1、 Reference number ISO/TR 11487:2008(E) ISO 2008TECHNICAL REPORT ISO/TR 11487 First edition 2008-12-01 Health informatics Clinical stakeholder participation in the work of ISO TC 215 Informatique de sant Participation clinique du dpositaire dans les travaux du TC 215 ISO/TR 11487:2008(E) PDF disclaim
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6、r body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2008 All rights reservedISO/TR 11487:2008(E) ISO 2008 All rights reserved iiiForeword IS
7、O (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 co
8、mmittee 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 electro
9、technical 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 me
10、mber 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
11、(“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is entirely informative in nature and does not have to be reviewed until the data it provides are considered to be no longer valid or useful. Atte
12、ntion 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/TR 11487:2008(E) iv
13、ISO 2008 All rights reservedIntroduction According to the ISO Code of Ethics1 , 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 standardi
14、zation organizations) are expected to take “appropriate measures to facilitate the participation of consumers and other affected parties from civil society, SMEs and public authorities”. Objective 2 of ISO Strategic Plan 2005-20102specifically addresses actions that national members should be taking
15、 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 tas
16、k 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 nation
17、al members and improved harmonization with other international standards organizations. TECHNICAL REPORT ISO/TR 11487:2008(E) ISO 2008 All rights reserved 1Health informatics Clinical stakeholder participation in the work of ISO TC 215 1 Scope This Technical Report is structured around four review a
18、reas: 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. Stakehol
19、ders 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 delegat
20、es 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
21、: 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 definit
22、ions 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
23、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 statistica
24、l purposes (e.g. classifications), and to reduce duplication of effort and redundancies”. ISO/TR 11487:2008(E) 2 ISO 2008 All rights reserved2.2 clinician healthcare professional who delivers healthcare services directly to a patient/consumer ISO/TS 18308:2004, definition 3.12 2.3 clinical stakehold
25、er 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, therap
26、ist, 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
27、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 gover
28、nments; 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 h
29、ealth 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 s
30、upplier 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
31、 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 t
32、he 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
33、 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 wo
34、rk 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. ISO/TR 11487:2008(E) ISO 2008 All rights reserved 33.5 For TC 215 purposes, a distinction needs to be made between: clinica
35、l 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
36、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 parti
37、cipate regularly, they develop the necessary expertise to contribute informed views to the standards process, but regular participation and interest cannot be relied upon as a route for involving all clinical stakeholder groups. Other ways may need to be found of engaging clinicians and clinical sta
38、keholders more widely and in a more representative way, but it is important to balance the challenges of doing this with the benefits of such participation. 4 Potential benefits of clinical stakeholder participation 4.1 Input and feedback from clinical stakeholders could be of benefit in the develop
39、ment of any health informatics standard that will have an impact on clinical practice. Even the “standards for standards” that TC 215 most often produces require knowledge of clinical practice and could have an impact on clinical practice and patient safety. Therefore, both individual clinicians and
40、 clinical stakeholders should be involved in the development and review of health informatics standards at the international level and in testing at the local (national, state, provincial) level. 4.2 The requirement for clinical input will vary depending on the type of standard and the stage of the
41、standard lifecycle. Clinical knowledge, clinical risk assessment, up-to-date understanding of clinical processes and the realities of ICT use in different clinical environments may be beneficial at all stages, from requirement specification through to review/revision of an existing standard based on
42、 post-deployment experience. 4.3 The extent to which clinical stakeholders can help ensure the market relevance of health informatics standards is limited by the stakeholders understanding of the specific topic of the standard. This, in turn, is affected by the way in which information about interna
43、tional health informatics standards is generally communicated. For example, the International Pediatric Association might not be concerned to see an International Standard for vocabulary of terminology but would recognise the relevance of a standard to ensure the consistent capture of details about
44、the provenance of health information on the web. 4.4 Clinical stakeholders could have a greater role in promoting effective use of standards. Through active participation, representative organizations would better understand the importance of health informatics standards and use their influence to p
45、romote the adoption of appropriate standards by national and other health enterprises. Individual clinicians involved in international health informatics standards can also use their skills and knowledge in being mentor to roles and peer-to-peer networks to “spread the word” amongst their colleagues
46、 and enhance the circle of knowledge, understanding and adoption. 4.5 Overall, participation that helps ensure the quality of clinical aspects of international health informatics standards will have benefits in the longer term with respect to improvements in clinical efficiency, data capture and dat
47、a utilization, clinical decision-making, patient outcomes, etc. These benefits are of major concern to clinical stakeholders and the organizations that advance the science (and art) of the health care professions. ISO/TR 11487:2008(E) 4 ISO 2008 All rights reserved5 Current participation models 5.1
48、The member organization of ISO is the organization most broadly representative of standardization in each country. That organization is expected to organize national input “in a timely and effective manner taking into account all relevant interests at national level”. See Reference 1. 5.2 Countries
49、that participate in TC 215 organize their national input in different ways. The most common model seems to be: open participation of volunteers in national working groups from which one or more individuals are delegated to attend TC 215 meetings. Participants may be self-funding or receive some financial support from their employers or from the national standards organization. 5.3 Less common models include: participation through subscription of national working groups attendance at TC 215 meetings is restr
