ISO/TR 12310:2015

Health informatics — Principles and guidelines for the measurement of conformance in the implementation of terminological systems

ISO/TR 12310:2015 is to define a framework of good practices for terminology system maintenance 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 ISO/TR 12310:2015 will include, 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.

Informatique de santé — Principes et lignes directrices pour le mesurage de la conformité dans la mise en oeuvre des systèmes terminologiques

General Information

• Status: Published
• Publication Date: 21-May-2015
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 3 - Semantic content
• Current Stage: 6060 - International Standard published
• Start Date: 22-May-2015
• Completion Date: 19-Apr-2025

Standards Content (Sample)

TECHNICAL ISO/TR
REPORT 12310
First edition
2015-05-15
Health informatics — Principles and
guidelines for the measurement of
conformance in the implementation of
terminological systems
Informatique de santé — Principes et lignes directrices pour le
mesurage de la conformité dans la mise en oeuvre des systèmes
terminologiques
Reference number
©
ISO 2015
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise 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 ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Objective . 1
3 Terms and definitions . 1
4 Purposes for conformance . 3
4.1 Interoperability . 4
4.2 Data analysis . 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 being 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 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 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 representations 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 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 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 order? .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
7.1.6 Shall the reference set or version be captured? .14
7.1.7 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-coordination.15
7.2.4 Presence and representation of translations between code systems .16
7.2.5 Presence 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 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 elements.21
9.7 Variations .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 .
...