ISO/TR 14639-1:2012

INTERNATIONAL ISO/TR
STANDARD 14639-1
First edition
2012-08-15

Health informatics — Capacity-based
eHealth architecture roadmap —
Part 1:
Overview of national eHealth initiatives
Informatique de santé — Feuille de route de l'architecture de santé
électronique fondée sur la capacité —
Partie 1: Aperçu des initiatives de santé électronique nationale




Reference number
ISO/TR 14639-1:2012(E)
©
ISO 2012

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ISO/TR 14639-1:2012(E)

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ISO/TR 14639-1:2012(E)
Contents Page
Foreword . v
Introduction . vi
1 Scope . 1
2 Terms and definitions . 1
3 Abbreviations . 6
4 Initiatives reviewed . 7
4.1 Health Metrics Network . 7
4.2 Australia . 7
4.2.1 National health system . 7
4.2.2 Focus of national health system . 9
4.2.3 Components of the national health information system . 10
4.2.4 National eHealth policies . 11
4.2.5 National eHealth architecture stage of development . 15
4.2.6 National data warehouse . 17
4.2.7 Standards in use . 17
4.2.8 Standards Development Organizations (SDOs) and Health Informatics Associations . 19
4.2.9 National reporting infrastructure for individual and/or summary data . 20
4.2.10 Households with Internet access . 20
4.3 Brazil . 20
4.3.1 National health system . 20
4.3.2 Focus of national health system . 20
4.3.3 Components of the national health information system . 22
4.3.4 National eHealth policies . 23
4.3.5 National eHealth architecture stage of development . 24
4.3.6 National data warehouse . 24
4.3.7 Standards in use . 25
4.3.8 Standards Development Organizations (SDOs) and Health Informatics Associations . 25
4.3.9 National reporting infrastructure for individual and/or summary data . 26
4.3.10 Households with Internet access . 26
4.4 Canada . 27
4.4.1 National health system . 27
4.4.2 Focus of national health system . 29
4.4.3 Components of the national health information system . 30
4.4.4 National eHealth policies . 31
4.4.5 National eHealth architecture stage of development . 32
4.4.6 National data warehouse . 34
4.4.7 Standards in use . 34
4.4.8 Standards Development Organizations (SDOs) and Health Informatics Associations . 34
4.4.9 National reporting infrastructure for individual and/or summary data . 35
4.4.10 Households with Internet access . 35
4.5 India . 35
4.5.1 National health system . 35
4.5.2 Focus of national health system . 36
4.5.3 Components of the national health information system . 37
4.5.4 National eHealth policies . 37
4.5.5 National eHealth architecture stage of development . 37
4.5.6 National data warehouse and national reporting infrastructure for individual and/or
summary data . 37
4.5.7 Standards in use . 37
4.5.8 Standards Development Organizations (SDOs) and Health Informatics Associations . 38
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ISO/TR 14639-1:2012(E)
4.5.9 Households with Internet access .38
4.6 Kenya .38
4.6.1 National health system; focus of national health system .38
4.6.2 Components of the national health information system .39
4.6.3 National eHealth policies .42
4.6.4 National eHealth architecture stage of development .43
4.6.5 Standards in use .43
4.6.6 Standards Development Organizations (SDO) and Health Informatics Associations .44
4.6.7 National reporting infrastructure for individual and/or summary data .44
4.6.8 Households with Internet access .44
5 International Monitoring and Evaluation frameworks .44
5.1 Overview .44
5.2 Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM) .44
5.3 Joint United Nations Program on HIV/AIDS (UNAIDS) .44
5.4 Pan American Health Organization (PAHO) Framework.45
5.5 Brazilian Health Indicators Framework .45
5.6 Canadian Health Indicators Framework .45
5.7 United States Health Indicators Frameworks .45
6 Key findings .46
7 Need for an eHealth Architecture Maturity Model (eHAMM) .49
Bibliography .52

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ISO/TR 14639-1:2012(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO/TR 14639-1 was prepared by Technical Committee ISO/TC 215, Health informatics.
ISO/TR 14639 consists of the following parts, under the general title Health informatics — Capacity-based
eHealth architecture roadmap:
 Part 1: Overview of national eHealth initiatives
The following parts are under preparation:
 Part 2: Architectural components and maturity model
This part of ISO/TR 14639 complements and supports the general requirements for the use of information in
health services which are to be set out in the proposed technical specification, ISO/TS 16555, Health
informatics — Framework for national health information systems. ISO/TS 16555 will provide specifications
defining data sources and business processes supporting the more general use of information within the
delivery, operation, management and planning of health services within a country.

