1、DRAFT FOR DEVELOPMENT DD ISO/TS 17117:2002 Health informatics Controlled health terminology Structure and high-level indicators ICS 01.040.35; 35.240.80 DD ISO/TS 17117:2002 This Draft for Development, having been prepared under the direction of the DISC Board, was published under the authority of t
2、he Standards Policy and Strategy Committee on 10 October 2002 BSI 10 October 2002 ISBN 0 580 40541 9 National foreword This Draft for Development reproduces verbatim ISO/TS 17117:2002 This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series
3、 of publications and is of a provisional nature because of the limited duration of the International Technical Specification. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. Comments arising from the use of this Draft f
4、or Development are requested so that UK experience can be reported to the international organization responsible for the Technical Specification. A review of this publication will be initiated not later than 3 years after its publication by the international organization so that a decision can be ta
5、ken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to suppor
6、t the conversion into an international standard, to extend the life of the Technical Specification for another 3 years or to withdraw it. Comments should be sent in writing to the Secretary of BSI Technical Committee IST/35, Health informatics, at BSI Standards House, at 389 Chiswick High Road, Lond
7、on W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international publi
8、cations referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. Summary of pages This document comprises a front cover,
9、an inside front cover, the ISO/TS title page, pages ii to v, a blank page, pages 1 to 24, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments Reference number
10、ISO/TS 17117:2002(E)TECHNICAL SPECIFICATION ISO/TS 17117 First edition 2002-02-15 Health informatics Controlled health terminology Structure and high-level indicators Informatique de sant Terminologie contrle relative la sant Structure et indicateurs de haut niveau DDISO/TS17117:2002DDISO/TS17117:20
11、02iiIS/OTS :71171(2002)E I SO 2002 All irthgs ersedevr iiiContents Page Foreword.iv Introduction.v 1 Scope 1 2 Normative references1 3 Terms and definitions .2 4 General3 4.1 Basics .3 4.2 Concept orientation.3 4.3 Purpose and scope4 4.4 Mapping 4 4.5 Systematic definitions.4 4.6 Formal definitions4
12、 4.7 Explicitness of relations .5 4.8 Reference terminologies.5 4.9 Atomic reference terminologies.5 4.10 Colloquial terminologies.5 5 Structure of the terminology model.5 5.1 Terminology structures.5 5.2 Compositional terminologies .5 6 Maintenance .8 6.1 Basics .8 7 Evaluation.9 7.1 Basics .9 Anne
13、x A (informative) History of classification .14 Annex B (normative) Principles for implementation .15 Bibliography23 DDISO/TS17117:2002iiiIS/OTS :71171(2002)E vi I SO 2002 All irthgs ersedevrForeword ISO (the International Organization for Standardization) is a worldwide federation of national stand
14、ards 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 orga
15、nizations, 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
16、in the ISO/IEC Directives, Part 3. 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
17、% of the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between
18、technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for public
19、ation if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years with a view to deciding whether it should be confirmed for a further three years, revised to become an International Standard, or withdrawn. In the case of a confirmed IS
20、O/PAS or ISO/TS, it is reviewed again after six years at which time it has to be either transposed into an International Standard or withdrawn. Attention is drawn to the possibility that some of the elements of this Technical Specification may be the subject of patent rights. ISO shall not be held r
21、esponsible for identifying any or all such patent rights. ISO/TS 17117 was prepared by Technical Committee ISO/TC 215, Health informatics. Annex B forms a normative part of this Technical Specification. Annex A is for information only. DDISO/TS17117:2002ivIS/OTS :71171(2002)E I SO 2002 All irthgs er
22、sedevr vIntroduction In 1839, William Farr stated in his First Annual Report of the Registrar-General of Births, Deaths and Marriages in England, “The nomenclature is of as much importance in this department of inquiry, as weights and measures in the physical sciences, and should be settled without
23、delay.” Since that time, this theme has been heard resounding from an increasingly large group of scientists (see Annex A). Today, the need for controlled terminologies to support health record systems has been widely recognized (E-1238, E-1239, E-1384, E-1633, ENV 12017). Controlled terminologies p
24、rovide systems with the means to aggregate data. This aggregation of data can be carried out at multiple levels of granularity and therefore can enhance the clinical retrieval of a problem-oriented record, data pertaining to a classification for billing purposes, or outcomes data for a given populat
25、ion. Maintenance of large-scale terminologies has become a burdensome problem, as the size of term sets has escalated. Without a well-structured backbone, large-scale terminologies cannot scale to provide the level of interoperability required by todays complex electronic health record applications.
