ISO/TR 14639-2:2014

TECHNICAL ISO/TR
REPORT 14639-2
First edition
2014-10-01
Health informatics — Capacity-based
eHealth architecture roadmap —
Part 2:
Architectural components and
maturity model
Informatique de santé — Feuille de route de l’architecture de santé
électronique fondée sur la capacité —
Partie 2: Composants architecturaux et modèle de maturité
Reference number
ISO/TR 14639-2:2014(E)
©
ISO 2014

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ISO/TR 14639-2:2014(E)

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ISO/TR 14639-2:2014(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 2
3 Abbreviations.12
4 Overview of business requirements .13
5 Development and application of eHealth enterprise architectures .13
5.1 eHealth enterprise architectures .13
5.2 Development of an eHealth architecture .13
5.3 Building up the architecture: A methodology .14
6 Health architecture components and requirements .20
6.1 Governance and national ownership .22
6.2 Health process domain components .44
6.3 Foundation Components — eHealth infostructure .85
6.4 Foundation components — ICT infrastructure .100
7 Profiling countries with the eHAM .111
8 Future Considerations .115
Annex A (informative) World Economic Forum — Global Health Data Charter .117
Annex B (informative) Generic component model .121
Annex C (informative) Health informatics — Service architecture (HISA) .122
Annex D (informative) Candidate standards supporting eHealth Architecture Model and
Maturity Models .125
Annex E (informative) WHO Indicator and Measurement Registry (IMR) .128
Annex F (informative) Statistical Data and Metadata Exchange for the Health
Domain (SDMX-HD) .129
Annex G (informative) List of figures and tables in this part of ISO 14639 .132
Bibliography .133
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ISO/TR 14639-2:2014(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is 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
— Part 2: Architectural components and maturity model
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ISO/TR 14639-2:2014(E)

Introduction
ISO/TC 215 has identified that there is an urgent need to provide International Standards for health
information architectures that includes requirements tailored also to low- and middle-income countries
with relatively immature resources available. A Public Health Task Force of international experts,
established by TC 215, has developed a report outlining the challenges these countries face and some of
the relevant standardization strategies.
This part of ISO/TR 14639 provides a guide to best practice business requirements and principles for
planning the use of information and communications technology (ICT) to support the development,
coordination, and delivery of healthcare services by countries and subordinate health authorities within
a country.
One of the activities motivating this work originates from a meeting in March 2010, in Bellagio, Italy to
[10]
explore how the “digital divide” between high-income and low-income countries could be addressed.
The following observations were noted.
a) There is a surge of interest in the development of eHealth infostructure to support effective Health
Information Systems (HIS) in low-income countries, including responding to disease outbreaks,
monitoring the health status of the population, and improving both public and individual health.
b) Health informatics International Standards help countries to make the proper decisions regarding
their eHealth architecture such that they can strengthen their health systems. HIS architectures
that are non-proprietary and based on International Standards are likely to be more robust and
future-proof.
c) The use of health informatics International Standards in low-income countries is hampered due
to lack of knowledge and awareness about appropriate standards, affordable access to standards
and implementation guides, and little participation in Standards Development Organization (SDO)
activities due to little or no funding to support such engagement.
d) Existing international health informatics International Standards insufficiently address the
needs of low-income countries (LICs) for developing their monitoring, public health, and patient
care systems. An example of this is mobile computing and the use of SMS for transmitting patient
information, reminders, and alerts. Thus, the participation of LICs in the International Standards
development process is essential.
e) Participation in ISO activities requires a national standards organization or government department
as an official member of ISO.
f) Development of International Standards has a cost. A significant amount of money and time needs
to be invested in preparation of documents, commenting on proposals, and participation in SDO
meetings and for adopting, adapting, and localization of standards. These costs represent a genuine
barrier to the participation of low-income countries.
g) Access to International Standards also comes with a cost that is often prohibitive for people and
organizations in low-income countries.
h) There is recognition that the business model of some SDOs is based on the sale of International
Standards to support the standards development process and operating expenses.
i) HIS strengthening can be promoted by using commonly shared International Standards to carry out
Monitoring and Evaluation (M & E) activities for government bodies, international organizations,
donors, and other interested parties.
j) There are duplications and overlaps in health informatics International Standards across multiple
SDOs. Low-income countries require a single set of usable International Standards based on the
work of ISO/TC 215, HL7, and CEN/TC 251 Joint Initiative Council (JIC) to harmonize International
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ISO/TR 14639-2:2014(E)

Standards and facilitate the global, international adoption, and adaption of organizational and
regional standards based on the ISO standards process.
k) Promotion of International Standards worldwide is consistent with the ISO mission yet barriers
exist to the achievement of this objective.
