1、Juni 2008DEUTSCHE NORM Normenausschuss Medizin (NAMed) im DINPreisgruppe 19DIN Deutsches Institut fr Normung e.V. Jede Art der Vervielfltigung, auch auszugsweise, nur mit Genehmigung des DIN Deutsches Institut fr Normung e.V., Berlin, gestattet.ICS 35.240.80!$N3a“1431662www.din.deDDIN EN 13606-3Medi
2、zinische Informatik Kommunikation von Patientendaten in elektronischer Form Teil 3: Referenzarchetypen und Begriffslisten;Englische Fassung EN 13606-3:2008Health informatics Electronic health record communication Part 3: Reference archetypes and term lists;English version EN 13606-3:2008Informatique
3、 de la sant Communication des dossiers de sant informatiss Partie 3: Archtypes de rfrence et listes de termes;Version anglaise EN 13606-3:2008Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 BerlinMit DIN EN 13606-2:2007-11Ersatz frDIN V ENV 13606-2:2000-09www.beuth.deGesamtumfang 49 SeitenDI
4、N EN 13606-3:2008-06 2 Nationales Vorwort Diese Norm enthlt unter Bercksichtigung des Prsidialbeschlusses 13/1983 den englischen Originaltext der Europischen Norm EN 13606-3:2008. Die Europische Norm wurde in der WG I Information Models“ des CEN/TC 251 Medizinische Informatik“ erarbeitet. Der Arbeit
5、sausschuss NA 063-07-02 AA Interopera-bilitt“ des Fachbereichs 7 Medizinische Informatik“ des Normenausschusses Medizin im DIN hat an der Erarbeitung mitgewirkt. nderungen Gegenber DIN V ENV 13606-2:2000-09 wurden folgende nderungen vorgenommen: a) die gesamte Norm wurde vollstndig neu strukturiert
6、(5 Teile statt 4 Teile) und technisch berarbeitet; b) vorliegender Teil 3 basiert auf der ehemaligen ENV 13606-2 Domain Termlist“; c) der Vornormcharakter wurde aufgehoben; d) Reduktion der Beschreibung auf den Kontext des Zugriffs auf eine EGA-Komponente. Frhere Ausgaben DIN V ENV 13606-2:2000-09 Z
7、usammenfassung Diese Norm dient der Kommunikation von Teilen oder kompletten elektronischen Gesundheitsakten (EGA; en: Electronic Health Record: EHR) eines einzelnen Behandelten zwischen verschiedenen EGA-Systemen oder zwischen EGA-Systemen und zentralen Datenspeichern fr EGA. Sie kann ebenso fr die
8、 Kommunikation zwischen EGA-System bzw. EGA-Datenspeicher und klinischen Anwendungen bzw. Middleware-Komponen-ten (wie Entscheidungshilfesystemen) genutzt werden, die einen Zugriff auf EGA-Daten bentigen oder Daten fr eine EGA bereitstellen. Diese Norm wird berwiegend zur Untersttzung der direkten P
9、flege von identifi-zierten Individuen oder fr die Untersttzung von Bevlkerungsberwachungssystemen, wie Krankheits-register und berwachungen der ffentlichen Gesundheit, verwendet werden. Die Verwendung von Gesundheitsakten fr andere Zwecke, wie Lehre, klinische Studien, Verwaltung und Berichterstattu
10、ng, Dienstverwaltung, Forschung und Epidemiologie, die oft die Anonymisierung oder die Zusammenfhrung einzelner Akten erfordern, sind nicht das Ziel dieser Norm, fr diese zustzlichen Anwendungen kann die Verwendung dieser Norm aber hilfreich sein. Dieser Teil 3 der Normenreihe legt einen Satz von Be
11、griffen fest, die den Wertebereich festschreiben, den bestimmte Attribute des in Teil 1 festgelegten Referenzmodels annehmen knnen. Es werden auch spezi-fische Archetypen festgelegt, die den ENTRY-Level der Datenstrukturen (en: Compound Data Structures) des Referenzmodels von openEHR und HL7 Version
12、 3 entsprechen, um solchen Instanzen eine konsistente Reprsentation fr die Kommunikation unter Nutzung dieser Norm zu ermglichen. EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN 13606-3March 2008ICS 35.240.80 Supersedes ENV 13606-3:2000 English VersionHealth informatics - Electronic health record
13、communication -Part 3: Reference archetypes and term listsInformatique de la sant - Communication des dossiers desant informatiss - Partie 3: Archtypes de rfrence etlistes de termesMedizinische Informatik - Kommunikation vonPatientendaten in elektronischer Form - Teil 3:Referenzarchetypen und Begrif
14、fslistenThis European Standard was approved by CEN on 28 February 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographi
15、cal references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN m
16、ember into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
17、Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Bruss
18、els 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13606-3:2008: EEN 13606-3:2008 (E) 2 Contents Page Foreword3 Introduction .4 0.1 Summary.4 0.2 Term Lists.4 0.3 Reference Archetypes.4 1 Scope 5 2 Terms and definitions .5 3 Ab
