A Perspective on Interoperability

W. Ed Hammond, Ph.D. defined regions. Since patients, for many

reasons, do not observe any geographical
boundaries, the rules, processes, and standards
Introduction must be global.
Leaders have long postulated that appropriate To achieve this ideal world, additional security
use of information technology (IT) in health and and privacy concerns must be satisfied in such a
health care would have significant positive way as to protect individuals but meet health
influence on creating a healthy society with a requirements of individuals, families, and society
long, high-quality life. In that ideal world we in general. Achieving this ideal world is what
would combine data, knowledge, and process to interoperability is all about.
inspire self-responsibility for health combined
with effective monitoring and mentoring by the Interoperability
professional community. In acute care situations
the most effective and productive decisions Interoperability has become the focus of attention
concerning treatment would be made with the in the HIT community. Some suggest it is
best possible outcomes. I believe this ideal world overrated; others think it is a mandatory
is attainable within a relatively short period of requirement for success in HIT. I suggest the
time and at an affordable cost. truth is somewhere in between. The National
Alliance for Health Information Technology
The vision for that ideal health information (NAHIT) defines interoperability as “…the ability
technology (HIT) application includes a structured of different information technology systems,
electronic health record (EHR) that contains all software applications, and networks to
data relevant to a person’s current and future communicate, to exchange data accurately,
health, aggregated and merged for all sites and effectively and consistently, and to use the
sources. In turn, that EHR serves multiple needs: information that has been exchanged.” [1] This
patient well-being and care, disease definition, although still open to interpretation,
management, research, performance evaluation, seems consistent with the scenario defined in the
outcome evaluation, cross-institutional care, ideal world. True interoperability seems to be an
specialists care and referrals, reimbursement, unattainable task, so a normal approach is to try
data analysis and data mining, regulatory to attain interoperability in steps. The challenge
considerations, education, resource allocation, and rewards are in choosing the right steps.
health surveillance, and other purposes that NAHIT defined levels of interoperability in an
arise. The EHR may coexist in different attempt to define workable steps.
presentations with different focuses. The EHR
will serve the needs of an institution, for public Level 1: Non-electronic data.
health, and for the individual. In this ideal Examples include paper, mail, and
situation the data collected are consistently phone call.
based on circumstance, purpose, and disease. Level 2: Machine-transportable data.
Data sets may be exchanged and fully Examples include fax, email, and
understood, fully usable, and fully trustable from unindexed documents.
any source. EHRs are easily navigable to find Level 3: Machine-organizable data
any data. Data may be exchanged in either a (structured messages, unstructured
push or pull method. Data exchange must content). Examples include
become rule-based, again based on purpose and indexed (labeled) documents,
circumstance. images, and objects.
Level 4: Machine-interpretable data
It is likely that management of such systems will (structured messages, standardized
occur in regions: in some cases these regions content). Examples include the
may be nations, in other cases states or automated transfer from an external
provinces, and in other cases geographically

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 lab of coded results into a provider’s interoperability. A number of other factors must
EHR. Data can be transmitted (or be considered. One important consideration is to
accessed without transmission) by make sure that each step toward interoperability
HIT systems without need for provides immediate value.
further semantic interpretation or
translation. Interoperability requires consideration in a
number of areas. Figure 1 below defines my
These definitions are useful as incremental steps current view of what is required for eHealth
toward interoperability but fall short of true Systemic Interoperability.

Human/computer Security/
Stakeholder Interface Privacy
Interoperability Interoperability Interoperability

Semantic Business
Interoperability Interoperability
eHealth
Systemic
Interoperability
Functional Communications
Interoperability Interoperability

Environmental Legal, ethical

Technical
Interoperability and societal
Interoperability
Interoperability

Figure 1. Categories of Interoperability Required for eHealth Systemic Interoperability.

Not all applications will necessarily require all of A barrier to the exchange and use of data among
these components to be addressed to the same disparate sources has always been the lack of a
level of detail. However, the ideal world will common set of data elements and a common
require dealing with all of these components. terminology. The informatics community has
There is also interaction among these different primarily focused on terminology rather than the
classes of interoperability. data element, which is a step in the right
direction, but in itself will not provide the required
Details of Interoperability level of interoperability.

