear to be mirroring the
challenges some of the UK regulators already observed in the context of remote medical care. In particular,
among the telemedicine-related concerns raised by the Care Quality Commission (CQC) are:
Regulating Remote Services in Other Industries

 access to patients’ long-term medical records — which relates to the requirement to ensure that sufficient
information regarding patients’ medical history and current condition is available for diagnosing and/or
treating patients;
 identification of the patient, including some key characteristics such as age, gender, body weight etc. —
which relates to the requirement to confirm patients’ identities;
 healthcare based on an asynchronous, text-based relationship (e.g. questionnaires or standardised emails
— which relates, again, to the requirement that sufficient medical information is obtained before forming
a diagnosis or starting treatment, but also to the fact that some regulators do not consider single-modality
communication to fall within the scope of telemedicine;
 requesting confidentiality being potentially abused by patients to avoid sensitive information being
shared between the remote doctor and their primary healthcare provider — which is closely matched by
the concerns of the USA and Canadian regulators that telemedicine increases the risk of patients being
treated in isolation of other healthcare services they receive, and which could be mitigated (as some
regulators and organisations from jurisdictions outside North America do) by a requirement (or
encouragement) to provide telemedicine only in cases of pre-established face-to-face relationship
between the patient and the doctor, or at least a physical intermediation from another healthcare
professional at the location of the patient.
Many of the interviewed regulators expressed a concern that, while telemedicine could be extremely helpful
in terms of increasing accessibility of healthcare in remote or rural areas, it is often difficult for the regulator
to monitor and ensure the same quality of care is provided as in medical services provided in a more
traditional, face-to-face setting. First, technology makes it possible to provide telemedicine services from
outside the regulator’s jurisdiction (and thus its area of influence), but also it means that in practice it is often
impossible to track who is in fact providing the medical service. Second, patients often seem to be willing to
accept a lower standard of care in exchange for increased privacy or immediate access to a doctor.
Even though in some jurisdictions we reviewed telemedicine has been practised for many years and appears
to be relatively common, the relevant regulation is still evolving.

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Appendix 1 — online survey — Summary

Appendix 1 — online survey

- 40 -
Survey Respondents

26 Telemedicine Online Survey

Introduction
Thank you for responding to our questionnaire.
Europe Economics has been commissioned by the General Medical Council (GMC) to conduct a review
of regulatory approaches to telemedicine, in order to contribute to the development of the GMC's policy in
this area. This questionnaire seeks to gather views and approaches across a range of healthcare regulators to
inform our review.
By way of context, our working definition of telemedicine is "the provision of medical services and patient
care at a distance, using information and communication technologies (ICT)". However, we invite other
definitions of telemedicine in the questionnaire.
We are interested in collating a broad range of information on the regulation of telemedicine, and as such
encourage you to answer all questions and include as much information as possible in your responses.
However, should this not be feasible we would still value brief or summarised answers.
We would appreciate if you could submit your responses by 2 October 2017.
Please contact Ada Kinczyk at [email protected] should you have any queries. 

About your organisation

1 Please provide the full name of your organisation.

2 Who or what does your organisation regulate?
 Individual healthcare professionals
 Healthcare systems
 Other

3 Please provide a few details about who or what your organisation regulates. In particular, whether your
organisation regulates individual professionals or wider healthcare organisation/systems. 

4 What is the geographical coverage of your organisation?

 Whole country (national regulator)
 State / province / etc. (regional regulator)
 Another geographical unit, please specify Please enter an 'other' value for this selection.

5 Please name the country (and, if applicable, region/state/province) where your organisation operates?

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Online survey responses

Your organisation and telemedicine

6 Does your organisation have specific regulations or policies relating to telemedicine?
 Yes – formal regulations and/or policies regarding telemedicine
 Yes – informal or “work-in-progress” regulations and/or policies, including non-binding
recommendations
 No – no specific regulations or policies relating to telemedicine

7 How does your organisation define telemedicine?

Please type in the box below or provide us with references to the relevant documents (links to websites
can be pasted in the box, pdfs and other formats can be sent to [email protected])

8 In what areas does your organisation place telemedicine-related requirements on those subject to your
regulation/oversight? Please tick all that apply.
 Licensing and/or registration
 Qualifications and training, including continuing professional development
 Standards of work
 Discipline and/or fitness to practise
 Other - Write In Please enter an 'other' value for this selection.

9 Please describe the telemedicine-related requirements and/or polices placed on those subject to your
regulation / oversight.
Please type in the box below or provide us with references to the relevant documents (links to websites
can be pasted in the box, pdfs and other formats can be sent to [email protected])

10 If you do not have a telemedicine regulation or policy in place, do you expect your organisation to
develop such regulation/policy in the near future?
 Yes
 No
 Don't know

11 If you expect your organisation to develop telemedicine regulation or policy in the near future, please
provide a description of the upcoming regulation/policy in the box below.
Please type in the box below or provide us with references to the relevant documents (links to websites
can be pasted in the box, pdfs and other formats can be sent to [email protected])

12 In the context of regulating telemedicine, are there other regulators or professional bodies you interact
with? Examples of interaction may include (the list is for illustration only):
 If your organisation regulates doctors you might interact with a health system regulator.
 Collaborate with other regulators on the development of telemedicine policy.
 Ensure compatibility of your policies with policies of other regulators.
Please provide the name of each regulator you interact with and a description of your interaction.

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Online survey responses

13 Are there any other issues related to telemedicine that are particularly relevant to your organisation
and/or the profession you regulate? Please describe these in the box below.

14 If you are willing to discuss your approach to the regulation of telemedicine with us by way on an
interview, please include your name and contact details here, or email us directly
at [email protected].

15 We're intending to use the information you provided in the report for the GMC about approaches to
regulating telemedicine. If you'd prefer any of your responses to be kept confidential, please specify that
in the box below.

Thank You!

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Survey Respondents

27 Survey Respondents
Organisation Jurisdiction
Australian Health Practitioner Regulation Agency Australia
Australia (New South
Medical Council of New South Wales
Wales)
Bhutan Medical and Health Council, Thimphu, Bhutan Bhutan
Federation of Medical Regulatory Authorities of Canada Canada
College of Physicians and Surgeons of Alberta Canada (Alberta)
College of Physicians and Surgeons of British Columbia Canada (British Columbia)
College of Physicians and Surgeons of Ontario Canada (Ontario)
College of Physicians and Surgeons of Saskatchewan Canada (Saskatchewan)
Danish Patient Safety Authority (Styrelsen for Patientsikkerhed) Denmark
French Medical Council (Conseil National de l`Ordre des Médecins) France
German Medical Association (Bundesärztekammer) Germany
Indonesia Medical Council Indonesia
Medical Council of Ireland Ireland
Kenya Medical Practitioners and Dentists' Board Kenya
Medical Council of New Zealand New Zealand
Polish Supreme Chamber of Physicians and Dentists (Naczelna Izba
Poland
Lekarska)
Singapore Medical Council Singapore
Health Professions Council of South Africa South Africa
South Sudan General Medical Council South Sudan
General Pharmaceutical Council (GPhC)  UK
Dubai Health Authority United Arab Emirates
American Academy of Family Physicians USA
Federation of State Medical Boards (FSMB) USA
National Board of Medical Examiners USA
Medical Board of California USA (California)
State of Maine Board of Licensure in Medicine USA (Maine)
North Carolina Medical Board USA (North Carolina)
Oklahoma State Board of Medical Licensure and Supervision USA (Oklahoma)
Oregon Medical Board USA (Oregon)
Washington, DC Board of Medicine USA (Washington)

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Online survey responses

28 Online survey responses

In this section we summarise all the responses to our online survey — both from the core countries and non-
core countries. We do not intend to analyse or discuss these results in detail, but provide the charts and tables
to illustrate the responses we received.
Table 10.12: Survey respondents — country of origin

Country Core or non-core Number of organisation

USA Core 9
Canada Core 5
Australia Core 2
United Kingdom Core 1
New Zealand Core 1
Denmark Core 1
France Core 1
Singapore Core 1
Bhutan Non-core 1
Germany Non-core 1
Indonesia Non-core 1
Ireland Non-core 1
Kenya Non-core 1
Poland Non-core 1
South Africa Non-core 1
South Sudan Non-core 1
United Arab Emirates Non-core 1
Total 29

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Online survey responses

Figure 10.7: Geographical coverage of the organisations

What is the geographical coverage of your organisation?

State / province /
etc. (regional
regulator)
Whole country
12
(national
regulator)
17

Note: Sample size: 29.

Figure 10.8: Areas of telemedicine-related requirements

In what areas does your organisation place telemedicine-related requirements on those subject to your
regulation/oversight?
20
18
18
16
14
12 13
10
10
8 9 9
6
4
2
0
1 2 3 4 5

Note: Sample size: 27.

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Online survey responses

Figure 10.9: Type of telemedicine regulation in place

Does your organisation have specific regulations or policies relating to telemedicine?

Yes ; formal regulations and/or

5 policies regarding telemedicine
No ; no specific regulations or
policies relating to telemedicine
Yes ; informal or

21

Note: Sample size: 29.

Figure 10.10: Development of telemedicine regulation

If you do not have a telemedicine regulation or policy in place, do you expect your organisation to
develop such regulation/policy in the near future?

Yes
Plans to update
4
3

Don't know
3

Note: Sample size: 10. All of those that replied “Yes” or “Don’t know” had no formal regulations and/or policies regarding telemedicine. Those that
are reported under “Plans to update” already had formal regulations and/or policies regarding telemedicine.

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Online survey responses

29 Summaries of Key Findings

In this section we replicate the summary tables from the main body of the report but provide direct links to
the relevant sections of Appendix 2 — core countries where more details can be found. We also note that
some of the findings come from interviews which are not transcribed here. As such, not all information
included in the summary tables could be directly referenced here.

30 Definition of telemedicine
Table 11.13: Definition of telemedicine — summary

Appendix 2
Doctor-to- Doctor-to- For For
Jurisdiction ICT Distance section
patient doctor diagnostics treatment
reference
40
Australia    
60
Denmark      108
125
France      
129
New Zealand      135
144
Portugal      
148
Singapore       156
Alberta     79
British Columbia      84
Newfoundland and
Labrador
     89
Ontario    94
Saskatchewan       99
California      214
Maine       190
North Carolina    194
Oklahoma      219
Oregon      199
Washington      203
Total 17 15 16 10 15 10
Source: Europe Economics

31 Licensing requirements
Table 11.14: Licensing requirements — summary

Telemedicine only Appendix 2

Jurisdiction Local license
license section reference
Australia   42
Denmark   110
France   127
New Zealand  encouraged 138
 146
Portugal 
150

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Online survey responses

Telemedicine only Appendix 2

Jurisdiction Local license
license section reference
Singapore 
Alberta   82
British Columbia   87
Newfoundland and Labrador   92
Ontario   97
Saskatchewan   102
California   217
Maine   192
North Carolina   197
Oklahoma   222
Oregon   201
Washington   206
Total 1 9
Source: Europe Economics.

32 Requirements for healthcare professionals

33 General requirements
Table 11.15: Telemedicine general requirements — summary

Having
Same Established
access to Appropriateness Appendix 2
Jurisdiction standard of relationship
sufficient of telemedicine section reference
care with patient
information
41
Australia  encouraged*
62
Denmark   109
France    126
New Zealand    137
Portugal   149
Singapore    157
Alberta 81
British Columbia  86
Newfoundland and Labrador    91
Ontario   96
Saskatchewan   101
California  216
Maine    192
North Carolina    196
Oklahoma   221
Oregon   201
Washington   205
Total 13 9 7 1
Note: * Encouraged by a medical association, not the regulator.
Source: Europe Economics.

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Online survey responses

34 Procedural requirements
Table 11.16: Telemedicine procedural requirements — summary

Procedural Maintainin Technical and Appendix 2

Confidentiality, Patient’s Patient’s
informatio g medical equipment section
safety, security consent identity
n records requirements reference
41
Australia      
62
Denmark    109
France    126
New Zealand   137
Portugal     149
Singapore     157
Alberta 81
British
Columbia
   86
Newfoundland
and Labrador
  91
Ontario    96
Saskatchewan  101
California    216
Maine      192
North Carolina   196
Oklahoma    221
Oregon  201
Washington     205
Total 13 11 5 5 8 7
Source: Europe Economics.

35 Specific requirements
Table 11.17: Telemedicine specific requirements — summary

Teleradiology, Appendix 2
Jurisdiction Prescribing Teledermatology
telepathology section reference
Australia
Denmark
France
136
New Zealand 
138
Portugal  145
Singapore
Alberta  81
British Columbia  86
Newfoundland and Labrador  91
Ontario
Saskatchewan  n/a
California
Maine  192
North Carolina  196
Oklahoma
Oregon
Washington
Total 6 1 1
Source: Europe Economics.

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Online survey responses

Appendix 2 — core countries

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Australia — Country level overview

1 Australia55
36 Country level overview

37 Relevant organisations
 Australian Health Practitioner Regulation Agency (AHPRA)
 governed by the Health Practitioner Regulation National Law, which is in force in all Australian
states and territories;
 regulates 14 health professions via nationally consistent legislation under the National Registration
and Accreditation Scheme and supports the 14 National Boards that are responsible for regulating
these professions;56
 publishes national registers of practitioners so important information about the registration of
individual health practitioners is available to the public;
 manages the registration and renewal processes for health practitioners and students around Australia;
 on behalf of the Boards, manages investigations into the professional conduct, performance or health
of registered health practitioners, except in New South Wales and Queensland;
 supports the Boards in the development of registration standards, and codes and guidelines;
 provides advice to the Ministerial Council about the administration of the National Registration and
Accreditation Scheme.57
 Medical Board of Australia (MBA)
 registers medical practitioners and medical students;
 develops standards, codes and guidelines for the medical profession; 
 investigates notifications and complaints about medical practitioners; 
 where necessary, conducts panel hearings and refers serious matters to Tribunal hearings; 
 assesses international medical graduates who wish to practise in Australia;
 approves accreditation standards and accredited courses of study;
 supported by boards in each state and territory, which have the delegated powers to make individual;
registration and notification decisions, based on the national policies and standards. 58
 RACGP (The Royal Australian College of General Practitioners)
 responsible for maintaining standards for quality clinical practice, education and training, and
research in Australian general practice;
 supports GPs, general practice registrars and medical students;
 activities of education, training and research;
55
In presenting the regulation for Australia and other countries, we have adhered to the wording and spelling used in
the regulatory documents (e.g. “practice” both as a verb and a noun for Australia, US or Canada).
56
Aboriginal and Torres Strait Islander Health Practice Board of Australia; Chinese Medicine Board of
Australia; Chiropractic Board of Australia; Dental Board of Australia; Medical Board of Australia;
Medical Radiation Practice Board of Australia; Nursing and Midwifery Board of Australia; Occupational
Therapy Board of Australia; Optometry Board of Australia; Osteopathy Board of Australia; Pharmacy
Board of Australia; Physiotherapy Board of Australia; Podiatry Board of Australia; Psychology Board of
Australia.
57
http://www.ahpra.gov.au/About-AHPRA/What-We-Do.aspx.
58
http://www.medicalboard.gov.au/About.aspx.
Australia — ACRRM (Australian College of Rural and Remote Medicine)

 assesses doctors' skills and knowledge;

 offers ongoing professional development activities;
 develops resources and guidelines;
 advocates for GPs on issues that affect their practice;
 develops standards that general practices use to ensure high quality healthcare. 59
 ACRRM (Australian College of Rural and Remote Medicine)
 setting professional medical standards for training, assessment, certification and continuing
professional development in the specialty of general practice;
 instils professional values, skills and competencies necessary for providing high quality, safe and
appropriate care to a rural or remote community. 60
 AMA (Australian Medical Association)
 membership organisation representing registered medical practitioners and medical students of
Australia;
 advocates on behalf of its members at the Federal, and State and Territory levels;
 improves patient care by supporting the medical profession through a range of essential services. 61
 The Royal Australasian College of Physicians
 professional medical College of physicians in Australia and New Zealand;
 provides accredited specialist training and continuing professional development;
 advocates for healthcare policies that promote the interests of the profession, patients and
communities.

38 Regulatory frameworks
The healthcare system and institutional regulators play supplementary roles in health professional regulation.
To ensure consistency in the regulation of medical professions, a single national scheme for accreditation
and registration was established in 2010 to set out a common set of principles. An umbrella organisations
(the Australian Health Practitioner Regulation Agency) and 14 National Boards, according to the regulated
profession were created to bring commonality to values and processes between professions.
The same procedures for registration, administration of the governing body, and complaints resolution and
professional discipline are followed by each Board. Australian medical professionals’ regulation is based on
co-regulation in partnership with the government, public, and local community. 62 There is compulsory
continued professional development for all healthcare professionals with the goal of maintaining professional
competence.
An independent body for receiving complaints, the National Health Practitioner Ombudsman and Privacy
Commissioner provide ombudsman, privacy and freedom of information oversight of the national health
practitioner regulation scheme, particularly in relation to the actions of AHPRA and the 14 National Health
Practitioner Boards.63
Australia has been a successful adopter of telemedicine, and its capabilities in this area have grown rapidly.
The country’s private healthcare industry successfully provides telemedicine to Australia’s remotest areas,
such as the Northern Territory, where geographic isolation and sparse populations make accessing face-to-

59
http://www.racgp.org.au/yourracgp/organisation/visionstatement/ .
60
http://www.acrrm.org.au/about-the-college.
61
https://ama.com.au/about-ama.
62
http://www.legco.gov.hk/yr13-14/english/panels/hs/hs_hps/papers/hs_hps1111cb2-260-2-e.pdf .
63
https://nhpopc.gov.au/about-us/.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

face medical care difficult. Yet, a number of factors stand in the way of telemedicine becoming a common
practice elsewhere. These include practitioner reimbursement and licensure laws, and concerns around legal
liability, quality of care, and patient safety. There is, in addition, a limited pool of specialists or care
providers to draw from.64

39 Medical Board of Australia

40 Definition of telemedicine
In 2012, the Medical Board of Australia published a set of Guidelines on technology-based patient
consultations under s. 39 of the Health Practitioner Regulation National Law Act (the National Law), which
are to be respected by MBA members in each state and territory.
The Guidelines define technology-based patient consultations as:
Patient consultations that use any form of technology, including, but not restricted to
videoconferencing, internet and telephone, as an alternative to face-to-face
consultations — Medical Board of Australia

41 Regulation of individual doctors who provide telemedicine services

The Guidelines complement “Good Medical Practice: A Code of Conduct for Doctors in Australia”, and
state that medical practitioners who advise or treat patients in technology-based patient consultations should:
 apply the usual principles for obtaining their patient’s informed consent, protecting their patient’s
privacy and protecting their patient’s rights to confidentially;
 make a judgement about the appropriateness of a technology-based patient consultation and in particular,
whether a direct physical examination is necessary;
 make their identity known to the patient;
 confirm to their satisfaction the identity of the patient at each consultation — doctors should be aware
that it may be difficult to ensure unequivocal verification of the identity of the patient in these
circumstances;
 provide an explanation to the patient of the particular process involved in the technology-based patient
consultation;
 assess the patient’s condition, based on the history and clinical signs and appropriate examination
 ensure they communicate with the patient to:
 establish the patient’s current medical condition and past medical history, and current or recent use of
medications, including non-prescription medications,
 identify the likely cause of the patient’s condition,
 ensure that there is sufficient clinical justification for the proposed treatment and. ensure that the
proposed treatment is not contra-indicated (this particularly applies to technology-based consultations
when the practitioner has no prior knowledge or understanding of the patient’s condition(s) and
medical history or access to their medical records);
 accept ultimate responsibility for evaluating information used in assessment and treatment, irrespective
of its source — this applies to information gathered by a third party who may have taken a history from,
or examined, the patient;
 make appropriate arrangements to follow the progress of the patient and inform the patient’s general
practitioner or other relevant practitioners;
64
https://www.strategyand.pwc.com/media/file/Australias-healthcare-system.pdf .

