1、BSI Standards PublicationHealth informatics Detailed clinical models, characteristics and processesPD CEN ISO/TS 13972:2015National forewordThis Published Document is the UK implementation of CEN ISO/TS13972:2015.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Hea
2、lth informatics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2015.Published
3、 by BSI Standards Limited 2015ISBN 978 0 580 81058 9ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 31 October 2015.Amendments/corrigenda issued sin
4、ce publicationDate Text affectedPUBLISHED DOCUMENTPD CEN ISO/TS 13972:2015TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 13972 October 2015 ICS 35.240.80 English Version Health informatics - Detailed clinical models, characteristics and processes (ISO/TS 13972:201
5、5) Informatique de sant - Modles cliniques dtaills, caractristiques et processus (ISO/TS 13972:2015) Medizinische Informatik - Detaillierte klinische Modelle, Charakteristika und Prozesse (ISO/TS 13972:2015) This Technical Specification (CEN/TS) was approved by CEN on 24 August 2015 for provisional
6、application. The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the e
7、xistence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS
8、into an EN is reached. CEN members are the 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, Neth
9、erlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All ri
10、ghts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 13972:2015 EPD CEN ISO/TS 13972:2015CEN ISO/TS 13972:2015 (E) 2 Contents Page European foreword . 3 PD CEN ISO/TS 13972:2015CEN ISO/TS 13972:2015 (E) 3 European foreword This document (
11、CEN ISO/TS 13972:2015) has been prepared by Technical Committee ISO/TC 215 “Health Informatics“ in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. Attention is drawn to the possibility that some of the elements of this document may be t
12、he subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specification: Austria,
13、 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, Romania, Slovakia, Slovenia, Spain, Sweden, S
14、witzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 13972:2015 has been approved by CEN as CEN ISO/TS 13972:2015 without any modification. PD CEN ISO/TS 13972:2015ISO/TS 13972:2015(E)Foreword vIntroduction vi1 Scope . 12 Terms and definition 13 Abbreviated terms 84 Defin
15、ition, purpose, contexts and position of Detailed Clinical Models . 84.1 Definition of Detailed Clinical Models . 84.2 Purpose for Detailed Clinical Models 104.3 Reference (Information) Models and Detailed Clinical Models .114.4 Types of Detailed Clinical Models 114.5 Context of Detailed Clinical Mo
16、dels . 124.6 Architectural approach to healthcare interoperability and Detailed Clinical Models 134.7 Architectural considerations for Detailed Clinical Models based on the GCM 145 Requirements and Methodology for Detailed Clinical Models 165.1 DCM application, structure and management 165.2 Clinica
17、l Requirements 195.2.1 General. 195.2.2 Clinician/user requirements, involvement, and verification for Detailed Clinical Models 205.3 Clinical acceptance, adoption, and use 205.4 DCM QMS Processes for the systematic approach for quality of DCMs 215.4.1 General. 215.4.2 General requirements .215.4.3
18、General DCM documentation requirements .215.5 DCM Governance 225.5.1 General. 225.5.2 Governance and Management responsibility for Detailed Clinical Models .225.5.3 Organizing Detailed Clinical Model governance 225.5.4 Submission criteria for Detailed Clinical Models 225.5.5 Search/access criteria f
19、or Detailed Clinical Models .235.5.6 Contributors and key competence 235.5.7 Clear Accountability .235.5.8 Quality 235.6 Stakeholder Participation 235.7 DCM Development Processes 245.7.1 General. 245.7.2 Hazards in data exchange between clinical information systems 245.7.3 Include data exchange spec
20、ifically in Detailed Clinical Model hazard analysis 255.7.4 Keep the Detailed Clinical Model as simple as possible 255.8 Detailed Clinical Model content and artefacts 255.8.1 General. 255.8.2 Clinical concept specification of a particular Detailed Clinical Model 265.8.3 Context of clinical concept i
21、n a Detailed Clinical Model .265.8.4 Purpose of the Detailed Clinical Model at instance level .265.8.5 Evidence Base for the Detailed Clinical Model topic 275.8.6 Description of data elements in the Detailed Clinical Model 285.8.7 Instructions for documentation of DCM content 335.8.8 Care process /
22、dependence . 345.8.9 Issues 345.8.10 Example of the DCM .355.8.11 References 35 ISO 2015 All rights reserved iiiContents PagePD CEN ISO/TS 13972:2015ISO/TS 13972:2015(E)5.8.12 Copyrights of source materials, Disclaimer, Terms of use and Copyrights for Detailed Clinical Model . 365.8.13 Metadata 375.