Semantic interoperability. Semantic First, we focus on terminology. There are over

interoperability is perhaps the first requirement for 200 sets of controlled terminologies that have
interoperability; without it, interoperability will not been created over the past 60 years. The
exist. Semantic interoperability means that the National Library of Medicine attempted to provide
basic element of information exchange – the data some completeness to the terminology issue by
element – is unambiguously understood in creating the Unified Medical Language System
content, meaning, and purpose by the receiver. (UMLS) in 1986. This set of databases includes
For semantic interoperability, the received data, over 150 different controlled terminologies and
with qualifying data such as date/time and attempts to match overlapping terms among
source, stands alone. In the HIT setting, this data some of the major terminology sets.
must be computable; that requirement is most Unfortunately, the terminology models differ
likely satisfied with structured data, perhaps with among the sets and mapping is, at best,
some supporting narrative. incomplete and error-prone. No single controlled
terminology is without error or is complete, even

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in the primary domains addressed by the some predominate terminologies that are likely to
terminology. The issue is further complicated by be part of either an integrated solution or of a
subtle differences in vocabulary, terminology, domain-specific solution. Figure 2 identifies a
nomenclature, taxonomy, classification, and now subset of these popular terminologies. An
ontology. In frustration, most sites – large or integrated solution is made even more
small – use a local vocabulary and frequently that complicated in that some terminologies are free,
local vocabulary is not used consistently and others have significant licensing fees. Many
throughout the institution. At one time Duke different vocabularies support demographic
University Medical Center used over 50 different terms, but frequently the permissible values,
terminologies. Mapping between terminologies is called the value set, are different and have
expensive and will contain errors. Further, the different representation. For example, for
task is never finished, and synchronization gender, one set may use male, female, and
among terminology sets is impossible. Even unknown; another may use M, F, and U; another
when mapping is the only choice, why require 0, 1, and 2; another 0, 1, and 9; and yet another
each group to do their own mapping rather than Y, N, and U. The result is a lack of semantic
to provide a universal set? In the Veterans interoperability. The issue of so-called “null
Administration IT system (VISTA), each site uses flavors” and the lack of consistent use and
a local vocabulary, which means that semantic meaning creates another problem. What is the
interoperability cannot occur. Further, Regional meaning of unknown? Does it mean
Healthcare Information Organizations that anatomically unknown? Does it mean
aggregate data over a number of sites rarely, if unavailable? Does it mean not asked? There
ever, are able to merge the data because of the are issues of pre-coordination (combining terms
lack of semantic interoperability. to be part of the vocabulary set) or post-
coordination (combining terms during use).
The existing numbers of used controlled
vocabularies make a solution of a single
terminology set impossible. There are, however,

Terminology Terminology Terminology

ICD-9-CM DSM-IV NANDA
ICD-10 MeSH NIC
ICD-11 HL7 NOC
SNOMED CT NDC PCDS
SNOMED RT RxNorm Omaha
SNOMED III VA RDF GHHCC
LOINC WHO Drug Codes ICNP
CPT WHO Adverse Drug Reactions AORN Perioperative
DRG MedDRA ICCS
ICPC ATC Outcome Classification
HCPSC MEDICOMP Genomic Ontology

Figure 2. List of some of the currently used controlled vocabularies.

In the absence of some integrated approach, it is names. Globally, ICD-10 is the most frequently
likely that, at least in the U.S., a combination of used controlled vocabulary.
controlled vocabularies will be used: SNOMED
CT, LOINC, RxNorm, ICD, CPT, and MedDRA. In Global South countries it is particularly
important to define and implement specific
SNOMED CT has now reformed as the controlled terminologies for specific purposes.
International Health Terminology Standards One of the first Returns on Investment (ROI) of
Development Organization (IHTSDO). Charter these countries will be the ability to aggregate
members include Australia, Canada, Denmark, data for multiple purposes. From an aggregated
Lithuania, the Netherlands, New Zealand, database, countries will be able to understand
Sweden, United Kingdom, and the United States. prevalence and location of disease and be able to
There is a licensing fee associated with the use recognize pandemic outbreaks of disease. Such
of SNOMED. In the U.S. a number of groups, a database will also permit an evaluation of the
including the U.S. government, have also effectiveness of various interventions to improve
committed to the use of LOINC for laboratory test health of these countries.

