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1、a Date: 10 November 2006 Origin: European Latest date for receipt of comments: 28 February 2007 Project no.: 2006/02967 Responsible committee: IST/35 Health informatics Interested committees: Title: Draft BS EN 13606-3 REV Health informatics - Electronic health record communication - Part 3: Referen
2、ce archetypes and term lists Supersession information: If this document is published as a standard, the UK implementation of it will supersede BSEN 13606-3 and partially supersede NONE . If you are aware of a current national standard which may be affected, please notify the secretary (contact detai
3、ls below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 28 February 2007. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement will normal
4、ly be sent. See overleaf for information on commenting. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organization for briefing purposes. Electronic circulation
5、 is limited to dissemination by e-mail within such an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or email ordersbsi-. British, International and foreign standards are also available from BSI Customer Services.
6、 British Standards on CD or Online are available from British Standards Publishing Sales Limited. Tel: 01344 404409 or email bsonlinetechindex.co.uk. Information on the co-operating organizations represented on the committees referenced above may be obtained from the responsible committee secretary.
7、 Cross-references The British Standards which implement International or European publications referred to in this draft may be found via the British Standards Online Service on the BSI web site http:/www.bsi-. Direct tel: 020 8996 7009 Responsible Committee Secretary: Committee Service Centre (BSI)
8、 E-mail: cscbsi- Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 Form 36 Version 6.1 DPC: 06/30158148 DC Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:04:36 GMT+00:00 2006, Unco
9、ntrolled Copy, (c) BSI b Introduction This draft standard is based on European discussions in which the UK took an active part. Your comments on this draft are welcome and will assist in the preparation of the consequent British Standard. If no comments are received to the contrary, then the UK will
10、 approve this draft and implement it as a British Standard. Comment is particularly welcome on national, legislative or similar deviations that may be necessary. Even if this draft standard is not approved by the UK, if it receives the necessary support in Europe, the UK will be obliged to publish t
11、he official English Language text unchanged as a British Standard and to withdraw any conflicting standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. BSI Committee Responsibilities Whether or not the standard is publis
12、hed in its original (international) form, or as a formal British Standard Implementation, the BSI committees responsibilities are to: - aid enquirers to understand the text; - present to the responsible international committee any enquiries on interpretation, or proposals for change, and keep UK int
13、erests informed; - monitor related International and European developments and promulgate them in the UK. Submission The guidance given below is intended to ensure that all comments receive efficient and appropriate attention by the responsible BSI committee. Annotated drafts are not acceptable and
14、will be rejected. All comments must be submitted, preferably electronically, to the Responsible Committee Secretary at the address given on the front cover. Comments should be compatible with Version 6.0 or Version 97 of Microsoft Word for Windows, if possible; otherwise comments in ASCII text forma
15、t are acceptable. Any comments not submitted electronically should still adhere to these format requirements. All comments submitted should be presented as given in the example below. Further information on submitting comments and how to obtain a blank electronic version of a comment form are availa
16、ble from the BSI web site at:http:/www.bsi- Template for comments and secretariat observations Date: xx/xx/200x Document: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB Clause No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justification for change)
17、 by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition is ambiguous and needs clarifying. Amend to read . so that the mains connector to which no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be s
18、upported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft and MS-DOS are registered trademarks, and Windows is a trademark of Microsoft Corporation. Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:04
19、:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM DRAFT prEN 13606-3 October 2006 ICSWill supersede ENV 13606-3:2000 English Version Health informatics - Electronic health record communication - Part 3: Reference archetypes and term lists Medizinische I
20、nformatik - Kommunikation von Patientendaten in elektronischer Form - Teil 3: Referenzarchetypen und Begriffslisten This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 251. If this draft becomes a European Standard, CEN members
21、 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. This draft European Standard was established by CEN in three official versions (English, French, German). A versio
22、n in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia,
23、Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Recipients of this draft are invited to submit, with their comments, notificati
24、on of any relevant patent rights of which they are aware and to provide supporting documentation. Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard. EUROPEAN COMMIT
25、TEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. prEN 13606-3:2006: E Licensed Copy: Londo
26、n South Bank University, London South Bank University, Sun Dec 24 04:04:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI prEN 13606-3:2006 (E) 2 Contents Page Foreword3 Introduction.4 1 Scope 5 2 Normative References.5 3 Terms and Definitions.5 4 Abbreviations.11 5 Conformance (Normative).12 5.1 Native
