ISO TR 12773-1-2009 Business requirements for health summary records - Part 1 Requirements《健康档案汇总用业务要求 第1部分 要求》.pdf

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1、 Reference number ISO/TR 12773-1:2009(E) ISO 2009TECHNICAL REPORT ISO/TR 12773-1 First edition 2009-06-01 Business requirements for health summary records Part 1: Requirements Exigences daffaire pour les enregistrements de sant sommaires Partie 1: Exigences ISO/TR 12773-1:2009(E) PDF disclaimer This

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5、ENT 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 or ISOs member body

6、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 ii ISO 2009 All rights reservedISO/TR 12773-1:2009(E) ISO 2009 All rights reserved iii Contents Page F

7、oreword iv Introduction v 1 Scope . 1 2 Terms and definitions. 1 3 Examples of health summary records 8 4 Nature and definition of health summary records 10 4.1 General. 10 4.2 Health record extracts 10 4.3 Standardized health record extracts. 11 4.4 Integrated care EHRs (ICEHRs). 12 4.5 Dynamic cre

8、ation of a health summary record List clinical summary/profile. 13 4.6 Defining health summary records. 13 5 Purposes of health summary records 14 6 Common use cases for health summary records . 16 6.1 Overview 16 6.2 Use case 1: Creating a health summary record 17 6.3 Use case 2: Querying, viewing,

9、 replacing (superseding) the HSR 17 6.4 Use Case 3: Provider-to-provider referrals 18 6.5 Use case 4: Acute care discharge to home or other ambulatory care environment . 19 6.6 Use case 5: Acute care discharge to a sub-acute care nursing facility (SNF) . 19 6.7 Use case 6: Initiate HSR transfer 20 6

10、.8 Secondary use cases . 20 7 Business requirements for health summary records . 21 8 Data and information management requirements for health summary records 22 8.1 General requirements. 22 8.2 Clinical content priorities for health summary records 22 8.3 Health summary record data development 24 9

11、Standardization of health summary records . 25 10 Recommendations 25 Acronym Index . 27 Bibliography . 28 ISO/TR 12773-1:2009(E) iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies)

12、. 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

13、-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

14、 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

15、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 Re

16、port. 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 b

17、e held responsible for identifying any or all such patent rights. ISO/TR 12773-1 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO/TR 12773 consists of the following parts, under the general title Business requirements for health summary records: Part 1: Requirements Part 2: En

18、vironmental Scan ISO/TR 12773-1:2009(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 “connected” care, which in turn requires improved communicat

19、ion 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 initiatives, but their conceptual foundations have not always bee

20、n articulated with a set of business requirements as their starting point. The purpose of ISO/TR 12773 is to identify the common business requirements these initiatives are seeking to address as well as the requirements for standards for health summary records (HSRs) that can guide future HSR develo

21、pment 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. Such HSR specifications are unlikely to require new standards, given tha

22、t 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 ISO/TR 12773-2. TECHNICAL REPORT ISO/TR 12773-1:2009(E) ISO 2009 All rights reserved 1 Business requirements for health summary records Pa

23、rt 1: Requirements 1 Scope This part of ISO/TR 12773 is based on a comprehensive review of a series of initiatives and implementations worldwide that for the purposes of this Technical Report are collectively called health summary records (HSRs). Project sponsors and/or authorities were contacted as

24、 needed to gather additional information and clarify questions or issues arising out of the review. This part of ISO/TR 12773 defines and describes HSRs in general as well as specific instances of HSRs and their most common use cases. It summarises the business requirements driving HSR development a

25、nd the content that is common across HSRs, as well as issues associated with them. Finally, it recommends some future ISO/TC 215 activities to support international standardization of HSRs. It is important to note that this part of ISO/TR 12773 focuses primarily on requirements that are specific (un

26、ique) to HSRs. It does not attempt to articulate, other than at a high level, requirements that are generally applicable to all health records or all electronic health records. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 2.1 agent see healthc

27、are agent (2.19) 2.2 client 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 h

28、ospital setting and medical practitioners in most clinical settings will use the term “patient” whereas allied health professionals may use the term “client”. 2.3 clinical data repository CDR data store that holds and manages clinical data collected from service encounters at point of service locati