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

 keep an appropriate record of the consultation;

 keep colleagues well informed when sharing the care of patients.
Moreover, the document mentions that in an emergency situation, it may not be possible to practise
according to the guidelines. If an alternative is not available, a technology-based patient consultation should
be as thorough as possible and lead to more suitable arrangements for the continuing care and follow up of
the patient.65

42 Cross-jurisdiction issues in telemedicine

The MBA has also issued in 2013 a document on inter-jurisdictional technology based patient consultations,
which provides additional information for medical practitioners who conduct inter-jurisdictional technology
based patient consultations. In the context of the document, jurisdiction refers to countries or regions outside
Australia (i.e. consultations which are conducted when the patient or the practitioner is outside Australia).
Specifically, the document states that medical practitioners, providing medical services to patients in
Australia:
 will be registered with the Board regardless of where the practitioner is located;
 consider the appropriateness of a technology based consultation for each patient’s circumstances;
 comply with the requirements of the Health Practitioner Regulation National Law as in force in each
state and territory (the National Law) and the Board’s registration standards, codes and guidelines
including the Professional Indemnity Insurance Registration Standard which requires that a medical
practitioner is covered for all aspects of their medical practice.
Those who conduct technology based consultations with a patient who is outside Australia:
 establish whether they are required to be registered by the medical regulator in that jurisdiction (for
example, the General Medical Council for a patient in the United Kingdom);
 ensure that their patients are informed in relation to billing arrangements for consultations and whether
the patient will be able to access Medicare or private health insurance rebates. 66

43 ACRRM (Australian College of Rural and Remote Medicine)

44 Definition of telemedicine
In its ACRRM TeleHealth Advisory Committee Standards Framework, the College defines telehealth as:
A means of delivering healthcare across many different clinical settings.
- ACRRM

The Guidelines67 published are meant to be applied by:

 doctors conducting synchronous (real time) video consultations between a patient, a health care provider
from the referring organisation, and a specialist medical practitioner to whom the patient has been
referred;
 general practices, Aboriginal medical services, primary care providers, specialist medical practitioners.

65
Guidelines: Technology-based patient consultations, Medical Board of Australia, 2012.
66
Inter-jurisdictional technology based patient consultations, Medical Board of Australia, 2013.
67
“ACRRM TeleHealth Advisory Committee Standards Framework”, ACRRM.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

These guidelines do not:

 apply to direct specialist to patient video consultations, with no involvement of the referring clinician or
their practice staff;
 contain clinical advice on the effectiveness of telehealth for different medical conditions.
The published document acknowledges that one set of standards or guidelines cannot cover all of these in
detail, therefore the ACRRM has chosen to establish a framework which relevant groups of specialists in
Australia can use to develop profession and health-organisation specific telehealth guidelines. This approach
was endorsed by the ACRRM Telehealth Advisory Committee (ATHAC) which includes representatives
from medical specialist and nursing colleges and organisations, peak Aboriginal health organisations,
consumer organisations, the National Rural Health Alliance, the Rural Doctors Association of Australia,
Standards Australia, the Australasian Telehealth Society, and the Royal Flying Doctor Service.
The ACRRM undertook a scan of Australian guidelines and standards, which were also considered in the
design of the Framework.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

45 Specific requirements for individual doctors

Figure 1 .11, Figure 1 .12 and Figure 1 .13 present the Framework that was subsequently transformed into
ACRRM’s telehealth guidelines.
Figure 1.11: Clinical aspects of telehealth

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

Source: ACRRM

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

Figure 1.12: Technical aspects of telehealth

Source: ACRRM

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

Figure 1.13: Contextual aspects of telehealth

Source: ACRRM

46 Cross-jurisdiction issues in telemedicine

The ACRRM has not made a statement on the issue of cross-jurisdiction in telemedicine.

47 RACGP (The Royal Australian College of General Practitioners)

48 Definition of telemedicine
The College defines telehealth as “video consultations”.
- RACGP

RACGP, with support from the Australian Government Department of Health, has developed a number of
resources to help general practices get familiar with video consultations. 68

49 Regulation of individual doctors who provide telemedicine services

There are two main documents addressing doctors and telemedicine. These are one set of guidelines for
inter-professional collaboration between general practitioners and other medical specialists providing video

68
http://www.racgp.org.au/telehealth.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

consultations; and a set of standards for general practices offering video consultations. We will focus here on
the published Standards for general practices. 69
Choosing to offer video consultations:
 Decisions about whether or not the practice will offer video consultation services, as an alternative to
face-to-face consultations should be made by the GPs in the general practice team and careful
consideration should be given to issues such as:
 patient safety,
 clinical needs of patients,
 clinical effectiveness,
 patient preference,
 location of the practice,
 location of telehealth facilities,
 availability of Australian registered participating specialists,
 access to appropriate training,
 professional indemnity insurance as provided by a medical defence organisation, employer or
commercial insurer.
 Update your practice information sheet.
 Patient information about video consultations. Such information would generally include:
 the rationale for a video consultation ,
 whether a support clinician is likely to be present at the patient-end of the video consultation and the
clinical support role they may perform on behalf of the distant specialist,
 confirmation that the patient may have their own support person present,
 confirmation that other parties will only be present if the patient agrees to this in advance (i.e. parties
other than their own support person, the GP or another support clinician at the patient-end and distant
specialist),
 advice that the patient will be asked to provide their name, address and date of birth at the
commencement of a video consultation as a means of confirming their identity and ensuring that any
patient-end clinician and the distant specialist are both consulting with the right patient for the right
reason and are using the right patient health record,
 confirmation that the patient can ask any support clinician to step out of the video consultation at any
time if they wish to have a private discussion with the specialist, provided the support clinician deems
it safe for this to occur,
 confirmation that the practice makes every effort to protect patient privacy by using secure video
conference systems and by not recording video consultations unless exceptional clinical
circumstances apply, and the patient gives explicit prior consent and repeats this consent on camera,
 an explanation that exceptional clinical circumstances for making a recording during a video
consultation may include still images (e.g. a wound or skin lesion) or moving images (e.g. a tremor,
gait abnormality, unusual movement or range of movement) where such images are deemed to have
clinical value,
 advice that patients are not authorised to make their own recording of a video consultation,
 information about how video recordings (including discrete still images) would be managed, stored
and accessed if they are made,

69
The provided text is an abridged summary of the most important points; to reads the full document:
https://gp2u.com.au/static/documents/RACGP_Standards_for_general_practices_offering_video_consulta
tions.pdf.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

 acknowledgment that in the unlikely event that the patient felt unable to continue with a video
consultation they could end the consultation, and that consultation fees may still apply,
 a patient information brochure containing standard information about video consultations.
 Where a video consultation with a specialist in a distant location is agreed, and where there will be a
clinician present at the patient-end of the video consultation, the practice should inform patients that two
professional fees will normally apply and that out-of-pocket expenses may apply for:
 a professional fee for the GP (or another support clinician) providing clinical support at the patient-
end of the video consultation where the fee will be billed by the general practice,
 a professional fee for the specialist where the fee will be billed by the specialist.
Managing risk
General practices are encouraged to reach written prior agreement with participating specialists on relevant
key risk management protocols.
Where a GP delegates another clinician to provide clinical support at the patient-end of a video consultation
with a distant specialist, the GP should nominate a colleague with the requisite knowledge, skills and
experience to act on their behalf. GPs need to be aware that the choice of support clinician may influence
decisions about the clinical appropriateness of a video consultation.
Establishing a practice directory of participating specialists
To maintain the continuity of safe and high quality healthcare, general practices are encouraged to keep
working with specialists who are already known to the practice or who are already involved in a patient’s
care. Where a general practice decides to refer patients to specialists who have video conference facilities but
are not already known to clinicians or patients of the practice, the practice should confirm that such
specialists are listed on the relevant Australian register of medical practitioners.
Professional indemnity
The general practice should confirm that GPs, practice nurses and registered Aboriginal health workers have
suitable professional indemnity for video consultations (whether provided by a medical defence organisation,
employer or commercial insurer) and whether any exclusions such as initial consultations may apply.
Additional information for referral letters
General practices offering video consultation services should follow their standard protocols for referral
letters to specialists and include additional key information such as:
 the rationale for a proposed video consultation,
 any extra clinical information that may assist a distant specialist to confirm whether a video consultation
would be safe and clinically appropriate (e.g. still images of a wound or skin lesion),
 the proposed clinical support person if patient-end clinical support is indicated.
In addition to the referral letter, practices are encouraged to send specialists a separate video consultation
booking checklist covering standard information about the practical aspects of the video consultation.
Culturally appropriate care
General practices should be mindful of cultural sensitivities about personal images and the recording of
personal images. Where an interpreter is required, qualified medical interpreters are recommended and the
practice should make technical provision for a separate audio lead where the interpreter is not present in
person.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

Patient consent
For a video consultation with a specialist at a distant location, it remains the patient’s prerogative to
consent/not consent in advance to parties other than the patient, a support clinician (if indicated) and
specialist being present during the consultation.
Additional training for video consultations
Where a general practice offers video consultations, GPs should have appropriate training in key components
of the practice’s video consultation system.
Reliable and secure technical systems fit for clinical purposes
For the purpose of these Standards, the technical systems needed to support safe, secure and effective video
consultations are deemed to be ‘medical’ as opposed to ‘office’ equipment.

50 Cross-jurisdiction issues in telemedicine

The RACGP has not made a statement on the issue of cross-jurisdiction in telemedicine.

51 AMA (Australian Medical Association)

52 Definition of telemedicine
According to the AMA Position Statement on On-Line and Other Broadband Connected Medical
Consultations, telemedicine refers to
On-line e-mail and other forms of broadband connected consultations into [GPs and
medical providers’] patient care”, as well as “non face-to-face health services
provided through either on-line or other telecommunication systems
- AMA

53 Regulation of individual doctors who provide telemedicine services

The AMA, recognising that increasing numbers of medical providers are incorporating online and other
forms of telecommunications consultations into their patient care, agrees that the following principles, in
conjunction with principles that may be developed by specific craft groups to meet the needs and practices of
their members, must guide the provision of such consultations systems and that such services must:
 only be used as an adjunct to normal medical practice;
 only replace services where the quality and safety of patient care is not compromised including where
they provide access to medical care services in areas where such services are otherwise unavailable;
 not replace face-to-face consultations where the provision of quality care requires a face-to-face
consultation;
 incorporate the ultimate right of the doctor to determine whether consultation or provision of specific
advice or care on-line is appropriate in any circumstance;
 incorporate the ultimate right of the doctor to determine whether or not he/she will provide any medical
care to any patient on-line;
 ensure that medical records reflect the content of on-line consultations as with any other medical record;
 normally only be available to patients that have an established relationship with the doctor or the practice
— the AMA does not support the provision of on-line consultations between medical practitioners and

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

patients where no established relationship exists unless there is no practical alternative or where they are
employed to access medical care services in areas where such services may otherwise be unavailable;
 reflect, in associated protocols or guidelines, that the duty of care remains unchanged;
 where offered to patients with an established relationship with the doctor or practice be underpinned by
signed patient agreement to strict written terms and conditions for eligibility to use that also outline the
limitations on the type of care that will be provided through the system and the right of the doctor to
determine whether the provision of any advice or care through such a system is inappropriate;
 provide for the registration of all patients who wish to use the system with access based on a minimum
of user name and password — the AMA encourages the use of stronger authentication mechanisms;
 be compliant with appropriate standards around hardware and software, secure transmission of data and
communications, including appropriate encryption.70

54 Cross-jurisdiction issues in telemedicine

The AMA has not issued an official statement on cross-jurisdiction issues.

55 The Royal Australasian College of Physicians

56 Definition of telemedicine
The Royal Australian College of Physicians has defined telehealth in its publication “Telehealth: Guidelines
and practical tips”, as:
Telehealth, in the context of the Australian healthcare setting, can be defined as the
use of videoconferencing technologies to conduct a medical consultation where
audio and visual information is exchanged in real time.
— Royal Australian College of Physicians

Telehealth can be conducted between a specialist and patient in the presence of their general practitioner or
other health worker, or can be conducted with no medical support at the patient end. 71
In the Glossary of the document, telehealth is defined as usually “the provision of health care from a
distance”, but notes that these Guidelines refer specifically to consultations conducted via videoconference.

57 Regulation of individual doctors who provide telemedicine services

The Guidelines focus on a few aspects of telehealth provision. 72
Clinical aspects of telehealth
 Physicians should determine which patients are suitable for telehealth based on available resources,
technology and the urgency of medical care.
 Physicians providing telehealth consultation services should determine whether a telehealth consultation
is the most appropriate type of consultation for each patient.

70
AMA Position Statement on On-Line and Other Broadband Connected Medical Consultations,
Australian Medical Association, 2006.
71
“Telehealth: Guidelines and practical tips”, The Royal Australasian College of Physicians.
72
The provided text is an abridged summary of the most important points; to reads the full document:
https://www.racp.edu.au/docs/default-source/advocacy-library/telehealth-guidelines-and-practical-
tips.pdf.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

 The patient and/or their informal carer need to be able and willing to participate in the telehealth
consultation.
 The decision to use telehealth incorporates the following factors: Clinical, continuity of care, shared
care, and the best model of care for the individual; Practical, availability of appropriate technology and
patient-end support. The quality of the technology at the remote site will play a significant role in the
information gained during the clinical consultation; patients’ needs: ability of the patient to travel, plus
their family, work and cultural situation. Physicians should also consider the patient’s capacity to
participate. For example, a video consultation may be inappropriate for patients with vision or hearing
impairments.
 Wherever possible, and with the patient’s consent, in cases where a local healthcare provider is already
involved in the patient’s care, physicians should support the continuation of the patient’s relationship
with local healthcare providers.
 Every effort should be made to facilitate the current healthcare provider’s direct involvement.
 Before conducting a telehealth consultation, physicians should ensure patients understand how the
consultation will proceed.
 Physicians should be satisfied that patients have consented to participate in the telehealth consultation. In
cases where the patient is not competent and does not have the capacity to give consent, consent should
be obtained in the same way as in a face-to-face consultation.
 In supported consultations, a health worker from the referring healthcare organisation is present with the
patient for some or all of the video consultation with the specialist. The referring health worker should
confirm the identity of the patient to the specialist or health service, and confirm the identity and
credentials of the distant specialist to the patient.
 For unsupported consultations, the patient may be alone or may elect to have a family member or carer
present during the consultation. For the first unsupported consultation, the specialist and patient
introduce themselves and the specialist provides some background information, including their
credentials and experience.
 Telehealth consultations should be private and confidential, and physicians should have processes in
place to facilitate this as per standard face-to-face consultations. The patient’s privacy and confidentiality
should be maintained at all times. The patient’s privacy is protected by considering what risks there are
to privacy when using telehealth, and developing procedures to manage such risks.
Technical aspects of telehealth
 The choice to use particular technologies rests with individual clinicians and is dependent on context.
 The information and communications technology used for telehealth should be fit for the clinical purpose
of the consultation.
 Physicians should conduct a risk analysis to determine the likelihood and magnitude of foreseeable
problems.
 Physicians should be mindful of the limitations of technology being used and have procedures in place
for detecting, diagnosing and fixing equipment problems.
 Physicians should be mindful when choosing telehealth technology solutions that some consumer-based
products do not offer support services.
 Physicians should ensure they have a back-up plan in cases of equipment or connectivity failure, which
is proportionate to the consequences of failure.
 If urgent medical assistance is likely to be provided by telehealth, physicians might consider installing an
uninterruptible power supply and a second source of connectivity.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

58 Cross-jurisdiction issues in telemedicine

Although the Guidelines do not refer explicitly to cross-jurisdiction issue, they do discuss distance-related
issues when providing specialist telehealth services.
Generally, services would not be provided across state boundaries except where there has been a tradition of
referral from neighbouring interstate towns. It would be generally expected that in providing telehealth
consultations, the specialist has knowledge of the region and an ongoing rapport with the healthcare
providers in that region. Ideally, outreach visits would be made to establish this rapport.

59 Australian Health Practitioner Regulation Agency (AHPRA)73

AHPRA works with the National Boards to regulate individual practitioners across 14 health professions.

60 Definition of telemedicine
Technology-based patient consultations are patient consultations that use any form of technology, including,
but not restricted to videoconferencing, internet and telephone, as an alternative to face-to-face consultations.

61 Frameworks for telemedicine regulation

AHPRA has formal regulations and/or policies regarding telemedicine. It develops requirements regarding
licensing and/or registration.

62 Regulation of individual doctors who provide telemedicine services

The Medical Board of Australia has guidelines for registered medical practitioners.
http://www.medicalboard.gov.au/Codes-Guidelines-Policies/Technology-based-consultation-guidelines.aspx
These guidelines complement “Good Medical Practice: A Code of Conduct for Doctors in Australia” ( Good
Medical Practice) and provide specific guidance on technology-based patient consultations. The Medical
Board of Australia expects medical practitioners to apply the principles contained in Good Medical Practice,
and these guidelines, when they consult a patient outside the traditional face-to-face setting.
Medical practitioners who advise or treat patients in technology-based patient consultations should: 74
 apply the usual principles for obtaining their patient’s informed consent, protecting their patient’s
privacy and protecting their patient’s rights to confidentially;
 make a judgement about the appropriateness of a technology-based patient consultation and in particular,
whether a direct physical examination is necessary;
 make their identity known to the patient;
 confirm to their satisfaction the identity of the patient at each consultation — doctors should be aware
that it may be difficult to ensure unequivocal verification of the identity of the patient in these
circumstances;
 provide an explanation to the patient of the particular process involved in the technology-based patient
consultation;
 assess the patient’s condition, based on the history and clinical signs and appropriate examination;
73
Information from the online survey.
74
NB These requirements are the same as those from Medical Board of Australia (MBA). The AHPRA
works together with the 14 National Boards (MBA being one of them), so it endorses the same
guidelines. The role of this agency is to support the boards and to jointly agree upon health profession
agreement.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

 ensure they communicate with the patient to:

 establish the patient’s current medical condition and past medical history, and current or recent use of
medications, including non-prescription medications,
 identify the likely cause of the patient’s condition,
 ensure that there is sufficient clinical justification for the proposed treatment,
 ensure that the proposed treatment is not contra-indicated. This particularly applies to technology-
based consultations when the practitioner has no prior knowledge or understanding of the patient’s
condition(s) and medical history or access to their medical records;
 accept ultimate responsibility for evaluating information used in assessment and treatment, irrespective
of its source — applies to information gathered by a third party who may have taken a history from, or
examined, the patient;
 make appropriate arrangements to follow the progress of the patient and inform the patient’s general
practitioner or other relevant practitioners;
 keep an appropriate record of the consultation;
 keep colleagues well informed when sharing the care of patients.

63 Cross-jurisdiction issues in telemedicine

http://www.medicalboard.gov.au/Codes-Guidelines-Policies/FAQ/Information-interjurisdictional-
technology-consultations.aspx
This additional information aims to assist medical practitioners in relation to their registration and liability
obligations for technology based patient consultations which are conducted when either the patient or the
practitioner is outside Australia.
The Board expects that medical practitioners:
 providing medical services to patients in Australia will be registered with the Board regardless of where
the practitioner is located;
 consider the appropriateness of a technology based consultation for each patient’s circumstances;
 comply with the requirements of the Health Practitioner Regulation National Law as in force in each
state and territory (the National Law) and the Board’s registration standards, codes and guidelines
including the Professional Indemnity Insurance Registration Standard which requires that a medical
practitioner is covered for all aspects of their medical practice;
 who conduct technology based consultations with a patient who is outside Australia establish whether
they are required to be registered by the medical regulator in that jurisdiction (for example, the General
Medical Council for a patient in the United Kingdom);
 ensure that their patients are informed in relation to billing arrangements for consultations and whether
the patient will be able to access Medicare or private health insurance rebates.

64 Medical Council of New South Wales75

The Council has jurisdiction over approximately 35% of all registered Australian medical practitioners.

