1、 Reference number ISO/TR 14639-1:2012(E) ISO 2012INTERNATIONAL STANDARD ISO/TR 14639-1 First edition 2012-08-15 Health informatics Capacity-based eHealth architecture roadmap Part 1: Overview of national eHealth initiatives Informatique de sant Feuille de route de larchitecture de sant lectronique f
2、onde sur la capacit Partie 1: Aperu des initiatives de sant lectronique nationale ISO/TR 14639-1:2012(E) COPYRIGHT PROTECTED DOCUMENT ISO 2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechani
3、cal, including photocopying and microfilm, without permission in writing 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.o
4、rg Published in Switzerland ii ISO 2012 All rights reservedISO/TR 14639-1:2012(E) ISO 2012 All rights reserved iiiContents 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 Natio
5、nal 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 Deve
6、lopment 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
7、 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 Natio
8、nal 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
9、.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 Househo
10、lds 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 wareh
11、ouse 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 ISO/TR 14639-1:2012(E) iv ISO 2012 All rights reserved4.5.9 Households with Internet access .38 4.6 Ken
12、ya 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 (
13、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
14、) .44 5.3 Joint United Nations Program on HIV/AIDS (UNAIDS) .44 5.4 Pan American Health Organization (PAHO) Framework45 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 eHealt
15、h Architecture Maturity Model (eHAMM) .49 Bibliography 52 ISO/TR 14639-1:2012(E) ISO 2012 All rights reserved vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards i
16、s 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 par
17、t 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 p
18、repare 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 tech
19、nical 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
20、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 suc
21、h 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 par
22、ts 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 Fr
23、amework 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. ISO/TR 14639-1:2012(E) vi
24、 ISO 2012 All rights reservedIntroduction 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 s
25、trengthening in low-income countries (LIC) in the international community has led to increasing interest in and support of this activity 3 . 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 th
26、at 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 var
27、ious 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
28、 this part of ISO/TR 14639, and was largely inspired by the Health Metrics Network (HMN) activities sponsored by the World Health Organization (WHO) 12 . This work has been motivated in part by a recognition that countries vary in terms of readiness and resources for health system strengthening, wit
29、h 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) t
30、o 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 manua
31、l 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
32、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 o
33、f 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 nati
34、onal 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. TECHNICAL REPORT ISO/TR 14639-1:2012(E) ISO 2012 All rights reserved 1Health informatics Capacity-based eHealt
35、h 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 Informati
36、on Systems (HIS). This part of ISO/TR 14639 reviews international experiences in the construction of national eHealth architectures and introduces a methodology for strategic development of HIS 4 , which will be elaborated upon in ISO/TR 14639-2. This part of ISO/TR 14639 is intended to assist natio
37、ns 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
38、governing their design and evolution over time, or a description of the structure and behaviour of a system, a systems components, its functions and inter-relationships NOTE 1 Adapted from Open Group Architecture Framework (TOGAF), 2009 14and Blobel, B., Application of the Component Paradigm for Ana
39、lysis and Design of Advanced Health System Architectures, 2000 86 . 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 threa
40、ts 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 CDC Concept Plan for the Impl
41、ementation of the National Biosurveillance Strategy for Human Health 88 2.3 clinical information information about a person, relevant to his or her health or healthcare ISO 13606-1:2008, definition 3.13 ISO/TR 14639-1:2012(E) 2 ISO 2012 All rights reserved2.4 chronic disease health condition of 3 mo
42、nths 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 funct
43、ioning 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. NOT
44、E 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 electron
45、ic 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 multi
46、ple 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 physicians o
47、ffice 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-c
48、entric 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 ISO/TR 14639-1:2012(E) ISO 2012 All rights reserved 32.12 health condition aspect
49、of a person or groups 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 t