While not all of these observations are addressed within the scope of this Technical Report, the report
is an attempt to respond to some of these observations, providing a robust framework for low-income
countries for their eHealth architecture planning and health system development. The other items are
intended to be addressed in due course.
This part of ISO/TR 14639 examines various activities and associated criteria for the effective use of
information and communication technology (ICT) in support of health service delivery, planning, and
coordination. It aims to provide relevant guidance on uses of information, based on model criteria by
which development of eHealth capability can be planned and progress toward its mature use can be
assessed.
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 and that there are potential lessons for all as they examine the way in
which information is produced, managed, and used 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 ISO/TR 14639-1 and was, in large part, inspired by experience with the Health Metrics
Network (WHO/HMN Framework) activities sponsored by the World Health Organization (WHO).
The particular focus of this part of ISO/TR 14639 is the potential for 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.
The enterprise-wide business reference architecture described in this part of ISO/TR 14639 represents a
starting point for the enterprise viewpoint or business layer of a comprehensive enterprise architecture,
which would include other layers or viewpoints, such as the information/data, computational/function,
engineering, and technology perspectives. This model would serve, for example, to assist in identifying
initiatives and exploring the attributes of the components that would form a national eHealth strategy.
A comprehensive enterprise architecture is typically set up and maintained using a structured process
that involves the following:
a) an organized approach to ensuring that investments in ICT technology and information systems
meet overall priorities for effective operation and delivery of healthcare services and the information
needed for their planning, development, and continuous improvement;
b) identifying and describing the main attributes of the eHealth information services, components,
activities, and policies needed to support the operational requirements for health services within a
jurisdiction (or organization);
c) development of structured requirements for more detailed planning and investment in health
information systems and for the development and dissemination of health information policies.
Where relevant, this part of ISO/TR 14639 takes advantage of and makes reference to the principles,
policies, and specifications set out in relevant International Standards and existing architectural
frameworks commonly used in the health sector including: ISO 12967, Health Informatics Service
[1][2][3]
Architecture (HISA), the vision and principles of the World Economic Forum (WEF) Global Health
[4] [5]
Data Charter as seen in Annex A, and the Health Enterprise Architecture Framework (HEAF).
A layered approach to structuring of information architectures and models is proposed in this part
of ISO/TR 14639, based on similar approaches such as the General Component Model introduced in
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[6] [7] [8] [9]
Annex B, the WHO Health Metrics Network Framework, TOGAF, and the Zachman framework.
In particular, HISA and the HEAF have been developed specifically to assist in the process of defining
eHealth architectures for use in health services. See Annex C for more information on HISA. A short list
of selected health informatics International Standards upon which the architectural components are
based is found in Annex D. See 6.1.4 regarding governance and national ownership of eHealth standards
adoption and implementation.
[93]
In May 2012, WHO and ITU published a National eHealth Strategy Toolkit that embodies most of the
concepts relevant to an Enterprise Architecture, tailored to the creation of a National eHealth Strategy.
This resulted in a process that is exhaustive yet streamlined and easier to understand and apply. The
Toolkit presents a thorough step-by-step set of methods, checklists, and examples to be used by country
or region-level managers when developing an eHealth Strategic Vision, an eHealth Action Plan, and a
Monitoring and Evaluation Plan. The WHO-ITU National eHealth Strategy Toolkit and ISO/TR 14639-1
and this part of ISO/TR 14639 form a complementary set of tools for the design and deployment of an
eHealth architecture.
