ISO INTERNATIONAL STANDARD 13972 First edition 2022-02 Health informatics Clinical information models Characteristics, structures and requirements Informatique de santé - Modeles d'informations cliniques - Caractéristiques, structures et exigences Reference number IS0 13972:2022(E) ISO @IS02022 IS0 13972:2022(E) COPYRIGHT PROTECTED DOCUMENT IS02022 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may the internet or an intranet, withoutpriorwrittenpermission.Permission can be requested from eitherIso at the addressbelow or Iso's member body in the country of the requester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214Vernier,Geneva Phone: +4122 749 0111 Email: [email protected] Website: www.iso.org PublishedinSwitzerland i @ IS0 2022 - All rights reserved IS0 13972:2022(E) Contents Page Foreword .V Introduction. ..vi 1 Scope.. .1 2 Normative references ..1 3 Terms, definitions and abbreviated terms 1 3.1 Terms and definitions. 1 3.2 Abbreviated terms.. .7 4 Health care information models - Concept, purpose, contexts and position. .8 4.1 The Concept of Clinical Information Models. 8 4.2 Purpose for Clinical Information Models 10 4.3 Context of Health and Care Information Models 11 4.4 Architectural Considerations for Clinical Information Models 13 4.4.1 General 13 4.4.2 CIMs in an architectural view.. 13 4.4.3 CIMs placed in the Generic Component Model 14 4.4.4 The Interoperability and Integration Reference Architecture in IS0 23903 .15 4.4.5 Representation of ReEIF through the ISO Interoperability and Integration Reference Architecture Framework 17 5 Quality Management System for Clinical Information Models 19 5.1 General 19 5.2 CIMs quality management system. 19 5.3 CIMs Requirements. 20 5.4 CIMs acceptance, adoption and use. 21 5.5 Achieving quality CIMs. 21 5.6 Governance of CIMs. 22 5.7 Repositories of CIMs .22 5.8 CIMs Development Processes 22 6 Clinical Information Model content, structure and requirements 23 6.1 Clinical Information Model content and context. 23 6.2 Concept specification of a Clinical Information Model 24 6.3 Purpose of the Concept 24 6.4 Patient Population for which the Clinical Information Model is intended. 24 6.5 Evidence Base for the Clinical Information Model topic 24 6.6 Description of the information model and its data elements in CIMs. 25 6.6.1 General requirements for the information model 25 6.6.2 Dataelements. 26 6.6.3 Data Element Name and Identifier 28 6.6.4 Data Element descriptions. 29 6.6.5 Semantic coding of data elements. 29 6.6.6 Datatype 30 6.6.7 Value 31 6.6.8 Value set expression. 32 6.6.9 Relationships in CIMs 32 6.6.10 Localization of CIMs. 33 6.7 Example instances.. 33 6.8 Interpretation 33 6.9 Constraints or Limitations for use 34 6.10 Instructions for use of CIMs.. 35 6.11 Care process / dependence.. .36 6.12 Issues 36 6.13 Example of the use of a CIM 37 6.14 References. 37 @ IS0 2022 - All rights reserved ii IS0 13972:2022(E) 6.15 Intellectual property issues around Clinical Information Models .37 7 Metadata for clinical information models .39 7.1 General .39 7.2 The metadata elements of the Clinical Information Models .39 8 Version management of clinical information models ..43 Annex A (informative) Release and maintenance process example in the Netherlands ..44 Annex B (informative) Version management backwards compatibility ..45 Annex C (informative) Guidelines and principles for Clinical Information Modelling ..46 Annex D (informative) Example mapping a CIM to ADL specification: Glasgow Coma Scale .53 Annex E (informative) Datatype profile used for the logical model parts for Clinical Information Models. ..61 Annex F (informative) Example Clinical Information Model in UML and Table format. .62 Annex G (informative) Example Clinical Information Model transformation in HL7? FHIR .. ...64. Bibliography .74 iv @ IS0 2022 - All rights reserved IS0 13972:2022(E) Foreword Iso (the Int