ISO-13606-2-2008.pdf

Reference number ISO 13606-2:2008(E) © ISO 2008 INTERNATIONAL STANDARD ISO 13606-2 First edition 2008-12-01 Health informatics Electronic health record communication Part 2: Archetype interchange specification Informatique de santé Communication du dossier de santé informatisé Partie 2: Spécification d'échange d'archétype Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 00:36:47 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 13606-2:2008(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT © ISO 2008 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii © ISO 2008 All rights reserved Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 00:36:47 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 13606-2:2008(E) © ISO 2008 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Conformance. 1 3 Normative references. 1 4 Terms and definitions. 2 5 Symbols and abbreviations. 3 6 Archetype representation requirements 4 6.1 General. 4 6.2 Archetype definition, description and publication information. 4 6.3 Archetype node constraints 6 6.4 Data value constraints 8 6.5 Profile in relation to EN 13606-1 Reference Model 10 7 Archetype model. 11 7.1 Introduction. 11 7.2 Overview 14 7.3 The archetype package 18 7.4 The archetype description package 20 7.5 The constraint model package 24 7.6 The assertion package. 31 7.7 The primitive package 35 7.8 The ontology package 42 7.9 The domain extensions package 44 7.10 The support package 47 7.11 Generic types package. 56 7.12 Domain-specific extensions (informative) . 57 8 Archetype Definition Language (ADL) 58 8.1 dADL Data ADL. 58 8.2 cADL Constraint ADL. 79 8.3 Assertions . 106 8.4 ADL paths 110 8.5 ADL Archetype definition language. 111 Bibliography. 123 Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 00:36:47 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 13606-2:2008(E) iv © ISO 2008 All rights reserved 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 carried 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. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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 patent rights. ISO 13606-2 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO 13606 consists of the following parts, under the general title Health informatics Electronic health record communication: Part 1: Reference model Part 2: Archetype interchange specification Part 3: Reference archetypes and term lists Part 5: Interface specification Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 00:36:47 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 13606-2:2008(E) © ISO 2008 All rights reserved v Introduction Comprehensive, multi-enterprise and longitudinal electronic health records will often in practice be achieved through the joining up of multiple clinical applications, databases (and increasingly devices) that are each tailored to the needs of individual conditions, specialties or enterprises. This requires that Electronic Health Record (EHR) data from diverse systems be capable of being mapped to and from a single comprehensive representation, which is used to underpin interfaces and messages within a distributed network (federation) of EHR systems and services. This common representation has to be sufficiently generic and rich to represent any conceivable health record data, comprising part or all of an EHR (or a set of EHRs) being communicated. The approach adopted in the ISO 13606 series of International Standards, underpinned by international research on the EHR, has been to define a rigorous and generic Reference Model that is suitable for all kinds of data and data structures within an EHR, and in which all labelling and context information is an integral part of each construct. An EHR Extract (as defined in ISO 13606-1) will contain all the names, structure and context required for it to be interpreted faithfully on receipt, even if its organization and the nature of the clinical content have not been “agreed” in advance. However, the wide-scale sharing of health records, and their meaningful analysis across distributed sites, also requires that a consistent approach be used for the clinical (semantic) data structures that will be communicated via the Reference Model, so that equivalent clinical information is represented consistently. This is necessary in order for clinical applications and analysis tools to safely process EHR data that have come from heterogeneous sources. Archetypes The challenge for EHR interoperability is therefore to devise a generalized approach to representing every conceivable kind of health record data structure in a consistent way. This needs to cater for records arising from any profession, speciality or service, whilst recognising that the clinical data sets, value sets, templates, etc., required by different health care domains will be diverse, complex and will change frequently as clinical practice and medical knowledge advance. This requirement is part of the widely acknowledged health informatics challenge of semantic interoperability. The approach adopted by this part of ISO 13606 distinguishes a Reference Model, used to represent the generic properties of health record information, and Archetypes (conforming to an Archetype Model), which are metadata used to define patterns for the specific characteristics of the clinical data that represent the requirements of each particular profession, speciality or service. The Reference Model is specified as an Open Distributed Processing (ODP) Information Viewpoint Model, representing the global characteristics of health record components, how they are aggregated, and the context information required to meet ethical, legal and provenance requirements. In the ISO 13606 series of International Standards, the Reference Model is defined in ISO 13606-1. This