23、8.14 Version management 415.8.15 Guidelines and principles for Detailed Clinical Modelling 425.8.16 Inclusion of other Detailed Clinical Models .485.8.17 Use of terminology 485.9 Measurement, analysis and improvement . 485.9.1 General. 485.9.2 Detailed Clinical Model maintenance 495.9.3 Monitoring a
24、nd measurement 49Annex A (informative) Data type profile used for the logical model parts for Detailed Clinical Models .50Annex B (informative) Example Detailed Clinical Model in UML and Table format .51Bibliography .54iv ISO 2015 All rights reservedPD CEN ISO/TS 13972:2015ISO/TS 13972:2015(E)Forewo
25、rdISO (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 member body interested in a subject for which a technica
26、l 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 Electrotechnical Commission (IEC) on all matters of ele
27、ctrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was
28、drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).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 paten
29、t rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not co
30、nstitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe
31、committee responsible for this document is ISO/TC 215, Health informatics. ISO 2015 All rights reserved vPD CEN ISO/TS 13972:2015ISO/TS 13972:2015(E)IntroductionIn current healthcare information technology, there is an identified need for clinical information recorded by one professional or in one i
32、nformation system and transferred electronically to another professional or information system to retain enough of its intended and precise meaning to be safe and useful HL7, ISO 13606, EC Recommendation COM (2008) 3282 final. In particular, clinical safety requires that the receiving system and use
33、r of all data elements contributing to clinical knowledge makes the exact same interpretation of their meaning as applied in the source system. Semantic interoperability enables actors in a clinical process to cooperate by ensuring they share a common understanding of information and activities pert
34、inent to the clinical process. When actors in a clinical process use a combined system containing two (or more) information systems, semantic interoperability occurs as an emergent (whole system) characteristic of those data exchanges that constitute meaningful communications between actors using di
35、fferent information systems. As is typical for engineering properties of systems, semantic interoperability is not absolute. It enables sufficiently unambiguous understanding of stored, used, and communicated data so that patients, health care professionals, and others including automated systems ca
36、n interpret and act upon data in health care information systems (health IT systems) consistently and accurately.Semantic interoperability is defined as “ensuring that the precise meaning of exchanged information is understandable by any other system or application not initially developed for this p
37、urpose” EC Recommendation, COM (2008) 3282 final. Semantic interoperability addresses issues of how to best facilitate seamless computer mediated processes of coding, transmission, and use of meaning across health services, between providers, patients, citizens and authorities, research, and trainin
38、g (modified from Semantic Health, 2009). A key requirement to achieve this is the standardization of clinical concept representation within health data, including content, structure, context, and transmission processes. This represents the core development need for future electronic health records (
39、EHR) and other health IT systems and for communication between these systems. In addition, standardization of clinical concept representation is a desirable and cost effective way to aggregate data from multiple health IT systems and operate as a cohesive whole, for example for clinical audit and re
40、search. Exchanging information using standardized clinical concept representations thereby takes its place as one of the specific kinds of semantic interoperability, with well-defined benefits and limitations.The ability to exchange information between clinical information systems without loss of cl
41、inical meaning is also essential to enable safe and effective implementation of automated decision support. Whether a decision support system requests specific information from an EHR system or an EHR system requests specific computations from a decision support system (and both of these patterns of
42、 interaction are used), it is essential that the clinical information exchanged is understood accurately and consistently by both systems.This Technical Specification provides guidance on representation format and processes to improve the quality of modular data specifications for clinical informati
43、on, here called Detailed Clinical Models (DCM). The modelling approach described in ISO/TR 17119 as the ISO Health Informatics Profiling Framework (HIPF) is followed. ISO/TR 17119 defines three levels of specificity for artefacts which are CONCEPTUAL, LOGICAL, and PHYSICAL and describes six perspect
44、ives for an artefact, the WHO, WHAT, HOW, WHERE, WHY, and WHEN perspectives.With respect to the processes for DCM, a Quality Management system (QMS) based on a framework such as ISO 9001 can be used. Defined processes for development, application, and governance ensure the quality of DCM artefacts.
45、In terms of the HIPF, this provides WHO, HOW, and WHEN perspectives at the LOGICAL level of specificity.The scope of this Technical Specification is the conceptual and logical aspects of a DCM and quality management processes for DCM artefacts. Although the DCM is modelling a clinical concept, we ar
46、e defining these concepts at the logical level. Therefore, these are logical constructs. There is ongoing debate in the Health Informatics community about the exact nature and role of modular data specifications for clinical information. This Technical Specification reflects a pragmatic consensus ba
47、sed on experience, in particular regarding the level of detail in the breakdown and representation vi ISO 2015 All rights reservedPD CEN ISO/TS 13972:2015ISO/TS 13972:2015(E)of a DCM and how instances of a DCM are likely to be used within an actual Healthcare Information Architecture.The following o
48、rganizers and participants contributed to the Technical Specification: Health Level 7 International (HL7) (USA) National ICT Institute in Health Care (NICTIZ, Netherlands) National Health Service (NHS) (England) Canada Infoway (Canada) National E-Health Transition Authority (NEHTA),(Australia) OpenE
49、HR (International) EN 13606 association (Europe) Intermountain Healthcare (USA) Center for Interoperable EHR (CiEHR) (South Korea) Parelsnoer Initiative (Netherlands) Netherlands Normalization Institute, Detailed Clinical Model Quality Center (Netherlands) Portavita (Netherlands) Clinical Information Modelling Initiative (CIMI) (International) Results 4 Care BV (Netherlands) And the many other individuals and organizations that contributed.Clinical concepts as core of EHR and message contentDetailed Clinical Models are highly special
