1、BSI Standards Publication Health informatics Detailed clinical models, characteristics and processes PD CEN ISO/TS 13972:2015National foreword This Published Document is the UK implementation of CEN ISO/TS 13972:2015. The UK participation in its preparation was entrusted to Technical Committee IST/3
2、5, Health informatics. A list of organizations represented 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 2015
3、. Published by BSI Standards Limited 2015 ISBN 978 0 580 81058 9 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 October 2015. Amendments/cor
4、rigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD CEN ISO/TS 13972:2015 TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 13972 O c t o b e r 2 0 1 5 ICS 35.240.80 English Version Health informatics - Detailed clinical models, characteristics
5、and processes (ISO/TS 13972:2015) 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
6、24 August 2015 for provisional 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
7、 are required to announce the existence 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 pos
8、sible conversion of the CEN/TS 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, Lit
9、huania, Luxembourg, Malta, Netherlands, 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,
10、B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 13972:2015 E PD 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 E
11、uropean foreword This document (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 el
12、ements 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. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this T
13、echnical Specification: 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, Romania, Slov
14、akia, Slovenia, Spain, Sweden, Switzerland, 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 13972:2015 ISO/TS 13972:2015(E)Foreword v Introduction vi 1 Scope . 1 2 T erms and def
15、inition 1 3 Abbreviated terms 8 4 Definition, purpose , c ont e xts and position of Detailed Clinical Models .8 4.1 Definition of Detailed Clinical Models . 8 4.2 Purpose for Detailed Clinical Models . .10 4.3 Reference (Information) Models and Detailed Clinical Models .11 4.4 Types of Detailed Clin
16、ical Models 11 4.5 Context of Detailed Clinical Models .12 4.6 Architectural approach to healthcare interoperability and Detailed Clinical Models 13 4.7 Architectural considerations for Detailed Clinical Models based on the GCM 14 5 Requirements and Methodology for Detailed Clinical Models 16 5.1 DC
17、M application, structure and management 16 5.2 Clinical Requirements 19 5.2.1 General.19 5.2.2 Clinician/user requirements, involvement, and verification for Detailed Clinical Models 20 5.3 Clinical acceptance, adoption, and use 20 5.4 DCM QMS Processes for the systematic approach for quality of DCM
18、s 21 5.4.1 General.21 5.4.2 General requirements .21 5.4.3 General DCM documentation requirements .21 5.5 DCM Governance 22 5.5.1 General.22 5.5.2 Governance and Management responsibility for Detailed Clinical Models .22 5.5.3 Organizing Detailed Clinical Model governance 22 5.5.4 Submission criteri
19、a for Detailed Clinical Models 22 5.5.5 Search/access criteria for Detailed Clinical Models .23 5.5.6 Contributors and key competence 23 5.5.7 Clear Accountability .23 5.5.8 Quality 23 5.6 Stakeholder Participation23 5.7 DCM Development Processes 24 5.7.1 General.24 5.7.2 Hazards in data exchange be
20、tween clinical information systems 24 5.7.3 Include data exchange specifically in Detailed Clinical Model hazard analysis 25 5.7.4 Keep the Detailed Clinical Model as simple as possible 25 5.8 Detailed Clinical Model content and artefacts 25 5.8.1 General.25 5.8.2 Clinical concept specification of a
21、 particular Detailed Clinical Model 26 5.8.3 Context of clinical concept in a Detailed Clinical Model .26 5.8.4 Purpose of the Detailed Clinical Model at instance level .26 5.8.5 Evidence Base for the Detailed Clinical Model topic 27 5.8.6 Description of data elements in the Detailed Clinical Model
22、28 5.8.7 Instructions for documentation of DCM content 33 5.8.8 Care process / dependence .34 5.8.9 Issues 34 5.8.10 Example of the DCM .35 5.8.11 References 35 ISO 2015 All rights reserved iii Contents Page PD CEN ISO/TS 13972:2015 ISO/TS 13972:2015(E)5.8.12 Copyrights of source materials, Disclaim
23、er, Terms of use and Copyrights for Detailed Clinical Model .36 5.8.13 Metadata 37 5.8.14 Version management 41 5.8.15 Guidelines and principles for Detailed Clinical Modelling 42 5.8.16 Inclusion of other Detailed Clinical Models .48 5.8.17 Use of terminology 48 5.9 Measurement, analysis and improv
24、ement .48 5.9.1 General.48 5.9.2 Detailed Clinical Model maintenance 49 5.9.3 Monitoring and measurement 49 Anne x A (informative) Data type pr ofile used for the logical model parts for Detailed Clinical Models .50 Anne x B (informative) Ex ample Detailed Clinical Model in UML and T able format .51
25、 Bibliogr aph y .54 iv ISO 2015 All rights reserved PD CEN ISO/TS 13972:2015 ISO/TS 13972:2015(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally ca
