1、 Reference number ISO/TR 12773-2:2009(E) ISO 2009TECHNICAL REPORT ISO/TR 12773-2 First edition 2009-06-01 Business requirements for health summary records Part 2: Environmental scan Exigences daffaire pour les enregistrements de sant sommaires Partie 2: Balayage environnemental ISO/TR 12773-2:2009(E
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5、RIGHT PROTECTED DOCUMENT ISO 2009 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 mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below
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7、d iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Terms and definitions. 1 3 Initiatives reviewed. 7 4 Key findings 19 5 Summary of initiatives 19 5.1 Overview 19 5.2 National E-Health Transition Authority (NEHTA) (Australia) Clinical data specifications and content specifications 20 5.3
8、COMPETE (Computerization of Medical Practices for the Enhancement of Therapeutic Effectiveness) Ontario, Canada 22 5.4 Core dataset Ontario Clinical Management System (sponsored by OntarioMD), Ontario, Canada . 23 5.5 Electronic medical summary (e-MS) British Columbia (BC), Canada. 24 5.6 Medical Su
9、mmary for Transfer of Patient Data Physician Office System Program (POSP), Alberta, CA 25 5.7 Report on the State of Developing Electronic Patient Summaries in European Union Member States and Beyond (2007) . 26 5.8 ISO 21549-3:2004 Health informatics Patient healthcard data Part 3: Limited clinical
10、 data. 26 5.9 NHS England . 28 5.10 NHS Scotland Emergency care summary (ECS) 31 5.11 NHS Wales Individual health record 31 5.12 Care record summary Implementation guide for HL7 CDA Release 2 Levels 1 and 2 (US Realm). 32 5.13 Continuity of care record E2369 Specification ASTM. 33 5.14 Continuity of
11、 care document (CCD) HL7/ASTM 35 5.15 Medical Summary Integration Profile and Medical Summary Content Specification IHE Integrating the Healthcare Enterprise. 35 5.16 VistA United States Veterans Health Administration 36 6 Sample health summary records overview of data groups, specifications for str
12、ucture, content as applicable . 37 6.1 Australia National E-Health Transition Authority (NEHTA) . 37 6.2 Canada Core Dataset OntarioMD. 37 6.3 Canada Medical Summary for Transfer of Patient Data (Alberta) . 37 6.4 Canada Electronic medical summary (British Columbia) 38 6.5 United States ASTM Continu
13、ity of Care Record . 38 6.6 United States IHE Content Profiles 39 6.7 United States HL7 CDA Care Record Summary Implementation Guide Levels 1 and 2 2006 Required and optional sections of a CRS (US Realm) 40 6.8 United States Personal Health Record Minimum Common Dataset AHIMA. 41 6.9 ISO 21549-3, He
14、alth informatics Patient healthcard data Part 3: Limited clinical data 42 6.10 NHS UK Scotland Emergency Care Summary (ECS) 43 Acronym index . 44 Bibliography . 45 ISO/TR 12773-2:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide f
15、ederation 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 co
16、mmittee. 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 accor
17、dance 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 requir
18、es 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 v
19、ote 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 doc
20、ument may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO/TR 12773-2 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO/TR 12773 consists of the following parts, under the general title Business requirements f
21、or health summary records: Part 1: Requirements Part 2: Environmental Scan ISO/TR 12773-2:2009(E) ISO 2009 All rights reserved v Introduction Consumer, clinician, industry and government demands for improved safety, quality, effectiveness and efficiency in healthcare are driving the need for more “c
22、onnected” care, which in turn requires improved communication of clinical information between multiple providers and subjects of care. Internationally, various “summary” or “snapshot” health records have been developed to meet these communication needs. Many similarities are evident in these initiat
23、ives, but their conceptual foundations have not always been articulated with a set of business requirements as their starting point. The purpose of this part of ISO/TR 12773 is to identify the common business requirements these initiatives are seeking to address as well as the requirements for stand
24、ards for health summary records (HSRs) that can guide future HSR development efforts. Any future ISO initiative to create standards for a generic HSR specification or specifications for one or more types of HSR will leverage existing initiatives and adopt/adapt relevant standards utilized therein. S
25、uch HSR specifications are unlikely to require new standards, given that much of their content is deemed “common”, “core”, “essential” or “emergency” in nature and is therefore part of most EHR initiatives world-wide as evidenced in this part of ISO/TR 12773. TECHNICAL REPORT ISO/TR 12773-2:2009(E)
26、ISO 2009 All rights reserved 1 Business requirements for health summary records Part 2: Environmental scan 1 Scope This part of ISO/TR 12773 reviews a series of initiatives and implementations worldwide that for purposes of this Technical Report are collectively called health summary records (HSRs).