The architectural components and their characteristics as described in this part of ISO/TR 14639
are designed to be reviewed and, where appropriate, adopted by countries and subordinate health
authorities at a level relevant to their specific needs. In particular:
a) The components and characteristics may be used as model requirements in developing enterprise
architectures or as a means of assessing and improving eHealth maturity.
b) Each component is configurable to meet local needs by describing characteristics indicative of a
range of capability from the most basic through to the highly advanced.
c) The characteristics of various capacity levels for each component form the basis of the underlying
maturity model.
d) Typical starting points for the development of capability are provided for each of the components at
the lowest maturity level, together with the basic principles the architecture should adhere to.
e) There is an emphasis on developing appropriately layered, well-structured eHealth architectures
with well-defined and preferably standardized interfaces between the various components and
layers.
f) There is a particular focus on potential eHealth requirements relevant to low- and middle-income
(LMIC) countries.
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TECHNICAL REPORT ISO/TR 14639-2:2014(E)
Health informatics — Capacity-based eHealth architecture
roadmap —
Part 2:
Architectural components and maturity model
1 Scope
This part of ISO/TR 14639 provides a guide to best practice business requirements and principles for
countries and their subordinate health authorities planning and implementing the use of information
and communications technology (ICT) to support the delivery and development of healthcare. A business
reference architecture is described in terms of components and capabilities that health authorities may
use as a framework for building their own eHealth architectures and also for measuring the maturity of
their health systems’ use of ICT to support the delivery and development of healthcare.
It is worth noting that while this part of ISO/TR 14639 was developed with a particular view to support
low- and middle-income countries, it can also be a useful guide for any country. Even if maturity is high
in some aspects, highly developed countries may still need advice on architectural components for some
aspects of a total eHealth system.
The development of eHealth architectures based on the guidelines set out in this part of ISO/TR 14639
will facilitate and optimize investments in Health Information Systems to achieve the following goals:
a) information being used cost-effectively for improvement of health services;
b) health information being harmonized, consistent, accessible, and able to be used effectively;
c) patients, health professionals, and policy-makers having the right data available to make decisions
about health services, treatment, and delivery of care;
d) appropriate information being available to support evidence-based practice and health services
planning, health services quality, and safety and to improve public health;
e) improving accessibility to healthcare services;
f) supporting harmonization of Health Information Systems and health information standards.
It is envisaged that this part of ISO/TR 14639 will be a valuable source of information for
g) personnel responsible for health services policy, planning, and provision,
h) those developing health information resources and eHealth policy at national and subordinate
levels in a country,
i) non-governmental organizations (NGOs) and others seeking to support or implement systems for
information gathering, statistics, and care delivery in developing and emerging economies,
j) developers and implementers of Health Information Systems and services,
k) academic and research institutions and students in health informatics, and
l) other stakeholders in the health sector.
This part of ISO/TR 14639 also proposes a maturity model and methodology that organizations may
consider in developing and evolving their eHealth capacities in specified areas of operational capability
from low to medium to high levels. The proposed business reference architecture identifies components
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and capabilities needed to support various health service activities along with the governance,
infostructure, and ICT infrastructure that is necessary for the effective and efficient use of information
in the delivery and development of health services.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1.1
architecture system
structure of components, their functions, and their inter-relationships and the principles and
guidelines governing their design and evolution over time
[SOURCE: Adapted from Open Group Architecture Framework (TOGAF), 2009.]
2.1.2
architecture system
description of the structure and behaviour of a system, a system’s components, its functions and
inter-relationships
[SOURCE: Adapted from Blobel B., Application of the Component Paradigm for Analysis and Design of
Advanced Health System Architectures, 2000.]
Note 1 to entry: See definition of system architecture (2.74).
2.2
business reference architecture
reference architecture that is evolved based on a set of identified, high-level business requirements
(functional, non-functional, and relevant supporting processes) for an enterprise, which the overall
enterprise strategy and its infrastructure (business and IT) must support
[SOURCE: Adapted from IBM Tivoli Reference Architectures and the SKMT definitions of business
architecture from Canada Health Infoway.]