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As noted above, terminology is only one each medical society will use a common process
component for semantic interoperability. A to create data elements of interest to that group,
literature review conducted for the 1994 unstable including all of the attributes. Each group will
angina guidelines documented 67 different then bring that work forward to the CIC. If
definitions in use for unstable angina [2]. When a overlaps in terminology occur, resolution and
single box is checked in a clinical trial data harmonization will occur as a CIC activity. HL7
collection form, which of those 67 definitions will, in turn, be responsible for defining the
applies? Semantic interoperability requires architectural structure for the master data
precise and unambiguous definitions for all data element repository and will identify and develop
elements. The focus, then, should be on data the tools necessary for easy use. Several
elements with a set of attributes that includes a medical groups, including the American Heart
unique and persistent numeric identifier (without Association and the American College of
meaning), a name that may be mapped to any Cardiology, are participating in this process.
controlled terminology, a data type from a
standardized set, standard units, and a complete Unfortunately, a number of groups have ongoing
value set. Data type must be taken from a efforts in defining data elements. The set of
standard set of data type specifications, and units attributes and structure are different, and terms
selected from a standard set. Other attributes are not semantically interchangeable. With a little
might include a categorization, semantic linkages, effort, that work could be incorporated into a
synonyms, and functional attributes. One set of master metadata dictionary. An International
attributes can be used to translate the name Standards Organization (ISO) standard,
attribute into other languages, translating the ISO 11179, “Information Technology —
clinical concept rather than just the name. By Specification and standardization of data
passing the code and using a selected language elements — Part 1 Framework” for the
for output, patient data can be interoperable specification and standardization of data
across language barriers. elements has been used loosely as the basis for
much of this work. Figure 3 below identifies
A master set of data elements should be defined several of the groups involved in the creation of a
and maintained internationally. A site is not set of data elements for their use.
required to collect all data elements, but any data
element it collects must be taken from the derived
set. The process of creating the master set of
data must involve the clinical community. Most of
the gaps in controlled terminology sets are a
consequence of not involving the clinical
community. Health Level Seven (HL7) has
created a Clinical Interoperability Council (CIC) in
which the membership will be the medical
societies and other appropriate participants. One
of the first projects proposed is the creation of the
master set of data elements. The idea is that
National Cancer Institute ASTM E31 InfoTerm
caBIG The Open Group UDEF NHLBI
CDISC CDC DEEDS NIAID
US Health Information HITSP Foundations AHIMA (with HL7)
Knowledgebase
HL7 X12N AMA
Detailed Clinical Models Tolven Others …
openEHR CTSA

Figure 3. Organizations defining data elements.

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Technical Interoperability. Technical must be built into the definition of the complex
interoperability includes syntax, structure and data element.
architecture. The technical component that ties
all these components together is the Reference Complex data elements may also be used to
Information Model (RIM) that serves as a define data collection structures. Examples
common model for classes and the relationship include a workup for a screening visit for a patient
among classes to build a common structure. The suspected of having asthma or the return visit for
RIM provides a common reference point for a patient diagnosed as having asthma. Other
defining the binding of data elements to classes, examples might include a well-baby workup, a TB
data interchange, semantic structures, and EHR screen or an admission profile. The power of
architecture. For the most part, XML is used as these structures is that they provide consistency
syntax in structures and in data interchange. and completeness to the data collected
independent of source, site or event.
Few data elements exist only in the atomic form;
in most cases there is a structure varying from A clinical statement fits somewhere into these
simple to complex that informs and aids in the structures. The clinical statement may simply be
capture of data. These structures are defined a phrase (data elements) that defines common
through a range of compound data elements, concepts, such as the “right upper lobe of the
complex data elements, clinical statements, and lung.” Clinical statements are also similar in use
documents. These data structures are called to complex data elements, and may, in fact, be
archetypes or templates and the equivalence of the same thing.
names is confused among different Standards
Development Organizations (SDOs). All of these data structures have some
characteristics in common with the data
The simplest structure is the compound data elements. They are assigned a number, have
element, and blood pressure is one of the persistence, include name and definition, and are
simplest examples. The structure includes available in a global repository.
systolic pressure, diastolic pressure, patient
position during measurement, location of Different types of media also come into play
measurement, cuff size, and method used. Even when defining structures. Waveforms have
this structure is insufficient for interoperability. In structure that depends on the type and purpose
many reality cases, the provider will record only of the waveform. These structures frequently
the systolic and diastolic pressures and leave the include both the actual waveform, measurements
rest of the components blank. Is this acceptable? on the waveform, and interpretations. Images
Does this mean that there are assumed default represent another structure as well, although
values for the rest of the components? Do we these structures are independent standards. The
need templates for each of the combinations of Digital Imaging and Communications in Medicine
the components? When does it matter? These (DICOM) standard is exclusively used globally for
are questions that must be answered by the images. The structure for images includes not
clinical community and built into the structure as only the image but additional data and
required and optional. On the other hand, annotations defining how the image was created
optional is frequently the enemy of and some data about the patient.
interoperability. A better approach is to use the
Another structure is the document standard. The
word conditional rather than optional; that is, the
most widely used document standard globally is
conditions in which the component is required is
the HL7 Clinical Document Architecture (CDA)
defined as part of the compound data element.
Standard [3, 4]. The CDA is used for a variety of
There are also administrative or demographic purposes including patient summaries, discharge
compound data elements such as a person’s summaries, infectious disease reporting, public
name, address, email address, telephone health reporting, referrals, claim attachments,
numbers, etc. In HL7, these administrative radiology reports, and other similar reports. The
compound structures are called Common CDA includes a header, including a registered,
Message Element Types (CMETS). unique document number, sender identification,
receiver identification, document name, and date
The complex data element usually involves some and time stamp. The body may be structured
logic and/or mathematical calculation. A simple using a schema to define content. Level 2
example is body mass index; even then supports content definition to the section level,
additional specifications are required. How long and Level 3 permits definition down to the data
is a height measurement effective? Is the answer element level. Archetypes or templates may be
a function of age? These additional requirements included within the body of the CDA. HL7 and

