Health informatics - Registration of coding systems

This European Standard specifies a procedure for the registration of coding schemes used in health for any purpose. It also specifies the allocation of a unique Health Coding Scheme Designator to each registered coding scheme. 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 European Standard. The association is achieved in any manner appropriate to the syntax used.
This European Standard does not specify the coding schemes to be used in health, give guidance on their selection nor describe methods of representing information in coded form.
Coding schemes maintained by different 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.

Medizinische Informatik - Registrierung von Kodierungsschemata

Informatique de santé - Enregistrement des systemes de codage

Le présent document décrit une procédure pour l'enregistrement des systemes de codage utilisés dans le
domaine de la santé quel que soit leur objectif. Elle spécifie également l'attribution a chaque systeme de
codage enregistré d'un identificateur de systeme de codage de santé unique (HCD, Health Coding System
Designator). Il est ainsi possible de donner une signification non ambiguë a une valeur de code en l'associant
a un HCD.
La présente Norme européenne ne définit pas la méthode permettant d?associer un HCD et un code. Cette
association est réalisée par toute méthode appropriée a la syntaxe utilisée.
Le présent document n'indique pas les systemes de codage a utiliser dans le domaine de la santé, ne donne
pas de conseil quant a leur choix et ne décrit pas les méthodes pour représenter les informations sous forme
codée.
Il est également possible de combiner des systemes de codage gérés par différentes organisations
responsables. De telles combinaisons peuvent etre considérées comme des modeles et par conséquent sont
exclues du domaine d'application du présent document.

Zdravstvena informatika – Registracija kodirnih sistemov

General Information

Status
Published
Publication Date
31-Aug-2005
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Sep-2005
Due Date
01-Sep-2005
Completion Date
01-Sep-2005

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zdravstvena informatika – Registracija kodirnih sistemovMedizinische Informatik - Registrierung von KodierungsschemataInformatique de santé - Enregistrement des systemes de codageHealth informatics - Registration of coding systems35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technology35.040Nabori znakov in kodiranje informacijCharacter sets and information codingICS:Ta slovenski standard je istoveten z:EN 1068:2005SIST EN 1068:2005en01-september-2005SIST EN 1068:2005SLOVENSKI

STANDARDSIST ENV 1068:20031DGRPHãþD
SIST EN 1068:2005
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1068
June 2005 ICS 11.020; 35.240.01 Supersedes ENV 1068:1993 English version

Health informatics - Registration of coding systems Informatique de santé - Enregistrement des systèmes de codage

Medizinische Informatik - 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-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 under 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 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: ESIST EN 1068:2005

EN 1068:2005 (E) 2 Contents Page Foreword..........................................................................................................................................................3 Introduction......................................................................................................................................................4 1 Scope...................................................................................................................................................5 2 Normative References........................................................................................................................5 3 Terms, definitions and abbreviations................................................................................................5 4 Identification 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 Organisations..............................................................................................................12 10 Disputes.............................................................................................................................................14 Annex A (normative)

Specification of the Health Coding System Designator.........................................15 Annex B (informative)

Illustration of terms used in this document..........................................................16 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.........................................................................................................................................22

SIST EN 1068:2005

EN 1068:2005 (E) 3 Foreword This European Standard (EN 1068:2005) has 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 national 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, Cyprus, 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. SIST EN 1068:2005

EN 1068:2005 (E) 4 Introduction The increased use 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. Representation 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 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 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 one 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 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 language; 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 information 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 situation 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 Standard 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 contains. 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 rules of procedure, are the subject for a separate supporting document (“Health Informatics – Health Information Interchange – Registration of Coding Systems – The Registration Authority“). SIST EN 1068:2005

EN 1068:2005 (E) 5

1 Scope This European Standard specifies a procedure for the registration of coding systems used in 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 European 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 different 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 dated 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 Information Technology — Metadata registries (MDR) — Part 6: Registration3 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 2382-4:1999] 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] SIST EN 1068:2005

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 which 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 value 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 meaning 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 annex 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 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 a data within a Registration Authority [ISO/IEC 11179-6:2005] 3.11 health coding system coding system used in health SIST EN 1068:2005

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 system 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 the 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 to 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 provisions 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 11179-6:2005] 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 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 of health coding systems from Responsible Organisations and submit them to the Registration Authority. SIST EN 1068:2005