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ISO/TR 14639-1:2012(E)
Introduction
This part of ISO/TR 14639 arises from the recognition that currently there is considerable diversity
internationally in the approach and scope of development and implementation of national health information
systems (HIS). Growing interest in health system strengthening in low-income countries (LIC) in the
[3]
international community has led to increasing interest in and support of this activity .
In preparing this part of ISO/TR 14639, the original aim was to provide guidance for developing and emerging
countries and for the many international groups that conduct health programs in the developing and emerging
world. As the work proceeded, it became clear that the work is more widely applicable to all health services,
for whom there are potential lessons to be learned as they examine the way in which information is used,
produced and managed in various aspects of their work. The identification of relevant health informatics
standards and the role of international standardization in support of eHealth were also important drivers.
This part of ISO/TR 14639 builds on lessons from many countries, including those whose activities are
summarized in this part of ISO/TR 14639, and was largely inspired by the Health Metrics Network (HMN)
[1][2]
activities sponsored by the World Health Organization (WHO) .
This work has been motivated in part by a recognition that countries vary in terms of readiness and resources
for health system strengthening, with the expectation that it will help to provide the tools needed for policy-
making, strategic planning and eHealth architecture development for robust and appropriate country HIS.
The particular focus of this part of ISO/TR 14639 is the potential for Information and Communications
Technology (ICT) to assist in the collection, communication, storage, processing and use of information to
support the delivery, planning and coordination of health services. However, it also recognizes the importance
of initial measures that involve paper-based collection and the need for a migration path from manual to semi-
automated to fully automated information management systems.
This part of ISO/TR 14639 presents a description of contemporary national enterprise-wide HIS. The resulting
landscape identifies key high-level categories for different aspects of such systems which should be
considered in any national architecture design endeavour. While not an exhaustive inventory of systems or
necessarily a description of best practices, it is roughly representative of all income levels and strives to
illustrate the diversity of HIS in different information technology environments with varying levels of capacity.
Supported by the findings from this review, this part of ISO/TR 14639 also proposes development of an
eHealth architecture maturity model (eHAMM) for expressing the extent of development of HIS and eHealth
architecture. The model can be used to direct planning and assess progress of national HIS towards maturity.
The maturity model will be elaborated upon in ISO/TR 14639-2 and includes a methodology for classifying HIS
according to descriptions of architectural components.
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TECHNICAL REPORT ISO/TR 14639-1:2012(E)