5
ASTM have created a harmonized standard to the use of technology. One such trend is
called the Continuity of Care Document (CCD) [5], Service Oriented Architecture (SOA) which
which incorporates the ASTM Continuity of Care defines a component approach to defining
Record (CCR) [6] into the CDA. standards and developing systems. HL7, for
example, is rapidly moving in this direction.
The architecture of the EHR itself has made little
progress toward standardization. There is Human/Computer Interoperability. A
ongoing work in the International Standards challenge that has yet to be overcome is solving
Organization Technical Committee 215 (ISO TC the human/computer interface. For the most part,
215) that is beginning to address this issue. The these interfaces that have been done by
European Committee for Standardization (CEN) engineers and computer scientists are still
13606 standard does provide some approach to lacking in ease of use, simplicity of use, and
the architectural content of the EHR. However, speed. Part of the challenge is that no one is
there is still disagreement about the nature of the able to define the ideal system – all users know is
architecture. Some view an architectural that they don’t like what they are forced to use.
structure in which the EHR is composed of Point and click, while popular, is somewhat
documents such as the CDA or Folders based on restrictive and requires good hand/eye
encounters. I propose that the EHR architecture coordination. Paged systems seem to be
must permit direct access to the data element, preferred over scroll bars. Clearly, response time
including structured data elements. influences this choice. Some progress has been
Interoperability requires independence of made with voice recognition, but it still seems to
collection, storage and use or presentation. At be an experiment in progress.
this point, most vendors have a proprietary
architecture for their EHR, and this situation is not Training of users is another challenge related to
likely to change in the near future. These this topic. The idea’ system is one that self-
proprietary architectures may not prevent data educates and requires little training for use.
exchange if the vendor can extract and exchange Turnover of users is quite high and training must
the data preserving semantic interoperability. be continually ongoing. Typically today, most
institutions have more than one system, so there
Navigation of the EHR is a difficult task in most is confusion to the users caused by variations in
existing systems. The architecture and the the computer/human interface. In a recent
structure of the EHR must be such that any piece survey, users rated high the desire to have the
of data contained within the EHR can be found screens of all systems look the same. Perhaps
with 100% certainty. In a recent cardiology one step in this direction would be some
research project, the most frequently missing standardization of screen design, icons and
piece of data was ejection fraction, although it presentation. Unsolved questions included how
was usually contained somewhere in the record. much data can be effectively displayed on the
The structure must be definable and data must screen versus using multiple screens.
exist in specified location. The architecture must
support this need. The grouping of data for data collection still
creates data entry problems. For example, in
The last area of discussion under this topic systems that use clinical guidelines, data
includes medical devices. Increasingly, there are collection for each guideline is different and
direct connections between medical devices and sometimes redundant. Data collection presented
the EHR. These linkages are important in to the user should be a logical integration of data
intensive care settings as well as in home health elements.
and other settings. Many countries report lab
results to patients using mobile phones. Medical Presentation of data is part of the requirement for
device standards are important for patient safety. human/computer interoperability. Only the data
Interfaces for mobile phones and implanted of interest and importance should be presented,
sensors must be included and standardized. A and the presentation should be prioritized.
number of countries, particularly Finland, are Presentations should be event driven.
focusing on mobile technology to exchange data
with its consumers. At the moment, adequate Communications Interoperability. Most
standards do not exist for these medical devices. required communication standards for the
Work on these standards is being done jointly by interchange of data have been developed with
IEEE, HL7, CEN, and ISO. limited input from the health informatics
community. Existing standards are adequate for
It is important to track technology and to what is currently required. The World Wide Web
recognize new technologies and new approaches Consortium (W3C) and the Internet Engineering

