1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 13606-1:2012Health informatics Electronic health record communicationPart 1: Reference model (ISO 13606-1:2008)BS EN ISO 13606-1:2012 BRITISH STANDARDNational forewordT
2、his British Standard is the UK implementation of EN ISO 13606-1:2012. It is identical to ISO 13606-1:2008. It supersedes BS EN 13606-1:2007, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented
3、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. The British Standards Institution 2012. Published by BSI Standards Limited 2012.ISBN 978 0 580 775
4、78 9 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME E
5、UROPENNE EUROPISCHE NORM EN ISO 13606-1 October 2012 ICS 35.240.80 Supersedes EN 13606-1:2007English Version Health informatics - Electronic health record communication - Part 1: Reference model (ISO 13606-1:2008) Informatique de sant - Communication du dossier de sant informatis - Partie 1: Modle d
6、e rfrence (ISO 13606-1:2008) Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 1: Referenzmodell (ISO 13606-1:2008) This European Standard was approved by CEN on 24 August 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which sti
7、pulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European
8、 Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are th
9、e national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romani
10、a, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means res
11、erved worldwide for CEN national Members. Ref. No. EN ISO 13606-1:2012: EBS EN ISO 13606-1:2012 EN ISO 13606-1:2012 (E) 3 Foreword The text of ISO 13606-1:2008 has been prepared by Technical Committee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has
12、 been taken over as EN ISO 13606-1:2012 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2013,
13、and conflicting national standards shall be withdrawn at the latest by April 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. Thi
14、s document supersedes EN 13606-1:2007. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugo
15、slav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 13606-1:2008
16、has been approved by CEN as a EN ISO 13606-1:2012 without any modification. BS EN ISO 13606-1:2012ISO 13606-1:2008(E) ISO 2008 All rights reserved iiiContents PageForeword iv0Introduction. v1Scope12Normative references13Terms and definitions .24Abbreviations.65Conformance75.1EHR Systemconformance75.
17、2Member countryconformance.76Reference model86.1 Index to packages86.2Package: EXTRACT package96.3Package: DEMOGRAPHICS package.266.4 Package: SUPPORT package.346.5Primitive data types.42Annex A (informative) UML profile 43Annex B (informative) Relationship to other standards45Annex C (informative)
18、Clinical example59Annex D (informative) Mapping to statements of requirement 72Bibliography80BS EN ISO 13606-1:2012ISO 13606-1:2008(E)iv ISO 2008 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bo
19、dies). 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 beenestablished has the right to be represented on that committee. International organizations, governmental and
20、 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closelywith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordancewith the rules given in the ISO/IEC Directives, Pa
21、rt 2.The main task of technical committees is to prepare International Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval byat least 75 % of the member bodies casting a
22、 vote. 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 such patent rights. ISO 13606-1 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO13606 consi
23、sts of the following parts, under the general title Health informatics Electronic health recordcommunication: Part 1: Reference model Part 2: Archetype interchange specification Part 3: Reference archetypes and termlists Part 5: Interface specification BS EN ISO 13606-1:2012ISO 13606-1:2008(E) ISO 2
24、008 All rights reserved v0 Introduction 0.1 Preface The overall goal of ISO13606 is to define a rigorous and stable information architecture for communicatingpart or all of the Electronic Health Record (EHR) of a single subject of care (patient). This is to support theinteroperabilityof systemsand c
25、omponents that need to communicate (access, transfer, add or modify) EHRdata via electronic messages or as distributed objects: preserving the originalclinical meaning intended by the author; reflecting the confidentiality of that data as intended by the author and patient. ISO13606 is not intended
26、to specify the internal architecture or database design of EHR systemsorcomponents.Nor isit intended to prescribe the kinds of clinical application that might require or contributeEHR data in particular settings, domains or specialities. For this reason, the information model proposed here is called
27、 the EHR Extract, and might be used to define a message, an XML document or sc hema, or an objectinterface. The information model in this part of ISO13606 is an ISO Reference Model for Open Distributed Processing (RM-ODP) RM-ODP Information Viewpoint of the EHR Extract. ISO13606 considers the EHR to
28、 be the persistent longitudinal and potentially multi-enterprise or multi-national record of health and care provision relating to a single subject of care (the patient), created andstored in one or more physical systems in order to inform the subjects futurehealthcare and to provide a medico-legal
29、record of care that has been provided. Whilst an EHR service or system will need to interactwithmany other services or systems providing terminology, medical k nowledge, guidelines, workflow, security,persons registries, billing etc., ISO13606 has onlytouched on those areas if some persistent trace
30、of such interactions is required in the EHR itself, and requires specific features in the reference model to allow theircommunication. ISO13606 may offer a practical and useful contribution to the design of EHR systems but will primarilyberealised as a common set of external interfaces or messages b
