1、 ISO 2015 Health informatics Principles and guidelines for the measurement of conformance in the implementation of terminological systems Informatique de sant Principes et lignes directrices pour le mesurage de la conformit dans la mise en oeuvre des systmes terminologiques TECHNICAL REPORT ISO/TR 1
2、2310 Reference number ISO/TR 12310:2015(E) First edition 2015-05-15 ISO/TR 12310:2015(E)ii ISO 2015 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise
3、 in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch.
4、de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org ISO/TR 12310:2015(E)Foreword v Introduction vi 1 Scope . 1 2 Objective 1 3 T erms and definitions . 1 4 Purposes for conformance . 3 4.1 Interoperability 4 4.2 Data ana
5、lysis . 4 4.3 Consistency of user experience 4 4.4 Application functionality 4 4.5 Acceptance filter 4 5 Conformance process 4 5.1 Documenting expectations . 4 5.1.1 Optionality . 5 6 Terminology artefact conformance considerations 6 6.1 Code system considerations 6 6.1.1 What is the code system bei
6、ng referenced? . 6 6.1.2 What version(s) of the code system are supported? 6 6.1.3 How are codes represented? . 7 6.1.4 What are the version migration expectations, if any? . 7 6.1.5 What is the authoritative source that will be used for processing updates to a given terminology? 7 6.1.6 What status
7、 must usable code system elements have? 8 6.1.7 Which codes and concepts are usable for what purpose? . 8 6.1.8 What representations are allowed for what purposes? . 8 6.1.9 What code system relationships must be understood and navigated?. 8 6.1.10 Are the semantics clearly defines? . 9 6.1.11 What
8、are the expectations for post-coordination? . 9 6.1.12 What partitions are included? 9 6.1.13 What code system supplements are supported? 10 6.2 Reference sets: sets of codes that are allowed 10 6.2.1 What code systems are drawn from? 10 6.2.2 How is the reference set defined? 10 6.2.3 Which represe
9、ntations are allowed from a code system?.11 6.2.4 What constraints are there on post-coordinated concepts? .11 6.2.5 What is post-coordinated vs. Pre-coordinated? .11 6.2.6 What happens if the concept exists more than once in the reference set? .11 6.3 Reference set bindings 11 6.3.1 Is the binding
10、to the reference set static or dynamic? 12 6.3.2 What reference set representation capabilities are supported? .12 6.3.3 Is the reference set extensible? 12 6.3.4 What expectation is there to support all codes within the bound reference set? 12 6.4 What is the reference set bound to? 13 6.5 When and
11、 where does the binding apply? .13 7 Terminology usage conformance considerations .13 7.1 Data capture .14 7.1.1 Are the code system contents expected to be exposed directly?.14 7.1.2 What aspects may be or must be exposed to users? 14 7.1.3 Are the available codes to be displayed in a particular or
12、der? .14 7.1.4 Are there constraints on how the codes are to be navigated? .14 7.1.5 Are deprecated, retired, or pending codes expected to be presented differently? .14 ISO 2015 All rights reserved iii Contents Page ISO/TR 12310:2015(E)7.1.6 Shall the reference set or version be captured? .14 7.1.7
13、Can external knowledge be applied to the selection of codes? .14 7.2 Data exchange .15 7.2.1 Identification of code systems .15 7.2.2 Identification of code system versions 15 7.2.3 Syntax for post-coordination15 7.2.4 Presence and representation of translations between code systems .16 7.2.5 Presen
14、ce of original text .16 7.2.6 Terminology specifications 16 7.3 Data analysis and searching .17 7.3.1 Are subsumed codes included? 17 7.3.2 What mathematical support is expected? .17 7.3.3 How are post-coordinated results handled? .17 7.3.4 How is cross code-system analysis managed? 17 7.3.5 Unknown
15、 data .18 8 Sharing and persisting conformance expectations .19 9 Asserting conformance .19 9.1 Conformance and non-conformance .19 9.2 Why conformance statements?20 9.3 What is conforming? .20 9.4 What is being conformed to? .20 9.5 Assumptions .21 9.6 Support for optional elements21 9.7 Variations
16、 22 9.8 Completeness 22 10 Evaluating conformance statements 23 11 Verifying conformance 23 11.1 What is verified? .23 11.2 Who verifies? .24 11.3 Can verification be automated? .24 12 Other considerations 24 12.1 Comparing conformance statements 24 12.2 Conformance with conflicting terminology spec
17、ifications 25 12.3 What IP considerations are associated with the code system? 25 12.4 Terminology services .25 Bibliography .27 iv ISO 2015 All rights reserved ISO/TR 12310:2015(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodi
18、es (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
19、, 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. The procedures used to develop this document and those intended for its further
20、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 drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
21、 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. Details of any patent rights identified during the development of the document will be in the Introd
22、uction 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 constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to c
23、onformity 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 information. The committee responsible for this document is ISO/TC 215, Health informatics. ISO 2015 All rights reserved v
24、ISO/TR 12310:2015(E) Introduction This work item is a Technical Report that will identify and discuss principles and guidelines for the measurement of conformance in the implementation of terminological systems, in particular, as applied to Electronic Health Record (EHR) systems. This item will leve
25、rage the current work under way in Canada and will be developed in liaison with International Health Terminology Standards Development Organization (IHTSDO) and the Vocabulary Committee of HL7 in the spirit of harmonization across organizations with similar interests. Additional terminology organiza
26、tions, active projects and existing expertise will be sought out for input into this work item. Conformance is a key step in helping stakeholders determine if implementations of terminology systems have been done in a correct and consistent manner, particularly as implemented in EHRs. Loose declarat
27、ions regarding terminological systems that cannot be tested with meaningful results do very little to support the end goal of the interoperable EHR. Therefore, the principles and guidelines for establishing and measuring conformance will focus on identifying the degrees of conformance of terminologi