6
Task Force (ITEF) have been responsible for component data at the right time and place.
most of these standards, along with the IEEE and Examples include a patient referred to another
the Object Management Group (OMG). These facility for a particular treatment or a patient seen
standards do influence applications. Applications in an emergency room for a specific acute
in health care do need to track trends and problem. Functional interoperability requires
changes including the advance of social defining these trigger events, defining the data to
networking and Web 2.0 and Web 3.0 activities. be exchanged, and dealing with corrections,
These interests will definitely influence additions and updates over the time of interest.
functionality for personal health record systems.
Although exchanging all kinds of data could be
Functional Interoperability. Functional easily accomplished with one kind of standard,
interoperability is the ability to exchange patient several domain-specific standards exist for the
related data and includes the ability to identify, exchange of data. The most widely implemented
without error, the person whose data is being general clinical data messaging standard is the
exchanged. It also includes the ability to HL7 v2.x series of data transport standard. This
understand what data is to be exchanged and to standard, first defined in 1987 and having
extract that data for the patient’s database or evolved to the current version 2.6 is used in over
Electronic Health Record (EHR) on the sending 95% of the hospitals in the U.S. as well as other
side, and the ability to receive that data and countries.
integrate it appropriately into the receiver’s
database or application for which it is intended. Version 2.x standards are based on messages
Functional interoperability also includes the ability with content based on specific trigger events.
to carry out certain common functions required to The format is a message consisting of segments
support common applications. These functions which in turn consist of data fields made of
include the functioning of an EHR System, components which are made of elements. Fields
decision support, queries, report generation and are separated by delimiters. The model for v2.x
other such applications. is implicit and was defined by experienced
individuals who knew what data they needed to
Data Transport Standards. Data transport exchange and when. Version 2.x is used when
means moving data from point A to point B. In both the sender and receiver are known, and
itself, it only requires a common, known conformance agreements can be put into place.
communication protocol and a shared syntax for If the receiver is not known, v2.x cannot provide
sending and receiving data. Exchanging data interoperability. Version 2.x standards have the
between a sender and receiver was one of the advantage of being easy to understand and
first applications in the use of IT for health care. implement. The disadvantage is in the high
Examples include reporting laboratory results, degree of optionality and, consequently,
reporting the admission or discharge of a patient, ambiguity. Later versions of v2.x use XML syntax
sending a claim for payment, and sending a to take advantage of XML tools.
prescription to a pharmacy. The requirement of
interoperability, however, goes far beyond those To solve the problems of interoperability for v2.x,
simple requirements. Unfortunately, even after HL7 began a new approach for an interoperable
40 years of performing these tasks, we still have Version 3 standard based on the Reference
problems obtaining interoperability. The Information Model. Version 3.0 is based on a
problems that prevent success for interoperability core structured content that includes a prescribed
lie in both methodology and in the fact that set of data types, data elements, vocabulary,
several disparate groups must come together to templates and clinical statements. This approach
solve the full spectrum of problems. provides an interoperable conceptual foundation
that is semantically interoperable and uses an
Functional interoperability usually begins with abstract design methodology. This version uses
messaging. The questions are “what data is XML syntax where the tags reflect the data
transmitted when.” Most of the scenarios we use model.
to define what must be done in data exchange
are often more hypothetical than real. While The Clinical Data Architecture HL7 standard is
transmitting complete, lifelong EHRs when a also based on the RIM and can itself be used for
person moves to a new location has value and the transport of data. ASTM’s CCR standard can
happens to about 10% of the population annually, also be used for clinical data transport as can the
it may not be an adequate business case to CCD discussed previously. The DICOM standard
justify the expense of creating an infrastructure is used for transporting images of any form; the
framework to justify the time and expense. A National Council for Prescription Drug Programs
greater challenge is providing the needed has created a suite of medication standards