29、ons (e.g. hospitals, clinics) ISO/TR 20514:2005, definition 2.5 NOTE Data from a CDR can be sent to the EHR for that subject of care; in that sense the CDR is recognised as a source system for a shared EHR or an integrated care EHR. ISO/TR 12773-1:2009(E) 2 ISO 2009 All rights reserved2.4 clinical d

30、ata warehouse CDW grouping of data accessible by a single data management system, possibly of diverse sources, pertaining to a health system or sub-system and enabling secondary data analysis for questions relevant to understanding the functioning of that health system, and hence supporting proper m

31、aintenance and improvement of that health system ISO/TR 22221:2006, definition 2.2 NOTE 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. 2.5 clinical information in

32、formation about a person, relevant to his or her health or healthcare ISO 13606-1:2008, definition 3.13 2.6 clinician health professional who delivers health services directly to a patient/client ISO/TR 20514:2005, definition 2.6 2.7 consumer individual who may become a subject of care ISO/TR 20514:

33、2005, definition 2.9 2.8 data object collection of data which has a natural grouping and may be identified as a complete entity 2.9 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 20514:20

34、05, definition 2.11 2.10 electronic health record composition EHR composition the set of information 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

35、, functional health assessment, diabetes review. 2.11 electronic health record extract EHR 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 ISO/TR 12773-1:2009(E) ISO 2009 All rights reserved

36、3 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 Adapted from ISO 13606-1:2008. 2.12 electronic health record (EHR) integrated care (ICEHR) repository of information regarding the health status of a subject of

37、 care, in computer processable form, stored and transmitted securely, and accessible by multiple authorized users and having a standardized or commonly agreed logical information model that is independent of EHR systems and whose primary purpose is the support of continuing, efficient and quality in

38、tegrated healthcare and which contains information that is retrospective, concurrent, and prospective NOTE 1 Adapted from ISO/TR 20514:2005. NOTE 2 The definition of the EHR for integrated care should be considered the primary definition of an electronic health record. The definition of a basic-gene

39、ric EHR is given only for completeness. 2.13 electronic health record repository database in which electronic health record information is persisted 2.14 electronic health record shareable EHR shareable electronic health record with a standardized information model, which is independent of electroni

40、c health record systems and accessible by multiple authorized users NOTE 1 The shareable EHR 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 clinic

41、al characteristics that are necessary for its effective use in an integrated care setting. NOTE 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 le

42、t alone have the additional characteristics required to comply with the definition of an Integrated care EHR. A definition of a basic-generic EHR has therefore been included to acknowledge this current reality. 2.15 electronic health record system EHR system system for recording, retrieving, and man

43、ipulating information in electronic health records ISO 13606-1:2008, definition 3.26 2.16 health state of complete physical, mental and social well-being and not merely the absence of disease or infirmity WHO:1948 2.17 healthcare activities, services, or supplies related to the health of an individu

44、al ISO 18308:, definition 3.28 2.18 healthcare activity undertakings (assessments, interventions) that comprise a healthcare service ISO/TR 12773-1:2009(E) 4 ISO 2009 All rights reserved2.19 healthcare agent person, device or software that performs a role in a healthcare activity ISO 13606-1:2008, d

45、efinition 3.31 2.20 healthcare organization organization involved in the direct or indirect provision of healthcare services to an individual or to a population ISO 13606-1:2008, definition 3.33 2.21 healthcare service service provided with the intention of directly or indirectly improving the healt

46、h of the person or populations to whom it is provided ISO 13606-1:2008, definition 3.35 2.22 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,

47、such as enhancing wellness, wellness promotion or illness prevention (e.g. immunization). b) symptoms, health problems (not yet diagnosed), diagnoses (known or provisional), e.g. diabetes, or physiological changes that affect the body as a whole or one or more of its parts, e.g. benign positional ve

48、rtigo, 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 2.23 health information see clinical information (2.5) 2.24 health problem see health condition (2.

49、22); see problem (2.39) 2.25 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. 2.26 health record repository of information regarding the health of a subject of care ISO/TR 20514:2005, definition 2.25 2.27 health record extract attestable unit of communication of all or part of a health record. ISO/TR 12773-1:2009(E) ISO 2009 All rights reserved 5 2.28 health summary re