1、BRITISH STANDARD BS EN 13606-3:2008 Health informatics Electronic health record communication Part 3: Reference archetypes and term lists ICS 35.240.80 BS EN 13606-3:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2008 BSI 2008 I
2、SBN 978 0 580 57889 2 National foreword This British Standard is the UK implementation of EN 13606-3:2008. It supersedes DD ENV 13606-3:2000 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics. A list of organizations represente
3、d 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. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/co
4、rrigenda issued since publication Date CommentsEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13606-3 March 2008 ICS 35.240.80 Supersedes ENV 13606-3:2000 English Version Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists Informatique de l
5、a sant - Communication des dossiers de sant informatiss - Partie 3: Archtypes de rfrence et listes de termes Medizinische Informatik - Kommunikation von Patientendaten in elektronischer Form - Teil 3: Referenzarchetypen und Begriffslisten This European Standard was approved by CEN on 28 February 200
6、8. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate 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 o
7、n 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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management C
8、entre has the same status as the official 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, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Po
9、land, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and
10、by any means reserved worldwide 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 Abbreviations.6 4 Conformance6 5 Term lists 7 5.1 Introd
11、uction7 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 Termlist MODE, Class FUNCTIONAL_ROLE, attribute mode10 5.6 T
12、ermlist 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 for LINK attribute role (Informative)13 5.8.3 Mapping of
13、 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) Reference archetypes.20 A.1 Introduction to the openEH
14、R 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 archetypes.28 A.3.1 Introduction28 A.3.2 HL7 Observation
15、 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 mapping between HL7 v3 and ISO 13606 .37 B.1 Introduc
16、tion37 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 BS EN 13606-3:2008EN 13606-3:2008 (E) 3 Foreword This document (EN 13606-3:2008) has been prepared by Technical Committee CEN/TC 251 “Health informatics”, the sec
17、retariat 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 shall be withdrawn at the latest by September 2008. Attention i
18、s 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 13606-3:2000. According to the CEN/CENELEC Internal Regulations, the
19、 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, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Nor
20、way, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 13606-3:2008EN 13606-3:2008 (E) 4 Introduction 0.1 Summary Part 3 of the 13606 standards series contains two kinds of specifications: 1 normative set of (coded) term lists that each defines a
21、 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 to represent information originating from: o set of HL7 version
22、 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 an invariant constraint in Part 1 of this standard series, by r
23、eferring 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 the phrase and description will therefore not affect the instances
24、 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 Reference Model identifier that shall then be used as the value of
25、 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 those wishing to adopt or interface this standard with HL7 version
26、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 HL7-13606 Implementation Guide (see below). It is therefore informat
27、ive 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 represent the classes and attributes of relevant HL7 v3 and openEHR c
28、lasses. 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 Reference Archetypes are included as an aid to those adopting
29、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 detail, including rich vocabulary and data type harmonisation, and
30、 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 efforts, and will be published as an HL7-13606 Implementation Guide
31、, 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 therefore been decided to offer what does exist towards harmonisatio
32、n 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. BS EN 13606-3:2008EN 13606-3:2008 (E) 5 1 Scope This Standard addresses the communication of part or all of el
33、ectronic 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 and clinical applications or middleware components (such as decision s
34、upport 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 lists that each specify the set of values that particular attributes of
35、 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 enable those instances to be represented within a consistent structure
36、 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, specifying the clinical concept and the value constraints that apply to one c
37、lass 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 electronic health record system and which constitutes part of the el
38、ectronic 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) responsible for creating, synthesising or organising information that
39、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 for recording, retrieving and manipulating information in electronic
40、 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 the particular Record Component class(es) that might be used to repr
41、esent them 3.9 patient synonym for a subject of care BS EN 13606-3:2008EN 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) con
42、dition or situation during the lifecycle of an object during which it satisfies some condition, performs some activity or waits for some event ISO/TS 18308:2004 3.12 subject of care person scheduled to receive, receiving, or having received health care 3 Abbreviations CEN Comit Europen de Normalisat
43、ion (European Committee for Standardization) CEN/ TC 251 CEN Technical Committee 251 EHR Electronic Health Record EU European Union HISA Health Information Systems Architecture HL7 Health Level Seven ISO International Organization for Standardization UML Unified Modelling Language XML Extensible Mar
44、k-up Language 4 Conformance When electronic health record information is to be communicated using the 13606 Standard Series and where an attribute of the Reference Model defined in Part 1 of this series requires a value to be taken from a bounded set of codes from a named term list, the code shall b
45、e one of those defined in Clause 5 of this standard for the correspondingly-named term list. BS EN 13606-3:2008EN 13606-3:2008 (E) 7 5 Term lists 5.1 Introduction The Reference Model defined in Part 1 of this standard series defines several attributes whose values are to be selected from a fixed lis
46、t of values. This section defines those value lists (term lists) for each of those attributes. Attributes not included in this section (or defined in Part 4 of this series) may take any value that conforms to the data type and invariant specifications defined in Part 1 of this series. 5.2 Termlist S
47、UBJECT_CATEGORY, Class ENTRY, attribute subject_of_information_category This attribute provides a coarse-grained definition of the person who is the subject of an ENTRY. The default value is DS00 (the patient or subject of care). A more fine-grained definition of the information subject (such as the
48、 precise relative with a family history) can be specified through the ENTRY.subject_of_information.relationship attribute. Code Meaning Description DS00 subject of care subject of care DS01 relative of subject of care any human relative, without limitation to biological or adoptive relatives DS02 fo
49、etus or neonate or infant baby or babies being described by an ENTRY in the EHR of the mother DS03 mother mother of a foetus or neonate, if being described in the EHR of a baby (e.g. during pregnancy) DS04 donor donor of an organ or body specimen being described by an ENTRY in the EHR of the recipient DS05 unrelated person any other person not related to the subject of care, such as an employer, friend, carer NOTE If ENTRY.subject_of_information_category is