7
including the SCRIPT standard for prescription informatics and terminology standards,
data; ASC X12(N) has created Electronic Data interoperability standards, business rules
Interchange standards for reimbursement; IEEE management, and workflow management). The
has standards for medical devices and home HL7 EHR-FM standard has been used by the
care sensors; and OASIS standards for the Certification Commission for Health Information
exchange of business information. Integrating Technology (CCHIT) to define requirements for
the Healthcare Environment (IHE), a collaborative certification of EHR vendors.
effort with the Radiological Society of North
America and the Healthcare Information and The creation and use of a Personal Health
Management Systems Society, working with Record has received a lot of interest
various clinical groups, provides profiles for end- internationally. HL7 recently balloted a standard
to-end requirements from the above sets of for Functional Requirements for the Personal
standards. A typical application will require Health Record.
expertise in all of these standards. The required
expertise is further extended when one includes Other standards required for functional
ISO and CEN standards. interoperability include functional standards for
regional health care information organizations
Decision Support Standards. The (RHIOs and HIEs) and National Healthcare
requirements for decision support applications Information Networks. Other standards include
and knowledge management, as part of an EHR developing functional profiles for different sites,
system, have long been postulated. The lack of EHR content standards, and structure and
semantic interoperability has prevented wide architectural standards.
spread application of clinical decision support
systems (CDSS). HL7 has a technical committee A related set of standards includes identification
that has created standards for knowledge standards for persons, providers, facilities, and
representation, logic structures for decision rules, employers. Actually, interoperability would be
clinical guidelines and disease management considerably easier if all objects, actors and
protocols. Specific standards include the Arden attributes were assigned a unique and universal
Syntax, GELLO, Guideline Interchange Format identification number. The pilot testing of
(GLIF), and the Infobutton. ASTM has a ePrescribing in the U.S. in 2005 found that
guideline standard, Guidelines Elements Model medication records from different sources could
(GEM). HL7 also has ongoing work based on a not be combined for an individual person with
virtual EHR that drives decision support acceptable accuracy in the absence of a unique
algorithms. As part of the CIC activities, HL7 will Personal Identification Number.
assist in the development and implementation of
Business Interoperability. Health care occurs
clinical guidelines and decision support
in many different settings. Data requirements
algorithms. The Infobutton standard should have
differ, priorities are different, and other influences
value to the provider community.
such as culture and environment affect what is
EHR Functional Standards. In spite of its done. In many cases, controlled interoperability
importance, there is no consistent, agreed upon can be accomplished through agreements with all
definition of the Electronic Health Record, or what trading partners. So what do these different sites
are its different flavors such as an Electronic have in common and what is different?
Medical Record, a Population Health Record, a Obviously a nursing home will have different date
Summary Health Record, and a Personal Health requirements than an intensive care setting. The
Record. Part of that definition, however, is what key to interoperability is to make sure all pertinent
functions or capabilities must exist in an EHR classes of interoperability are satisfied. Any data
system for it to meet a minimum set of element used at any site must come from the
requirements. HL7 has created a standard, the common metadata registry. Every site should
Electronic Health Record – Functional Model that keep a registry that identifies what data elements
became a normative standard in February 2007. are collected by that site. Business agreements
This standard defines functionalities in three should be in place with each business partner
categories: direct care (care management, that defines the circumstances and the data
clinical decision support, and operations elements that will be exchanged between sites
communications, and management); supportive and under what circumstances. For example, a
(clinical support, measurement analysis, research nursing home should create a profile that would
and reports, and administrative and financial); define what data elements should accompany the
and information infrastructure (security, health transfer of a patient from that hospital to the
record information and management, unique nursing home and a second profile that would
identity, registry and directory services, health define what data elements would accompany a