model defines the set of classes that form the generic building blocks of the EHR. It reflects the stable characteristics of an electronic health record, and would be embedded in a distributed (federated) EHR environment as specific messages or interfaces (as specified in ISO 13606-5). Archetypes are effectively pre-coordinated combinations of named RECORD_COMPONENT hierarchies that are agreed within a community in order to ensure semantic interoperability, data consistency and data quality. For an EHR_Extract, as defined in ISO 13606-1, an archetype specifies (and effectively constrains) a particular hierarchy of RECORD_COMPONENT subclasses, defining or constraining their names and other relevant attribute values, optionality and multiplicity at any point in the hierarchy, the data types and value ranges that ELEMENT data values may take, and may include other dependency constraints. Archetype Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 00:36:47 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 13606-2:2008(E) vi © ISO 2008 All rights reserved instances themselves conform to a formal model, known as an Archetype Model (which is a constraint model, also specified as an ODP Information Viewpoint Model). Although the Archetype Model is stable, individual archetype instances may be revised or succeeded by others as clinical practice evolves. Version control ensures that new revisions do not invalidate data created with previous revisions. Archetypes may be used within EHR systems to govern the EHR data committed to a repository. However, for the purposes of this interoperability standard, no assumption is made about the use of archetypes within the EHR provider system whenever this standard is used for EHR communication. It is assumed that the original EHR data, if not already archetyped, may be mapped to a set of archetypes, if desired, when generating the EHR_EXTRACT. The Reference Model defined in ISO 13606-1 has attributes that can be used to specify the archetype to which any RECORD_COMPONENT within an EHR_EXTRACT conforms. The class RECORD_COMPONENT includes an attribute archetype_id to identify the archetype and node to which that RECORD_COMPONENT conforms. The meaning attribute, in the case of archetyped data, refers to the primary concept to which the corresponding archetype node relates. However, it should be noted that ISO 13606-1 does not require that archetypes be used to govern the hierarchy of RECORD_COMPONENTS within an EHR_EXTRACT; the archetype-related attributes are optional in that model. It is recognised that the international adoption of an archetype approach will be gradual, and may take some years. Archetype repositories The range of archetypes required within a shared EHR community will depend upon its range of clinical activities. The total set needed on a national basis is currently unknown, but there might eventually be several thousand archetypes globally. The ideal sources of knowledge for developing such archetype definitions will be clinical guidelines, care pathways, scientific publications and other embodiments of best practice. However, de facto sources of agreed clinical data structures might also include: the data schemata (models) of existing clinical systems; the lay-out of computer screen forms used by these systems for data entry and for the display of analyses performed; data-entry templates, pop-up lists and look-up tables used by these systems; shared-care data sets, messages and reports used locally and nationally; the structure of forms used for the documentation of clinical consultations or summaries within paper records; health information used in secondary data collections; the pre-coordinated terms in terminology systems. Despite this list of de facto ways in which clinical data structures are currently represented, these formats are very rarely interoperable. The use of standardized archetypes provides an interoperable way of representing and sharing these specifications, in support of consistent (good quality) health care record-keeping and the semantic interoperability of shared EHRs. The involvement of national health services, academic organizations and professional bodies in the development of archetypes will enable this approach to contribute to the pursuit of quality evidence-based clinical practice. The next key challenge is to foster communities to build up libraries of archetypes. It is beyond the scope of this part of ISO 13606 to assert how this work should be advanced, but, in several countries so far it would appear that national health programmes are beginning to organize clinical- informatics-vendor teams to develop and operationalize sets of archetypes to meet the needs of specific healthcare domains. In the future, regional or national public domain libraries of archetype definitions might be accessed via the Internet, and downloaded for local use within EHR systems. Such useage will also require processes to verify and certify the quality of shared archetypes, which are also beyond the scope of this part Copyright International Organization for Standardization Provided by IHS under license with ISO Licensee=Boeing Co/5910770001 Not for Resale, 01/31/2009 00:36:47 MSTNo reproduction or networking permitted without license from IHS -,-,- ISO 13606-2:2008(E) © ISO 2008 All rights reserved vii of ISO 13606 but are being taken forward by non-profit-making organizaitons such as the openEHR Foundation and the EuroRec Institute. Communicating archetypes This part of ISO 13606 specifies the requirements for a comprehensive and interoperable archetype representation, and defines the ODP Information Viewpoint representation for the Archetype Model and an optional archetype interchange format called Archetype Definition Language (ADL). This part of ISO 13606 does not require that a