65 Definition of telemedicine
The Council defines telemedicine as “Technology based (phone/internet) consultations.“

75
Information from the online survey.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

66 Frameworks for telemedicine regulation

The Medical Council of New South Wales has informal or "work-in-progress" regulations and/or policies,
including non-binding recommendations.
Upcoming regulation and policy on the topic includes more detailed regulation about the appropriate use of
technology, as well as on the use of social media for communication of personal health information.
The Council considers online prescriptions of regulated medicine to be a particularly relevant issue to be
further investigated and potentially regulated.
The Council imposes requirements for physicians in the following areas:
 Licensing and/or registration
 Qualifications and training, including continuing professional development
 Standards of work
Additionally, the Council cooperates on a regular basis with Australian organisations, such as the Health
Care Complaints Commission (NSW), Australian Health Professions Regulation Agency and Medical Board
of Australia.

67 Regulation of individual doctors who provide telemedicine services

See regulations published in the Medical Board of Australia Guidelines, which apply to all medical
practitioners in Australia.

68 Cross-jurisdiction issues in telemedicine

[not mentioned in the survey]

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

69 Canada
70 Country level overview

71 Relevant organisations
 Federation of Medical Regulatory Authorities of Canada.
 Royal College of Physicians and Surgeons of Canada.
 Medical Council of Canada.
 Health Products and Food Branch.
 Medical regulatory authorities in 13 provinces and territories of Canada.

72 Regulatory frameworks
The Canadian federal authorities have limited power in what concerns regulation of health care and provision
of medical services. The federal government and its bodies are broadly responsible for:
 funding of public health care and, in particular, allocation of the budget across provinces and territories;
 approval of drugs, health-related products and medical equipment;
 competition and antitrust regulation on health care markets. 76,77
Provincial and territorial regulatory authorities are responsible for regulating health care (hospitals and
medical professionals) as well as insurance arrangements. If the province wishes to obtain federal funding
(note that it is not required to do so), its insurance programme has to meet certain criteria.
The Federation of Medical Regulatory Authorities of Canada (FMRAC) provides a forum for provincial
medical authorities to discuss common problems and issues, and develop a common approach and policies in
relation to health care. The FMRAC does not provide specific rules and regulations, rather it provides
recommendations to its member authorities on what should be covered in a given regulation.
The Royal College of Physicians and Surgeons of Canada oversees the medical education and training in
Canada while the Medical Council of Canada is responsible for examination and evaluation of individual
medical professionals. Neither of the two bodies grants license to practice medicine, this is reserved to
provincial and territorial authorities.
The Health Products and Food Branch is responsible for the regulation of drugs, medical products and
devices.

73 Federation of Medical Regulatory Authorities of Canada78

FMRAC per se is not a regulatory authority, nor does it have any authority over its members. Its members
are the 13 provincial and territorial medical regulatory authorities across Canada that in turn regulate
individual physicians.

76
https://www.physiciansforlife.ca/wp-content/uploads/2015/09/Regulation-of-Medicine-Web-Final.pdf .
77
http://www.mcmillan.ca/files/Health_Law_in_Canada.pdf .
78
Some information from the online survey.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

74 Definition of telemedicine
Telemedicine is the provision of medical expertise for the purpose of diagnosis and patient care by means of
telecommunications and information technology where the patient and the provider are separated by
distance. Telemedicine may include, but is not limited to, the provision of pathology, medical imaging and
patient consultative services.

75 Frameworks for telemedicine regulation

The FMRAC has issued formal regulations and/or policies regarding telemedicine.
However, as it not a regulatory authority, their Policy on Telemedicine provides suggested approaches to the
medical regulatory authorities across Canada.
The Board has directed that the current policy from 2010 be reviewed and updated. In addition, FMRAC will
consider the regulatory aspects that are necessary in the realms of virtual and digital health care.

76 Regulation of individual doctors who provide telemedicine services

Each Medical Regulatory Authority should:
 publish its requirements for the provision of telemedicine services for their jurisdictions;
 inform its members and the public of its mandate to investigate a complaint in regards to telemedicine
services received in its jurisdiction or for services provided by a physician on its register;
 make it known to its members that it expects registered physicians to comply with the licensing or
registration requirements of any jurisdiction into which they provide telemedicine services; and
 take steps to ensure that the delivery of teleradiology and telepathology services is subject to qualified
local medical direction and control; and
 take reasonable steps to know of the existence of telemedicine services provided in its jurisdiction by
physicians from outside the province or territory.
In addition, FMRAC recommends that:
 Where a medical regulatory authority does not currently assess the qualifications of physicians providing
telemedicine services from outside jurisdictions, the Medical Regulatory Authority should assist
healthcare institutions offering telemedicine services by physicians from outside the province or territory
to ensure that the qualifications of those physicians are equivalent to those required for licensure in the
province or territory.
 Where a medical regulatory authority has authority or influence over healthcare institutions offering
telemedicine services, the medical regulatory authority should require that all physicians from outside
the province or territory are registered and licensed to practise medicine in at least one Canadian
province or territory.
 Where a medical regulatory authority has authority or influence over healthcare institutions offering
telemedicine services, the medical regulatory authority should require that each patient is informed of:
 the location of the physician;
 how complaints about the care provided by a physician from outside the province or territory will be
addressed; and,
 how the privacy, confidentiality and security of the patient’s personal health information will be
assured.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

77 Cross-jurisdiction issues in telemedicine

Where a medical regulatory authority has authority or influence over healthcare institutions offering
telemedicine services, the medical regulatory authority should require that all physicians from outside the
province or territory are registered and licensed to practise medicine in at least one Canadian province or
territory.
The FMRAC recommends that:
 in case the provincial authority does not have specific requirements for individual professionals offering
telemedicine service to local patients but located in another province, then the medical professional
should meet the licence requirements of the patient’s province;
 a medical professional offering telemedicine service should be registered in at least one province
(territory) of Canada.

78 College of Physicians and Surgeons of Alberta79

The College regulates Individual healthcare professionals. It regulates physicians in Alberta, Canada.

79 Definition of telemedicine
They define telemedicine as “provision of medical diagnosis and patient care through electronic
communication where the patient and the provider are in different locations”.

80 Frameworks for telemedicine regulation

The College has formal regulations and/or policies regarding telemedicine.
It develops requirements in the following areas:
 licensing and/or registration;
 qualifications and training, including continuing professional development;
 standards of work.
The College works with Alberta Health Services, the single regional health authority in Alberta. It needs to
ensure its standards are consistent with their needs as the main telemedicine provider in the province.

81 Regulation of individual doctors who provide telemedicine services

 A physician must not issue or sign a prescription, by electronic or other means, unless the physician 80:
 obtains a medical history and conducts an appropriate examination of the patient adequate to establish
a diagnosis and identify underlying conditions;
 ensures there are no absolute contraindications to the treatment recommended or provided; and

79
Based on information from the survey.
80
“We placed a requirement in our standards that physicians cannot prescribe medication following a
telemedicine encounter without doing a physical exam. This requires a provider at the other end. The
main reason for this was to stop entrepreneurial service providers who are only interested in making
money vs providing good care (e.g. marijuana prescribers). However, in the age of digital medicine this
is a requirement that may be a barrier to good care.” – College of Physicians and Surgeons of Alberta
reply to Europe Economics’ survey.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

 has an appropriate, informed discussion to ensure the patient understands the risks, benefits and
course of action if concerns are identified.
 Notwithstanding section 5, a physician may issue a prescription without meeting the full scope of the
requirements listed above in the following circumstances:
 for emergency treatment of a patient; or
 in consultation with another physician who has an ongoing relationship with the patient and who has
agreed to provide ongoing supervision of the patient’s treatment; or
 in an on-call or cross-coverage situation in which the prescribing physician has access to the patient’s
medical records.
Additionally, the College has replied to our survey that they will be updating their telemedicine standards in
the future.

82 Cross-jurisdiction issues in telemedicine

 A physician who practises telemedicine for a patient located within Alberta must:
 hold a valid and active Alberta practice permit with the College; and
 adhere to the College Standards of Practice, Code of Conduct and Code of Ethics.
 Notwithstanding subsection 2 (a), a physician who does not hold a valid and active Alberta practice
permit may practise telemedicine for a patient located within Alberta if:
 the total number of telemedicine events are limited to five (5) times per year; or
 the telemedicine event is for emergency assessment or treatment of a patient.
 A physician who holds a valid and active Alberta practice permit and practises telemedicine for a patient
located outside Alberta must comply with the licensing or registration requirements of the jurisdiction in
which the patient is located.

83 College of Physicians and Surgeons of British Columbia81

The College covers physicians and surgeons in British Columbia, including those on the educational register.

84 Definition of telemedicine
The College defines telemedicine as the provision of medical expertise for the purpose of diagnosis and
patient care by means of telecommunication and information technology where the patient and provider are
separated by distance.
Also, the College refers to the definition by Federation of Medical Regulatory Authorities of Canada
(FMRAC):
“Telemedicine is the provision of medical expertise for the purpose of diagnosis and
patient care by means of telecommunications and information technology where the
patient and the provider are separated by distance. Telemedicine may include, but is
not limited to, the provision of pathology, medical imaging and patient consultative
service”

81
Information from the online survey.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

85 Frameworks for telemedicine regulation

The College has formal regulations and/or policies regarding telemedicine. It develops requirements
regarding standards of work. They also work with FMRAC to harmonise regulations across Canada.
A standard reflects the minimum standard of professional behaviour and ethical conduct on a specific topic
or issue expected by the College of all physicians in British Columbia. Standards also reflect relevant legal
requirements and are enforceable under the Health Professions Act, RSBC 1996, c.183 (HPA) and College
Bylaws under the HPA.
A guideline reflects a recommended course of action established based on the values, principles and duties of
the medical profession. Physicians may exercise reasonable discretion in their decision making based on the
guidance provided.

86 Regulation of individual doctors who provide telemedicine services

The regulation of telemedicine is set out in the College’s Standard on Telemedicine. 82 As a standard, the
contents of this regulation are considered binding and reflect the minimum standards expected by the
College, and as such are enforceable by law.
In providing medical care using telecommunications technologies, physicians are advised that they are
responsible to:
 ensure that both the physician-site and the patient-site are using appropriate technology that complies
with legal requirements regarding privacy and security and accreditation standards where required;
 ensure that the physician’s identity is known to the patient and the identity of the patient is confirmed at
each consultation;
 ensure that the patient is aware of the physician’s location, licensure status and the privacy and security
issues involved in accessing medical care in this manner;
 follow all ethical and legal requirements to obtain valid informed consent and to protect the privacy and
confidentiality of patient information;
 explain the appropriateness and limitations of technology-based patient consultation and consider
whether a physical examination is necessary;
 create and maintain, in accordance with professional and legal requirements, medical records of the
consultation;
 provide an appropriate medical assessment based on the current symptoms or condition, past history,
medications and limited examination possible;
 communicate with referring and other treating physicians and provide follow-up and after-hours care as
medically appropriate;
 exercise caution when providing prescriptions or other treatment recommendations to patients whom
they have not personally examined;
 not prescribe narcotic83 or other controlled medications to patients whom they have not personally
examined or with whom they do not have a longitudinal treating relationship unless they are in direct
communication with another licensed health-care practitioner who has examined the patient;
 not complete a document for the authorization of marijuana for medical purposes for a patient unless
they have a longitudinal treating relationship with the patient or are in direct communication with
another physician or nurse practitioner who has a longitudinal treating relationship and both are in
agreement with;
82
Note that by “narcotic” the regulator most likely means opioids, i.e. a type of drug inducing drowsiness
and relieving pain.
83
These are also knows as “drugs with potential for misuse/diversion”. For more information, refer to
https://www.cpsbc.ca/files/pdf/PSG-Safe-Prescribing.pdf.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

 the issuance of a document for the authorization of marijuana for medical purposes.

87 Cross-jurisdiction issues in telemedicine

Physicians in British Columbia should advise patients that accessing medical care from a physician who is
not located/registered in this province may pose risks related to lack of appropriate medical licensure or
training and that this College may not be able to assist them with complaints relating to inappropriate
medical care.
Physicians should also be aware that practising medicine using only electronic communication or across
different jurisdictions may affect their liability insurance and they should disclose such information to their
liability insurer.

88 College of Physicians and Surgeons of Newfoundland and Labrador84

89 Definition of telemedicine
Telemedicine is the provision of medical expertise for the purpose of diagnosis and patient care by means of
telecommunications and information technology where the patient and the provider are separated by
distance. Telemedicine may include, but is not limited to, the provision of pathology, medical imaging, and
patient consultative services.

90 Frameworks for telemedicine regulation

The College will not be issuing telemedicine licences.
All physicians must also hold professional liability coverage which includes the provision of telemedicine to
the intended patient.

91 Regulation of individual doctors who provide telemedicine services

A Standard of Practice in Telemedicine is the minimum standard of professional behaviour and ethical
conduct on a specific issue expected by the College. 85
Physicians practising telemedicine are held to the same standard of legal, ethical, competent, and
professional care as physicians providing personal face to face medical services. Patient quality, safety, and
appropriateness of care are always kept in high regard.
When practising telemedicine, a physician must:
 consider the patient’s existing health status, healthcare needs and circumstances, and only recommend
telemedicine if it is in the patient’s best interest;
 identify what resources (e.g., technology, equipment, support staff, etc.) are required, and only proceed if
those resources are available and can be used effectively;
 ensure the reliability, quality, and timeliness of the patient information obtained via telemedicine is
sufficient;
 obtain informed consent from the patient, when applicable;
 take reasonable steps to ensure that all medical information is transmitted in a manner which protects the
privacy and confidentiality of the patient;

84
Information from the online survey.
85
https://www.cpsnl.ca/web/files/2017-Mar-11%20-%20Telemedicine.pdf

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

 ensure the physical setting in which the medical care is being delivered is appropriate and safe and that a
plan is in place to manage adverse events and/or emergencies;
 refrain from prescribing narcotics or other controlled or regulated medications to patients whom they
have not personally examined or with whom they do not have a longitudinal treating relationship unless
they are in direct communication with another licensed health-care practitioner who has examined the
patient.

92 Cross-jurisdiction issues in telemedicine

The College considers the practice of medicine to take place in the jurisdiction in which the physician resides
and holds a licence. As a result, all physicians practising medicine via telemedicine must hold either a
licence to practise medicine in Newfoundland and Labrador and/or a licence to practise medicine in the
jurisdiction in which the physician is located.
Physicians who are licensed to practice medicine in Newfoundland and Labrador and wish to provide care to
a patient in another province, territory or country via telemedicine should take note they must comply with
the licensing requirements of that jurisdiction. The College recommends that physicians intending to provide
such care should contact the regulatory College in the jurisdiction where the intended patient is located to
obtain information about any applicable licensing requirements.

93 College of Physicians and Surgeons of Ontario86

The College regulates physicians and surgeons in Ontario, Canada.

94 Definition of telemedicine
The College’s Telemedicine Policy, which can be found on their website, 87 defines "telemedicine" as
follows:
 Telemedicine is both the practice of medicine and a way to provide or assist in the provision of patient
care at a distance using information and communication technologies. Additionally:
 Patients, patient information and/or physicians may be separated by space (e.g., not in same physical
location) and/or time (e.g., not in real-time).
 The specific technology that can be used is constantly evolving. Some current examples include, but
are not limited to, the use of telephones (e.g., land lines and mobile phones), email, video and audio
conferencing, remote monitoring and telerobotics.

95 Frameworks for telemedicine regulation

The College has formal regulations and/or policies regarding telemedicine.
Requirements are in the following areas:
 licensing and/or registration;
 qualifications and training, including continuing professional development;
 standards of work;
 discipline and/or fitness to practise.

86
Information from the online survey.
87
http://www.cpso.on.ca/Policies-Publications/Policy/Telemedicine

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

The CPSO would expect physicians who are members to comply with all of the regulatory requirements
(whether they are practising telemedicine or otherwise). They would be subject to all of the above.

96 Regulation of individual doctors who provide telemedicine services

The policy applies to all physicians who are members of the CPSO, regardless of where the physician or
patient is physically located when telemedicine is practised. Expectations are provided in relation to
providing or assisting in the provision of patient care via telemedicine, which includes consulting with and
referring patients to other health-care providers, and practising telemedicine across borders. This policy
applies broadly to the practice of telemedicine, regardless of the specific area of practice or practice setting
in which telemedicine is used.
In addition, this policy sets out the CPSO's expectations of physicians who are not members of the CPSO,
but who practise telemedicine by providing or assisting in the provision of care to patients who are
physically located in Ontario at the time of care. These expectations are set out in the last section of the
policy, titled 'Expectations for Non-CPSO Members' (see Section 97). Please see the policy for details.
In brief, physicians must:
 consider the patient’s existing health status, specific health-care needs and specific circumstances, and
only use telemedicine if the risks do not outweigh the potential benefits and it is in the patient’s best
interest;
 identify what resources (e.g. information and communication technology, equipment, support staff, etc.)
are required, and only proceed if those resources are available and can be used effectively;
 ensure the reliability, quality and timeliness of the patient information obtained via telemedicine is
sufficient, and the patient is accurately identified;
 protect the privacy and confidentiality of the patient’s personal health information — more specifically:
 evaluate whether the information and communication technology and physical setting being used by
the physician has reasonable security protocols in place to ensure compliance with physicians’ legal
and professional obligations to protect the privacy and confidentiality of the patient’s personal health
information,
 take reasonable steps to confirm the information and communication technology and physical setting
being used by the patient permits the sharing of the patient’s personal health information in a private
and secure manner;
 ensure the physical setting in which the care is being delivered is appropriate and safe; there must be a
plan in place to manage adverse events and/or emergencies.

97 Cross-jurisdiction issues in telemedicine

The College considered the positions/policies of medical and health regulators in other jurisdictions when the
policy was last updated in 2014. In the context of regulating their members who practice telemedicine, the
CPSO may interact with health system organizations such as the Ministry of Health and Long-Term Care
(e.g. to obtain Ontario Health Insurance Plan billing information for an investigation) and other medical
regulators if members are practising telemedicine in other jurisdictions or if Ontario patients are being
treated via telemedicine by a non-CPSO member who is physically located outside of Ontario.
When physicians consult with or refer patients to out-of-province physicians for care via telemedicine, they
must inform their patients that the out-of-province physician is not physically located in Ontario, and may or
may not be licensed in Ontario. It is recommended that physicians alert patients to the ‘patient information
sheet’ appended to this policy, and communicate the relevant content contained in that document, as
appropriate.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

The CPSO recognizes that Ontario patients may seek care via telemedicine from non-CPSO members who
are physically located outside of Ontario, independent of any involvement of a CPSO member. The CPSO
expects that non-CPSO members will comply with licensing requirements in their jurisdiction, and will
provide care in accordance with the standard of care.

98 College of Physicians and Surgeons of Saskatchewan88

The College regulates individual healthcare professionals and their practice of medicine, and is also able to
grant Podiatric Surgery permits.

99 Definition of telemedicine
The College defines telemedicine as the provision of a medical opinion concerning diagnosis or treatment of
a patient in Saskatchewan by a physician located outside of Saskatchewan as a result of transmission of
individual patient information by electronic or other means from within Saskatchewan to such physician or
his or her agent; or The provision of treatment to a patient in Saskatchewan by a physician located outside of
Saskatchewan as a result of transmission of individual patient information by electronic or other means from
within Saskatchewan to such physician or his or her agent.

100Frameworks for telemedicine regulation

The College has formal regulations and rules regarding the practice of telemedicine.
It places telemedicine-related requirements on its members in the following areas:
 Licensing and/or registration
 Qualifications and training, including continuing professional development
 Standards of work
 Discipline and/or fitness to practise

101Regulation of individual doctors who provide telemedicine services89

The College expects physicians who practise telemedicine in Saskatchewan to meet the same standards of
practice, whether the physician is located within or without Saskatchewan.
The College expects that physicians who provide telemedicine services should, wherever possible, ensure
that the care provided to the patient through telemedicine will provide the same level of care to the patient as
would be provided if the physician was physically present.
The College expects that physicians who provide telemedicine services should provide all relevant
information to the patient about the nature of the telemedicine services that are provided, including the nature
of the limitations on those services, if any, and any extra risks that may be inherent in the provision of those
services.
See also the Regulatory Bylaws for rules specific to teleradiology. 90

88
Information comes from online survey.
89
Please refer to “Policy – The Practice of Telemedicine”, section 3 “Standards of practice of
telemedicine” for more details. https://www.cps.sk.ca/iMIS/Documents/Legislation/Policies/POLICY
%20-%20The%20Practice%20of%20Telemedicine.pdf
90
College of Physicians and Surgeons of Saskatchewan (2017), “Regulatory Bylaws for medical practice in
Saskatchewan”, Bylaw 25.1, http://www.cps.sk.ca/iMIS/Documents/Legislation/Legislation/Regulatory
%20Bylaws%20-%20September%202017.pdf.