28、cal systems with or without use in messaging standards. This Technical Report is intended to define what is meant by conformance with respect to terminology systems, particularly as applied to EHR systems, and it is expected to facilitate the formulation of policies and governance practices locally
29、or nationally. This Technical Report is timely as the emerging IHTSDO and progressive implementation of the EHR will lead to the increasing awareness of conformance with respect to terminologies and consistent implementations that allow interoperability by all end-users. The focus of this Technical
30、Report is to define best practices and a framework for establishing and measuring conformance. The scope of this Technical Report will include the identification of definitions and best practice considerations for what constitutes conformance to terminology systems and the principles for which confo
31、rmance can be demonstrated.vi ISO 2015 All rights reserved Health informatics Principles and guidelines for the measurement of conformance in the implementation of terminological systems 1 Scope The purpose of this Technical Report is to define a framework of good practices for terminology system ma
32、intenance and the principles for which conformance can be demonstrated. The primary focus is the application of terminology system to Electronic Health Record (EHR) systems, although the principles and guidelines can be applied broadly in health informatics The scope of this Technical Report will in
33、clude, at a minimum, the following considerations for keeping terminology systems and associated reference material clinically and/or technically relevant and valid: governance models and practices; high level processes; requirements for managing the change. The scope of this Technical Report will n
34、ot include a definition of the detailed processes for performing terminology maintenance. This Technical Report aims to define the framework of good practices for EHRs and systems regarding terminology maintenance within these systems. This Technical Report relates directly to the ability of these r
35、ecords to be safe and legally accurate records of healthcare in the environment of changing technologies related to the use of clinical terminologies to represent meaning within these systems. 2 Objective This Technical Report identifies considerations for the expression and evaluation of conformanc
36、e for solutions that make use of terminology. The specific focus of this Technical Report is terminology used in healthcare solutions. However, the principles should apply to solutions implementing terminology across the health industry. “Solutions” is interpreted broadly and includes both software
37、and hardware technical implementations, as well as other specifications that are based on or claim to adhere to all or part of the specification against which conformance is being assessed. Implementation in this Technical Report does not consider procedural or governance requirements. By using the
38、definitions and recommendations found here-in, standards bodies, implementers, and other parties can better achieve their objectives in the development and use of specifications that make use of terminologies and can better express their terminology capabilities. This Technical Report is intended to
39、 be independent of any particular terminology or terminological approach, though some portions of the guidance provided will only apply to certain types of terminologies. 3 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. NOTE Because “terminolog
40、y” is such a broad term, conformance actually needs to be stated in terms of the various terminology components that are referenced in a specification. These components will also be defined. TECHNICAL REPORT ISO/TR 12310:2015(E) ISO 2015 All rights reserved 1 ISO/TR 12310:2015(E) 3.1 conformance adh
41、erence of a system or specification to the expectations set by another specification Note 1 to entry: The general definition for conformance has changed over time and been refined for specific standards. In 1991, ISO/IEC 10641 defined conformance testing as “test to evaluate the adherence or non- ad
42、herence of a candidate implementation to a standard.” ISO/IEC/TR 13233 defined conformance and conformity as “fulfillment by a product, process or service of all relevant specified conformance requirements.” In recent years, the term conformity has gained international use and has generally replaced
43、 the term conformance in International Standards. Note 2 to entry: In 1996 ISO/IEC Guide 2 defined the following three major terms used in this field: conformity - fulfillment of a product, process, or service of specified requirements; conformity assessment - any activity concerned with determining
44、 directly or indirectly that relevant requirements are fulfilled; conformity testing - conformity evaluation by means of testing. 3.2 code system managed collection of concept representations (3.4) intended for use in persisting or sharing of information 3.3 concept single mental representation of s
45、ome real or abstract thing Note 1 to entry: Concepts should be unique within a code system (3.2). 3.4 concept representation mechanism by which the system can express a concept (3.3) Note 1 to entry: Different representations can serve different purposes. Most code systems (3.2) support multiple rep
46、resentations for each concept (3.3), sometimes even multiple representations of a given type. In some cases, distinct representations of a concept (3.3) may have their own identifier assigned within the code system (3.2) for maintenance and internal reference purposes. The types of representations a
47、re code (3.4.1), concept id (3.4.2), and concept designation (3.4.3). 3.4.1 code concept representation (3.4) intended for use when representing a concept (3.3) in a computable manner EXAMPLE Passing into a decision support tool or for use in data exchange. 3.4.2 concept id concept representation (3
48、.4) that is unique within the code system (3.2) and that is used internally by the code system (3.2) when referencing concepts (3.3) 3.4.3 concept designation human consumable representation of the concept (3.3) Note 1 to entry: A concept designation may or may not be a string of characters (could b
49、e multimedia); generally subject to language variants.2 ISO 2015 All rights reserved ISO/TR 12310:2015(E) 3.4.3.1 concept name concept designation (3.4.3) that is the unique designation of the concept (3.3) in the code system (3.2) and intended for human understanding Note 1 to entry: This is usually text but might also be graphical for some code systems (3.2). For example, images of different facial expressions for a code systems (3.2) representing pain scales. 3.5 code system partition result of dividing a code identifier namespace into
