ISO/TS 18864:2017

TECHNICAL ISO/TS
SPECIFICATION 18864
First edition
2017-11
Health informatics — Quality metrics
for detailed clinical models
Informatique de santé — Indicateurs de qualité pour modèles
cliniques détaillés
Reference number
©
ISO 2017
© ISO 2017, 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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 5
5 Relationship with other activities . 6
5.1 ISO/TS 13972 . 6
5.2 ISO 13606-2 . 6
5.3 EuroRec quality criteria for archetypes . 6
5.4 Delphi study . 6
6 The purpose and importance of DCM quality . 6
7 Quality aspect of DCMs . 7
8 DCM quality framework . 7
8.1 DCM quality framework component . 7
8.2 DCM Quality characteristics . 8
8.3 DCM Quality metrics . 8
8.4 Expected benefits of high quality DCMs . 9
9 Quality metrics for DCMs . 9
9.1 Design and development . 9
9.1.1 General. 9
9.1.2 Stakeholders participated in the development (or design) of DCM .10
9.1.3 Stakeholders participated in the verification/approval of DCM .10
9.1.4 Translations, only if applicable .10
9.1.5 Relationships .11
9.2 Per detailed clinical model .11
9.2.1 Compliance to standard .11
9.3 Metadata .13
9.3.1 DCM Version .13
9.3.2 Purpose of DCM .13
9.3.3 Appropriate description of application target patient or population of DCM .14
9.3.4 Description of multiple uses .14
9.3.5 Appropriate description of discipline of DCM user .15
9.3.6 DCM author(s) .15
9.3.7 Authoring date .15
9.3.8 Modification date .15
9.3.9 Initial review round date .16
9.3.10 Number of review rounds .16
9.3.11 Last review round date . .16
9.3.12 Status of content publication .17
9.3.13 Mention of reference(s) used in DCM development, only if applicable .17
9.4 Per data element .17
9.4.1 Valid value of DCM .17
9.4.2 Terminology binding .18
9.5 Governance .18
9.5.1 Maintenance organization of DCM .18
9.5.2 Existence of user feedback mechanism for DCM .18
9.5.3 Realm-specific specializations and extensions .19
9.5.4 Multiple outputs .19
9.5.5 Clinicians participated in the verification/validation of DCM for
determining customer satisfaction .19
Annex A (informative) Some published quality requirements and criteria for DCMs .21
Annex B (informative) Comparison of Detailed Clinical Modelling approach .24
Bibliography .28
iv © ISO 2017 – 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.
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 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).
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 Introduction 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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics.
Introduction
Normalization and formalization of evidence-based clinical data are fundamental requirements towards
enabling a high quality and safe healthcare system. Normalized data elements and clinical models can
help to ensure data consistency and comparability among users and systems, and formalized data
specifications can support the sharing of clinical knowledge among diverse jurisdictions with higher
efficiency and lower cost.
The goal of shareable, executable clinical guidelines is both worthwhile and challenging. One of the
greatest hurdles is that of representing the clinical information in a precise and shareable manner. The
Detailed Clinical Model (DCM) is an information model that is an essential part of the infrastructure
supporting the codification and standardization of evidence-based knowledge elements across
EHR systems. Each DCM is a logical model that shows the meaning, structure, possible content and
relationships between data elements for a given subject of EHR documentation. The coded elements
have explicit bindings to allowed coded values. Models are independent of any specific programming
language or type of database. DCMs support explicit, unambiguous query statements against data
instances. The DCM aids decision making by medical staff, and supports the valid reuse of medical data
for example for epidemiology, quality assurance and managerial goals.
The DCM for supporting evidence-based clinical practice is already in common use in the EHR systems of
some countries and regions. The Clinical Element Model of Intermountain Healthcare, templates defined
by HL7 International, archetypes defined by the openEHR Foundation and ISO 13606, the Clinical
Information Model in the Netherlands, and the Clinical Content Model by the Center for Interoperable
EHR in South Korea are examples of published DCM formalisms that can be used to organize the
clinical content of an EHR interoperability message and an EHR repository, share decision logic, and
build a data capture form of a clinical applica
...