8
patient being transferred from the nursing home Legal, Ethical, and Societal Interoperability.
to the hospital. Reimbursement claim For the most part, little attention has been paid to
requirements could be driven by profiles that issues of legal, ethical and societal
depend on problems and events. Research interoperability. Included under societal
protocols and clinical trials would be a interoperability are cultural issues. Cultural
specification of what data elements were issues are particularly important, particularly in
exchanged based on what triggers events. Some the Global South. These issues need to be
of these profiles are currently being defined by understood and accommodated consistent with
Integrating the Healthcare Enterprise (IHE). It is excellent and desired outcomes. Legal issues
likely that any site will have many of these need to be defined and accommodated in such a
business profiles. way that the effectiveness and usability of
systems are not compromised. What are key
Security and Privacy Interoperability. Perhaps characteristics of the population? What is the
the greatest pitfall in trying to achieve systemic model for the health delivery system? How are
interoperability is the failure to properly deal with decisions related to health care made?
security and privacy. How a system will deal with
security and privacy must be very visible and Stakeholder Interoperability. For much of the
must be one of the first things shared with the history of informatics and the use of IT in health
consumers. Major systems have been brought care, the stake holders have been largely the
down by the failure to do this in an obvious and industry (vendors), the providers of care, and a
timely manner. In some cases, systems have general community that includes consultants, a
over responded to privacy issues and actually few academicians and a few representing the
have designed systems that are unsafe. In other government. To achieve eHealth Systemic
cases, privacy has not been dealt with Interoperability, a much broader set of
adequately. stakeholders must be educated, made interested
and engaged. These stakeholders include
The general rule for privacy and security is that almost all aspects of today’s society, including
first, the patient must not be damaged by the use consumers, payers, regulators, governments,
or release of data. Of equal importance, device manufacturers, the clinical community in
however, is that effective and appropriate contrast to clinical IT people, quality assessment
treatment for the patient must not be withheld people, media, consumer groups such as the
because of privacy concerns. In many cases, AARP, and many others. For example, the
timely and appropriate treatment requires dealing manufacturers of the equipment that perform
with identified data. Further, there is a societal laboratory tests need to be involved. Their
responsibility to share personal data for such products are the starting point of an end-to-end
purposes as identifying pandemic outbreaks, interoperability challenge that involve, the device
adverse drug events, bioterrorists attacks, and manufacturers, the commercial laboratories, the
new vectors for disease. When possible, data vendors of IT systems, the users of those
should always be shared as de-identified data. In systems, the clinical community, the payers, and
many cases, the identity of the patient can be others.
restricted to the computer and not humans
through the use of anonymous identifiers. As Environmental Interoperability. Understanding
data is shared among many sites, it is important the environment is very important to success in
to ensure that a patient’s privacy requirements the use of IT in health care, particularly in the
are maintained. Global South. Access to the internet might be a
prime consideration in the development of
A number of effective security standards are systems and the access to systems. What is the
available, but the informatics community has availability of electrical power in the universal
been slow to identify which of these standards we setting? How is the internet available? Is it
will use. Effective standards exist for digital available only from satellites? What percentage
signatures, and these should be accepted of the population has access to the internet? Are
globally and used immediately. Adequate land lines available? What role will mobile
authentication processes exist, but, in the United telephones play in the implementations strategy?
States, these certificates are expensive (because What is the population density? What are the
of the large numbers) and must be renewed availability of hospitals? Are these general
annually. Authentication processes should be at hospitals or specialist hospitals? What are the
the national level and should be done without age distributions? What percent of the population
cost to an individual. is over age 65? What is needed and how it is
delivered comes from the answer to these
questions.

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Interoperability for the Global South cases should include what will be the evaluations
to prove the value of such systems. The question
Interoperability should be treated as a direction is what shared data will have an impact on the
for the Global South rather than as the end point. health of individuals in these countries of interest.
There are clearly immediate incentives for taking Suggestions would include creating and
steps toward that goal. Already there are aggregating data for a country that would assist
examples of countries that have implemented IT in understanding the health status of a country
systems, but, due to lack of semantic and the level of the ability of the country to deal
interoperability, cannot aggregate the data to with those problems. The balance between the
produce key national statistics. These statistics reality of what can be done and the perceived
will be important in understanding where to focus needs is important. For example, it is likely that
resources. From a clinical perspective, patient making laboratory results available at the point
data will be useful in understanding disease, the and time of care might have an immediate impact
spread of disease, and in educating the on the health of the population. Education of the
population. Knowing what disease exists in what people may be more important than imaging
regions will be important in dealing with cause. In equipment. Simple will always, in any
most cases, time is extremely important in environment, be better than complex. What will
recognizing pandemic outbreaks and bringing be the impact of ePrescribing in a population that
them immediately under control. Involving may not have access to drugs needed for
stakeholders, particularly political leadership, will treatment? In any case, the focus must be on the
be important in setting national goals and receivers and users of the IT systems rather than
objectives. Much of these comments relate to “If the developers of such systems.
you can’t measure it, you can’t change it.”
In some cases, the adoption of clinical guidelines
There are currently several IT activities that and decision support will be important. These
involve countries that are part of the Global guidelines might be incorporated into educational
South. While many of these systems are components to help local providers be better
effective, they come far short in making a prepared for disease management and patient
significant impact on the health of these care.
countries. Planning effective IT systems and
understanding the requirements for HL7 standards can be made available for little
interoperability in these countries will be a real cost. The standards we propose are simple to
challenge. The concept of appropriate use and easy to implement. It is important to
technology should be a major focus. Whatever is identify and provide the stability to adopt
done must have immediate value and must make standards and put them into immediate use.
an immediate impact. There needs to be an infrastructure in place that
can make the decision that standards will be
The first step seems obvious. A common set of used and to identify those standards.
data elements with an associated terminology
should be adopted by each country. Ideally, the There exists already a number of groups who are
same set would be shared among all nations. committed to advising Global South countries on
Even if the focus is only on adopting a defined set implementation of eHealth Standards. These
from existing controlled vocabularies, countries organizations include ISO, WHO, IMIA, AMIA,
can realize value in the effort. This is probably and others. HL7 would be willing to bring these
the highest value-add in the interoperability countries in as HL7 affiliates and assign a twining
space. Having a common terminology set is affiliate to work with them in implementing
essential for the earliest received value. It is standards. The primary barrier to progress is the
likely that a data interchange standard such as inability to identify the appropriate individuals to
HL7 v2 messages will be adequate and simple to provide leadership and stability to the efforts.
implement. In fact, it makes more sense to use
an existing standard rather than to create flat files It is likely that these efforts would be affordable.
with simple delimiters to exchange data. The The systems need not be so sophisticated and
HL7 messaging standards have already could provide immediate value. There are
addressed many problems and have workable examples of some countries, not necessarily
and proven solutions. The HL7 standard is Global South, that have involved a single
expandable, and it will be easy to add data individual to advise them in the implementation of
element without additional programming. standards. Many of these countries, such as
Vietnam, Thailand and Uganda have already
In addressing this issue, appropriate use cases shown an interest and have individuals and
must be defined and discussed. These use groups working with them. The problem is

