ISO/TR 12309:2009

TECHNICAL ISO/TR
REPORT 12309
First edition
2009-12-15

Health informatics — Guidelines for
terminology development organizations
Informatique de santé — Lignes directrices pour établir une
normalisation de la terminologie internationale des soins de santé




Reference number
ISO/TR 12309:2009(E)
©
ISO 2009

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ISO/TR 12309:2009(E)
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ISO/TR 12309:2009(E)
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.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no
longer valid or useful.
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/TR 12309 was prepared by Technical Committee ISO/TC 215, Health informatics.
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ISO/TR 12309:2009(E)
Introduction
Healthcare terminological systems (terminologies) are developed to support accurate representation,
communication and analysis of information about the healthcare of individuals and populations. The
development and maintenance of healthcare terminologies require a robust and sustainable infrastructure and
processes so that safe and consistent representation and interpretation of data and information can be
supported over time.
Those wishing to use a specific terminological system (terminology), adopt it as a national or International
Standard or incorporate it into other International Standards, need assurance that the required infrastructure,
policies and processes are in place. This Technical Report gives a non-exhaustive list of principles and high-
level processes that should be exhibited by a terminology development organization (hereafter referred to as
organization in order to distinguish it from other kinds of organization) if it is to provide this assurance and
support international healthcare terminology standardization.
Terminology standardization in general differs from other standardization in that it should address the
language and cultural differences inherent in terminology itself. Standardization related to healthcare
terminologies differs significantly from many other International Standards activities because of the technical
nature of the content and the rapid versioning that is required. Specifically, terminologies often require a highly
responsive organization that can accommodate the complex harmonization of nuanced “concepts”, while
maintaining longitudinal consistency and utility. Furthermore, terminologies often form the foundation of many
dependent systems, applications and operations, and thus should achieve a reliability and rigour coupled with
availability and dissemination that are not always required of other standards. A “safety-critical” example is the
use of terminologies in healthcare decision support systems such as drug interaction warnings for prescribing
support.

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TECHNICAL REPORT ISO/TR 12309:2009(E)

Health informatics — Guidelines for terminology development
organizations
1 Scope
1.1 Main purpose
This Technical Report specifies principles and processes that should be exhibited by developers of healthcare
terminologies in support of international healthcare terminology standardization. The primary target group for
this Technical Report is those establishing or reviewing organizations, and those evaluating the services or
products maintained by such organizations, in the context of international healthcare terminology
[1] [2]
standardization. It complements standards such as ISO 17115 and ISO 17117 (which address the
content of terminologies) by specifying good governance requirements for the lifecycle of those terminologies.
1.2 Topics considered outside the scope
Detailed specifications of appropriate governance structures and how organizations should undertake good
governance are outside the scope of this Technical Report, which is limited to high-level principles and
processes. Standards and guidance for the development, identification, maintenance and evaluation of
healthcare terminological systems are provided elsewhere and are therefore outside the scope of this
Technical Report.
2 Conformance
There is considerable literature on standards conformance assessment of organizations in general, for
[3]
example related to ISO 9000 standards for management systems. However, there is little experience
specific to the domain of health informatics. One exception is the HITSP Standards Harmonization Committee,
which uses a four-point scoring system against performance criteria relevant to its “preferred standards
developer organization and process”. See reference [4]. Those evaluating healthcare terminology standards
development organizations could consider using such a scoring system to demonstrate conformance to the
subclauses in Clause 4 of this Technical Report.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
standard
document, established by consensus and approved by a recognised body, that provides, for common and
repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the
optimum degree of order in a given context
[ISO/IEC Guide 2:2004, definition 3.2]
NOTE In the health informatics context the term “standard” can also refer to specifications, implementation guides,
code sets, terminologies, integration profiles and other artefacts. See reference [4].
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ISO/TR 12309:2009(E)
3.2
International Standard
standard that is adopted by an international standardizing/standards organization and made available to the
public
[ISO/IEC Guide 2:2004, definition 3.2.1.1]
NOTE An International Standard is one that has been drafted in accordance with the rules given in the
ISO/IEC Directives, Part 2 and published by ISO. An artefact adopted as an international standard by an international
organization might not be an International Standard.
3.3
healthcare terminological system
healthcare terminology
set of designations within the domain of healthcare, with, where appropriate, any associated rules,
relationships and definitions
3.4
standardization of healthcare terminology
official adoption of a healthcare terminology by an authoritative body, for a specific purpose
EXAMPLE The official adoption of the International Classification of Functioning (ICF) as a data entry standard by
the health department of a country.
3.5
standards development organization
body that is recognised at national, regional or international level, that has as a principal function, by virtue of
its statutes, the preparation, maintenance and publication of standards that are made generally available
4 Healthcare terminology standardization: organizations and process
4.1 Principles
ISO members are committed to voluntary standards development: “a transparent, consensus-based process
relying on the contributions of concerned stakeholders”. Members are required to “ensure fair and responsive
application of the principles:
⎯ due process
⎯ transparency
⎯ openness
⎯ impartiality”, see reference [6].
These principles are extended in the context of healthcare terminology standardization to meet the specific
requirements of the domain, including: responsiveness, balance of interests, willingness to collaborate,
sustainability, clear accountability boundaries, utility and safety.
4.2 Application in healthcare terminology standards development organizations
4.2.1 Governance and due process
The organization should have a governance structure that focuses on responsible stewardship of the
standard(s) and responsiveness to all stakeholders within its defined scope. The structure should be capable
of supporting unbiased decisions that take account of the inputs of all stakeholders.
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ISO/TR 12309:2009(E)
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