ISO-13606-1-2008.pdf
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1、 Reference number ISO 13606-1:2008(E) ISO 2008 INTERNATIONAL STANDARD ISO 13606-1 FIrst edition 2008-02-15 Health informatics Electronic health record communication Part 1: Reference model Informatique de sant Communication du dossier de sant informatis Partie 1: Modle de rfrence -,-,- ISO 13606-1:2
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5、 COPYRIGHT PROTECTED DOCUMENT ISO 2008 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
6、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 ii ISO 2008 All rights reserved -,-,- ISO 13606-1:2008(E) ISO 2008 All right
7、s reserved iii Contents Page Foreword iv 0 Introduction. v 1 Scope 1 2 Normative references1 3 Terms and definitions .2 4 Abbreviations.6 5 Conformance7 5.1 EHR System conformance7 5.2 Member country conformance.7 6 Reference model8 6.1 Index to packages8 6.2 Package: EXTRACT package9 6.3 Package: D
8、EMOGRAPHICS package.26 6.4 Package: SUPPORT package.34 6.5 Primitive data types.42 Annex A (informative) UML profile 43 Annex B (informative) Relationship to other standards45 Annex C (informative) Clinical example59 Annex D (informative) Mapping to statements of requirement 72 Bibliography80 ISO 13
9、606-1:2008(E) iv ISO 2008 All rights reserved 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 mem
10、ber 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 El
11、ectrotechnical 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 prepare International Standards. Draft International Standards ado
12、pted 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. Attention is drawn to the possibility that some of the elements of this document may be the subject of pat
13、ent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 13606-1 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO 13606 consists of the following parts, under the general title Health informatics Electronic health record communication: P
14、art 1: Reference model Part 2: Archetype interchange specification Part 3: Reference archetypes and term lists Part 5: Interface specification ISO 13606-1:2008(E) ISO 2008 All rights reserved v 0 Introduction 0.1 Preface The overall goal of ISO 13606 is to define a rigorous and stable information ar
15、chitecture for communicating part or all of the Electronic Health Record (EHR) of a single subject of care (patient). This is to support the interoperability of systems and components that need to communicate (access, transfer, add or modify) EHR data via electronic messages or as distributed object
16、s: preserving the original clinical meaning intended by the author; reflecting the confidentiality of that data as intended by the author and patient. ISO 13606 is not intended to specify the internal architecture or database design of EHR systems or components. Nor is it intended to prescribe the k
17、inds of clinical application that might require or contribute EHR data in particular settings, domains or specialities. For this reason, the information model proposed here is called the EHR Extract, and might be used to define a message, an XML document or schema, or an object interface. The inform
18、ation model in this part of ISO 13606 is an ISO Reference Model for Open Distributed Processing (RM-ODP) RM-ODP Information Viewpoint of the EHR Extract. ISO 13606 considers the EHR to be the persistent longitudinal and potentially multi-enterprise or multi- national record of health and care provis
19、ion relating to a single subject of care (the patient), created and stored in one or more physical systems in order to inform the subjects future healthcare and to provide a medico-legal record of care that has been provided. Whilst an EHR service or system will need to interact with many other serv
20、ices or systems providing terminology, medical knowledge, guidelines, workflow, security, persons registries, billing etc., ISO 13606 has only touched on those areas if some persistent trace of such interactions is required in the EHR itself, and requires specific features in the reference model to
21、allow their communication. ISO 13606 may offer a practical and useful contribution to the design of EHR systems but will primarily be realised as a common set of external interfaces or messages built on otherwise heterogeneous clinical systems. This part of ISO 13606 is the first part to be publishe
22、d of a five-part series. In this part of ISO 13606 dependency upon one of the other parts of this series is explicitly stated where it applies. 0.2 Technical approach ISO 13606 has drawn on the practical experience that has been gained in implementing a European precursor prestandard, ENV 13606, oth
23、er EHR-related standards and specifications, commercial systems and demonstrator pilots in the communication of whole or part of patients EHRs, and on fifteen years of research findings in the field. ISO 13606 builds on ENV 13606, in order to provide a more rigorous and complete specification, to ac
24、commodate new requirements identified, to incorporate a robust means of applying the generic models to individual clinical domains, and to enable communication using HL7 version 3 messages. A mapping from the European prestandard is also provided to support implementers of systems that conformed to
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