31、uilt on otherw ise heterogeneous clinical systems.This part of ISO13606 is the first part to be published of a five-part series. In this part of ISO13606dependencyupon one of the other parts of this series is explicitly stated where it applies.0.2 Technical approach ISO 13606 has drawn on the practi
32、cal experience that has been gained in implementing a European precursorprestandard, ENV 13606, other EHR-related standards and specifications, commercial systems anddemonstrator pilots in the communication of whole or part of patients EHRs, and on fifteen years of researchfindings in the field. ISO
33、13606 builds on ENV 13606, in order to provide a more rigorous and completespecification, to accommodate new requirements identified, to incorporate a robust means of applying thegeneric models to individual clinical domains, and to enable communication using HL7 version 3 messages. A mapping from t
34、he European prestandard is also provided to support implementers of systems that conformed to it. The technical approach to producing ISO13606 has taken into account several contemporary areas ofrequirement. a) In addition to a traditional message-based communication between isolated clinical system
35、s, the Electronic Health Recordwillin some cases beimplemented as a middleware component (a recordserver) using distributed object technology and/or web services. BS EN ISO 13606-1:2012ISO 13606-1:2008(E)vi ISO 2008 All rights reservedb) “Customers” of such record services will be not only other ele
36、ctronic health record systems but also othermiddleware services such as s ecurity components,work flow systems, alerting and de cision supportservices and other medical knowledge agents.c) There is wide international interest in this work, and this part of ISO13606 has been drafted jointly through C
37、EN and ISOwith significant input frommanymembercountries. d) Mapping to HL7 version 3 has been considered an important goal, to enable conformance to this part ofISO 13606 within an HL7 version 3 environment. e) The research and development (R provide a framework appropriate to the needs of professi
38、onals and enterprises to analyse and interpretEHRs on an individual or population basis; incorporate the necessary medico-legal constructs to support the safe and relevant communication of EHR entries between professionals working on the same or different sites.This work includes the GEHR 41, 48, 57
39、, EHCR-SupA 36-38, Synapses 42, 43, I4C and Noraprojects and work by the Swedish Institute for Health Services Development (SPRI). These key requirement publications are listed in the Bibliography 51. These requirements have recentlybeen consolidated on the internationalstage within an ISO Technical
40、 Specification, ISO/TS 183089. In this reference model the keyEHR contextual requirements for such faithfulness are related to a set of logical building block classes, with suitable attributesproposed for each level in the EHR extract hierarchy. ISO/TS18308 has been adopted as the reference set of r
41、equirements to underpin the features within thisEHR communications reference model, and a mapping of these requirements statements to the constructs in the reference model is given in Annex D. 0.5Overview of the EHR extract record hierarchyThe information in a health record is inherentlyhierarchical
42、. Clinical observations, reasoning and intentionscan have a simple or a more complex structure. They are generally organized under headings, and containedin “documents” such as consultation notes, letters and reports. These documents are usually filed in folders,and a patient may have more than one
43、folder within a healthcare enterprise (e.g. medical, nursing, obstetric).The EHR extract reference model needs to reflect this hierarchical structure and organization, meetingpublished requirements in order to be faithful to the original clinical context and to ensure meaning ispreserved when record
44、s are communicated betweenheterogeneous clinical systems. To do this, the modelformally sub-divides the EHR hierarchyinto parts that have been found to provide a consistent mapping to theways which individual EHRs are organized within heterogeneous EHR systems.BS EN ISO 13606-1:2012ISO 13606-1:2008(
45、E)viii ISO 2008 All rights reservedThese parts are summarised in Table 1.Table 1 Main hierarchy components of the EHR Extract Reference Model EHR hierarchycomponent Description Examples EHR_EXTRACT The top-level container of part or all of the EHR of a single subject of care, for communication betwe
46、en an EHR provider system and an EHR recipient.Not applicable FOLDER The high level organization within an EHR,dividing it into compartments relating to care provided for a single condition, by a clinicalteam or institution, or over a fixed time period such as an episode of care. Diabetes care,schiz
47、ophrenia, cholecystectomy, paediatrics,St Mungos Hospital, GP folder, Episodes2000-2001, ItalyCOMPOSITIONThe set of information committed to one EHR by one agent, as a resultof a single clinical encounter or record documentationsession. Progress note, laboratory test result form, radiology report, r
48、eferral letter, clinic visit,clinic letter, discharge summary,functional health assessment, diabetes reviewSECTIONEHR data within a COMPOSITION that belongs under one clinical heading, usuallyreflecting the flow of information gatheringduring a clinical encounter, or structuredfor the benefit of fut
49、ure human readership. Reason for encounter, past history, familyhistory, allergy information, subjectivesymptoms, objective findings,analysis, plan, treatment, diet, posture,abdominal examination, retinal examination ENTRYThe information recorded in an EHR as a result of one clinical action, one observation, one clinical interpretation, or an intention. This is also known as a clinical statement. A symptom, an observation, one test result, a prescribed drug, an allergy reaction, a diagnosis, a differential diagnosi
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