26、 The solution rests with standards 7 . Over the past ten or more years, medical informatics researchers have been studying controlled terminology issues directly. They have examined the structure and content of existing terminologies to determine why they seem unsuitable for particular needs, and th
27、ey have proposed solutions. In some cases, proposed solutions have been carried forward into practice and new experience has been gained. 8As we have entered the twenty-first century, it seems appropriate to pause to reflect on this experience, and to publish a standard set of goals for the developm
28、ent of comparable, reusable, multipurpose and maintainable controlled health terminologies (ISO 12200, ISO 12620). This Technical Specification is the first deliverable for the ISO/TC 215 Health informatics, Working group 3, Health concept representation, that is also working on an International Sta
29、ndard to be the basis for future standards in this area. It will serve as a guide for governments, funding agencies, terminology developers, terminology integration organizations and the purchasers and users of controlled health terminology systems toward improved terminological development and reco
30、gnition of value in a controlled health terminology. This ISO/TS 17117 on quality indicators of controlled health terminologies is based on previous work in ASTM that naturally could not be harmonized with ISO work already in progress. The present work is therefore published as a Technical Specifica
31、tion at this time with the intent to revise it to be compatible with the planned basic terminology standard and converted to a full International Standard after a maximum of three years. DDISO/TS17117:2002vTECINHCAICEPS LFICATION IS/OTS :71171(2002)EI SO 2002 All irthgs ersedevr 1Health informatics
32、Controlled health terminology Structure and high-level indicators 1 Scope This Technical Specification specifies the principal ideas which are necessary and sufficient to assign value to a controlled health terminology. It is applicable to all areas of healthcare about which information is kept or u
33、tilized. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this Technical Specification. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties
34、 to agreements based on this Technical Specification are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintai
35、n registers of currently valid International Standards. ISO 704, Terminology work Principles and methods ISO 860, Terminology work Harmonization of concepts and terms ISO 1087-1, Terminology work Vocabulary Part 1: Theory and application ISO 1087-2, Terminology work Vocabulary Part 2: Computer appli
36、cations ISO/IEC 11179-3, Information technology Specification and standardization of data elements Part 3: Basic attributes of data elements ISO 12620, Computer applications in terminology Data categories ISO/IEC 2382-4, Information technology Vocabulary Part 4: Organization of data ISO/IEC/TR 9789,
37、 Information technology Guidelines for the organization and representation of data elements for data interchange Coding methods and principles E-1284, Standard Guide for Construction of a Clinical Nomenclature for Support of Electronic Health Records E-1712, Standard Specification for Representing C
38、linical Laboratory Test and Analyte Names ENV 12264, Health Informatics Categorical Structures of Systems of Concepts Model for Representation of Semantics DDISO/TS17117:20021IS/OTS :71171(2002)E 2 I SO 2002 All irthgs ersedevr3 Terms and definitions For the purposes of this Technical Specification,
39、 the following terms and definitions apply. 3.1 terminology set of terms representing a system of concepts within a specified domain NOTE This implies a published purpose and scope from which one can determine the degree to which this representation adequately covers the domain specified. 3.2 contro
40、lled health terminology set of terms intended for clinical use NOTE This implies enough content and structure to provide a representation capable of encoding comparable data, at a granularity consistent with that generated by the practice within the domain being represented, within the purpose and s
41、cope of the terminology. 3.3 classification terminology which aggregates data at a prescribed level of abstraction for a particular domain NOTE 1 This fixing of the level of abstraction that can be expressed using the classification system is often done to enhance consistency when the classification
42、 is to be applied across a diverse user group, such as is the case with some of the current billing classification schemes. NOTE 2 See Annex A for the history of classification. 3.4 ontology organization of concepts for which a rational argument can be made EXAMPLE A hierarchy of qualifiers would be
43、 a qualifier ontology. NOTE Colloquially, this term is used to describe a hierarchy constructed for a specific purpose. 3.5 qualifier string which, when added to a term, changes the meaning of the term in a temporal or administrative sense EXAMPLES “History of ” or “recurrent”. 3.6 modifier string w
44、hich, when added to a term, changes the meaning of the term in the clinical sense EXAMPLES “Clinical stage” or “severity of illness”. 3.7 canonical term preferred atomic or pre-coordinated term for a particular medical concept 3.8 term word or words corresponding to one or more concepts DDISO/TS1711
45、7:20022IS/OTS :71171(2002)E I SO 2002 All irthgs ersedevr 34 General 4.1 Basics The basic characteristics of a terminology influence its utility and appropriateness in clinical applications. Terminologies should be evaluated within the context of their stated scope and purpose and are intended to co
46、mplement and utilize those notions already identified by other national and international standards bodies. This Technical Specification explicitly refers only to terminologies that are primarily designed to be used for clinical concept representation or to the aspect of a terminology designed to be
47、 used for clinical concept representation. This Technical Specification will also provide terminology developers and authors with the quality guidelines needed to construct useful and maintainable controlled health terminologies. These tenets do not attempt to specify all the richness which can be i
48、ncorporated into a health terminology. However, this Technical Specification does specify the minimal requirements, which, if not adhered to, will assure that the terminology will have only limited generalizability and will be very difficult, if not impossible, to maintain. Terminologies which do no
49、t currently meet these criteria, can be in compliance with this Technical Specification by putting in place mechanisms to move toward these goals. Principles for implementation are specified in Annex B. This Technical Specification will provide terminology developers with a sturdy starting point for the development of controlled health terminologies. This foundation serves as the basis from which terminology developers will build r
