1、 Reference number ISO/TR 12309:2009(E) ISO 2009TECHNICAL REPORT ISO/TR 12309 First edition 2009-12-15 Health informatics Guidelines for terminology development organizations Informatique de sant Lignes directrices pour tablir une normalisation de la terminologie internationale des soins de sant ISO/
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7、ights reserved iiiForeword 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 sub
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12、 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 informat
13、ics. ISO/TR 12309:2009(E) iv ISO 2009 All rights reservedIntroduction 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
14、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 Inte
15、rnational 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 developme
16、nt 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 i
17、t 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
18、. 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
19、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 s
20、upport. TECHNICAL REPORT ISO/TR 12309:2009(E) ISO 2009 All rights reserved 1Health 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
21、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
22、 standardization. It complements standards such as ISO 17115 1and ISO 17117 2(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 str
23、uctures 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 prov
24、ided 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 example related to ISO 9000 standards 3for management systems. However, there is little experience specific
25、 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 s
26、tandards 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
27、 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 informati
28、cs context the term “standard” can also refer to specifications, implementation guides, code sets, terminologies, integration profiles and other artefacts. See reference 4. ISO/TR 12309:2009(E) 2 ISO 2009 All rights reserved3.2 International Standard standard that is adopted by an international stan
29、dardizing/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 st
30、andard 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 healthc
31、are 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
32、 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 Prin
33、ciples 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”, se
34、e 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
35、 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 sh
36、ould be capable of supporting unbiased decisions that take account of the inputs of all stakeholders. ISO/TR 12309:2009(E) ISO 2009 All rights reserved 3It should support open and effective editorial processes, balancing the requirements of existing users of the standard with responsiveness to devel
37、opments in technology and healthcare. The overriding principle for editorial decision-making and for evaluation of healthcare terminologies should be patient safety. Governance and all activities of the organization should include a broad representation from all concerned stakeholders, for example:
38、clinicians and providers or their representative organizations; vendors that develop, market, install and support health IT products or their representative organization; healthcare purchasers or employers or their representative organization; healthcare payers or health insurance companies or their
39、 representative organization; healthcare consumers or their representative organization; clinical and health services researchers or their representative organization. The organization should consider the benefits of conformance to ISO 9000 standards 3for its management systems. Decisions should inc
40、lude due process so that all views are considered and a dispute resolution process exists. An identifiable, realistic, impartial and readily available appeals process should exist, with appeals addressed promptly and fairly. Decisions should respond to regulatory and market needs, as well as scienti
41、fic and technological developments and should be reached through consensus among those affected. Total costs of implementation by users of the standard should also be considered in decision-making, for example the cost of implementing a change to the distribution format. Developers of terminologies
42、that are intended as International Standards need to consider the conceptual and language differences within and among countries; processes for consultation and negotiation are required for conceptual/cultural harmonization to support translation. 4.2.2 Openness and transparency Essential informatio
43、n regarding governance, activities and decisions of the organization should be accessible to all stakeholders in a timely manner. Participation in editorial policy processes should be open to all affected interests and there should be no undue financial barriers to participation. This participation
44、should include but is not limited to: input from content experts relevant to scope and purpose of the terminology; appropriate review by “customers” to reconcile well-recognised tensions between logical rigour and clinical utility without compromising either; vendors to vet implementation feasibilit
45、y; authoritative review by native speakers and users of translations and language variants (including dialects and languages) with quality control to ensure consistent concept representation across human language variants. Formal published procedures should govern the approach to development and app
46、roval of the standard. There should be published mechanisms for wide dissemination of materials for consultation, testing and review. 4.2.3 Impartiality and balance No one interest, individual or organization should unduly dominate the development process or be favoured over another. Participants fr
47、om all affected interests should be sought with the aim of achieving balance in the consensus process. ISO/TR 12309:2009(E) 4 ISO 2009 All rights reserved4.2.4 Sustainability and responsiveness The financial viability and long-term sustainability of the organization need to be assured. It should dem
48、onstrate adequate funding sources to maintain the standard. Although legitimate costs can be recovered, no individual or organization should profit from contribution to the development or ongoing support of the terminology. There should be no reliance on proprietary systems in the development, maint
49、enance and distribution process if the viability and responsiveness of these cannot also be assured. An easily accessed, open and flexible mechanism should be in place to respond to stakeholder requirements in a timely manner, for example to identify and incorporate new content or increase the frequency of updates. This mechanism should include version control and issue change notices as well as guidance for users on managing changes in their systems. The organization should demonstrate that the terminology has bee
