EN 1068-2005 en Health informatics - Registration of coding systems《健康信息学 编码系统的注册》.pdf

1、BRITISH STANDARD BS EN 1068:2005 Health informatics Registration of coding systems The European Standard EN 1068:2005 has the status of a British Standard ICS 11.020; 35.240.01 BS EN 1068:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 8

2、 July 2005 BSI 8 July 2005 ISBN 0 580 46275 7 National foreword This British Standard is the official English language version of EN 1068:2005. The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics, which has the responsibility to: A list of organiza

3、tions represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspond

4、ence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of it

5、self confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and

6、 promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 22, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since

7、 publication Amd. No. Date CommentsEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMEN 1068 June 2005 ICS 11.020; 35.240.01 Supersedes ENV 1068:1993 English version Health informatics - Registration of coding systems Informatique de sant - Enregistrement des systmes de codage Medizinische Informatik

8、 - Registrierung von Kodierungsschemata This European Standard was approved by CEN on 17 April 2005. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up

9、-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation und

10、er the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ic

11、eland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassa

12、rt, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1068:2005: EEN 1068:2005 (E) 2 Contents Page Foreword 3 Introduction4 1 Scope .5 2 Normative References 5 3 Terms, definitions and abbreviations5 4 Identif

13、ication of health coding systems 8 5 User agreements.9 6 The Registration Authority.9 7 The Register of Health Coding Systems .9 8 Submitting Organisations 11 9 Responsible Organisations12 10 Disputes.14 Annex A (normative) Specification of the Health Coding System Designator.15 Annex B (informative

14、) Illustration of terms used in this document16 Annex C (informative) Multiple registrations of health coding systems 17 Annex D (informative) Version control and changes to coding systems.19 Bibliography.21 Alphabetical Index .22EN 1068:2005 (E) 3 Foreword This European Standard (EN 1068:2005) has

15、been prepared by Technical Committee CEN /TC 251, “ Health Informatics“, the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2005, and conflicting nat

16、ional standards shall be withdrawn at the latest by December 2005. This European Standard supersedes ENV 1068:1993. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cypr

17、us, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 1068:2005 (E) 4 Introduction The increased use

18、of data processing and telecommunications capabilities has made possible the interchange of information in machine readable and machine processable formats. As automated interchange of information in health increases it is essential to provide the appropriate information interchange standards. Repre

19、sentation of information in coded form facilitates its processing by computer and enables it to be expressed with a precision and independence from language that may be difficult to achieve in other forms. Coded representation is therefore frequently used in information interchange for all types of

20、application. There are many coding systems in use in health. In the development of this European Standard it was recognised that immediate international adoption of a single coding system for each type of health information is impracticable. Therefore, when interchanging information, it is necessary

21、 to identify unambiguously the coding systems used for its representation. This European Standard recognises existing coding systems and provides a means for using them in a uniform way in health information interchange. It allows an occurrence of health information to be represented by more than on

22、e coding system. However the registration procedure is also intended to discourage the unnecessary proliferation of coding systems used for the interchange of health information. The use of the procedures in this European Standard will: a) facilitate the representation of health information in coded

23、 form for all purposes; b) reduce the potential ambiguity of information in coded form; c) reduce the need for human intervention in information interchange between applications; d) diminish the time required for the introduction of information interchange agreements; e) provide independence from la

24、nguage; f) in consequence of the foregoing, reduce the cost of information interchange. It has been produced by the European Body because, to date, there has been no successful implementation of an International Standard addressing the same needs, while it is urgently required to facilitate informat

25、ion interchange in health within Europe. It is nevertheless recognised that the subject is a matter for world-wide co-operation. This European Standard has therefore been written in conformance with the ISO/IEC Directives and every attempt has been made to avoid introducing regional bias. In the sit

26、uation resulting from the instatement of ISO/IEC 11179-6, this European Standard should be considered as providing a mean for a sectorial for health , and regional at least for Europe implementation of the International Standard. As a consequence, the Registration Authority meant by this European St

27、andard should eventually refer to the Central Registration Authority planned in the International Standard. As per this European Standard, a comprehensive international register of health coding systems will be created and will be made available to all those who may benefit from the information it c

28、ontains. It might also occur that organisations outside Europe submit health coding systems for registration in accordance with it. The role to be played by the Registration Authority as per this European Standard, (referred to in Clause 6, and elsewhere in this European Standard), and its basic rul

29、es of procedure, are the subject for a separate supporting document (“Health Informatics Health Information Interchange Registration of Coding Systems The Registration Authority“). EN 1068:2005 (E) 5 1 Scope This European Standard specifies a procedure for the registration of coding systems used in

30、health for any purpose. It also specifies the allocation of a unique Health Coding System Designator to each registered coding system. A code value can thus be given an unambiguous meaning by association with a HCD. The method by which a HCD and a code value are associated is not defined by this Eur