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 11179-6:2005] 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) identifier assigned to a version under which a data element is submitted or updated [ISO/IEC 11179-6:2005] 4 Identification of health coding systems 4.1 Purpose of the identification procedure The procedure described in this Clause provides for the unambiguous identification of registered health coding systems when they are used for the purpose of information interchange in health. A code value is given an unambiguous meaning by association between: a) Health Coding System Designator (HCD), and b) code value. 4.2 Health Coding System Designator (HCD) The HCD shall have a fixed length of 9 (nine) characters and shall conform to the formal specification in Annex A. A HCD shall be allocated by the Registration Authority upon acceptance of a request for registration of a health coding system in accordance with Clause 4 “Processing of requests for new registrations“ of the supporting document to this document (“Health Informatics –Registration of Coding Systems – The Registration Authority “). A HCD once allocated shall be included in the Register of Health Coding Systems and the same HCD value shall not be reallocated or deleted. Instances of the HCD in which both the third and fourth characters are the digit "9" (nine) shall not be allocated by the Registration Authority but shall be reserved for identification of non-registered coding systems within user agreements described in Clause 5. Together with the Registration Authority Identifier (RAI, the HCD shall compose the International Registration Data Identifier (IRDI), as defined in ISO/IEC 6523-1, and ISO/IEC 11179. 4.3 Code Value The code value shall conform to the interchange format and character set specified, in the entry identified by the associated HCD, in the Register of Health Coding Systems (see 7.1). SIST EN 1068:2005

EN 1068:2005 (E) 9 Code values not included in a registered health coding system specification may be used in an information interchange that is subject to a user agreement as described in Clause 5. Otherwise the code value shall represent a code meaning that can be ascertained by reference to the health coding system specification for the coding system identified by the associated HCD (see 9.2). 4.4 Methods of Association The method by which a HCD and a code value are associated in an information interchange is not specified by this document. Possible methods include specification of the association: a) within a prior agreement between the parties to the information interchange; b) within message implementation guidelines applicable to all messages of a particular type; c) within an information interchange in such a manner that it is applicable to several messages; d) within individual messages; e) within the representation of the code value. 5 User agreements Health coding systems that have not been registered in accordance with this document may be used in health information interchange between parties who have entered into an appropriate agreement. A non-registered coding system shall be identified by a HCD conforming to layout specification in Annex A, in which both the first and second characters are the digit "9" (nine) and the values of the third, fourth, fifth, sixth, seventh, eighth, and ninth characters are agreed between the parties to the agreement. (ie the HCD shall have the form 99XXXXXXX in which the characters represented by a "X" are agreed between the parties to the agreement). The coding systems associated with HCD values in this series shall be determined by prior agreement between the parties using them. It shall be the responsibility of these parties to ensure that, in the environment in which they are operating, ambiguities do not occur. 6 The Registration Authority The role to be played by the Registration Authority, and its basic rules of procedure, are the subject for a separate supporting document (“Health Informatics – Registration of Coding Systems – The Registration Authority“). 7 The Register of Health Coding Systems 7.1 Contents of the Register The Register of Health Coding Systems shall contain the information described below in respect of each registered health coding system. Items marked with an asterisk (*) shall not be amended. a) The following information shall be provided in every request for registration or for amendment of a registration entry and shall be included in the Register: 1)* the preferred name of the health coding system as advised by the Responsible Organisation; 2)* the interchange format of the code values used in the coding system including the maximum number of characters used in any code value if a character code or the maximum number of bits if binary; 3)* the character set required to express the full range of code values used by the coding system; SIST EN 1068:2005

EN 1068:2005 (E) 10 4)* the minimum period that may elapse between the withdrawal of a code value and its reallocation. This shall be 100 years unless a different period is agreed between the Submitting Organisation and Responsible Organisation; 5) the name, postal address, telephone number, facsimile number, electronic mail address, Universal Resource Link – URL – (if existing) of the Responsible Organisation and the name of any individual in the Responsible Organisation with particular responsibility for the coding system; 6) the name, address, telephone number facsimile number and any electronic mail address of the Submitting Organisation and the name of any individual in the Submitting Organisation with particular responsibility for the coding system; 7) a statement of the types of information and application areas for which it is intended to be used; 8) the languages used in the health coding system specification. b) The following information shall, where appropriate, be provided in a request for registration or for amendment of a registration entry and if provided shall be included in the Register: 1) notes on the use of the coding system; 2) the HCD assigned to any previous versions of the coding system; 3) any alternative names or abbreviations used to refer to the coding system. c) The Register of Health Coding Systems shall also contain the following information which shall be added or amended by the Registration Authority: 1)* the HCD value assigned to the coding system; 2)* the date of the issue of the HCD value; 3) the date of the latest amendment to the register; 4) any additional comments made by the Submitting Organisation or added by the Registration Authority. d) If the coding system ceases to be supported, or is superseded by a new registration, the Registration Authority shall add or amend the following information in the Register: 1) the date on which the Registration Authority determines that the Responsible Organisation is no longer maintaining the coding system in accordance with the requirements of this document; 2) the reason the system ceased to be supported; 3) the HCD assigned to any subsequent versions of the coding system. 7.2 Language of the Register The Register of Health Coding Systems shall be maintained in English. At the request of a Submitting Organisation entries submitted in one of the other official languages of CEN shall be accepted and maintained in that language. The Registration Authority shall also conduct all business relating to the Register in English or such other languages as the Registration Authority and the corresponding party may find mutually convenient. 7.3 Availability of the Register The Register of Health Coding Systems and its indexes shall be available at no charge on a web site maintained by the Registration Authority. The Register of Health Coding Systems shall be made downloadable from the above mentioned web site in those formats that, evolving with time, are currently the most commonly used for electronic documents with personal computers. 7.4 Order of the Register The Register of Health Coding Systems shall facilitate the retrieval of entries in order of HCD or in alphabetical order of the name of the health coding system. If the Register is maintained in one of these SIST EN 1068:2005