Health informatics — Capacity-based eHealth architecture
roadmap —
Part 1:
Overview of national eHealth initiatives
1 Scope
This part of ISO/TR 14639 aims to identify the business requirements of an eHealth architecture as well as
providing a generic and comprehensive context description to inform architectural structuring of Health
Information Systems (HIS).
This part of ISO/TR 14639 reviews international experiences in the construction of national eHealth
[4]
architectures and introduces a methodology for strategic development of HIS , which will be elaborated upon
in ISO/TR 14639-2.
This part of ISO/TR 14639 is intended to assist nations which are in the early or mid stages of developing
such systems.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
architecture system
structure of components, their functions and their inter-relationships, and the principles and guidelines
governing their design and evolution over time, or a description of the structure and behaviour of a system, a
system’s components, its functions and inter-relationships
[14]
NOTE 1 Adapted from Open Group Architecture Framework (TOGAF), 2009 and Blobel, B., Application of the
[86]
Component Paradigm for Analysis and Design of Advanced Health System Architectures, 2000 .
NOTE 2 This term also includes architecture and system architecture.
2.2
biosurveillance
process of active data-gathering with appropriate analysis and interpretation of biosphere data that might
relate to disease activity and threats to human or animal health (whether infectious, toxic, metabolic, or
otherwise, and regardless or intentional or natural origin) in order to achieve early warning of health threats,
early detection of health events and overall situational awareness of disease activity
[88]
[CDC Concept Plan for the Implementation of the National Biosurveillance Strategy for Human Health ]
2.3
clinical information
information about a person, relevant to his or her health or healthcare
[ISO 13606-1:2008, definition 3.13]
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ISO/TR 14639-1:2012(E)
2.4
chronic disease
health condition of 3 months' duration or longer
[US National Center for Health Statistics]
2.5
data warehouse
grouping of data accessible by a single data management system, possibly of diverse sources, pertaining to a
system or sub-system and enabling secondary data analysis for questions relevant to understanding the
functioning of that system, and hence supporting proper maintenance and improvement of that system
NOTE 1 A data warehouse tends not to be used in real time; however, depending on the rapidity of transfer of data to
the data warehouse, and data integrity, near real time applications are not excluded.
NOTE 2 Adapted from ISO/TR 22221:2006.
2.6
eHealth
the combined use of electronic communication and information technology in the health sector to enable
better health and healthcare
[World Health Organization]
2.7
eHealth architecture
structure of a system of eHealth components and services
2.8
electronic health record
EHR
information relevant to the wellness, health and healthcare of an individual, in computer-processable form and
represented according to a standardized information model, or the longitudinal electronic record of an
individual that contains or virtually interlines to data in multiple EMRs and EPRs, which is to be shared and/or
interoperable across healthcare settings and is patient-centric
NOTE Adapted from ISO 18308:2011 and the European 2011 eHealth Strategies Final Report, January 2011.
2.9
electronic medical record
EMR
electronic record of an individual in a physician’s office or clinic, which is typically in one setting and is
provider-centric
[European 2011 eHealth Strategies Final Report, January 2011]
2.10
electronic patient record
EPR
electronic record of an individual in a hospital or health care facility, which is typically in one organisation and
is facility-centric
[European 2011 eHealth Strategies Final Report, January 2011]
2.11
health
state of complete physical, mental and social well-being and not merely the absence of disease or infirmity
[World Health Organization 1948]
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ISO/TR 14639-1:2012(E)
2.12
health condition
aspect of a person or group’s health that requires some form of intervention
NOTE These interventions could be anticipatory or prospective, such as enhancing wellness, wellness promotion or
illness prevention (e.g. immunization).
[Canada Health Infoway EHRS Blueprint v1.0: 2003]
2.13
health information
information about a person relevant to his or her health
[ISO 18308:2011, definition 3.28]
2.14
health information system
HIS
system that combines vital and health statistical data from multiple sources to derive information and make
decisions about the health needs, health resources, costs, uses, and outcomes of healthcare
NOTE Adapted from Canada Health Infoway, Canadian Electronic Drug Messaging (CeRx) Standards 1-2010/03/29.
2.15
health worker
person engaged in actions that are primarily intended to enhance health
NOTE 1 This term also includes healthcare worker.
NOTE 2 Adapted from World Health Report, January 01, 2006.
2.16
healthcare
activities, services or supplies related to the health of an individual
[EN 13940-1:2007]
2.17
healthcare activity
activity performed for a subject of care with the intention of directly or indirectly improving or maintaining the
health of that subject of care
[EN 13940-1:2007]
2.18
healthcare professional
person authorized to be involved in the direct provision of certain healthcare provider activities in a jurisdiction
according to a mechanism recognized in that jurisdiction
NOTE Adapted from EN 13940-1:2007.
2.19
healthcare provider
healthcare organization or healthcare professional involved in the direct provision of healthcare
[EN 13940-1:2007]
2.20
interoperability