31、opean Standard. The association is achieved in any manner appropriate to the syntax used. This European Standard does not specify the coding systems to be used in health, give guidance on their selection nor describe methods of representing information in coded form. Coding systems maintained by dif

32、ferent Responsible Organisations may also be used in combinations. Such combinations can be considered as templates, and as such they lie outside the scope of the current document. 2 Normative References The following referenced documents are indispensable for the application of this document. For d

33、ated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO/IEC 6523-1:1999 Information technology - Structure for the identification of organizations and organization parts ISO/IEC 11179-6:2005 Inform

34、ation Technology Metadata registries (MDR) Part 6: Registration 3 Terms, definitions and abbreviations For the purposes of this European Standard, the following terms and definitions apply: 3.1 bit; binary digit either of the digits 0 or 1 when used in the pure binary numeration system ISO/IEC 2382-

35、4:1999 3.2 character member of a set of elements that is used for the representation, organisation or control of data ISO/IEC 2382- 4:1999 EN 1068:2005 (E) 6 3.3 character set finite set of different characters that is complete for a given purpose ISO/IEC 2382-4:1999 3.4 coded set set of elements wh

36、ich is mapped on to another set according to a coding scheme ISO/IEC 2382-4:1999 3.5 code meaning element within a coded set EXAMPLE: “Paris Charles-De-Gaulle“ which is mapped on to the three-letter abbreviation “CDG“ by the coding system for three-letter abbreviations of airport names. 3.6 code val

37、ue result of applying a coding scheme to a code meaning EXAMPLE: “CDG“ as the representation of “Paris Charles-De-Gaulle“ in the coding system for three-letter representations of airport names. (based on ISO 2382-4, modified to use preferred terms defined above: coding system for code and code meani

38、ng for an element of a coded set.) NOTE 1 The definition provided by ISO 2382-4:1999 is modified in order to use the preferred (synonymous) terms coding scheme (instead of the deprecated code), and code NOTE 2 A diagrammatic illustration of the terms defined in 3.4, 3.5, 3.6 and 3.8 is provided in a

39、nnex B. 3.7 coding scheme collection of rules that maps the elements of one set on to the elements of a second set ISO/IEC 2382-4:1999 NOTE NOTE: The two sets considered here are (1) a set of code meanings (or coded set), and (2) a set of code values (or code set). 3.8 coding system combination of a

40、 set of code meanings and a set of code values, based on a coding scheme 3.9 data element unit of data for which the definition, identification, representation, and permissible values are specified by means of a set of attributes ISO/IEC 11179-6:2005 3.10 Data Identifier (DI) identifier assigned to

41、a data within a Registration Authority ISO/IEC 11179-6:2005 3.11 health coding system coding system used in health EN 1068:2005 (E) 7 NOTE According to ISO/IEC 11179, a health coding System is a data element. 3.12 Health Coding System Designator HCD unique permanent identifier of a health coding sys

42、tem registered for use in information interchange under the terms of this document NOTE A formal specification of the health coding system designator is included in Annex A. 3.13 health coding system specification source of information about a health coding system maintained and made available by th

43、e Responsible Organisation in accordance with the terms of this document 3.14 International Registration Data Identifier internationally unique identifier for a data element ISO/IEC 11179-6:2005 3.15 organisation unique framework of authority within which a person or persons act, or are designated t

44、o act, towards some purpose ISO/IEC 6523-1:1999 NOTE Groupings and subdivisions of an organisation may also be considered as organisations where there is a need to identify these in information interchange. 3.16 Register of Health Coding Systems register that is maintained in accordance with the pro

45、visions of this document 3.17 Registration Authority (for health coding systems) organisation responsible for assigning Health Coding System Designators and for maintaining the Register of Health Coding Systems as described in this document Organisation authorised to register data elements ISO/IEC 1

46、1179-6:2005 3.18 Registration Authority Identifier identifier assigned to a Registration Authority ISO/IEC 11179-6:2005 3.19 Responsible Organisation (of a health coding scheme) organisation which assumes responsibility for the administration of a specific health coding scheme. Organisation or unit

47、within an organisation that is responsible for the contents of the mandatory attributes by which a data element is specified ISO/IEC 11179-6:2005 3.20 Submitting Organisation (for health coding systems) organisation recognised by the requirements of this document to receive requests for registration

48、 of health coding systems from Responsible Organisations and submit them to the Registration Authority. EN 1068:2005 (E) 8 Organisation or unit within an organisation that has submitted the data element for addition, change, or cancellation/withdrawal in the data element dictionary ISO/IEC 11179-6:2

49、005 NOTE The definitions of Registration Authority, Submitting Organisation and Responsible Organisation for health coding systems are based on the generic definitions of these authorities and organisations in ISO/IEC 6523-1, and ISO/IEC 11179-6:2005. 3.21 version identification of an issue of a data element in a series of evolving data element specifications within a Registration Authority ISO/IEC 11179-6:2005 3.22 Version Identifier (VI) identifi