19、breviations.6 4 Conformance6 5 Term lists 7 5.1 Introduction7 5.2 Termlist SUBJECT_CATEGORY, Class ENTRY, attribute subject_of_information_category.7 5.3 Termlist ITEM_CATEGORY, Class ITEM, attribute item_category .8 5.4 Termlist VERSION_STATUS, Class AUDIT_INFO, attribute version_status9 5.5 Termli
20、st MODE, Class FUNCTIONAL_ROLE, attribute mode10 5.6 Termlist ACT_STATUS, Class ENTRY, attribute act_status11 5.7 Termlist LINK_NATURE, Class LINK, attribute nature.12 5.8 Termlist LINK_ROLE, Optional term list for LINK attribute role (Informative) 13 5.8.1 Introduction13 5.8.2 Optional term list fo
21、r LINK attribute role (Informative)13 5.8.3 Mapping of extended term list to ENV13606-2 categories of Link (Informative).16 5.8.4 Mapping of extended term list to HL7 act.Relationship codes (Informative) 17 5.9 Termlist STRUCTURE_TYPE, Class CLUSTER, attribute structure_type19 Annex A (informative)
22、Reference archetypes.20 A.1 Introduction to the openEHR and HL7 mapping archetypes 20 A.2 openEHR ENTRY archetypes .21 A.2.1 Introduction21 A.2.2 openEHR ENTRY23 A.2.3 openEHR Evaluation .24 A.2.4 openEHR Observation.25 A.2.5 openEHR Instruction .26 A.2.6 openEHR Action.27 A.3 HL7 Version 3 entry ar
23、chetypes.28 A.3.1 Introduction28 A.3.2 HL7 Observation Act .28 A.3.3 HL7 Procedure Act.30 A.3.4 HL7 Substance Administration Act31 A.3.5 HL7 Supply Act 32 A.3.6 HL7 Act .33 A.3.7 HL7 Encounter Act.34 A.4 Code set for RECORD_COMPONENT.meaning attribute 35 Annex B (informative) Clinical example of the
24、 mapping between HL7 v3 and ISO 13606 .37 B.1 Introduction37 B.2 HL7 v3 representation of the Barthel Index 37 B.3 Table of correspondence between HL7 v3 and ISO 13606 for the Barthel Index38 DIN EN 13606-3:2008-06 EN 13606-3:2008 (E) 3 Foreword This document (EN 13606-3:2008) has been prepared by T
25、echnical 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 September 2008, and conflicting national standards shal
26、l be withdrawn at the latest by September 2008. 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. This document supersedes ENV 13606-3:2
27、000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, It
28、aly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. DIN EN 13606-3:2008-06 EN 13606-3:2008 (E) 4 Introduction 0.1 Summary Part 3 of the 13606 standards series contains two kinds of specifica
29、tions: 1 normative set of (coded) term lists that each defines a controlled vocabulary for a Reference Model attribute that is defined in Part 1 of this standard series; 2 informative set of Reference Archetypes: expressed as mappings that each specifies how the Part 1 Reference Model should be used
30、 to represent information originating from: o set of HL7 version 3 Acts that form part of the Clinical Statement Domain Message Information Model; o specialisations of ENTRY that are defined in the openEHR Reference Model. 0.2 Term Lists Each term list is referenced by its corresponding attribute as
31、 an invariant constraint in Part 1 of this standard series, by referring to its term list name. For each term list, every code value is accompanied by a phrase and description; however, in each case it is the code that is to be used as the Reference Model attribute value. Language translations of th
32、e phrase and description will therefore not affect the instances of RECORD_COMPONENT that are communicated using this standard. Should any future revision prove necessary for these term lists, a technical revision of this standard will be required. Such a revised standard shall specify an updated Re
33、ference Model identifier that shall then be used as the value of the rm_id of an EHR_EXTRACT, to inform the recipient of the version of this standard that was used in its creation. A cross-mapping of the term list for LINK.role to HL7 actRelationship codes is also provided for the convenience of tho
34、se wishing to adopt or interface this standard with HL7 version 3. This is part of a longer-term vocabulary harmonisation project between the health informatics standards development organizations (SDOs), and might therefore be extended in the future via other publications, such as the planned HL7-1
35、3606 Implementation Guide (see below). It is therefore informative in this standard. 0.3 Reference Archetypes Each Reference Archetype is represented in this standard as a mapping correspondence table to indicate the way in which the ITEM structure within a 13606 Part 1 ENTRY is to be used to repres