see semantic interoperability (2.34) and syntactic interoperability (2.36)
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ISO/TR 14639-1:2012(E)
2.21
low income country
LIC
country where income is USD 1 005 gross national income (GNI) per capita or less, calculated using the
World Bank Atlas method
NOTE 1 An LIC is part of the classification system of all World Bank member countries (187), and all other economies
with populations of more than 30,000 (213 total). Economies are divided according to 2009 GNI per capita, calculated
using the World Bank Atlas method. The groups are: low income, $995 or less; lower middle income, $996 - $3,945; upper
middle income, $3,946 - $12,195; and high income, $12,196 or more.
NOTE 2 Adapted from World Bank Country Classifications.
2.22
monitoring and evaluation
M & E
routine tracking of the key elements of programme/project performance, usually inputs and outputs, through
record-keeping, regular reporting and surveillance systems, as well as health facility observation and client
surveys, and the episodic assessment of the change in targeted results that can be attributed to the
programme or project/project intervention
NOTE Evaluation attempts to link a particular output or outcome directly to an intervention after a period of time has
passed.
[Global Fund]
2.23
notifiable diseases
list of diseases determined by the International Health Regulations used as a decision instrument for the
assessment and notification of events that may constitute a public health emergency of international concern
[World Health Organization, International Health Regulations]
2.24
organization
unique framework of authority within which a person or persons act, or are designated to act, towards some
purpose
NOTE Adapted from ISO/IEC 6523-1:1998, definition 3.1.
2.25
patient
individual who is a subject of care
NOTE Adapted from ISO/TR 20514:2005, definition 2.30.
2.26
personal health information
any information that concerns a person's health, health history, health treatment or genetic characteristics in a
form that enables the person to be identified
NOTE Adapted from ISO/TR 18307:2001, definition 3.112.
2.27
policy
set of rules such as legal, political or organizational which can be expressed as obligations, permissions or
prohibitions
NOTE Adapted from ISO/TS 22600-1:2006, definition 2.13.
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ISO/TR 14639-1:2012(E)
2.28
primary care
first level of care (access to first contact), characterized mainly by longitudinality, comprehensive care and
coordination of care within the health system itself
NOTE It may have additional features such as family counselling and community and cultural competence.
[Starfield, B., Primary care: concept, evaluation and policy. New York, Oxford University Press, 1992]
2.29
privacy
freedom from intrusion into the private life or affairs of an individual when that intrusion results from undue or
illegal gathering and use of data about that individual
[ISO/IEC 2382-8:1998, definition 08.01.23]
2.30
register
formal or official recording of items, names or actions
[ISO/IEC 10036:1996, definition 3.3]
2.31
registry
server capable of holding data for the systematic and continuous follow-up of information objects maintained
in accordance with specific rules
[ISO/TR 21089:2004, definition 3.79]
2.32
roadmap
detailed plan to guide progress towards a goal
[Merriam-Webster Dictionary]
2.33
secure messaging
set of means for cryptographic protection of [parts of] command-response pairs
[ISO/IEC 7816-4:2005, definition 3.39]
2.34
semantic interoperability
ability for data shared by systems to be understood at the level of fully defined domain concepts
[ISO/TS 18308:2011, definition 3.45]
2.35
subject of care
person seeking to receive, receiving, or having received healthcare
[EN 13940-1:2007]
2.36
syntactic interoperability
capability of two or more systems to communicate and exchange data through specified data formats and
communication protocols
[ISO 18308:2011, definition 3.48]
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ISO/TR 14639-1:2012(E)
2.37
teleconsultation
provision of healthcare via a telehealth service, generally for the purpose of diagnosis or treatment of a
subject of care at a site remote from the patient or their primary care provider
NOTE Adapted from the Medical Conditions Dictionary.
2.38
telehealth
the use of telecommunication techniques for the purpose of providing telemedicine, medical education and
health education over distance
[ISO/TS 16058:2004, definition 3.13]
2.39
vocabulary
terminological dictionary which contains designations and definitions from one or more specific subject fields
NOTE Adapted from ISO 1087-1:2000, definition 3.7.2.
3 Abbreviations
AIDS  Acquired Immunodeficiency Syndrome
CDA  Clinical Document Architecture
eHAMM  eHealth architecture maturity model
EHR  Electronic Health Record
EMR  Electronic Medical Record
HIC  Health Information Custodian
HIS  Health Information System
HIV  Human Immunodeficiency Virus
HL7  Health Level Seven
ICD  International Statistical Classification of Diseases and Related Health Problems
ICT  Information and Communications Technology
IHE  Integrating the Healthcare Enterprise
IHTSDO  International Health Terminology Standards Development Organization
ISO  International Organization for Standardization
ISO/TC 215 ISO Technical Committee 215 (Health Informatics)
IT  Information Technology
LIC  Low Income Country
M & E  Monitoring & Evaluation
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ISO/TR 14639-1:2012(E)
MoH  Ministry of Health
NGO  Non-governmental organization
PHR  Personal Health Record
SNOMED CT Systematized Nomenclature of Medicine Clinical Terms
TB  Tuberculosis
4 Initiatives reviewed
4.1 Health Metrics Network
[1][2]
The Health Metrics Network (HMN), under the auspices of the World Health Organization (WHO) , is the
first global health partnership that focuses o
...