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102Cross-jurisdiction issues in telemedicine91

Section 2 “Licensure to practise medicine in Saskatchewan”, paragraph 1-2.
The College accepts that a physician who practises telemedicine as defined above is practicing medicine in
Saskatchewan and is required by The Medical Profession Act, 1981 to be licensed with the College of
Physicians and Surgeons to do so.
Based upon the College’s interpretation of The Medical Profession Act, 1981, the College accepts that a
physician who is physically located in Saskatchewan, but who provides telemedicine services to patients
located outside of Saskatchewan is required by The Medical Profession Act, 1981 to be licensed with the
College of Physicians and Surgeons to do so.
The College accepts that an expedited form of licensure should be available to physicians who are fully
qualified physicians, who meet the criteria for full registration in Saskatchewan, who are licensed without
restrictions in another province and who only practise telemedicine in Saskatchewan on an occasional basis.
Such physicians will be required to meet the same requirements for CMPA membership or other insurance
coverage as apply to other physicians licensed to practise in Saskatchewan.
Section 5 “Saskatchewan-licensed physicians who practise telemedicine outside Saskatchewan”
The College recognizes that a Canadian regulatory authority may, or may not, require physicians to become
licensed in their provinces or territories in order to practise telemedicine with patients located in that
province. The College expects physicians that it licenses to meet the licensing requirements of another
province or territory, if any, in order to practise telemedicine with patients in that province or territory. The
College of Physicians and Surgeons considers it unprofessional conduct for a physician whom it licenses to
practise telemedicine in another province or territory unless the physician meets the licensing requirements
of that province or territory.

91
Please refer to “Policy – The Practice of Telemedicine”, for more details.
https://www.cps.sk.ca/iMIS/Documents/Legislation/Policies/POLICY%20-%20The%20Practice%20of
%20Telemedicine.pdf

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103 Denmark
104 Country level overview

105Relevant organisations
 Danish Health Authority
 tasked to promote public health and establish a good framework for the health service in Denmark;
 gives advice to municipalities and regions and offer recommendations, guidelines and action plans;
 offers advice to the Danish Ministry of Health and other governmental, regional and municipal
authorities in the area of health and elderly care.
 National Board of eHealth (part of the Danish Ministry of Health)
 the Board of Directors consists of a total of 7 members. 3 members are appointed by the Danish state,
3 members are appointed by the Danish Regions and 1 member is appointed by Local Government
Denmark;
 the Board performs its tasks during its 2-4 yearly meetings;
 advises the Minister of Health regarding healthcare IT strategy, overall IT architecture,
standardisation etc. with a view to keep eHealth in line with the national requirements and standards
for eHealth;
 discusses the developments in the field and conducts the ongoing coordination of the policy and
annual reporting regarding progress and milestones to the government and the Danish Regions;
 conducts quality assurance of proposals for new investments.
 Danish Patient Safety Authority
 supervises authorised health professionals and health organisations;
 offers advice about communicable diseases, health conditions relevant in the issuance of driving
licences and to conduct inquests, etc.;
 issues registrations in 16 different healthcare professions to both Danish and foreign healthcare
professionals;
 issues permissions to practice independently as a medical doctor, dentist or chiropractor;
 issues specialist registrations in the 38 medical specialities and specialist registrations in the two
dental specialties;
 resolves complaints about infringement of patient rights and complaints about treatment provided in
the health service when the criticism concerns a treatment facility and not an individual healthcare
provider;
 handles the central administration of the reporting system for adverse events in the health service and
contribute to using knowledge about adverse events and knowledge from patient and compensation
cases in a preventive way;
 gives advice about the right to medical assistance in other countries pursuant to Danish legislation,
EU regulation and other international agreements.

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106Regulatory frameworks
The main participants in the health care regulatory framework are public authorities at various administrative
levels.
The national government sets the regulatory framework for health services and is in charge of general
planning and supervision. Five administrative regions governed by democratically elected councils are
responsible for the planning and delivery of specialized services and also have tasks related to social care and
coordination. The regions own, manage, and finance hospitals and finance the majority of services delivered
by private general practitioners (GPs), office-based specialists, physiotherapists, dentists, and pharmacists.
The general regulation, planning, and supervision of health services, including cost-control mechanisms, take
place at the national level through the Parliament, the Ministry of Health, the Danish Health Authority, the
Danish Medicines Agency, and the Danish Patient Safety Authority. The national authorities are responsible
for the general supervision of health personnel and for development of quality management in line with
national clinical guidelines and standards, usually in close collaboration with representatives from medical
societies.
The regions are in charge of supervising and paying general practitioners and specialists. Municipalities have
important roles in prevention, health promotion, and long-term care. Doctors’ associations negotiate with a
collective body of the regions, also including state representatives. Organized patient groups engage in
policymaking at the national, regional, and municipal levels. The Danish Patient Safety Authority handles
patient complaints and compensation claims, collects information about errors for systematic learning, and
provides information about treatment abroad.
Information technology (IT) is used at all levels of the health system as part of a national strategy supported
by the National Agency for Health IT. 92 The Danish Medical Association is the professional body of medical
professionals in Denmark. Almost all doctors working in Denmark are members of the organization, which
represents the interests of doctors and health issues in general.
The DDKM is the national model for quality assessment and improvement. Its principal task is to provide
ongoing feedback to individual health care institutions, including processed indicator data. The National
Board of Health registers and supervises qualified practitioners and other health care personnel. It is in
charge of granting and, if necessary, removing authorization. The 2004 Act on Patient Safety states that
authorization can be revoked or activity can be reduced if a qualified health care worker takes an
unnecessary risk regarding a patient’s health or has shown serious or repeated unsafe professional activity. 93
Training is regulated centrally by the Ministry of Science, Technology and Innovation, together with a
number of councils, such as the Health Training Council and the Social and Health Training Council, which
work in cooperation with the Ministry of Health, the National Board of Health and others. Further training in
the health sector for specialists is the responsibility of the National Board of Health, and it is adjusted
continually to meet the needs of the health sector with regard to subjects, content and capacity.

107 Danish Health Authority

108Definition of telemedicine
Telemedicine is traditionally considered a health technology that can improve the accessibility of health care
in sparsely populated and remote areas. The current use of telemedicine comprises a teleconference between
physicians that does not involve the patients.

92
http://international.commonwealthfund.org/countries/denmark/.
93
WHO Health Laws Denmark, 2017.

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The “Guidance on responsibilities for doctors who use telemedicine” defines telemedicine as: 94
By telemedicine, this guide intends that a physician uses video, images, sound and
measurement results to request an opinion of a specialist, who is not physically
present at the same location as the patient

109Regulation of individual doctors who provide telemedicine services95

 The Guidance claims that with regards to the use of telemedicine services by doctors, no special liability
is applicable. Thus, there is no independent regulation regarding these services.
 A doctor's usual commitment to care and ethics is relevant in all situations in which the doctor
participates and is responsible for patient treatment. This is applicable to both the physician involved in
telemedicine as a specialist and the doctor who initiates treatment based on the specialist's assessment.
 The individual physician has as his/her sole responsibility to ensure that the assessments and treatments
that he/she performs are sound and substantiated by the necessary studies and information.
 In the case of telemedicine services, it should be clear to all involved parties (the patient and the
specialist) which assumptions are being taken, in particular what is the role of the specialist in obtaining
assessment.
 The doctor who initiates treatment on the basis of a telemedicine assessment is responsible for the
treatment to be professionally sound.
 The physician, who requests the specialist consultation is responsible for ensuring that the information
being used for the treatment is sufficient for the purpose of providing a professional treatment.
 The doctor who requests telemedicine assistance is responsible for documenting how and when the
request has been sent. It is also their responsibility for ensuring that feedback is received and to follow
up on it.
 The patient's informed consent must be obtainable before examination and treatment. Such consent shall
in principle also be deemed to be requested when telemedicine assessment is used to treat.
 It must be ensured that confidentiality is complied with in the provision of confidential information and
disclosure of health information. As a starting point, the relevant disclosure of health information during
telemedicine treatment should be subject to the patient's consent.

110Cross-jurisdiction issues in telemedicine

In cases where specialist attention for diagnostics, treatment, etc. is obtained outside Denmark’s borders, it is
the physician in Denmark, who initiated the treatment, who is responsible for the treatment and the reporting
obligations.

94
The Guidance on responsibilities for doctors who use telemedicine (VEJ No. 9719 of 09/11/2005),
available in Danish at: https://www.retsinformation.dk/Forms/R0710.aspx?id=10132
95
Adapted with minor changes from the “Guidance on responsibilities for doctors who use telemedicine”
(VEJ No. 9719 of 09/11/2005).

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111 National Board of eHealth

112Definition of telemedicine
In a report96 by the Danish Government, Local Government Denmark and the Danish Regions 97 briefly
defines telemedicine solutions “as videoconferencing, digital exchange of images and monitoring patients in
their own homes”.

113Regulation of individual doctors who provide telemedicine services

The Board does not regulate doctors or institutions per se. Rather its functions involve guiding and
monitoring the progress of the National Strategy for Digitalisation of the Danish Healthcare Sector 2013-
2017.

114Cross-jurisdiction issues in telemedicine

The Board has not dealt with the issue of cross-jurisdiction.

115 Danish Patient Safety Authority98

The Authority supervises both individuals and organizations.

116Definition of telemedicine
The Authority defines telemedicine as an opportunity for a specialist, who is not physically present around
the patient, to be included in the patient's diagnostics and treatment. This is done by the use of video,
pictures, sound and test results.

117Frameworks for telemedicine regulation

The DPSA has in place telemedicine-related requirements on the subjects of standards of work
The Authority cooperates with Danish Medical Agency regarding medical devices.

118Regulation of individual doctors who provide telemedicine services

The Authorities refers to the “Guidance on responsibilities for doctors who use telemedicine” as the key
document in the area of telemedicine regulation in Denmark (see section 3.2.1 above for the Guidance
summary).

119Cross-jurisdiction issues in telemedicine

The Authority admits it is difficult to regulate when the health professional treats patients in other countries,
and calls for common European regulations.

96
“Telemedicine — A Key to Health Services of the Future”, Danish Government, Local Government
Denmark and the Danish Regions 2012.
97
We assume the definition applied in this report to be the one adopted by the Board, as it is comprised of
members of the organisations that co-wrote it.
98
Information collected from our online survey.

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120 France
121 Country level overview

122Relevant organisations
 Haute Autorité de Santé (HAS) (National Authority for Health) — the authority was set up by the French
government in order to bring together under a single roof a number of activities designed to improve the
quality of patient care and to guarantee equity within the healthcare system. HAS activities range from
assessment of drugs, medical devices, and procedures to publication of guidelines to accreditation of
healthcare organisations and certification of doctors. HAS is not a government body, but an independent
public body with financial autonomy. It is mandated by law to carry out specific roles which it reports on
to Government and Parliament. It liaises closely with government health agencies, national health
insurance funds, research organization, unions of healthcare professionals, and patient representatives. 99
 Haut Conseil de la Santé Publique (HCSP) (National Council of Public Healthcare) — the HCSP co-
ordinates the preparation of forward-looking opinions on public health issues, engages in annual
monitoring and evaluation of the national health strategy, illness prevention and health security,
including economic dimension of healthcare policy in terms of the resources and benefits.
 L’Ordre National des Médecins (National Order of Doctors) — the Order is an independent body
financed by doctors’ subscriptions, and which has Councils at each administrative level operating
different regulatory functions. For example, the Order produces the medical Code of Ethics, which is
part of a broader Code of Public Health. In recent years, greater emphasis has been placed on aspects of
the doctor-patient relationship in ethical medical practice, such as issues of confidentiality, the
importance of explaining the options for treatment and the risks involved, and gaining informed
consent.100 The Order also registers doctors and manages their licenses.

123Regulatory frameworks
There are three main levels of government in France — national, regional and departmental, each of which
plays a role in regulation of medical professionals. In addition, the National Order of Doctors is responsible
for working with those bodies in establishing regulatory standards. The National Doctors’ Order does not
report to the Government, representatives from both the Ministry of Health and the Ministry of Higher
Education and Research sit on the Council of the National Order. The Ministry of Health has a particular
remit to ensure that the training options and career options available to students of medicine in France are
aligned to the country’s workforce needs. It works closely with the Ministry of Higher Education and
Research.
There is no accreditation based system for assuring the quality of medical education and training in France.
The general framework which governs medical education and training is set by the MHER, but within this
broad framework, individual faculties have considerable latitude to innovate with respect to teaching
methods, curriculum content and student assessment. Another indirect mechanism used to ensure the quality
of education is through national competitive examinations which determine the appointment of clinical
teaching staff to medical faculties.
99
https://www.has-sante.fr/portail/jcms/r_1455134/en/about-has.
100
http://www.professionalstandards.org.uk/docs/default-source/publications/international-
reports/regulation-of-doctors-in-france-2012---draft-report.pdf?sfvrsn=2 .

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In France, registration is a precursor to licensure, but both are managed by the Departmental Council of the
National Order of Doctors in the Department where the doctors plans to practise medicine. In order to
register a doctor must prove to the Departmental Council that the full medical degree (the State Diploma of
Doctor of Medicine) and that they fulfil citizenship requirements. Once registered, a doctor can practise
anywhere in France, but they cannot be registered with two different departments of the National Order at
the same time.
France is one of the first countries in the EU to vote a specific legal framework for telemedicine, with
implementation of Article 78 of Law 2009-879 and a decree a year later. This decree has been inserted in the
public health code, which is a way to consider, from legal point of view, telemedicine as a standard medical
act (which adds to and does not replace current medical acts).

124 National legal system

125Definition of telemedicine
Article 78 of Law 2009-879 states that:
Telemedicine is a form of remote medical practice using information and
communication technologies. It connects two or more healthcare professionals to
each other, or a patient to one or more healthcare professionals. Amongst them at
least one has to be a medical professional, and where appropriate, more than one
professional can provide care to the patient.
"Telemedicine makes it possible to establish a diagnosis, to provide preventive
follow-up or post-therapeutic care for a patient at risk, to request specialized advice,
to decide on a therapeutic path, to prescribe products, to prescribe or to perform
medical services, or to monitor the condition of patients.
"What constitutes telemedicine activities, as well as their conditions for
implementation and the financial support a patient is entitled to, are set by decree that
takes into account the deficiencies in the provision of care due to insularity and
geographical isolation."
— Loi nº 2009-879 du 21 juillet 2009.

The October 2010 Decree has defined the main telemedicine fields (teleconsultation, teleexpertise,
telemomitoring, teleassistance and telesurveillance), the implementation of telemedicine (in particular
authentication of health professionals involved in the telemedicine act, identification of the patient, access by
the professionals to patient’s data) and telemedicine organisation (by programs, contracts or agreements).

126Regulation of individual doctors who provide telemedicine services

Telemedicine was recognised as a legal form of providing medical services in 2009 and a year later, a
description of its regulatory framework was published. After which, a national deployment strategy was put
in place.
Doctors’ eligibility to perform telemedicine
Companies and health professional willing to participate must get the agreement of their local ARS (Agence
Régionale de Santé, i.e. Regional Health Agency). Those public entities check if patients’ personal records
are well-secured and if the telemedical activity doesn’t compete with existing medical facilities or doctors of

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the area. When getting this agreement, remote consultations can be reimbursed by social security and doctors
will even be authorized to deliver prescriptions.
Otherwise, doctors would be able to practice "telecounseil" via Internet, under several conditions:
 the authentication of health professionals intervening in the process;
 the identification of the patient;
 the access to patient’s medical record in order to perform the act.
Above all, only doctors that are allowed to provide services in France are authorized to perform telemedicine
activity.
Billing
French doctors are entitled to bill the government for some medical services provided over the phone at the
same rate that they invoice for services provided in their offices or hospitals, under new French legislation
aimed at promoting the use of telemedicine and redressing regional inequities in the availability of medical
services.
Physicians will be entitled to bill for telemedicine services in four situations: consultations without the
physical presence of the patient, in which the patient may be alone or accompanied by another physician in
loco, in order to clarify clinical data or collaborate in the physical examination; the exchange of medical
information between two physicians or specialists; medical follow-ups; and during “teleassistance” of a
physician performing a medical procedure.101
Privacy concerns
The protection of patients’ medical records is one significant legal barrier to the development of telemedicine
in France. The decree n° 2015-1263 from October the 9th, 2015, sets the strict control on the collect and the
transfer of medical data between patients, medical professionals and social entities. 102

127Cross-jurisdiction issues in telemedicine

The Law and the Decree do not touch upon the cross-jurisdiction issues in telemedicine.

128 L’Ordre National des Médecins103

129Definition of telemedicine
In its publication “Telemedicine: Recommendations of the Council of the National Order of Doctors the
following definition is provided:
Telemedicine is one form of cooperation in medical practice, putting in contact a
patient (and/or the necessary medical data) and one or more physicians and health
professionals, with the means of information and communication technology, for the
purpose of medical diagnosis, decision-making, care and treatment in accordance
with the rules of medical ethics.
— Council of the National Order of Doctors

101
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3080554/.
102
https://www.linkedin.com/pulse/telemedicine-france-development-opportunities-healthcare/ .
103
Parts of the information taken from our online survey.

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Additionally, the French Law defines telemedicine as a way of medical practice using information and
communication technologies, which is a definition supported by the Council of the National Order of
Doctors.
Also, the FMC’s White Book on e-Health makes a distinction between telemedicine as defined by the
legislation and e-Health as a broader concept that implies “the combined use of the internet and of
information technologies for clinical, educational and administrative purposes, both locally and at a
distance”.

130Framework for telemedicine regulation

The Council of the Order has specific regulations and/or policies regarding telemedicine, which fall broadly
under the following categories:
 qualifications and training, including continuing professional development;
 discipline and/or fitness to practise.
They also issue non-binding recommendations.
In addition to the national law regarding telemedicine in France, the Council is also expecting to produce a
“soft law” document to be publicly available for physicians and other healthcare professionals.
The Council works in cooperation with the French government, regional health agencies and the French
National Commission on Informatics and Liberty (Commission Nationale de l'Informatique et des Libertés,
CNIL).

131Regulation of individual doctors who provide telemedicine services104

The Council regulates individual healthcare professionals. It regulates all registered physicians in France
whatever their specialties.
The Council has adopted formal regulations and/or policies regarding telemedicine. They also issue non-
binding recommendations. The Council places telemedicine-related requirements in the following categories:
 Qualifications and training, including continuing professional development;
 Discipline and/or fitness to practise;
 Ethical framework of the medical practice.
An overview of doctors’ responsibilities when practicing telemedicine (included in the 2009 Telemedicine
Statement) includes:
 The general responsibilities that apply to telemedicine.
 The patient should provide his/her consent for a telemedicine consultation or treatment.
 The doctor must ensure the confidentiality of data.
 The doctor should be familiar with the equipment, ensure that it functions properly and recognise the
limitations of technology.
The 2009 Telemedicine statement suggests that national healthcare regulators should define the situations
and conditions when telemedicine could be used, how the referring doctor and the telemedicine specialist
should interact, as well as technical requirements.

104
Please find the two of our publications translated into English (one and two); the other publications are available in
French here.

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132Cross-jurisdiction issues in telemedicine

[not mentioned in the survey]

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133 New Zealand

134 Medical Council of New Zealand105
The Council regulates all medical doctors in New Zealand.

135Definition of telemedicine
The Council uses the term "telehealth" rather than "telemedicine". Telehealth is defined by the use of
information and video conferencing technologies, to deliver health services to a patient and/or transmit
health information regarding that patient between two or more locations at least one of which is within New
Zealand.

