ISO/TS 18864:2017
(Main)Health informatics — Quality metrics for detailed clinical models
Health informatics — Quality metrics for detailed clinical models
The purpose of ISO/TS 18864:2017 is to define objective, reliable and reproducible quality metrics for detailed clinical models (DCM). ISO/TS 18864:2017 specifies the principal metrics which are necessary and sufficient to evaluate DCMs. The intended audiences of this document are: - DCM developers, all users of information represented using DCMs, and evaluators of DCM quality; - clinical and IT professionals of healthcare institutions; - technical staff in the healthcare technology industry; - experts involved in standards development; - national and regional healthcare information technology leadership including certification bodies. ISO/TS 18864:2017 defines a set of quality metrics required to evaluate DCMs objectively. These quality metrics can be used to support rational decision making by DCM developers who will have the essential qualitative and quantitative quality requirements to use as guidelines as they create new content. Clinical users can then use the quantitative assessments as they select models for specific use cases and implement them in their clinical systems.
Informatique de santé — Indicateurs de qualité pour modèles cliniques détaillés
General Information
Standards Content (Sample)
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
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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
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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
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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
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