26、rried out through ISO technical committees. Each member body interested in a subject for which a technical 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
27、. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical 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 diffe
28、rent approval criteria needed for the different types of ISO documents should be noted. This document was 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 m
29、ay be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent 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/pate
30、nts). Any trade name used in this document is information given for the convenience of users and does not constitute 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 princi
31、ples in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 215, Health informatics. ISO 2015 All rights reserved v PD CEN ISO/TS 13972:2015 ISO/TS 13972:2015(E) Introduction In current healthcare inf
32、ormation technology, there is an identified need for clinical information recorded by one professional or in one information 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,
33、EC Recommendation COM (2008) 3282 final. In particular, clinical safety requires that the receiving system and user 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 i
34、n a clinical process to cooperate by ensuring they share a common understanding of information and activities pertinent 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 (whol
35、e system) characteristic of those data exchanges that constitute meaningful communications between actors using different information systems. As is typical for engineering properties of systems, semantic interoperability is not absolute. It enables sufficiently unambiguous understanding of stored,
36、used, and communicated data so that patients, health care professionals, and others including automated systems can 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 meani
37、ng of exchanged information is understandable by any other system or application not initially developed for this purpose” EC Recommendation, COM (2008) 3282 final. Semantic interoperability addresses issues of how to best facilitate seamless computer mediated processes of coding, transmission, and
38、use of meaning across health services, between providers, patients, citizens and authorities, research, and training (modified from Semantic Health, 2009). A key requirement to achieve this is the standardization of clinical concept representation within health data, including content, structure, co
39、ntext, and transmission processes. This represents the core development need for future electronic health records (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 ag
40、gregate data from multiple health IT systems and operate as a cohesive whole, for example for clinical audit and research. Exchanging information using standardized clinical concept representations thereby takes its place as one of the specific kinds of semantic interoperability, with well-defined b
41、enefits and limitations. The ability to exchange information between clinical information systems without loss of clinical 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
42、system or an EHR system requests specific computations from a decision support system (and both of these patterns of interaction are used), it is essential that the clinical information exchanged is understood accurately and consistently by both systems. This Technical Specification provides guidanc
43、e on representation format and processes to improve the quality of modular data specifications for clinical information, 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 def
44、ines three levels of specificity for artefacts which are CONCEPTUAL, LOGICAL, and PHYSICAL and describes six perspectives 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
45、9001 can be used. Defined processes for development, application, and governance ensure the quality of DCM artefacts. 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 aspec
46、ts of a DCM and quality management processes for DCM artefacts. Although the DCM is modelling a clinical concept, we are 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
47、of modular data specifications for clinical information. This Technical Specification reflects a pragmatic consensus based on experience, in particular regarding the level of detail in the breakdown and representation vi ISO 2015 All rights reserved PD CEN ISO/TS 13972:2015 ISO/TS 13972:2015(E) of a
48、 DCM and how instances of a DCM are likely to be used within an actual Healthcare Information Architecture. The following organizers and participants contributed to the Technical Specification: Health Level 7 International (HL7) (USA) National ICT Institute in Health Care (NICTIZ, Netherlands) Natio
49、nal Health Service (NHS) (England) Canada Infoway (Canada) National E-Health Transition Authority (NEHTA),(Australia) OpenEHR (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 individ