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sustainability. I think it is essential to have gigabyte memory stick that is wearable as a
government backing, even with a small bracelet. There are now very capable computers
expenditure of funds, to make these projects available for less than $200.
work.
Summary and Conclusions
I think many vendors would be willing to work to
create systems for Global South countries. As a Most of the standards necessary to make valued
first step, I would engage the EHR Vendors progress toward systemic interoperability
Association (U.S.) and other similar organizations currently exist. Part of the problem is that there
in discussions in what could be done for some of are duplicating and overlapping standards, and
these countries as pilot projects. which standards will be used must be identified.
There are some gaps in the required standards,
The President’s Commission on Systemic but SDOs are working to identify those gaps, and
Interoperability [7] suggests a practical approach most of those additional standards will be
to systemic interoperability. In this case, the developed in time. There are still some questions
focus is on creating a medication record. That in the extent of standardization versus proprietary
focus may be inappropriate in the case of Global design.
South. However, what can be accomplished calls
for imagination and innovation. For example, the The systems that are implemented in the Global
cost of memory sticks with adequate memory is South need only be adequate for appropriate
minimal. Simple personal health records could applications. It is important that all necessary
be stored on these devices, water-proofed and stakeholders be identified early on and engaged
made into a wearable object. The National in the implementations. What is needed is
Library of Medicine gives its students at the innovative leadership in making these visions
Woods Hole Medical Informatics course a one happen.

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References

1. The National Alliance for Health Information Technology. “What is Interoperability?” 2006. Available
at http://www.nahit.org/cms/index.php?option=com_content&task=view&id=186&Itemid=195.
Accessed October 31, 2007.

2. Braunwald E, Mark DB, Jones RH, et al. “Unstable Angina: Diagnosis and Management. Clinical
Practice Guideline Number 10.” AHCPR Publication No. 94-0602. Rockville, MD, Agency for Health
Care Policy and Research and National Heart, Lung, and Blood Institute, Public Health Service,
U.S. Department of Health and Human Services. March 1994.

3. Health Level Seven, Inc. HL7 Clinical Data Architecture, Release 2. Available at http://www.hl7.org.
Accessed June 25, 2008.

4. Dolin RH et al. The HL7 Clinical Document Architecture. J Am Med Inform Assoc 2001:8:552-569.

5. Health Level Seven, Inc. HL7 Continuity of Care Document, Release 1. Available at
http://www.hl7.org. Accessed June 25, 2008.

6. ASTM International. ASTM E 2369 Standard Specification for Continuity of Care Record (CCR).
2005. Referenced ASTM Standards, available www.astm.org.

7. Commission on Systemic Interoperability. “Ending the Document Game: Connecting Your Healthcare
through Information Technology.” U.S. Government Printing Office, Washington, DC, 2005. Available
at http://www.EndingTheDocumentGame.gov. Accessed June 25, 2008.

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