1、BSI Standards Publication Health informatics Capacity-based eHealth architecture roadmap Part 2: Architectural components and maturity model PD ISO/TR 14639-2:2014National foreword This Published Document is the UK implementation of ISO/TR 14639-2:2014. The UK participation in its preparation was en
2、trusted to Technical Committee IST/35, Health informatics. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Th
3、e British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 84642 7 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committe
4、e on 31 October 2014. Amendments issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TR 14639-2:2014 ISO 2014 Health informatics Capacity-based eHealth architecture roadmap Part 2: Architectural components and maturity model Informatique de sant Feuille de route de larchitecture de
5、 sant lectronique fonde sur la capacit Partie 2: Composants architecturaux et modle de maturit TECHNICAL REPORT ISO/TR 14639-2 First edition 2014-10-01 Reference number ISO/TR 14639-2:2014(E) PD ISO/TR 14639-2:2014 ISO/TR 14639-2:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT IS
6、O 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be re
7、quested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland PD ISO/TR 14639-2:2014 ISO/TR 14639-2
8、:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 T erms and definitions . 2 3 Abbreviations12 4 Overview of business requirements .13 5 Development and application of eHealth enterprise architectures 13 5.1 eHealth enterprise architectures .13 5.2 Deve
9、lopment 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 compone
10、nts ICT infrastructure .100 7 Pr ofiling c ountries 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 A
11、nnex D (informative) Candidat e standar ds supporting eHealth Ar chit ectur e Model and Maturity Models .125 Annex E (informative) WHO Indicat or and Measur ement R egistry (IMR) .128 Annex F (informative) Statistical Data and Metadata Ex change for the Health Domain (SDMX-HD) 129 Annex G (informati
12、ve) List of figur es and tables in this part of ISO 14639 .132 Bibliogr aph y .133 PD ISO/TR 14639-2:2014 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 Interna
13、tional 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
14、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,
15、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 t
16、he 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
17、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 IS
18、Os 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 informat
19、ics Capacity- based eHealth architecture roadmap: Part 1: Overview of national eHealth initiatives Part 2: Architectural components and maturity modeliv ISO 2014 All rights reserved PD ISO/TR 14639-2:2014 ISO/TR 14639-2:2014(E) Introduction ISO/TC 215 has identified that there is an urgent need to p
20、rovide 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
21、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,
22、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 explore how the “digital divide” between high-income and low-income countries could be addre
23、ssed. 10 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 im
24、proving 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 Standard
25、s 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 Stan
26、dards 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 car
27、e 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 organiza
28、tion 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 locali
29、zation 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 so
30、me 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 however, it also recognizes the importance of i
31、nitial 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 enterp
32、rise 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 e
33、xploring 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 inform
34、ation 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
35、 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 poli
36、cies. 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
37、 Architecture (HISA), 123the vision and principles of the World Economic Forum (WEF) Global Health Data Charter 4as seen in Annex A, and the Health Enterprise Architecture Framework (HEAF). 5A layered approach to structuring of information architectures and models is proposed in this part of ISO/TR
38、14639, based on similar approaches such as the General Component Model introduced in vi ISO 2014 All rights reserved PD ISO/TR 14639-2:2014 ISO/TR 14639-2:2014(E) Annex B, 6the WHO Health Metrics Network Framework, 7TOGAF, 8and the Zachman framework. 9In particular, HISA and the HEAF have been devel
39、oped 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 rega
40、rding governance and national ownership of eHealth standards adoption and implementation. In May 2012, WHO and ITU published a National eHealth Strategy Toolkit 93that embodies most of the concepts relevant to an Enterprise Architecture, tailored to the creation of a National eHealth Strategy. This
41、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
42、 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
43、 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 a
44、s 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
45、 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 la
46、yered, 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. ISO 2014 All rights reserved vii PD ISO/TR 14639-2:2014