EN 1068:2005 (E) 11 orders, an index shall be provided in the other. If the Register is not maintained in either of these orders, indexes shall be provided in both of these orders. If it is necessary to use an extended character set within the Register, the Registration Authority shall select an appropriate ISO Standard character set and shall explicitly inform those accessing the Register of the set chosen and the effect of this upon the order of entries in the Register and its indices. 7.5 Copyright of the Register The copyright for the Register of Health Coding Systems shall belong to the organisation that appoints the Registration Authority. 8 Submitting Organisations 8.1 General Requests to the Registration Authority shall be forwarded by a recognised Submitting Organisation. However a Submitting Organisation shall not forward a request to the Registration Authority in respect of a coding system of which it is the Responsible Organisation but shall submit such requests through another recognised Submitting Organisation. 8.2 Recognition of Submitting Organisations Any of the following bodies or organisations shall be recognised as Submitting Organisations for the purposes of this document: a) ISO Technical Committee or Subcommittee; b) Member Body of ISO; c) International Organisation having a liaison status with ISO or with any of its Technical Committees or Subcommittees (for example: CEN TC251). d) body recognised by the organisation that appoints the Registration Authority as having responsibility for the provision or control of health on a national or international scale. 8.3 Responsibilities of Submitting Organisations The responsibilities of a Submitting Organisation are to: a) receive requests for additions or amendments to the Register of Health Coding Systems from Responsible Organisations within their country or organisations; b) rationalise or co-ordinate these requests so that unnecessary proliferation of health coding systems is minimised; c) satisfy itself that Responsible Organisations understand and accept the responsibilities specified in Clause 9; d) forward to the Registration Authority those requests that have its support; e) submit requests in the form requested by the Registration Authority. This may involve translation into a language acceptable to the Registration Authority; f) make known within their country or organisations the decisions transmitted to them by the Registration Authority; g) advise the Registration Authority should it become aware of a change in circumstances that renders incorrect any of the information shown in the Register. This includes but is not limited to receiving and forwarding appropriate requests for amendment of register entries; SIST EN 1068:2005

EN 1068:2005 (E) 12 h) advise the Registration Authority should it become aware that an Responsible Organisation has breached any of its responsibilities or undertakings specified in Clause 9; i) in case of cessation of existence of an Responsible Organisation, seek agreement with the Registration Authority about whether, and under which conditions, in particular with regard to the registration fees, a registered coding system has to be kept included in the Register. 8.4 Evaluation criteria to be applied by Submitting Organisations Before forwarding a request to the Registration Authority a Submitting Organisation shall evaluate it against the following criteria; a) a valid need exists in health for the interchange of information which may be coded using the coding system; b) the coding system is either in common usage within at least one country or satisfies a need not met satisfactorily by an existing registered health coding system; c) the Responsible Organisation is of good national or international standing and has the resources to undertake the responsibilities specified in Clause 9; d) the information provided by the Responsible Organisation is adequate for and appropriate to the request being made (see 7.1, and Clause 3 “Evaluation of requests“ of the supporting document to this document (“Health Informatics – Registration of Coding Systems – The Registration Authority“)). 8.5 Coding systems registered with other authorities The existence of another international registration authority under which a coding system either is or could be registered shall not necessarily preclude registration to obtain a HCD. Such requests for registration shall be considered in accordance with the responsibilities described in 8.3 and the evaluation criteria in 8.4. 9 Responsible Organisations 9.1 Responsibilities of Responsible Organisations For each health coding system to which this document applies the Responsible Organisation shall be responsible for: a) providing the information specified in 7.1 a), and if appropriate in 7.1 b), in the form required by the Submitting Organisation dealing with the request; b) providing any additional information that may reasonably be required by the Submitting Organisation to enable it to perform its responsibilities as specified in Clause 8; c) maintaining a health coding system specification as specified in 9.2; d) the assignment of code values to code meanings; e) ensuring that, when the relationship between a code value and a code meaning has been promulgated in any way, the relationship is not changed within the period specified in 7.1 a) 5); • This shall not preclude the promulgation of proposed codes values and associated code meanings for consultation provided that they are incorporated within a communication which makes this clear and includes a warning that the codes are subject to change and must not be used. f) without charge and without request making the health coding system specification and every updated version of it, or change to it, available to the Registration Authority and to the Submitting Organisation and permitting these authorities to distribute copies, to member bodies and liaison organisations of ISO/IEC, for their reference only; g) making the coding system specification available at

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