Note 1 to entry: This architecture also needs to take into consideration the “wants and needs” of the clients
served that may not map exactly to business drivers but nonetheless offer functional value to clients. It is the
business “blueprint” for how a technical project will roll out and what it is trying to accomplish.
Note 2 to entry: See definition of reference architecture (2.65).
2.3
care plan
personalized statement of planned healthcare activities relating to one or more specified health issues
[SOURCE: EN 13940-1:2007]
2.4
chronic disease
health condition of 3 months duration or longer
[SOURCE: U.S. Centers for Disease Control and Prevention (CDC) National Center for Health Statistics]
2.5
classification
terminology which aggregates data at a prescribed level of abstraction for a particular domain
[SOURCE: ISO/TS 17117:2002]
2.6
client
person receiving social or medical services
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2.7
clinical data warehouse
CDW
grouping of data pertaining to a health system or sub-system, possibly of diverse sources, accessible
by a single data management system that enables secondary data analysis for questions relevant to
understanding the functioning of that health system or sub-system, and hence supporting proper
maintenance and improvement of that system or sub-system
[SOURCE: Adapted from ISO/TR 22221:2006.]
Note 1 to entry: A CDW 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.
2.8
clinical decision support
type of system that assists healthcare providers in making medical decisions
[SOURCE: Health Level Seven International (HL7)]
Note 1 to entry: These types of systems typically require input of patient-specific clinical variables and, as a
result, provide patient-specific recommendations.
2.9
clinical information
information about a person, relevant to his or her health or healthcare
[SOURCE: ISO 13606-1:2008]
2.10
clinical process
set of interrelated or interacting healthcare activities performed by one or more healthcare professionals
[SOURCE: ISO 18308:2011]
2.11
clinical vocabulary
system of standardizing the terms used in describing client-centred health and health service-related
concepts
[SOURCE: ISO/TS 22789:2010]
2.12
community-based services
blend of health and social services provided to an individual or family at his/her place of residence or
at other non-institutional locations within the community for the purposes of promoting, maintaining,
or restoring health, minimizing the effects of illness and disability, and supporting and facilitating self-
help and self-care
[SOURCE: Adapted from WHO 2004 A Glossary of Terms for Community Healthcare and Services for
Older Persons.]
Note 1 to entry: Services and programs can include visiting nurses, delivered meals, home care, palliative care,
community mental health, health education, screening, immunizations, family planning, sexual health, etc.
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2.13
country income
classification of all World Bank member countries and all other economies with populations of more
than 30,000 (213 total)
[SOURCE: World Bank Country Classification]
Note 1 to entry: 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 to $3,945; upper middle income,
$3,946 to $12,195; and high income, $12,196 or more.
2.14
data warehouse
grouping of data, possibly of diverse courses, pertaining to a system or sub-system, accessible by a single
data management system that enables secondary data analysis for questions relevant to understanding
the functioning of that system or sub-system, and hence supporting its proper maintenance and
improvement
[SOURCE: Adapted from ISO/TR 22221:2006.]
Note 1 to entry: 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.
2.15
eHealth
use of information and communication technologies (ICT) for health
[SOURCE: World Health Organization (WHO) eHealth]
Note 1 to entry: In its broadest sense, eHealth is about improving the flow of information, through electronic
[93]
means, to support the delivery of health services and the management of health systems.
Note 2 to entry: Health and health-related fields include healthcare services, health surveillance, health literature,
[26]
and health education, knowledge, and research.
2.16
eHealth architecture
architecture of a system of eHealth components and services
[SOURCE: ISO 18308:2011]
2.17.1
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
[SOURCE: ISO 18308:2011]
2.17.2
electronic health record
EHR
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
[SOURCE: Adapted from ISO 18308:2011.]
Note 1 to entry: EHRs often capture data from multiple point-of-service systems and enable authorized access by
the various providers of care to pertinent patient data across multiple service delivery locations or organizations
in order to ensure continuity of care for the patient.
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2.18
electronic health record architecture
EHRA
formal description of a system of components and services for recording, retrieving, and handling
information in electronic health records
[SOURCE: ISO 18308:2011]
2.19
electronic medical record
EMR
electronic record of
...