136Frameworks for telemedicine regulation

The Council has formal regulations and/or policies regarding telemedicine.
It develops requirements in the following areas:
 licensing and/or registration;
 qualifications and training, including continuing professional development;
 standards of work;
 discipline and/or fitness to practise.
They insist that there are contracts between the parties to the agreement (i.e. NZ health provider and
telehealth provider) including patient complaint procedures and dispute resolution procedures, taking
account of the fact that the practitioner is not local.
The Council interaction with the following bodies on a regular basis:
 Health and Disability Commissioner - ensures rights of health consumers are upheld. Making sure that
complaints about health or disability services providers are taken care of fairly and efficiently.
 Vocational colleges such as the Royal Australian and New Zealand College of Radiologists (RANZCR)
in relation to registration requirements in the special purpose scope of teleradiology.

137Regulation of individual doctors who provide telemedicine services

If a physician provides care to New Zealand-based patients via telehealth, the Council holds the view that
this is practising medicine within New Zealand and the practitioner should therefore be registered with the
Council.
In providing care, the physician should ensure that:
 Any device, software or service used for the purposes of telehealth should be secure and fit for purpose,
and must preserve the quality of the information or image being transmitted.
 If a patient is treated, the physician is responsible for gathering and assessing the information used to
form a diagnosis, irrespective of its source. If the physician receive a referral which does not contain the

105
Information from the online survey.

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information required to make a fair assessment, the Council expects that the practitioner requests the
relevant information or return the referral to the referrer with a request for more specific information.
 Council expects that the treatment provided to a patient in another location meets the same required
standards as care provided in an in-person consultation. This includes standards relating to patient
selection, identification, cultural competence, assessment, diagnosis, consent, maintaining the patient’s
privacy and confidentiality, updating the patient’s clinical records and communicating with the patient’s
relevant primary care provider in a timely manner (unless the patient expressly states that the details of
the telehealth consultation are not to be shared with their primary care provider), and follow-up. If,
because of the limits of technology, the physician is unable to provide a service to the same standard as
an in-person consultation then they must advise the patient of this.
 It is particularly important that the physician considers whether a physical examination would add
critical information before providing treatment to a patient or before referring the patient to another
health practitioner for services including diagnostic imaging and pathology testing. If a physical
examination is likely to add critical information, then it should not proceed until a physical examination
can be arranged. In some circumstances, it may be reasonable to ask another practitioner in the patient’s
locality to conduct a physical examination on your behalf. In those instances, it is important that patient’s
consent is obtained for that arrangement, the request should be communicated clearly to the other
practitioner, and the primary physician should be available to answer any queries that the other
practitioner might have.
 Specific distance medical services have been demonstrated to provide safe and effective care and are the
subject of College approved clinical guidelines. Such guidelines may place additional requirements on
your practice.106
 If a physician works with or receives reports from telehealth providers, they should ensure that the above
standards are followed and must notify that telehealth provider, their management and /or other
appropriate reporting channels if there are concerns about the quality of care being provided.

138Cross-jurisdiction issues in telemedicine

Medical Council of New Zealand is governed by the Health Practitioners Competence Assurance Act 2003
(HPCAA). The purpose of the HPCAA is to protect the health and safety of the NZ public by establishing
mechanisms to ensure that health practitioners are competent and fit to practise their professions (Nb. other
health professions such as nurses, dentists and pharmacists are also governed by the HPCAA). Under the
HPCAA, they do not have any authority to require doctors who are overseas and who are providing care to
patients in NZ to be registered with MCNZ. As such, clause 5 of MCNZ's statement on Telehealth uses the
phrase "you should therefore be registered with the Council" rather than "you must therefore be registered
with the Council".
To protect the health and safety of patients in NZ, the special purpose scope in teleradiology lists a number
of requirements that overseas-based doctors practising telehealth must meet in order to be registered with us.
We also encourage such doctors to have a robust contractual relationship with a NZ body which creates or
enables an effective mechanism for dealing with performance and service provision concerns (see footnote
3).

106
You can refer to the NZ Telehealth Forum and Resources Centre website
(http://telehealth.co.nz/resources/regulations-standards) for a summary of telehealth regulations in New
Zealand.

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139 Portugal
140 Country level overview
The government centralizes policy-making in the health sector. Health policymaking often involves the
government officially hearing the opinion of several organized interest groups. These include professional
associations such as the Portuguese Medical Association — Ordem dos Médicos, the Portuguese Nurse
Association — Ordem dos Enfermeiros, the Portuguese Pharmacists’ Association — Ordem dos
Farmacêuticos, while others are traditional unions and nongovernmental organizations, most notably
patients’ associations.
The EU’s Directives on public health and the organization of the different groups of health professionals’
policies largely determine national policies on those topics. 107

141Relevant organisations
 Public healthcare system
 Ministry of Health is responsible for healthcare policy-making, planning and regulation;
 the National Health System provides universal medical coverage;
 High Commissariat for Health (ACS) is responsible for the design, implementation and evaluation of
the National Health Plan.
 National legal framework (Order 3571/2013 of 6th March 2013)
 a Ministry of Health-issued governmental decree regarding telemedicine adoption;
 establishes general rules of using telemedicine;
 provides working definition of telemedicine;108
 Ordem dos Médicos (Order of Physicians)
 responsible (jointly with the Ministry of Health) about specialty postgraduate training;
 membership is mandatory for practising physicians;
 grants accreditation and licences to practise;
 grants certifications of specialist training; and
 applies the disciplinary code, with powers to warn and punish doctors.

142Regulatory frameworks
Planning and regulation take place largely at the central level in the Ministry of Health and its institutions.
The Ministry is responsible for the design, implementation and evaluation of the National Health System
(NHS). The management of the NHS takes place at the regional level. The Order of Physicians is responsible
for granting licenses to practice and applying the disciplinary code.

107
http://www.euro.who.int/__data/assets/pdf_file/0019/150463/e95712.pdf.
108
http://spms.min-saude.pt/wp-content/uploads/2015/08/Implementing-Telemonitoring-in-the-Portuguese-
NHS-Med-e-tel-2015.pdf.

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143 Order 3571/2013 of 6th March 2013

144Definition of telemedicine
In the context of the provision of telemedicine services, the following are considered:
 "Real-time” teleconsultation: provided by a doctor, who is physically away from the patient, using
interactive, audio-visual and data communication and through specialist equipment and when the
communication takes place simultaneously (synchronously);
 "Store and forward" teleconsultation: the use of interactive, audio-visual and data communications,
which is collected in the presence of the patient and sent to a receiving entity who will evaluate and give
a qualified opinion at a later time (asynchronously);
 "Dermatological teletracking": consultation involving a dermatologist examining digital images with
sufficient quality to ensure the work of screening for skin lesions and subsequent referral of the case.

145Regulation of individual doctors who provide telemedicine services

In the area of dermatology, the use of telemedicine should follow these recommendations:
 the first consultation should be, whenever possible, a real-time teleconsultation;
 the use of store and forward teleconsultation as a form of screening must be contracted by an ARS
(Regional Health Administration) to hospitals that have the necessary conditions;
 subsequent consultations, whenever possible, should be real-time teleconsultations;
 teledermatoscopy or equipment of equivalent quality should be used whenever possible;
 hospitals with waiting lists for dermatology appointments should articulate efforts with ACES
(Decentralised Health Centre Groups) to promote teledermatological screenings.
In all other medical specialties, the first consultation must always be on-site, but subsequent consultations,
should be conducted whenever possible in real-time. 109

146Cross-jurisdiction issues in telemedicine

The Decree does not mention cross-jurisdiction provision of telemedicine.

147 Ordem dos Médicos (Order of Physicians)110

148Definition of telemedicine
The Order is a member of the European Council of Medical Orders (CEOM), which has issued an official
statement on telemedicine in 2014.
The CEOM calls for telemedicine to be defined as a form of medical activity in which ICT is used for the
benefit of the patient. This technology allows for a remote link to be established with a patient and a
physician or for two or more physicians, possibly assisted by other healthcare professionals, to exchange
medical data and assist each other in making a diagnosis, taking decisions and providing care and treatment,
whilst ensuring that the deontological rules incumbent upon each medical and healthcare profession are
109
Order 3571/2013 of 6th March 2013, Ministry of Health of Portugal.
110
As the Order is a member of the European Council of Medical Orders (CEOM), which has issued an
official statement on telemedicine in 2014, we give a summery here of this document. Moreover, the
Order has published this document on its own webpage. The text is adapted from “Statement of the
European Council of Medical Orders on telemedicine”, European Council of Medical Orders 2014.

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adhered to. They must be licensed to practice their profession in the Member State of establishment and
throughout the European Union.
“CEOM reminds that a clear legal distinction should be drawn between telemedicine and other e-health
services, including other health-related digital aspects. Whilst some e-healthcare applications may fall under
the scope of e-commerce, telemedicine does not, as it is a medical act ruled by its own legal framework to
ensure physician competence and respect of patients' rights.

149Regulation of individual doctors who provide telemedicine services

CEOM underscores that the use of ICT in the practice of telemedicine does not introduce any specific
provisions in EU Member States' codes of medical ethics nor the European Charter of Medical Ethics.
Existing ethical and deontological principles shall indeed remain in place and be applicable to telemedicine
practice.
CEOM reminds that in the practice of telemedicine, patients' rights are to be respected in the same way as
when treatment is traditionally provided in person. In the practice of remote medical care, greater awareness
is needed of the security restrictions regarding medical data confidentiality, the robustness and reliability of
IT systems used. The patient must be informed of the need for treatment, the advantages, consequences and
impact thereof and the means by which the treatment shall be administered and free consent must be given.
CEOM recommends that the scope of individual liability be defined for each party as well as the one which
would be shared by all healthcare professionals engaged in a telemedicine act. These responsibilities are
initially vis-a-vis the patient but are also shared by colleagues, other healthcare professionals or technical
staff with whom physicians may be working.
All healthcare professionals shall work within their field of competency, for which there is a legal regulatory
framework. In the framework of validated protocols and by ensuring IT security, the implementation of best
practices must be guaranteed in remote communication including collecting, storing, sending and processing
patients' personal health data. The safety, availability and reliability of technological devices whose
responsibility falls under the technological third-party must be guaranteed.

150Cross-jurisdiction issues in telemedicine

All practitioners must be covered by liability insurance stating the competent jurisdiction in case of any
disputes. Article 3d) of Directive 2011/24/EU on cross border healthcare states that the applicable law is that
of the Member State in which the practitioner is established.

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151 Singapore
152 Country level overview

153Relevant organisations
 Ministry of Health of Singapore
 Singapore Medical Council

154Regulatory frameworks
Regulation of health care in Singapore includes two main elements: licencing of medical organisations and
regulation of medical professionals. The umbrella organisation is the Ministry of Health of Singapore
(MoHS). There are seven professional bodies that cover different types of individual professionals: 111
 Singapore Medical Council;
 Singapore Dental Council;
 Singapore Nursing Board;
 Singapore Pharmacy Council;
 Traditional Chinese Medicine Practitioners Board;
 Optometrists & Opticians Board;
 Allied Health Professions Council.
Further, the Health Science Authority is responsible for regulating health related products, medical
equipment, and healthcare supplement.
The MoHS is responsible for licencing medical organisations, clinics, hospitals, laboratories, etc. The MoHS
publishes guidelines for medical organisations, processes licencing application and conducts inspections
The SMC regulates registered medical practitioners in Singapore. The functions of the SMC under section 5
of the Medical Registration Act (MRA) are as follows: 112
 to keep and maintain registers of registered medical practitioners;
 to approve or reject applications for registration under the MRA or to approve any such application
subject to such restrictions as it may think fit;
 to issue practising certificates to registered medical practitioners;
 to make recommendations to the appropriate authorities on the courses of instructions and examinations
leading to the Singapore degree;
 to make recommendations to the appropriate authorities for the training and education of registered
medical practitioners;
 to determine and regulate the conduct and ethics of registered medical practitioners;
 to determine and regulate standards of practice and the competence of registered medical practitioners
within the medical profession;
 to provide administrative services to other bodies (whether corporate or unincorporate) responsible for
the regulation of healthcare professionals; and

111
https://www.moh.gov.sg/content/moh_web/home/our_healthcare_system/HealthcareRegulation.html
112
Information from the online survey.

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 generally to do all such acts and matters and things as are necessary to be carried out under the MRA.
Regulation of telemedicine is part of guidelines and ethics standards for doctors published by the SMC.
As per information from the online survey — the SMC has formal regulations and/or policies regarding
telemedicine. It develops requirements in the following areas:
 standards of work;
 discipline and/or fitness to practise.
Interaction with the Ministry of Health of Singapore (MoHS):
 The MoHS has issued a set of National Telemedicine Guidelines in 2015 via the National Telemedicine
Advisory Committee (NTAC) to guide healthcare providers in the safe and appropriate delivery of
healthcare services through the use of telemedicine. The Health Regulation Group in the MoHS is also
looking into regulating telemedicine services under a new legislation, the Healthcare Services Act
(HCSA), in the coming 1-2 years. In the interim, MOH will be actively engaging the telehealth providers
to better understand their existing and emerging business models, so as to develop an efficient and
effective regulatory regime for telemedicine under HCSA. SMC partners closely with MOH in
complementing the regulation of telemedicine conducted by doctors in Singapore.
There has been a recent interest and rise of telemedicine apps in Singapore. MoHS and SMC’s views on this
issue were reported in the press on Friday, 15 Sep 2017:
 The issuance of a medical certificate by a doctor, regardless of whether it is in a paper or electronic
format, carries with it the responsibility to ensure that the patient requires it on proper medical grounds
and that such grounds have been arrived at through comprehensive clinical assessment,” an MOH
spokesperson told Channel NewsAsia.
 When medical certificates are generated electronically and where doctors are in control of the systems,
doctors must ensure that there are security protocols to prevent fraudulent issuance of the certificates.

155 Singapore Medical Council

156Definition of telemedicine
Telemedicine refers to the systematic, structured use of telecommunications and
information technology to deliver medical services or information over distances,
across geographical or legal borders, with or without an intervening or intermediary
healthcare professional. The essential characteristics of telemedicine are that
interventions, diagnostic and treatment decisions and recommendations are based on
data transmitted across distances by electronic, digital and other transmission
systems. Telemedicine also affords the possibility of engaging in education and
research by means of transmitted information.
— “SMC Handbook on Medical Ethics 2016”, Section A6.1

157Regulation of individual doctors who provide telemedicine services

The doctors who wish to practice telemedicine have to follow the SMC guidance on telemedicine. These are
covered under the relevant sections in the two documents published by the SMC in 2016, namely Handbook
on Medicine, and Ethical Code and Ethical Guidance.

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In summary, the doctor practicing telemedicine should:

 be able to verify patients’ identity;
 obtain patients’ consent (similar to face-to-face interactions);
 ensure patients’ confidentiality;
 have training to use the ICT and other equipment and software;
 if applicable, ensure that the patient is familiar with and knows how to use the ICT equipment at his or
her end or has someone to assist him or her using the equipment;
 ensure the remote examination provides sufficient information to form an opinion;
 monitor the patients he or she knows;
 if consulting a new patient, ensure that the patient’s data provided to them is adequate and sufficient to
form an opinion and provide further guidance to the patient;
 obey the same professional and ethical requirements for robotic telemedicine procedures as for
immediate/face-to-face procedure.
Further information obtained from our online survey — Guideline A6 of the 2016 edition of the SMC ECEG
states the following with regard to ethical matters concerning the professional conduct of registered medical
practitioners:
“Telemedicine can improve patient access to medical care. Yet, it is not equal to conventional in-person care
and has to be provided in a responsible manner. Providing telemedicine responsibly means:
 If you engage in telemedicine, you must endeavour to provide the same quality and standard of care as
in-person medical care. This includes ensuring that you have sufficient training and information to
manage patients through telemedicine. Otherwise, you must state the limitations of your opinion.
 If you perform remotely guided medical procedures or give remote guidance to others to perform
procedures, you and the person you guide must have the necessary expertise to provide and follow the
remote guidance unless there are exceptional circumstances that justify a departure from this guideline.
 If you avail your patients of robotic procedures performed by other doctors remotely, you have only
delegated an aspect of care but still retain responsibility for the overall management of the patients. If
you perform robotic surgery on a patient remotely, the standard of care you are required to provide to the
patient is no different than if you were to perform the operation in person.
 You must give patients sufficient information about telemedicine for them to consent to it. You must
also ensure that your patients understand any limitations of telemedicine that may affect the quality of
their care in relation to their specific circumstances.
 You must take reasonable care to ensure confidentiality of medical information shared through
technology and ensure compliance with any applicable existing legislation and regulations governing
personal data.
 If you ask your patients to operate telemedicine equipment from their locations, you must ensure that
they are sufficiently trained to do so. You must also ensure that prompt assistance is available in case of
equipment failure or inability of the patients to operate the systems, where such failure or inability poses
material risks to patients.
The 2016 edition of the HME provide further elaborations.

158Cross-jurisdiction issues in telemedicine

The SMC does not provide any specific guidance for practicing telemedicine across borders.

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159 United Kingdom

160 Country level overview

161Relevant organisations
 Care Quality Commission
 executive non-departmental public body of the Department of Health of the United Kingdom;
 stated role is to make sure that hospitals, care homes, dental and general practices and other care
services in England provide people with safe, effective and high-quality care, and to encourage them
to improve;
 what do they regulate — single, integrated regulator for England's health and adult social care;
 how do they regulate — they set out what good and outstanding care looks like and make sure
services meet fundamental standards below which care must never fall. 113
 Medicines and Healthcare products Regulatory Agency
 executive agency of the Department of Health in the United Kingdom which is responsible for
ensuring that medicines and medical devices work and are acceptably safe;
 what do they regulate — medicines and medical devices;
 how do they regulate — determines what is defined as a medicine or a medical device and assesses
their safety.114
 British Medical Association
 the trade union and professional body for doctors in the UK;
 individual members receive protection in the workplace;
 collective interests of all doctors are defended and promoted;
 responsibility for negotiating conditions of service at both a national and local level. 115

162Regulatory frameworks
Public regulation of health care in England comprises two main elements: regulation of the quality and safety
of care offered by health care providers, currently undertaken by the Care Quality Commission (CQC), and
regulation of the market in health care services, currently the responsibility of Monitor (in relation to
foundation trusts) and the Department of Health. The other countries within the UK each have their own
independent healthcare provider regulator, which all perform a similar function of ensuring and sometime
enforcing high-quality standards of healthcare provision. 116

113
http://www.cqc.org.uk/about-us.
114
https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-
agency/about.
115
https://www.bma.org.uk/about-us.
116
Guide to the Healthcare System in England, NHS May, 2013.

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There are 12 organisations117 in the UK known as health and social care regulators. Each organisation
oversees one or more of the health and social care professions by regulating individual professionals across
the UK.
These organisations, also known as regulators, were set up to protect the public, as health or social care
professionals, whether private or in the NHS, are required to meet the standards set by the relevant regulator.
To practise one of the regulated professions people must be registered with the relevant regulator. If they are
not registered and still practise, then they are breaking the law and they may be prosecuted. Registers are
made up of only those professionals who have demonstrated that they have met the standards set. 118
The Professional Standards Authority for Health and Social Care is responsible for overseeing the health and
care professional regulatory bodies. The Authority assesses their performance, conducts audits, scrutinises
their decisions and reports to Parliament. It also sets standards for organisations holding voluntary registers
for health and social care occupations and accredits those that meet them. 119
In England, healthcare providers must apply to the CQC, in order to begin providing their services, and
secure registration for the regulated activities they intend to deliver. Providers must satisfy the CQC that the
care and treatment to be provided will meet the requirements of the Health and Social Care Act 2008 and its
associated regulations.
Currently, there is no formal legal framework regulating standards in telemedicine, nor are there registration
requirements or non-binding professional standards.
The General Medical Council, the royal colleges and the professional associations are in the midst of
publishing standards of practice, procedures and protocols that will cover the use of telemedicine. 120
Organisations providing NHS services are regulated to ensure they meet essential standards. In England, the
Government has decided that, for NHS Foundation trusts and NHS trusts, the Care Quality Commission
would focus on assessing the level of quality of care, and Monitor would focus on using their powers, where
necessary, to intervene to resolve quality failings. 121
Professional regulators, on the other hand are responsible for ensuring that health and social care
professionals are providing safe care. They are focused on the individuals who give care, rather than
organisations that provide care. In order to practise legally, health professionals must be registered with the
relevant professional regulator. If a registered professional breaches any of the rules of their profession by
harming or failing to treat a patient properly, patients may complain directly to the relevant professional
regulator. The regulator takes a decision whether to investigate and if necessary, require that additional
training is undertaken, restrict or ban that professional from practising.
The interests of the patient and the public are further safeguarded through the role of four other bodies
covering specific areas of healthcare. These are the Medicines and Healthcare Products Regulatory Agency
(MHRA), Human Tissue Authority, Human Fertilisation and Embryology Authority, NHS Blood and
Transplant.
Participating in the policy-making processes are also trade unions and professional bodies, who uphold their
members’ rights and interests in front of public institutions. 122
117
General Medical Council (GMC), Nursing and Midwifery Council (NMC), Health and Care Professions
Council (HCPC), General Dental Council (GDC), Care Council for Wales, General Chiropractic Council
(GCC), General Optical Council (GOC), General Osteopathic Council (GOsC), General Pharmaceutical
Council (GPhC), Northern Ireland Social Care Council (NISCC), Pharmaceutical Society of Northern
Ireland (PSNI), and Scottish Social Services Council (SSSC).
118
“Who regulates health and social care professionals?” GMC publication.
119
http://www.professionalstandards.org.uk/about-us/how-we-work.
120
https://www.nursingtimes.net/telemedicine-and-the-law/205428.article.
121
“Monitor: Regulating NHS foundation trusts”, National Audit Office, 2014.
122
http://www.hse.gov.uk/healthservices/arrangements.htm .

