Health informatics — Clinical stakeholder participation in the work of ISO TC 215

ISO/TR 11487:2008 is structured around four review areas: stakeholder groups concerned with the work of TC 215; potential benefits/outcomes of clinical stakeholder participation; current nature of stakeholder participation; recommendations for improving clinical stakeholder participation. The review is limited to clinical stakeholder groups. Stakeholders from industry, consumer groups and other non-clinical groups are outside the scope of this Technical Report as are the specific issues related to participation of clinical stakeholders in developing countries. The content of ISO/TR 11487:2008 is based on informal consultation among delegates attending TC 215 meetings and e-mail communication with interested individuals. Opportunities to comment on the draft report were provided prior to and during the 2007 Montreal plenary meeting in accordance with the TC Resolution at 2006 Jeju plenary. The purposes of ISO/TR 11487:2008 are: to clarify and confirm TC 215 support for clinical stakeholder participation; to make recommendations to the TC and to national member organizations on approaches to improving clinical stakeholder participation based on examples of existing effective participation models.

Informatique de santé — Participation clinique du dépositaire dans les travaux du TC 215

General Information

Status
Published
Publication Date
16-Nov-2008
Current Stage
6060 - International Standard published
Due Date
26-Sep-2010
Completion Date
17-Nov-2008
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ISO/TR 11487:2008 - Health informatics -- Clinical stakeholder participation in the work of ISO TC 215
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TECHNICAL ISO/TR
REPORT 11487
First edition
2008-12-01

Health informatics — Clinical stakeholder
participation in the work of ISO TC 215
Informatique de santé — Participation clinique du dépositaire dans les
travaux du TC 215




Reference number
ISO/TR 11487:2008(E)
©
ISO 2008

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ISO/TR 11487:2008(E)
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ii © ISO 2008 – All rights reserved

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ISO/TR 11487:2008(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
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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 11487 was prepared by Technical Committee ISO/TC 215, Health informatics.
© ISO 2008 – All rights reserved iii

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ISO/TR 11487:2008(E)
Introduction
[1]
According to the ISO Code of Ethics , the development of International Standards is a consensus-based
process that relies on “the contributions of the relevant experts and the participation of the concerned
stakeholders”. ISO members (i.e. national standardization organizations) are expected to take “appropriate
measures to facilitate the participation of consumers and other affected parties from civil society, SMEs and
[2]
public authorities”. Objective 2 of ISO Strategic Plan 2005-2010 specifically addresses actions that national
members should be taking to ensure the involvement of stakeholders. Stakeholder participation is seen as key
to both the market relevance and effective use of standards. See Reference [3].
Building on an initial enquiry into the participation of nursing experts and stakeholders in the work of TC 215, a
multi-disciplinary task force was formed to review clinical stakeholder participation in TC 215 in broader and
more general terms. This review is undertaken in the context of increasingly widespread deployment of health
information technologies, renewed demands on TC 215 to respond rapidly to the business needs of national
members and improved harmonization with other international standards organizations.

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TECHNICAL REPORT ISO/TR 11487:2008(E)

Health informatics — Clinical stakeholder participation in the
work of ISO TC 215
1 Scope
This Technical Report is structured around four review areas:
⎯ stakeholder groups concerned with the work of TC 215;
⎯ potential benefits/outcomes of clinical stakeholder participation;
⎯ current nature of stakeholder participation;
⎯ recommendations for improving clinical stakeholder participation.
The review is limited to clinical stakeholder groups. Stakeholders from industry, consumer groups and other
non-clinical groups are outside the scope of this Technical Report, as are the specific issues related to
participation of clinical stakeholders in developing countries.
The content of this Technical Report is based on informal consultation among delegates attending TC 215
meetings and e-mail communication with interested individuals. Opportunities to comment on the draft report
were provided prior to and during the 2007 Montreal plenary meeting in accordance with the TC Resolution at
the 2006 Jeju plenary.
The purposes of this Technical Report are:
a) to clarify and confirm TC 215 support for clinical stakeholder participation;
b) to make recommendations to the TC and to national member organizations on approaches to improving
clinical stakeholder participation based on examples of existing effective participation models.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
TC 215 stakeholder
person, group or organization with a legitimate interest in the activities and outputs of TC 215; those who will
direct the use of the standards and those who will use or be affected by the use of the standards
NOTE The scope of TC 215 is “Standardization in the field of information for health, and Health Information and
Communications Technology (ICT) to achieve compatibility and interoperability between independent systems. Also, to
ensure compatibility of data for comparative statistical purposes (e.g. classifications), and to reduce duplication of effort
and redundancies”.
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ISO/TR 11487:2008(E)
2.2
clinician
healthcare professional who delivers healthcare services directly to a patient/consumer
[ISO/TS 18308:2004, definition 3.12]
2.3
clinical stakeholder
representative of a health care professional organization (see 3.3)
2.4
health care professional
person authorized by a nationally-defined mechanism to be involved in the direct provision of certain health
care activities
[EN 13940-1]
EXAMPLE General medical practitioner, medical consultant, therapist, dentist, nurse, social worker, radiographer.
3 TC 215 stakeholders
3.1 Those developing consensus-based standards in the field of health informatics should solicit and take
account of the views of those who will use the standards or be affected by their use, i.e. the stakeholders. The
preamble to each standard normally includes a list of target groups for the standard. The target group will
depend on the scope and purpose of the specific standard, but examples include:
⎯ developers of other health informatics standards;
⎯ developers and purchasers of health information systems;
⎯ national governments;
⎯ clinical work flow experts;
⎯ end users of health information systems such as health care professionals and teams, health care
funding organizations, managers, subjects of care (patients, clients) and health care provider
organizations.
3.2 TC 215 needs the active participation of experts in health informatics standards and in related general
standards; e.g. standards for devices in general and standards for terminology in general. The work also
requires understanding of evolving information and communication technologies related to healthcare, i.e. the
expectations and feedback of the supplier community need to be captured. Health informatics standards must
be responsive to evolving health service policy and management, i.e. the “business” requirements for health
informatics standards must be captured and feedback obtained from policymakers, health care providers and
purchasers of health information systems.
3.3 Individual end users of health information systems would not generally be directly involved in the
development and review of health informatics standards. Clinical participation for many enterprises is usually
sought through representative organizations for each of the professional disciplines. For the purposes of this
Technical Report, clinical stakeholders equate to representatives of health care professional organizations. At
the international level, membership of such organizations is usually made up of national organizations, for
example, the International Pediatric Association comprises national pediatric associations of many countries.
3.4 At present, individual clinicians may participate in the work of TC 215 but generally do so as experts in
health informatics standards or health informatics, bringing their specific clinical expertise into the work when
relevant. They may “speak as” a clinician (with acknowledgement of the currency of their clinical expertise) but
they do not “speak for” a specific clinical discipline.
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ISO/TR 11487:2008(E)
3.5 For TC 215 purposes, a distinction needs to be made between:
⎯ clinical experts/clinical workflow experts who may or may not have health informatics expertise;
⎯ health informatics standards experts with clinical backgrounds who may or may not have current clinical
expertise;
⎯ clinical stakeholders, who are representatives from health care professional organizations who may or
may not have health informatics expertise.
3.6 The complex nature of most health informatics standards at the international level means that even
clinicians with health informatics expertise can find standards development and review challenging. If
clinicians develop an interest and can participate regularly, they develop the necessary expertise to contribu
...

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