27、 It provides an environmental scan and descriptive information on HSR initiatives internationally, including “lessons learned”. The environmental scan was completed by performing web searches and obtaining publicly available documentation on key projects. Project sponsors and/or authorities were con
28、tacted as needed to gather additional information and clarify questions and issues arising out of the review. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 agent person, device or software that performs a role in a healthcare activity 2.2 c
29、lient patient individual who is a subject of care ISO/TR 20514:2005, definition 2.30 NOTE The terms “client” and “patient” are synonymous but the usage of one or the other of these terms tends to differ between different groups of health professionals. Clinicians working in a hospital setting and me
30、dical practitioners in most clinical settings will use the term “patient” whereas allied health professionals may use the term “client”. 2.3 clinical information information about a person, relevant to his or her health or healthcare ISO 13606-1:2008, defintion 3.13 2.4 clinician health professional
31、 who delivers health services directly to a patient/client ISO/TR 20514:2005, definition 2.6 ISO/TR 12773-2:2009(E) 2 ISO 2009 All rights reserved2.5 consumer individual who may become a subject of care ISO/TS 20514:2005, definition 2.9 2.6 data object collection of data that has a natural grouping
32、and may be identified as a complete entity 2.7 electronic health record EHR basic generic form repository of information regarding the health status of a subject of care, in computer processable form ISO/TR 20514:2005, definition 2.11 2.8 electronic health record composition EHR composition set of i
33、nformation committed to one EHR by one agent, as a result of a single clinical encounter or record documentation EXAMPLES Progress Note, radiology report, referral letter, clinic visit record, discharge summary, functional health assessment, diabetes review. 2.9 electronic health record extract EHR
34、extract a) unit of communication of the EHR which is itself attestable and which consists of one or more EHR compositions ISO/TR 20514:2005, definition 2.13 b) part or all of the electronic health record of a subject of care communicated between an EHR provider system and an EHR recipient NOTE Adapt
35、ed from ISO 13606-1:2008. 2.10 electronic health record (EHR) integrated care (ICEHR) repository of information regarding the health status of a subject of care in computer processable form, stored and transmitted securely, and accessible by multiple authorized users and having a standardized or com
36、monly agreed logical information model that is independent of EHR systems and whose primary purpose is the support of continuing, efficient and quality integrated healthcare and which contains information that is retrospective, concurrent and prospective NOTE 1 Adapted from ISO/TR 20514:2005. NOTE 2
37、 The definition of the EHR for integrated care should be considered the primary definition of an electronic health record. The definition of a basic-generic EHR is given only for completeness. 2.11 electronic health record repository database in which electronic health record information is persiste
38、d ISO/TR 12773-2:2009(E) ISO 2009 All rights reserved 3 2.12 electronic health record shareable EHR shareable electronic health record with a standardized information model, which is independent of electronic health record systems and accessible by multiple authorized users NOTE 1 The shareable EHR
39、per se is an artefact between a basic-generic EHR and the integrated care EHR (ICEHR) which is a specialization of the shareable EHR. The shareable EHR is probably of little use without the additional clinical characteristics that are necessary for its effective use in an integrated care setting. NO
40、TE 2 Whilst the ICEHR is the target for interoperability of patient health information and optimal patient care, it should be noted that the large majority of EHRs in use at present are not even shareable let alone have the additional characteristics required to comply with the definition of an inte
41、grated care EHR. A definition of a basic-generic EHR has therefore been included to acknowledge this current reality. 2.13 electronic health record system EHR system system for recording, retrieving and manipulating information in electronic health records ISO 13606-1:2008, definition 3.26 2.14 heal
42、th state of complete physical, mental and social well-being and not merely the absence of disease or infirmity WHO: 1948 2.15 healthcare activities, services, or supplies related to the health of an individual ISO 18308:, definition 3.28 2.16 healthcare activity undertakings (assessments, interventi
43、ons) that comprise a healthcare service 2.17 healthcare organization organization involved in the direct or indirect provision of healthcare services to an individual or to a population ISO/EN 13606-1:2008 2.18 healthcare service service provided with the intention of directly or indirectly improvin
44、g the health of the person or populations to whom it is provided ISO/EN 13606-1:2008 2.19 health condition a) aspect of a person or groups health that requires some form of intervention Canada Health Infoway EHRS Blueprint v1.0: 2003 NOTE These interventions could be anticipatory or prospective, suc
45、h as enhancing wellness, wellness promotion or illness prevention (e.g. immunization). ISO/TR 12773-2:2009(E) 4 ISO 2009 All rights reservedb) symptoms, health problems (not yet diagnosed), diagnoses (known or provisional), e.g. diabetes, physiological changes that affect the body as a whole or one
46、or more of its parts, e.g. benign positional vertigo and/or affect the persons well-being, e.g. psychosis, and/or affect the persons usual physiological state, e.g. pregnancy, lactation Canada Health Infoway, iEHR Clinical Standards Glossary 2007 2.20 health information see clinical information (2.3
47、) 2.21 health problem see health condition (2.19); see problem (2.34) 2.22 health professional person who is authorized by a recognised body to directly provide certain healthcare services NOTE Adapted from ISO/TR 20514:2005 and EN 13940-1:2007. 2.23 health record repository of information regarding
48、 the health of a subject of care ISO/TR 20514: 2005, definition 2.25 2.24 health record extract attestable unit of communication of all or part of a health record. 2.25 health summary record health record extract comprising a standardized collection of clinical and contextual information (retrospect
49、ive, concurrent, prospective) that provides a snapshot in time of a subject of cares health information and healthcare 2.26 HL7 Clinical Document Architecture CDA documentation that defines structure and semantics of medical documents for the purpose of exchange NOTE CDA documents are encoded in Extensible Mark-up Language (XML). They derive their meaning from the HL7 Reference Information Model (RIM) and use the HL7 Version 3 Data