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163 Care Quality Commission

164Definition of telemedicine
As a regulator of healthcare providers, the CQC is interested in telemedicine, as far as digital healthcare
providers are concerned. By ‘digital healthcare providers’, the CQC intends “Healthcare services that
provide a regulated activity by an online means. This involves transmitting information by text, sound,
images or other digital forms for the prevention, diagnosis, or treatment of disease and to follow up patients’
treatment.”

165Regulation of individual doctors who provide telemedicine services

The CQC regulates service providers of health and adult social care in England. It inspects and ensure
medical practices achieve certain level of excellence.
CQC regulates primary care providers of digital healthcare services in England where they provide the
regulated activities of: ‘treatment of disease, disorder or injury’ and ‘transport services, triage and medical
advice provided remotely’ or ‘diagnosis and screening’. The CQC’s recently released digital methodology
and guidelines for digital health providers, states that regulation covers such digital providers within primary
care. Examples include providers delivering GP consultations over the internet and providers prescribing
medications in response to online forms.123
The Guidelines thus infer that those primary care providers, who use digital means should be regulated in the
same way that non-digital providers are. The Commission would collect data on the provider, inspect the
main office location using standard procedure, make judgement on the quality of a practice, after which the
outcome is published on their website. Where a concern is found during inspection, the Commission takes
proportionate measures. If the concern is linked to a breach of any legal requirement or standard, the CQC
has a wide range of enforcement powers, for example, requiring improvement to protect people from harm or
the risk of harm, imposing or varying conditions of registration and suspending or cancelling registration. 124
Additionally, the appendix of the guidelines contains questions that digital healthcare providers should ask
themselves when providing telemedicine services.
Moreover, the CQC appears to be investigating telemedicine in the context of online pharmacies. Based on
the information available at the time of preparing this report, the concerns are predominantly around doctors
not complying with general standards of practice rather than issues specifically associated with telemedicine
(however, the fact the services are provided remotely might increase the likelihood of such non-compliance
cases). See CQC’s press release here: http://www.cqc.org.uk/news/releases/cqc-continues-take-action-
against-websites-selling-prescription-medicines.

166Cross-jurisdiction issues in telemedicine

The Guidelines do not explicitly address the question on provision of services from non-CQC regulated
jurisdictions. However, as the CQC is a regulator of health care providers and not doctors themselves, it is
implicitly assumed that doctors under regulation are to be based in England and to provide services from the
office of the CQC-regulated provider. Furthermore, one of the evaluation questions in the “Additional
prompts for digital healthcare providers in PMS” asks whether the provider checks, “when appropriate, that
GPs are on the GMC register and have a licence to practise”.

123
https://www.cqc.org.uk/sites/default/files/documents/ra_10_transport_services_triage_and_medical_adv
ice_provided_remotely.pdf.
124
“Clarification of regulatory methodology: PMS digital healthcare providers”, CQC 2017.

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167 Medicines and Healthcare Products Regulatory Agency

168Definition of telemedicine
In the UK the Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating
apps, smartphone-connected devices and wearable technologies which constitute a medical device: defined
in general terms as “any software which is ‘standalone’ i.e. not a part of a physical medical device at its time
of being first placed onto the market, and which is intended to be used in the treatment, prevention,
alleviation or diagnosis of a medical condition.”
This definition leaves the space for interpretation of the difference between a technology-enabled care device
and a medical device, particularly as these technologies become more sophisticated and more targeted.
Additionally, if a software or hardware is considered a medical device, it would fall under the regulatory
power of the Medical Devices Directives. Under the current EU regulatory framework, medical devices need
to be CE marked by their manufacturer before they are placed on the market. The Directive covers the vast
majority of medical devices used in and on humans such as diagnostic medical devices and implantable
devices, as well as “standalone software”, when specifically intended by the manufacturer to be used for one
or more of the medical purposes set out in the definition of a medical device. 125
The MHRA’s head of regulatory affairs, Rob Higgins, has stated:
“In the UK apps, wearables and other technology-enabled care devices are monitored
for safety and compliance by the MHRA’s adverse incident centre, through which
users and manufacturers can report adverse incidents which have occurred though the
use of medical devices.”126

The MHRA has in its powers the right to impose penalties for companies that fail to adhere to safety and
compliance rules, when placing a non-compliant or unsafe medical devices onto the market.

169Specific requirements for individual doctors

The MHRA does not regulate doctors. The Agency is responsible for ensuring medical devices on the market
meets the UK and EU standards. Therefore, doctors practicing telemedicine are affected by its decisions,
insofar as the software/digital device used is considered a medical device. If that is so and the device
experiences some errors while in use, the doctor should (although is not required) to report the fault to the
MHRA.127

170Cross-jurisdiction issues in telemedicine

The MHRA has not made an official statement on cross-jurisdiction in telemedicine, however it does
currently uphold European standards of medical device safety.

125
https://uk.practicallaw.thomsonreuters.com/2-619-533?
transitionType=Default&contextData=(sc.Default)&firstPage=true .
126
http://www.pharmafile.com/news/198036/e-clinical-rise-new-health-technologies.
127
http://www.nhs.uk/conditions/medicinesinfo/pages/mhra.aspx.

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171 British Medical Association

172Definition of telemedicine
The BMA has not adopted a formal definition of telemedicine. However, in statements telehealth has been
broadly referred to “the principle of using communications technology to deliver healthcare”, acknowledging
the vast range of telehealth applications.128

173Regulation of individual doctors who provide telemedicine services

The BMA does not regulate doctors, it is a professional organisation representing medical professionals. As
such, it aims to protect the rights of its members and promote their views and well-being.
The BMA has stated that, if used carelessly telehealth can threaten professional standards and data security.
But in certain cases, doctors can use it cautiously and successfully, while stressing it must supplement and
never replace personal contact.

174Cross-jurisdiction issues in telemedicine

The BMA has not made a statement on the issue of cross-jurisdiction in telemedicine.

175 General Pharmaceutical Council (GPhC)129

176Definition of telemedicine
In a ‘traditional’ pharmacy all parts of the service are provided at the same registered pharmacy, so this
guidance applies to pharmacy services when any of the activities above are carried out at different registered
pharmacies or places. It also applies in all cases when a member of staff or a third party providing any part of
the pharmacy service, and the patient or person who uses the pharmacy service, are not both in the same
registered pharmacy together.

177Frameworks for telemedicine regulation

GPhC does not have specific regulations or policies relating to telemedicine.
They do not have any specific standards or guidance on telemedicine, but have issued relevant guidance to
support standards for registered pharmacies. The Guidance for registered pharmacies providing pharmacy
services at a distance, including on the internet applies whenever pharmacy services or a range of activities
that would usually happen in a registered pharmacy, happen when the member of staff providing the service,
and the person receiving the pharmacy service, are not both in the same registered pharmacy together.
The GPhC works closely with a number of organisations in the course of their regulatory work, but not
specifically in relation to telemedicine.130

128
https://www.bma.org.uk/news/2013/august/talking-telehealth-crossroads-for-consultations .
129
Information from the online survey.
130
More information about who they work with and the agreements held with other organisations and
regulators can be found here: https://www.pharmacyregulation.org/about-us/who-we-work.

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178 United States

179 Country level overview

180Relevant organisations
 Federation of State Medicinal Boards
 represents all of the state osteopathic and medical boards;
 lobbies state and federal governments for legislation the state medical boards want;
 national jurisdiction over all the state medical boards;
 license physicians in all states and other healthcare professionals in some states;
 non-profit private organisation.131
As per its response to the online survey — FSMB represents the 70 state medical and osteopathic
regulatory boards -- commonly referred to as state medical boards — within the United States, its
territories and the District of Columbia. It supports its member boards as they fulfil their mandate of
protecting the public's health, safety and welfare through the proper licensing, disciplining, and regulation
of physicians and, in most jurisdictions, other health care professionals.
Their membership is comprised of the United States' state medical and osteopathic boards, which regulate
physicians and other health care professionals.
FSMB has formal regulations and/or policies regarding telemedicine.
The FSMB has adopted this model policy for state medical boards to consider adopting in whole, in part,
or not at all.
 American Telemedicine Association
 lobbies state and federal government for policy regarding telemedicine;
 supports the patients and doctors in making telemedicine simple and affordable;
 private non-profit company;
 regulates healthcare providers to provide quality and affordable service. 132
 Telehealth Resource Centre
 oversees 2 national telehealth centres and 12 regional centres;
 creates policy to improve healthcare systems to make telemedicine more accessible at a state and
federal level;
 educates individuals wanting to practice telemedicine;
 private agency funded by the Health Resources and Services Administration. 133

181Regulatory Framework
Policy regarding healthcare is created on federal and state levels through legislation and regulations created
by agencies under the Department of Health and Human Services. At the federal level legislation regarding

131
https://www.fsmb.org/about-fsmb/.
132
http://www.americantelemed.org/about/about-ata.
133
https://www.telehealthresourcecenter.org/who-your-trc .

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healthcare is rare but the Affordable Care Act was passed through Congress in March of 2010. All other
federal level regulations are created through agencies that were delegated the responsibility 134. The process
for policy at the state level varies but is also mainly created by agencies.
Licensure authority defines who has the legal responsibility to grant a health professional the permission to
practice their profession. Historically, under Article X of the U.S. Constitution, states have the authority to
regulate activities that affect the health, safety, and welfare of their citizens including the practice of healing
arts within their borders. Laws governing individual health care providers are enacted through state
legislative action, with authority to implement the practice acts delegated to the respective state licensing
board.135
The numerous agencies involved in health care create a system of quality assurance and high standards. The
Federation of State Medical Boards (FSMB) and all the state medical boards regulate the doctors and
physicians to maintain that the public is receiving proper care. The boards issue licensing to health care
providers and discipline those who are not following the regulations. Each of the state boards have their own
standards of conduct for the physicians, the FSMB exists to support them and to promote good practice. Like
nearly all other agencies the FSMB also represents health care providers and lobbies federal and state
government to pass legislation that serves to benefit the health care providers and the patients. Agencies such
as the American Telemedicine Association (ATA) and the Telehealth Resource Center (TRC) exist to
expand the field of telemedicine. The TRC oversees 2 national centres and 12 regional centres that help train
doctors interested in telemedicine and educate patients interested in Telemedicine. TRC was funded by the
Health Resources and Services Administration whose goal is to provide health care to those who are unable
to access it, including those who live in a remote area. The regional centres under the TRC help patients
located telemedicine services. To maintain the quality and advancement of telemedicine, the American
Telemedicine Association (ATA) lobbies state and federal government. ATA creates policy that makes it
easier for telemedicine physicians to practice and easier for patients to access it. With whatever policies that
are put in place from the help of the TRC or ATA it is up to the state medical boards to ensure their health
care providers are following the new regulations.

182 Federation of State Medical Boards

183Definition of telemedicine
A report by the Boards’ Appropriate Regulation of Telemedicine Workgroup states that 136:
“Telemedicine” means the practice of medicine using electronic communications,
information technology or other means between a licensee in one location, and a
patient in another location with or without an intervening healthcare provider.
Generally, telemedicine is not an audio-only, telephone conversation, e-mail/instant
messaging conversation, or fax. It typically involves the application of secure
videoconferencing or store and forward technology to provide or support healthcare
delivery by replicating the interaction of a traditional, encounter in person between a
provider and a patient.
“Telemedicine Technologies” means technologies and devices enabling secure
electronic communications and information exchange between a licensee in one

134
https://www.hhs.gov/regulations/index.html.
135
https://www.telehealthresourcecenter.org/toolbox-module/cross-state-licensure .
136
Model policy for the appropriate use of telemedicine technologies in the practice of medicine, FSMB
2014.

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location and a patient in another location with or without an intervening healthcare

provider.
— Federation of State Medical Boards, 2014

184Regulation of individual doctors who provide telemedicine services137

As per information from the online survey — the FSMB model policy covers the following aspects:
 Licensure;
 Establishment of a Physician-Patient Relationship;
 Evaluation and Treatment of the Patient;
 Informed Consent;
 Continuity of Care;
 Referrals for Emergency Services;
 Medical Records;
 Privacy and Security of Patient Records & Exchange of Information;
 Disclosures and Functionality on Online Services Making Available Telemedicine Technologies;
 Prescribing.
A physician using telemedicine technologies in the provision of medical services to a patient (whether
existing or new) must take appropriate steps to establish the physician-patient relationship and conduct all
appropriate evaluations and history of the patient consistent with traditional standards of care for the
particular patient presentation. As such, some situations and patient presentations are appropriate for the
utilization of telemedicine technologies as a component of, or in lieu of, in-person provision of medical care,
while others are not.
A physician is discouraged from rendering medical advice and/or care using telemedicine technologies
without:
 fully verifying and authenticating the location and, to the extent possible, identifying the requesting
patient;
 disclosing and validating the provider’s identity and applicable credential(s); and
 obtaining appropriate consents from requesting patients after disclosures regarding the delivery models
and treatment methods or limitations, including any special informed consents regarding the use of
telemedicine technologies.
An appropriate physician-patient relationship has not been established when the identity of the physician
may be unknown to the patient. Where appropriate, a patient must be able to select an identified physician
for telemedicine services and not be assigned to a physician at random.
The Boards have adopted the following guidelines for physicians utilising telemedicine technologies in the
delivery of patient care, regardless of an existing physician-patient relationship prior to an encounter:
Licensure
A physician must be licensed, or under the jurisdiction, of the medical board of the state where the patient is
located. The practice of medicine occurs where the patient is located at the time telemedicine technologies
are used. Physicians who treat or prescribe through online services sites are practicing medicine and must
possess appropriate licensure in all jurisdictions where patients receive care.

137
Text taken with minor changes from the FSMB Model policy for the appropriate use of telemedicine
technologies in the practice of medicine guidelines, or from our online survey.

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Establishment of a Physician-Patient Relationship

Where an existing physician-patient relationship is not present, a physician must take appropriate steps to
establish a physician-patient relationship consistent with the guidelines identified above, and, while each
circumstance is unique, such physician-patient relationships may be established using telemedicine
technologies provided the standard of care is met.
Evaluation and Treatment of the Patient
A documented medical evaluation and collection of relevant clinical history along with the presentation of
the patient to establish diagnoses and identify underlying conditions and/or contra-indications to the
treatment recommended/provided must be obtained prior to providing treatment, including issuing
prescriptions, electronically or otherwise. Treatment and consultation recommendations made in an online
setting, including issuing a prescription via electronic means, will be held to the same standards of
appropriate practice as those in traditional (encounter in person) settings. Treatment, including issuing a
prescription based solely on an online questionnaire, does not constitute an acceptable standard of care.
Informed Consent
Evidence documenting appropriate patient informed consent for the use of telemedicine technologies must be
obtained and maintained. Appropriate informed consent should, as a baseline, include the following terms:
 identification of the patient, the physician and the physician’s credentials;
 types of transmissions permitted using telemedicine technologies (e.g. prescription refills, appointment
scheduling, patient education, etc.);
 the patient agrees that the physician determines whether or not the condition being diagnosed and/or
treated is appropriate for a telemedicine encounter;
 details on security measures taken with the use of telemedicine technologies, such as encrypting data,
password protected screen savers and data files, or utilizing other reliable authentication techniques, as
well as potential risks to privacy notwithstanding such measures;
 hold harmless clause for information lost due to technical failures; and
 requirement for express patient consent to forward patient-identifiable information to a third party.
Continuity of Care
Patients should be able to seek, with relative ease, follow-up care or information from the physician who
conducts an encounter using telemedicine technologies. Physicians solely providing services using
telemedicine technologies with no existing physician-patient relationship prior to the encounter must make
documentation of the encounter using telemedicine technologies easily available to the patient, and subject to
the patient’s consent, any identified care provider of the patient immediately after the encounter.
Referrals for Emergency Services
An emergency plan is required and must be provided by the physician to the patient when the care provided
using telemedicine technologies indicates that a referral to an acute care facility or ER for treatment is
necessary for the safety of the patient. The emergency plan should include a formal, written protocol
appropriate to the services being rendered via telemedicine technologies.
Medical Records
The medical record should include, if applicable, copies of all patient-related electronic communications,
including patient-physician communication, prescriptions, laboratory and test results, evaluations and
consultations, records of past care, and instructions obtained or produced in connection with the utilization of
telemedicine technologies. Informed consents obtained in connection with an encounter involving
telemedicine technologies should also be filed in the medical record. The patient record established during

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the use of telemedicine technologies must be accessible and documented for both the physician and the
patient, consistent with all established laws and regulations governing patient healthcare records.
Privacy and Security of Patient Records & Exchange of Information
Physicians should meet or exceed applicable federal and state legal requirements of medical/health
information privacy, including compliance with the Health Insurance Portability and Accountability Act
(HIPAA) and state privacy, confidentiality, security, and medical retention rules. Physicians are referred to
“Standards for Privacy of Individually Identifiable Health Information,” issued by the Department of Health
and Human Services (HHS). Written policies and procedures should be maintained at the same standard as
traditional face-to-face encounters for documentation, maintenance, and transmission of the records of the
encounter using telemedicine technologies. Such policies and procedures should address:
 privacy,
 health-care personnel (in addition to the physician addressee) who will process messages,
 hours of operation,
 types of transactions that will be permitted electronically,
 required patient information to be included in the communication, such as patient name, identification
number and type of transaction,
 archival and retrieval, and
 quality oversight mechanisms.
Policies and procedures should be periodically evaluated and maintained in an accessible and readily
available manner for review. Sufficient privacy and security measures must be in place and documented to
assure confidentiality and integrity of patient-identifiable information. Transmissions, including patient e-
mail, prescriptions, and laboratory results must be secure within existing technology (i.e. password protected,
encrypted electronic prescriptions, or other reliable authentication techniques). All patient-physician e-mail,
as well as other patient-related electronic communications, should be stored and filed in the patient’s medical
record, consistent with traditional recordkeeping policies and procedures.
Disclosures and Functionality on Online Services Making Available Telemedicine Technologies
Online services used by physicians providing medical services using telemedicine technologies should
clearly disclose:
 specific services provided;
 contact information for physician;
 licensure and qualifications of physician(s) and associated physicians;
 fees for services and how payment is to be made;
 financial interests, other than fees charged, in any information, products, or services provided by a
physician;
 appropriate uses and limitations of the site, including emergency health situations;
 uses and response times for e-mails, electronic messages and other communications transmitted via
telemedicine technologies;
 to whom patient health information may be disclosed and for what purpose;
 rights of patients with respect to patient health information; and
 information collected and any passive tracking mechanisms utilized.
Online services used by physicians providing medical services using telemedicine technologies should
provide patients a clear mechanism to:
 access, supplement and amend patient-provided personal health information;
 provide feedback regarding the site and the quality of information and services; and

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 register complaints, including information regarding filing a complaint with the applicable state medical
and osteopathic board(s).
Online services must have accurate and transparent information about the website owner/operator, location,
and contact information, including a domain name that accurately reflects the identity.
Advertising or promotion of goods or products from which the physician receives direct remuneration,
benefits, or incentives (other than the fees for the medical care services) is prohibited. Notwithstanding,
online services may provide links to general health information sites to enhance patient education; however,
the physician should not benefit financially from providing such links or from the services or products
marketed by such links. When providing links to other sites, physicians should be aware of the implied
endorsement of the information, services or products offered from such sites. The maintenance of preferred
relationships with any pharmacy is prohibited. Physicians shall not transmit prescriptions to a specific
pharmacy, or recommend a pharmacy, in exchange for any type of consideration or benefit form that
pharmacy.
Prescribing
Telemedicine technologies, where prescribing may be contemplated, must implement measures to uphold
patient safety in the absence of traditional physical examination. Such measures should guarantee that the
identity of the patient and provider is clearly established and that detailed documentation for the clinical
evaluation and resulting prescription is both enforced and independently kept. Measures to assure informed,
accurate, and error prevention prescribing practices (e.g. integration with e-Prescription systems) are
encouraged. To further assure patient safety in the absence of physical examination, telemedicine
technologies should limit medication formularies to ones that are deemed safe by a State Board. Prescribing
medications, in-person or via telemedicine, is at the professional discretion of the physician. The indication,
appropriateness, and safety considerations for each telemedicine visit prescription must be evaluated by the
physician in accordance with current standards of practice and consequently carry the same professional
accountability as prescriptions delivered during an encounter in person. However, where such measures are
upheld, and the appropriate clinical consideration is carried out and documented, physicians may exercise
their judgment and prescribe medications as part of telemedicine encounters.