36、ent the classes and attributes of relevant HL7 v3 and openEHR classes. These two external models have been chosen for inclusion as these are the most likely internationally-used source models from which fine-grained clinical data may need to be transformed into this standard for communication. These
37、 Reference Archetypes are included as an aid to those adopting this standard and wishing to transform Electronic Health Record (her) data from existing HL7 v3 or openEHR instances or messages. It is recognised that full two-way interoperability between these various representations requires more det
38、ail, including rich vocabulary and data type harmonisation, and a corresponding set of technical artefacts such as eXtensible Markup Language (XML) Schemata and Extensible Stylesheet Language Transformation (XSLT) scripts. Such interoperability is very much the goal of current SDO harmonisation effo
39、rts, and will be published as an HL7-13606 Implementation Guide, possibly as an open-access and regularly updated resource. However, the outstanding work required to achieve this level of interoperability might take up to another year from when this standard is expected to be published. It has there
40、fore been decided to offer what does exist towards harmonisation in an informative form within this standard, as an aid to those already needing to make such data transformations. A worked example of the HL7 v3 to ISO 13606 mapping is given in Annex B. DIN EN 13606-3:2008-06 EN 13606-3:2008 (E) 5 1
41、Scope This Standard addresses the communication of part or all of electronic health records (EHR) of a single identified subject of care between EHR systems, or between EHR systems and a centralised EHR data repository. It may also be used for EHR communication between an EHR system or repository an
42、d clinical applications or middleware components (such as decision support components) that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system. This Standard, Part 3 of the 13606 EHR Communications Standard Series, defines term lis
43、ts that each specify the set of values that particular attributes of the Reference Model defined in Part 1 of this Series may take. It also defines informative Reference Archetypes that correspond to ENTRY-level compound data structures within the Reference Models of openEHR and HL7 Version 3, to en
44、able those instances to be represented within a consistent structure when communicated using this standard. 2 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 archetype instance individual metadata class instance of an Archetype Model, specifyin
45、g the clinical concept and the value constraints that apply to one class of Record Component instances in an electronic health record extract 3.2 clinical information information about a person, relevant to his or her health or health care 3.3 committed information that has been persisted within an
46、electronic health record system and which constitutes part of the electronic health record for a subject of care 3.4 committer agent (party, device or software) whose direct actions have resulted in data being committed to an electronic health record 3.5 composer agent (party, device or software) re
47、sponsible for creating, synthesising or organising information that is committed to an electronic health record 3.6 electronic health record extract part or all of the electronic health record for a subject of care, communicated in compliance with EN 13606 3.7 electronic health record system system
48、for recording, retrieving and manipulating information in electronic health records 3.8 entries health record data in general (clinical observations, statements, reasoning, intentions, plans or actions) without particular specification of their formal representation, hierarchical organisation or of
49、the particular Record Component class(es) that might be used to represent them 3.9 patient synonym for a subject of care DIN EN 13606-3:2008-06 EN 13606-3:2008 (E) 6 3.10 Record Component part of the electronic health record extract of a single subject of care, represented as a node within a hierarchical data structure conforming to EN 13606 3.11 state (of a process) condition or situation during the lifecycle of an object during which it satisfies some condition, performs some activity or waits for some event ISO/T