27、 mode12 5.2 openEHR mode12 5.3 HL7 mode12 6 Term Lists (Normative)13 6.1 Introduction13 6.2 Termlist SUBJECT_CATEGORY, Class ENTRY, attribute subject_of_information_category.13 6.3 Termlist ITEM_CATEGORY, Class ITEM, attribute item_category .13 6.4 Termlist VERSION_STATUS, Class AUDIT_INFO, attribut
28、e version_status15 6.5 Termlist MODE, Class FUNCTIONAL_ROLE, attribute mode16 6.6 Termlist ACT_STATUS, Class ENTRY, attribute act_status17 6.7 Termlist LINK_NATURE, Class LINK, attribute nature.17 6.8 Termlist LINK_ROLE, Optional term list for LINK attribute role (Informative) 19 6.9 Termlist STRUCT
29、URE_TYPE, Class CLUSTER, attribute structure_type25 7 Reference archetypes (Normative) 26 7.1 Introduction to the openEHR and HL7 mapping archetypes 26 7.2 openEHR ENTRY archetypes .26 7.3 HL7 Version 3 Entry archetypes.32 7.4 Code set for RECORD_COMPONENT.meaning attribute 39 Licensed Copy: London
30、South Bank University, London South Bank University, Sun Dec 24 04:04:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI prEN 13606-3:2006 (E) 3 Foreword This document (prEN 13606-3:2006) has been prepared by Technical Committee CEN/TC 251 “Health informatics”, the secretariat of which is held by NEN. Th
31、is document is currently submitted to the CEN Enquiry. This document will supersede ENV 13606-3:2000. This multipart standard under the general heading Health informatics Electronic health record communication consists of the following parts: Part 1: Reference model Part 2: Archetype interchange spe
32、cification Part 3: Reference archetypes and term lists Part 4: Security Part 5: Exchange models Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:04:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI prEN 13606-3:2006 (E) 4 Introduction This part standard contains t
33、wo kinds of specifications: 1 a 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; 2 a set of archetype mappings that each specifies how the Reference Model is to be used to represent a particular part of: o
34、 HL7 version 3 : the set of Acts that are included within the Clinical Statement DMIM o openEHR: the specialisations of ENTRY that are included in the openEHR Reference Model Each term list is referenced by its corresponding attribute as an invariant constraint in Part 1 of this standard, by referri
35、ng to its term list name. For each term list each code is accompanied by a phrase and description; however, in each case it is the code that is to be used as the part 1 attribute value. Language translations of the phrase and description will therefore not affect the instances of RECORD_COMPONENT th
36、at are communicated by this standard. 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 3. Each archetype is, in this part standard, represented as a mapping correspo
37、ndence table to indicate the way in which the ITEM structure within a 13606-1 ENTRY is to be used to represent the classes and attributes of relevant HL7 v3 or openEHR classes. These two external models have been chosen for inclusion as these are the most likely internationally-used source models fr
38、om which fine-grained clinical data may need to be transformed into this standard for communication. Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:04:36 GMT+00:00 2006, Uncontrolled Copy, (c) BSI prEN 13606-3:2006 (E) 5 1 Scope This standard is for the comm
39、unication of part or all of the electronic health record (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 middlewa
40、re components (such as decision support components) that need to access or provide EHR data. This standard will predominantly be used to support the direct care given to identifiable individuals, or to support population monitoring systems such as disease registries and public health surveillance. U
41、ses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymisation or aggregation of individual records, are not the focus of this standard but such secondary uses might also find t
42、he standard useful. This Part 3 of the multipart standard defines a set of term lists, that defines the set of values that particular attributes of the Reference Model defined in Part 1 may take. It also defines specific archetypes that correspond to ENTRY-level compound data structures within the R
43、eference Models of openEHR and HL7 Version 3, to enable those instances to be represented consistently when communicated using this standard. 2 Normative References This document incorporates by dated or undated references, provisions from other publications. These normative references are cited in
44、the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments and revisions of any of these publications apply to this European standard only when they are incorporated in it by amendment and revision. For undated references the latest edit
45、ion of the publication referred to, applies. EN 14822-1 Health informatics General Purpose Information Components : Part 1: General EN 14822-2 Health informatics General Purpose Information Components : Part 2: Non-Clinical EN 14822-3 Health informatics General Purpose Information Components : Part
46、3: Clinical CEN/TS 14796: 2004 Health informatics - Data types ISO/TS 18308: 2004 Health informatics - Requirements for an electronic health record architecture ISO/TR 20514:2005 Health informatics - Electronic health record - Definition, scope and context ISO/IEC 11179-3: 2003 Information technolog
47、y - Metadata registries (MDR) - Part 3: Registry metamodel and basic attributes 3 Terms and Definitions For the purposes of this European standard, the following definitions apply. 3.1 abstract class “virtual” common parent to two or more classes that will never be instantiated Note: This term is us
48、ed in the Unified Modeling Language,. Its value is to provide a container for attributes and associations that might apply to several other classes, the sub-classes of an abstract class. Licensed Copy: London South Bank University, London South Bank University, Sun Dec 24 04:04:36 GMT+00:00 2006, Un
49、controlled Copy, (c) BSI prEN 13606-3:2006 (E) 6 3.2 access control means of ensuring that the resources of a data processing system can be accessed only by authorised entities in authorised ways ISO/IEC 2382-8 3.3 accountability property that ensures that the actions of an entity may be traced uniquely to that entity ISO/IEC 2382-8 3.4 archetype instance individual metadata class instance of an Archetype Model, specifying the clinical concept a