185Cross-jurisdiction issues with telemedicine138

Telehealth makes it possible for providers to connect with patients in other states. When this happens, the
originating site (the location of the patient) is considered the “place of service”, and therefore the distant site
provider must adhere to the licensing rules and regulations of the state in which the patient is located. Each
state has their own laws and regulations around licensing which are typically enforced by the state medical
board.
Most state medical boards enforce strict licensure rules, requiring providers to have a full medical license in
the state the patient is physically located in. Therefore, in the case of a telehealth consultation between a
provider in California and a patient in Hawaii, for example, the provider must obtain a Hawaii medical
license before performing the telemedicine consultation.
Under certain circumstances, such as emergencies, an exception may be made to the requirements for state
licensure. If all of the patient interactions are within the State in which a doctor is licensed, he/she maintains
the licensure in good standing, and complies with accepted standards, the doctor is unlikely to have any
significant licensure issues. Additional restrictions may apply if medical professionals are prescribing
medication across state lines.

138
Taken with minor changes from the FMSB’s Telemedicine Policies Board by Board Overview, 2014 and
from the Telehealth Resource Center’s Telehealth Legal and Regulatory Module.

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 Forty-eight state boards, plus the medical boards of District of Columbia, Puerto Rico, and the Virgin
Islands, require that physicians engaging in telemedicine are licensed in the state in which the patient is
located.
 Fifteen state boards issue a special purpose license, telemedicine license or certificate, or license to
practice medicine across state lines to allow for the practice of telemedicine.
 Four state boards require physicians to register if they wish to practice across state lines.
 Twenty-eight states, plus the District of Columbia, require both private insurance companies and
Medicaid to cover telemedicine services to the same extent as face-to-face consultations.
 Eighteen states currently require only Medicaid to cover telemedicine services.
 One state requires only private insurance companies to reimburse for services provided through
telemedicine.

186 American Telemedicine Association

187Definition of telemedicine
The American Telemedicine Association, in its FAQs defines telemedicine as:
In brief, telemedicine is the remote delivery of health care services and clinical
information using telecommunications technology. This includes a wide array of
clinical services using internet, wireless, satellite and telephone media.
While some have parsed out unique definitions for each word, ATA treats
"telemedicine" and "telehealth" as synonyms and uses the terms interchangeably. In
both cases, we are referring to the use of remote health care technology to deliver
clinical services.
— American Telemedicine Association

188Regulation of individual doctors who provide telemedicine services

The ATA describes the ethical code that physicians should follow while practicing telemedicine. A
telemedicine physician is held to very similar ethics as a conventional physician. In telemedicine the
physician must inform the patient of their rights and responsibilities, have no conflict of interest, and help
patients answer ethical questions.139

189 State of Maine Board of Licensure in Medicine140

The Board regulates allopathic physicians and physician assistants.

190Definition of telemedicine
“Telemedicine” means the practice of medicine or the rendering of health care services using electronic
audio-visual communications and information technologies or other means, including interactive audio with
asynchronous store-and-forward transmission, between a licensee in one location and a patient in another
location with or without an intervening health care provider. Telemedicine includes asynchronous store-and-
forward technologies, remote monitoring, and real-time interactive services, including teleradiology and
telepathology. Telemedicine shall not include the provision of medical services only through an audio-only
139
https://health.maryland.gov/mhqcc/Documents/Standards_Framework.pdf .
140
Information from the online survey.

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telephone, e-mail, instant messaging, facsimile transmission, or U.S. mail or other parcel service, or any
combination thereof.

191Frameworks for telemedicine regulation

State of Maine Board of Licensure has formal regulations and/or policies regarding telemedicine. It develops
requirements in the following areas:
 licensing and/or registration;
 standards of work;
 discipline and/or fitness to practise.
The Board cooperates with the Federation of State Medical Boards on policy guidance.

192Regulation of individual doctors who provide telemedicine services

See SECTION 3. PRACTICE GUIDELINES that covers:141
 Maine Medical License Required
 Standards of Care and Professional Ethics
 Scope of Practice
 Identification of Patient and Physician
 Physician-Patient Relationship
 Medical History and Physical Examination
 Non-Physician Health Care Providers
 Informed Consent
 Coordination of Care
 Follow-Up Care
 Emergency Services
 Medical Records
 Privacy and Security
 Technology and Equipment
 Disclosure and Functionality of Telemedicine Services
 Patient Access and Feedback
 Financial Interests
 Circumstances Where the Standard of Care May Not Require a Licensee to Personally Interview or
Examine a Patient
 Prescribing Based Solely on an Internet Request, Internet Questionnaire or a Telephonic Interview
Prohibited

193 North Carolina Medical Board142

The Board is responsible for the regulation of medicine and surgery for in North Carolina for the benefit and
protection of the people of North Carolina. This includes licensing and discipline of physicians (MD and
DO) and physician assistants (PA).

141
NB these requirements are specifically developed in relation to telemedicine. For more details see
www.maine.gov/sos/cec/rules/02/373/373c006.docx.
142
Information from the online survey.

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194Definition of telemedicine
"Telemedicine" is the practice of medicine using electronic communication, information technology or other
means between a licensee in one location and a patient in another location with or without an intervening
health care provider. Physician must be licensed in North Carolina to treat any patients in North Carolina,
including via telemedicine. The full North Carolina Medical Board Policy on Telemedicine can be found on
the North Carolina Medical Board Website: NCMedBoard.org under Position Statements on Clinical
Practice.

195Frameworks for telemedicine regulation

North Carolina Medical Board has formal regulations and/or policies regarding telemedicine.
It develops requirements in the following areas:
 licensing and/or registration;
 standards of work;
 discipline and/or fitness to practise.
It cooperation with the Federation of State Medical Boards on policy guidance.

196Regulation of individual doctors who provide telemedicine services

The Telemedicine policy statement covers the following aspects:
 Training of Staff
 Evaluations and Examinations
 Licensee-Patient Relationship
 Prescribing
 Medical Records
 Licensure

197Cross-jurisdiction issues in telemedicine

The practice of medicine is deemed to occur in the state in which the patient is located. Therefore, any
licensee using telemedicine to regularly provide medical services to patients located in North Carolina
should be licensed to practice medicine in North Carolina. (3) Licensees need not reside in North Carolina,
as long as they have a valid, current North Carolina license.
North Carolina licensees intending to practice medicine via telemedicine technology to treat or diagnose
patients outside of North Carolina should check with other state licensing boards. Most states require
physicians to be licensed, and some have enacted limitations to telemedicine practice or require or offer a
special registration. 

198 Oregon Medical Board143

The Board regulates individuals: physicians, podiatric physicians, physician assistants and acupuncturists.
They also send systems letters when an investigation uncovers a systems problem.

143
Information from the online survey.

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199Definition of telemedicine
Telemedicine: the direct rendering to a person of a written or otherwise documented medical opinion
concerning diagnosis or treatment of that person located in Oregon for the purpose of patient care by a
physician located outside Oregon as a result of transmission of individual patient data by electronic or other
means. Also the direct rendering of medical treatment to a patient in Oregon by a physician outside Oregon
by electronic or other means

200Frameworks for telemedicine regulation

Oregon Medical Board has formal regulations and/or policies regarding telemedicine.
It develops requirements in the following areas:
 licensing and/or registration;
 standards of work;
 discipline and/or fitness to practise.
They started regulating telemedicine in the mid-1990s and have had few difficulties in the regulation of this
practice.
They cooperation work with CTeL, an executive telehealth group on a regular basis. 144

201Cross-jurisdiction issues in telemedicine

 Section 677.135 to 677.141 in Chapter 677 — Regulation of Medicine, Podiatry and Acupuncture
https://www.oregonlegislature.gov/bills_laws/ors/ors677.html
 RULES FOR LICENSURE TO PRACTICE MEDICINE ACROSS STATE LINES
http://arcweb.sos.state.or.us/pages/rules/oars_800/oar_847/847_025.html
“The practice of medicine across state lines” means:
 The rendering directly to a person of a written or otherwise documented medical opinion concerning the
diagnosis or treatment of that person located within this state for the purpose of patient care by a
physician located outside this state as a result of the transmission of individual patient data by electronic
or other means from within this state to that physician or the physician’s agent; or
 The rendering of medical treatment directly to a person located within this state by a physician located
outside this state as a result of the outward transmission of individual patient data by electronic or other
means from within this state to that physician or the physician’s agent. [1999 c.549 §2]
A physician issued a license under ORS 677.139 is subject to all the provisions of this chapter and to all the
rules of the Oregon Medical Board. A physician issued a license under ORS 677.139 has the same duties and
responsibilities and is subject to the same penalties and sanctions as any other physician licensed under this
chapter.

202 Washington, DC Board of Medicine145

The DC Board of Medicine regulates various individual professions, including physicians (MD & DO),
physician assistants, anaesthesiologists’ assistants, surgical assistants, naturopathic physicians,
acupuncturists, polysomnographers and trauma technologists.

144
http://ctel.org/
145
Information from the online survey.

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203Definition of telemedicine
Telemedicine is defined as "[t]he practice of medicine by a licensed practitioner to provide patient care,
treatment or services, between a licensee in one location and a patient in another location with or without an
intervening healthcare provider, through the use of health information and technology communications,
subject to the existing standards of care and conduct."

204Frameworks for telemedicine regulation

Washington, DC Board of Medicine has informal or "work-in-progress" regulations and/or policies,
including non-binding recommendations. It develops requirements regarding standards of work.
We interact with healthcare facilities regulators regarding incidents at hospitals involving our licensees, as
well as with the Department of Healthcare Finance regarding regulations on reimbursement of telemedicine
services.

205Regulation of individual doctors who provide telemedicine services

Extracts from the Policy document “Establishing rules on the practice of telemedicine”:
 In order to practice telemedicine for a patient located within the District of Columbia, a license to
practice medicine in the District of Columbia is required.
 A physician shall adhere to the same standards of care as when making medical decisions in an in-person
encounter with a patient.
 Adequate security measures shall be implemented to ensure that all patient communications, recordings
and records remain confidential.
 All relevant patient-physician, communications, including those done via an electronic method such as
email or other electronic messaging system, shall be documented and filed in the patient's medical record
 If a physician-patient relationship does not include a prior in-person interaction with a patient, the
physician may use real-time telemedicine to allow a free exchange of protected health information
between the patient and the physician to establish the physician-patient relationship and perform the
patient evaluation.

206Cross-jurisdiction issues in telemedicine

In order to practice telemedicine for a patient located within the District of Columbia, a license to practice
medicine in the District of Columbia is required.

207 American Academy of Family Physicians146

The Academy is a membership society for individual U.S. Family Physicians, which regulates individual
healthcare professionals across the country.147

207.1.1 Definition of telemedicine

The AAFP defines telehealth and telemedicine as:

146
Information from the online survey.
147
The Academy is not a compulsory regulator, rather a voluntary associations. As they say in the
survey “[our policy] does not require individuals to do anything”.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

“Telemedicine is the practice of medicine using technology to deliver care at a distance, over a
telecommunications infrastructure, between a patient at an originating (spoke) site and a physician, or other
practitioner licensed to practice medicine, at a distant (hub) site. Telehealth refers to a broad collection of
electronic and telecommunications technologies and services that support at-a-distance healthcare delivery
and services. Telehealth technologies and tactics support virtual medical, health and education services.
Telehealth is different from telemedicine in that it refers to a broader scope of remote healthcare services
than telemedicine. While telemedicine refers specifically to remote clinical services, telehealth can refer to
remote non-clinical services such as provider training, continuing medical education or public health
education, administrative meetings, and electronic information sharing to facilitate and support assessment,
diagnosis, consultation, treatment, education, and care management.”

207.1.2 Frameworks for telemedicine regulation

They are a membership organization, not a regulatory body. Their policy states AAFP's position on
telemedicine, but does not require individuals to do anything.
On the topic of telemedicine, the AAFP interacts with other physician organizations, Centers for Medicaid
and Medicare Services (CMS), Federation of State Medical Boards (FSMB), Private Payers, Office of the
National Coordinator for Health IT (ONC), Federal Drug Administration (FDA).
The AAFP considers continuity of care, freedom of choice by patient and physicians, appropriate
reimbursement, appropriate oversight to ensure standard of care is met, to be areas of particular importance
to the organisation.

208 National Board of Medical Examiners148

The Board co-sponsors the examination series that leads to unrestricted licensure in the USA.

209Definition of telemedicine
There is no formal definition of telemedicine at this time, however the Board typically uses the medical
literature for grounding principles.

210Frameworks for telemedicine regulation

The Board has no specific regulations or policies relating to telemedicine. If it did, however, these would be
placed under the following categories:
 licensing and/or registration;
 qualifications and training, including continuing professional development.
Telephone medicine appears in their standardized clinical skills assessment.
The Board collaborates with the Federation of State Medical Boards on a regular basis and is a co-sponsor of
United States Medical Licensing Examination program.

211Regulation of individual doctors who provide telemedicine services

[not mentioned in the survey]

148
Based on information from the survey.

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212Cross-jurisdiction issues in telemedicine

[not mentioned in the survey]

213 Medical Board of California149

The Board regulates all California allopathic physicians and surgeons, other allied health providers (licensed
midwives, research psychoanalysts, and polysomnographic trainees, technicians, and technologists).

214Definition of telemedicine
"Telehealth" means the mode of delivering health care services and public health via information and
communication technologies to facilitate the diagnosis, consultation, treatment, education, care management,
and self-management of a patient's health care while the patient is at the originating site and the health care
provider is at a distant site. Telehealth facilitates patient self-management and caregiver support for patients
and includes synchronous interactions and asynchronous store and forward transfers.
"Asynchronous store and forward" means the transmission of a patient's medical information from an
originating site to the health care provider at a distant site without the presence of the patient. "Distant site"
means a site where a health care provider who provides health care services is located while providing these
services via a telecommunications system. "Originating site" means a site where a patient is located at the
time health care services are provided via a telecommunications system or where the asynchronous store and
forward service originates. "Synchronous interaction" means a real-time interaction between a patient and a
health care provider located at a distant site.
Telehealth is not a telephone conversation, email/instant messaging conversation, or fax; it typically involves
the application of videoconferencing or store and forward technology to provide or support health care
delivery.

215Frameworks for telemedicine regulation

The Board has formal regulations and/or policies regarding telemedicine, which fall under the scope of
standards of work.

216Regulation of individual doctors who provide telemedicine services

Physicians must maintain the same standard of care whether they are providing the care in-person or via
telehealth.150
We provide here some important points of the Practicing Medicine Through Telehealth Technology in
California:
The standard of care is the same whether the patient is seen in-person, through telehealth or other methods
of electronically enabled health care. Physicians need not reside in California, as long as they have a valid,
current California license.

149
Information taken from our survey.
150
See also, “Practicing Medicine Through Telehealth Technology in California”.
http://www.mbc.ca.gov/Licensees/Telehealth.aspx. See also, Business and Professions Code section
2290.5 for the section of law pertaining to telehealth for the Medical Board of California
https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=BPC&sectionNum=2290.5.

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In 1996, Senate Bill 1665 (M. Thompson; Chap 864, Stats of 1996) enacted the "Telemedicine Development
Act of 1996" which imposed several requirements governing the delivery of health care services through
telemedicine and also made several changes to different sections of law, which are also related to
telemedicine.
Below are listed a few highlights of Senate Bill 1665:
 The act shall not be construed to alter the scope of practice of any health care provider or authorize the
delivery of health care services in a setting, or in a manner, not otherwise authorized by law.
 Exempts out-of-state practitioners, as defined, from the Medical Practice Act when consulting either
within this state or across state lines, with a licensed practitioner in California. Prohibits the out-of-state
practitioner from having ultimate authority over the care or primary diagnosis of a patient in California.
 Requires the practitioner to obtain verbal and written informed consent from the patient prior to
delivering health care via telemedicine, and also requires that this signed written consent statement
becomes part of the patient's medical record.
 Provides that no health care service plan contract that is issued, amended, or renewed, on and after
January 1, 1997, shall require face-to-face contract between a health care provider and patient for
services appropriately provided through telemedicine, subject to all terms and conditions of the contract
agreed upon.
In 2011, AB 415 repealed existing law related to telemedicine and replaced this law with the Telehealth
Advancement Act of 2011, which revises and updates existing law to facilitate the advancement of telehealth
as a service delivery mode in managed care and the Medi-Cal program. This bill repeals and replaces section
2290.5 of the Business and Professions Code to do the following:
 Defines “Asynchronous store and forward” as the transmission of a patient’s medical information from
an originating site to the health care provider at a distant site without the presence of the patient.
 Defines “Distant Site” as a site where a health care provider is located while providing services via a
telecommunications system.
 Defines “Originating Site” as a site where a patient is located at the time health care services are
provided via a telecommunications system or where the asynchronous store and forward transfer occurs.
 Defines “telehealth” as the mode of delivering health care services and public health via information and
communication technologies to facilitate the diagnosis, consultation, treatment, education, care
management, and self-management of a patient’s health care while the patient is at the originating site
and the health care provider is at the distant site. States that telehealth facilitates patient self-management
and caregiver support for patients and includes synchronous interactions and asynchronous store and
forward transfers.
 States that this section shall not be construed to alter the scope of practice of any health care provider.
 Provides that all laws regarding the confidentiality of health care information and a patient’s rights to his
or her medical information shall apply to telehealth interactions.
 This bill also applies the Business and Professions Code Section to the laws relating to Health Care
Service Plans and to the Insurance code and requires health care service plans and health insurance
companies to adopt payment policies to compensate health care providers who provide covered health
care services through telehealth. This bill also applies these requirements to the Medi-Cal managed care
program.
In 2015, AB 809 revised the informed consent requirements relating to the delivery of health care via
telehealth by permitting consent to be made verbally or in writing, and by deleting the requirement that the
health care provider who obtains the consent be at the originating site where the patient is physically located.
This bill requires the health care provider to document the consent.

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217Cross-jurisdiction issues in telemedicine

Physicians need not reside in California, as long as they have a valid, current California license.
Physicians using telehealth technologies to provide care to patients located in California must be licensed in
California.

218 Oklahoma State Board of Medical Licensure and Supervision151

The Oklahoma Medical Board is the state regulatory agency responsible for licensing and regulating
approximately 11,000 medical doctors and an additional 12,000 licensees in 13 related health professions.
The OMB also provides the necessary staff for 2 separate regulatory boards: Oklahoma Board of Podiatric
Examiners and the Oklahoma Board of Licensed Perfusionist Examiners.

219Definition of telemedicine
Telemedicine is defined as the practice of healthcare delivery, diagnosis, consultation and treatment, by
transfer of medical data, or exchange of medical education information by means of audio, video, or data
communications.
Telemedicine is not a consultation provided by telephone or facsimile machine (Oklahoma Statutes, Title 36,
Sec. 6802). This definition excludes phone or Internet contact or prescribing and other forms of
communication, such as web-based video, that might occur between parties that does not meet the equipment
requirements as specified in OAC 435:10-7-13 and therefore requires an actual face-to-face encounter.
Telemedicine physicians who meet the requirements of OAC 435:10-7-13 do not require a face to face
encounter

220Frameworks for telemedicine regulation

The Board has formal rules and regulations on the topic of telemedicine that fall under the following
categories:
 standards of work;
 discipline and/or fitness to practise.
The Board might interact with a health system regulator. They collaborate with other regulators on the
development of Telemedicine policy as they try to ensure compatibility of their policies with policies of
other regulators.
The Board has some concern about telemedicine, in particular about interfering with the doctor/patient
relationship; concerns about patient safety and confidentiality, as well as potential complications to the
investigative process to protect the public.

221Regulation of individual doctors who provide telemedicine services152

435:10-7-13. Telemedicine

151
Based on information from the survey.
152
Taken from the Oklahoma Administrative Code (Last Updated: November 26,2015) Title 435. State
Board of Medical Licensure and Supervision Chapter 10. Physicians and Surgeons Subchapter 7.
Regulation of Physician and Surgeon Practice http://okrules.elaws.us/oac/435:10-7-13

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(a) Physicians treating patients in Oklahoma through telemedicine must be fully licensed to practice
medicine in Oklahoma; and
(b) Must practice telemedicine in compliance with standards established in these rules. In order to be exempt
from the face-to-face meeting requirement set out in these rules, the telemedicine encounter must meet
the following:
(1) Telemedicine encounters. Telemedicine encounters require the distant site physician to perform an
exam of a patient at a separate, remote originating site location. In order to accomplish this, and if
the distant site physician deems it to be medically necessary, a licensed healthcare provider trained
in the use of the equipment may be utilized at the originating site to "present" the patient, manage the
cameras, and perform any physical activities to successfully complete the exam. A medical record
must be kept and be accessible at both the distant and originating sites, preferably a shared
Electronic Medical Record, that is full and complete and meets the standards as a valid medical
record. There should be provisions for appropriate follow up care equivalent to that available to face-
to-face patients. The information available to the distant site physician for the medical problem to be
addressed must be equivalent in scope and quality to what would be obtained with an original or
follow-up face-to-face encounter and must meet all applicable standards of care for that medical
problem including the documentation of a history, a physical exam, the ordering of any diagnostic
tests, making a diagnosis and initiating a treatment plan with appropriate discussion and informed
consent.
(2) Equipment and technical standards.
(A) Telemedicine technology must be sufficient to provide the same information to the provider as if
the exam has been performed face-to-face.
(B) Telemedicine encounters must comply with HIPAA (Health Insurance Portability and
Accountability Act of 1996) security measures to ensure that all patient communications and
records are secure and remain confidential.
(3) Technology guidelines.
(A) Audio and video equipment must permit interactive, real-time communications.
(B) Technology must be HIPAA compliant.
(4) Board Approval of Telemedicine.
In the event a specific telemedicine program is outside the parameters of these rules, the Board
reserves the right to approve or deny the program.

222Cross-jurisdiction issues in telemedicine

Physicians treating patients in Oklahoma through telemedicine must be fully licensed to practice medicine in
Oklahoma.

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Appendix 3 — non-core countries

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223 Bhutan
224 Bhutan Medical and Health Council153

225Definition of telemedicine
Patient consultation through various modes such as through email and wechat.

226Frameworks for telemedicine regulation

No ; no specific regulations or policies relating to telemedicine.

227Regulation of individual doctors who provide telemedicine services

[not mentioned in the survey]

228Cross-jurisdiction issues in telemedicine

[not mentioned in the survey]

153
Information from our survey.
Australia — ACRRM (Australian College of Rural and Remote Medicine)

229 Germany
230 German Medical Association154
The German Medical Association (Bundesärztekammer) is the federation of the 17 state chambers of
physicians in Germany (Landesärztekammer). As the central organisation in the system of medical self-
governance, it represents the professional interests of the 496,240 physicians in Germany (as of 31 December
2016).

231Definition of telemedicine
Telemedicine is used as a generic term for different approaches in patient care. The common feature of all
telemedical services in patient care is the use of ICT for clinical diagnostics, therapy and rehabilitation as
well as for medical counselling over distance (or time).

232Frameworks for telemedicine regulation

The GMA has formal regulations and/or policies regarding telemedicine.
It develops requirements in the following areas:
 standards of work;
 discipline and/or fitness to practise.
There is a regular interaction with the health ministry at the federal level and other health care regulators or
health insurances.

233Regulation of individual doctors who provide telemedicine services

The professional code for physicians art 7 (3) states: "Physicians may not perform individual medical
treatment, in particular medical counselling, exclusively via print and communications media. It must also be
ensured that that physicians treat patients directly in the case of telemedicine procedures." Whereas this
Provision does not exclude telemedicine it still seems fairly strict. Some regional state chambers have
therefore started pilot projects enabling an easier use of telemedicine for physicians.

154
Information from the online survey.

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234 Indonesia
235 Indonesia Medical Council155
The Indonesia Medical Council (IMC) is an independent state organization directly under the jurisdiciton
President of Republic of Indonesia. The IMC regulates:
 Register Medical and Dental Practitioners
 De-register Medical and Dental Practitioners through disciplinary proceedings
 Examine and verify registration requirements submitted by the applicants
 Approve or disapprove Medical and Dental Educational Standard
 Approve or disapprove of Practice Standard for Medical and Dental practitioners.

236Definition of telemedicine
Telemedicine is defined by the IMC as technology based (phone/internet) consultations, as well as m edical
practice which is done with consultation in long distance.

237Frameworks for telemedicine regulation

The IMC has certain informal or "work-in-progress" regulations and/or policies, including non-binding
recommendations on the topic of telemedicine.
The IMC places telemedicine regulation in the following category:
 Licensing and/or registration, as it requires a particular regulation on the qualification and competency of
the doctor who is practicing telemedicine.
The Council cooperates with the Ministry of Health, Professional Medical Society, as well as the Ministry of
Communication and Informatics in the area of telemedicine.

238Regulation of individual doctors who provide telemedicine services

[no regulation in place]

239Cross-jurisdiction issues in telemedicine

[not mentioned in the survey]

155
Based on information from the survey.

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240 Ireland
241 Medical Council of Ireland156
The Medical Council regulates medical practitioners (doctors) in Ireland. All doctors must be registered
with them. We regulate by setting standards for medical education and training at all levels, professional
competence schemes, ethics and professionalism standards, maintaining a register of medical practitioners,
and managing complaints about doctors.

242Definition of telemedicine157
Telemedicine describes the delivery of health care services through information and communication
technologies to promote the health of individuals and their communities. It involves the exchange of
information between doctors and patients, or between doctors and professional colleagues, for the diagnosis,
treatment and prevention of disease and injuries, and for research, evaluation and continuing education.

243Frameworks for telemedicine regulation

The Council has adopted rules and regulations on the topic of telemedicine, which deal with the following
categories:
 licensing and/or registration;
 qualifications and training, including continuing professional development;
 standards of work;
 discipline and/or fitness to practise.

244Regulation of individual doctors who provide telemedicine services158

The Medical Council of Ireland’s general guidance to doctors providing telemedicine services consists of the
following points:
 If you provide telemedicine services to patients within the State, you should be registered with the
Medical Council. This is to maintain public confidence in telemedicine.
 You must follow the standards of good practice set out in this guide, whether you provide services using
telemedicine or traditional means. In particular, you should:
 make sure that patients have given their consent to conduct the consultation through telemedicine and
consent to any treatment provided. See paragraphs 9 to 13;

156
Based on information from the survey.
157
See Guide to Professional Conduct and Ethics for Registered Medical Practitioners, 8th Edition, 2016,
Section 43 “Telemedicine”, paragraph 43.1 for more details: https://www.medicalcouncil.ie/News-and-
Publications/Reports/Guide-to-Professional-Conduct-Ethics-8th-Edition.html
158
See Guide to Professional Conduct and Ethics for Registered Medical Practitioners, 8th Edition, 2016,
Section 43 “Telemedicine”, paragraphs 43.2 to 43.4 for more details:
https://www.medicalcouncil.ie/News-and-Publications/Reports/Guide-to-Professional-Conduct-Ethics-
8th-Edition.html

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 follow paragraph 44 of this guide if you advertise on websites or similar media; protect the privacy of
patient information through effective security measures; protect patients’ privacy by following the
guidance on confidentiality and medical records set out in paragraphs 29 and 33, and explain your
information policies to users;
 comply with data protection principles if you transfer any personal patient information to other
jurisdictions; and
 inform the patient’s general practitioner of the consultation.
 You must satisfy yourself that the services you provide through telemedicine are safe and suitable for
patients. You should explain to patients that there are aspects of telemedicine that are different to
traditional medical practice – for example, a consultation through telemedicine does not involve a
physical examination and any additional risks that may arise as a result.

245Cross-jurisdiction issues in telemedicine

If you provide telemedicine services to patients within the State, you should be registered with the Medical
Council. This is to maintain public confidence in telemedicine.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

246 Kenya
247 Kenya Medical Practitioners and Dentists' Board159
The Board regulates medical doctors and Dentists, as well as health institutions.

248Definition of telemedicine
Telemedicine is defined as the use of mobile or IT technology in medical practice.

249Frameworks for telemedicine regulation

The Board does not currently have any rules or regulations on telemedicine, however Kenya’s E-health
Policy is being developed, which may include the practice of telemedicine.
Concerns regarding telemedicine would fall into the following categories:
 licensing and/or registration;
 standards of work.
The Board cooperates with the Nursing Council of Kenya Clinical Officers, Council Pharmacy board of
Kenya. Joint regulation of HCPs and Health products prescribed through the system.

250Regulation of individual doctors who provide telemedicine services

All HCPs have to be licensed locally by the regulatory body and all data for patients has to be stored
securely.

251Cross-jurisdiction issues in telemedicine

[not mentioned in the survey]

159
Based on information from the survey.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

252 Poland
253 Polish Supreme Chamber of Physicians and Dentists (Naczelna Izba
Lekarska) 160
Together with the 24 regional chambers of physicians and dentists, the Polish Supreme Chamber of
Physicians and Dentists forms a professional self-government which oversees all medical doctors and all
dental practitioners who can practice the profession in Poland.
The tasks and competencies of the chambers of physicians and dentists in Poland include supervision over
the exercise of the two professions (regulatory authorities), and awarding the right to practice, setting
principles of professional ethics, carrying out disciplinary / fitness to practice proceedings (medical courts),
as well as accreditation and supervision over Continuing Professional Development, representation and
protection of the profession.

254Definition of telemedicine
The chambers have not adopted for their own use any formal definition of telemedicine. Following an
amendment to the law on the professions of physician and dentist, a physician and dentist may perform their
professional activities (i.e. provide health services) also by means of information and communication
technologies (“za pośrednictwem systemów teleinformatycznych lub systemów łączności”).

255Frameworks for telemedicine regulation

There are some informal rules and regulation on telemedicine provision, which would fall under the
categories of:
 standards of work;
 discipline and/or fitness to practise.
They collaborate with the Ministry of Health - e.g. by providing comments on the draft legislation which
relates to telemedicine (recently a draft regulation of the Minister of Health on organizational standards for
healthcare facilities providing radiology services by means of IT technologies).

256Regulation of individual doctors who provide telemedicine services

The Code of Medical Ethics IS adopted by the professional self-government states that "A physician may
undertake treatment only after having examined the patient. Exceptions are situations where medical advice
can be provided only from a distance." To date there are no recommendations indicating in which situations
there is no necessity for a personal examination.

257Cross-jurisdiction issues in telemedicine

[not mentioned in the survey]

160
Based on information from the survey.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

258 South Africa

259 Health Professions Council of South Africa161
The HPCSA, in conjunction with its 12 Professional Boards, is committed to promoting the health of the
population, determining standards of professional education and training, and setting and maintaining
excellent standards of ethical and professional practice.
The 12 boards are as follows:
 Dental Therapy & Oral Hygiene.
 Dietetics and Nutrition.
 Emergency Care.
 Environmental Health.
 Medical and Dental (and medical science).
 Medical Technology.
 Occupational Therapy.
 Medical Orthotics.
 Prosthetics & Arts Therapy.
 Optometry & Dispensing Opticians.
 Physiotherapy.
 Podiatry and Biokinetics.
 Psychology.
 Radiography & Clinical Technology.
 Speech, Language and Hearing Professions.
In order to safeguard the public and indirectly the professions, registration in terms of the Act is a
prerequisite for practising any of the health professions with which Council is concerned.
The Council guides and regulates the health professions in the country in aspects pertaining to registration,
education and training, professional conduct and ethical behaviour, ensuring continuing professional
development, and fostering compliance with healthcare standards. All individuals who practise any of the
health care professions incorporated in the scope of the HPCSA are obliged by the Health Professions Act
No. 56 of 1974 to register with the Council. Failure to do so constitutes a criminal offence.

260Definition of telemedicine162
The practice of medicine using electronic communications, information technology or other electronic means
between a healthcare practitioner in one location and a healthcare practitioner in another location. This is for
facilitating, improving and enhancing clinical, educational and scientific healthcare and research, particularly
to the under serviced areas in the Republic of South Africa.

161
Based on information from the survey.
162
Taken from “General ethical guidelines for good practice in telemedicine”, section 3.1
http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/Booklet%2010.pdf .

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

261Frameworks for telemedicine regulation

The Council has adopted some regulations and/or policies regarding telemedicine, which fall under the
following categories:
 licensing and/or registration;
 qualifications and training, including continuing professional development;
 standards of work;
 discipline and/or fitness to practise.
The policy are to be reviewed with the 12 professional boards.

262Regulation of individual doctors who provide telemedicine services163

The Council has stated that all telemedicine services should involve a healthcare provider where there is an
actual face-to-face consultation and physical examination of the patient in a clinical setting. The consulting
practitioner will communicate the information to the servicing practitioner, who will then provide the
necessary assistance.
The ethical guidance includes:
 Competence, registration and authorisation: practitioner must be licenced in South Africa.
 Healthcare practitioner-patient relationship: formally, the location of telemedicine service is the patient’s
location.
 Assumption of primary responsibility: the consulting practitioner is ultimately responsible for treatment.
The servicing practitioner must keep the medical record.
 Evaluation and treatment of patient: prescription based only an on online questionnaire is not allowed.
 Professional duties: obtain informed consent of the patient specifically for use of telemedicine; verify the
locations of the consulting and servicing practitioners; verify patient’s identity.

263Cross-jurisdiction issues in telemedicine164

In the case of telemedicine across country borders, practitioners serving South African patients should be
registered with the regulating bodies in their original states as well as with the HPCSA.

163
Also, see “General ethical guidelines for good practice in telemedicine”, Section 4,
http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/Booklet%2010.pdf.
164
“General ethical guidelines for good practice in telemedicine”, Section 4.1.3,
http://www.hpcsa.co.za/Uploads/editor/UserFiles/downloads/conduct_ethics/Booklet%2010.pdf .

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

264 South Sudan

265 South Sudan General Medical Council165
The Council registers and regulates medical doctors, dentists and pharmacists as well as healthcare
organisations especially hospitals and clinics.

266Definition of telemedicine
Telemedicine is defined as the diagnosis and treatment of medical conditions from a distance using modern
telecommunication techniques.

267Frameworks for telemedicine regulation

There are no formal regulations regarding telemedicine.
The Council cooperates with the Association of Medical Councils of Africa, by attending conferences and
exchanging ideas with all member countries on the African continent

268Regulation of individual doctors who provide telemedicine services

[no regulation in place]

269Cross-jurisdiction issues in telemedicine

[no regulation in place]

165
Based on information from the survey.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

270 Sweden
271 The National Board of Health and Welfare166
The National Board of Health and Welfare (Socialstyrelsen) is a government agency in Sweden under the
Ministry of Health and Social Affairs with a very wide range of activities and many different duties within
the fields of social services, health and medical services, patient safety and epidemiology.
The majority of their activities focus on staff, managers and decision-makers in the above mentioned areas.
The Board supports and exerts influence in many different ways:
 It collects, compiles, analyses and passes on information.
 It develops standards based on legislation and the information collected.
 It also undertakes other official duties such as maintaining health data registers and official statistics.

272Definition of telemedicine
This is usually the case when a physician or healthcare provider offers diagnosis and treatment on the
Internet or through telephone applications.
Examples of telemedicine providers: https://kry.se , https://www.mindoktor.se/.

273Frameworks for telemedicine regulation

There are several formal regulations regarding telemedicine.
In Sweden, telemedicine may be performed only if an encrypted connection is established and the physician
and recipients/patients can be identified in a safe and encrypted connection. The physician must also be able
to make a correct diagnosis using the media.
The sender and receiver of the information must be verified by strong authentication (a two way
verification). There is also a possibility to send a reminder of a booked visit to the physicians without
encryption if nothing about the health issues is displayed or revealed and the patient has given his/her
permission to do so.
In case of a positive diagnosis of certain serious infectious diseases or sexually transmitted diseases, the
laboratory which has conducted the analysis shall notify the Infectious Disease Control (no identification
information, only the case) and send the patient to a physician for treatment and (if needed) his/her contact
information.
There is also the possibility to send via the internet x-ray images to another physicians abroad for diagnosis.
In one case, the Supervisory Authority decided to criticise a health care provider who sent x-ray images over
the internet to a radiologist in Spain. There were quality shortcomings to his work and the provider was
criticized for not ensuring the quality matched Swedish regulations.

166
Information collected from an email exchange with the Board.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

274Regulation of individual doctors who provide telemedicine services

Regulations can be found on https://www.socialstyrelsen.se/Lists/Artikelkatalog/Attachments/20165/2016-4-
44.pdf

275Cross-jurisdiction issues in telemedicine

[not mentioned]

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

276 United Arab Emirates

277 Dubai Health Authority167
The Authority regulates healthcare providers, healthcare facilities as well as tele-health.

278Definition of telemedicine
Telehealth: Is the use and exchange of patients’ medical information from one side to another via the
available electronic communications such as two-way video, email, smart phones, wireless tools and other
forms of telecommunication technology to assess and evaluate the patient's health status and treatment.
Telehealth includes a growing variety of applications and services, such as using video-conferencing,
transmission of still images and other data, e-health including patient portals. Remote monitoring, continuing
medical education, and medical call centres, are all considered to be part of telehealth.
Teleconsultation: Is the use of various secured health information technologies and telecommunications to
support and leverage electronic communication between the Healthcare Professional and the Patient.
Teleconsultation allows the Healthcare Professionals to support diagnosis, and provide medical consultation
for treatment or to guide the patient to the health facilities that have the appropriate treatment or to obtain a
second opinion, when required.

279Frameworks for telemedicine regulation

The Authority has adopted formal regulations regarding telemedicine, which broadly fall under the following
categories:
 licensing and/or registration;
 qualifications and training, including continuing professional development;
 standards of work;
 other: policies.

280Regulation of individual doctors who provide telemedicine services

Physicians are regulated according to the following lines:
 Patient Assessment and Treatment Plan
 Documentation to maintain patient information and health records
 Continuity of care records
 Patient consent
 Continuity of healthcare professional and admin staff development
 Data security - receiving, transmission and storage
 Patient referral
 Quality improvement and performance management
 Business continuity plan
 Accreditation

167
Based on information from the survey.

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Australia — ACRRM (Australian College of Rural and Remote Medicine)

281Cross-jurisdiction issues in telemedicine

[not mentioned in the survey]

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United Arab Emirates — Dubai Health Authority [confidential]

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