BS EN ISO 21549-6-2008 Health informatics - Patient healthcard data - Administrative data《健康信息学 病人医疗卡数据 管理数据》.pdf

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1、BRITISH STANDARDBS EN ISO 21549-6:2008Health informatics Patient healthcard data Part 6: Administrative dataICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g4

2、4g42g43g55g3g47g36g58BS EN ISO 21549-6:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 May 2008 BSI 2008ISBN 978 0 580 55978 5National forewordThis British Standard is the UK implementation of EN ISO 21549-6:2008. The UK participation

3、in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its

4、correct application.Compliance with a British Standard cannot confer immunity from legal obligations.Amendments/corrigenda issued since publicationDate CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 21549-6April 2008ICS 35.240.80English VersionHealth informatics - Patient healthcard d

5、ata - Part 6:Administrative data (ISO 21549-6:2008)Informatique de sant - Donnes relatives aux cartes desant des patients - Partie 6: Donnes administratives (ISO21549-6:2008)Medizinische Informatik - Patientendaten auf Karten imGesundheitswesen - Teil 6: Verwaltungsdaten (ISO 21549-6:2008)This Europ

6、ean Standard was approved by CEN on 14 March 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concer

7、ning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own la

8、nguage and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu

9、xembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All righ

10、ts of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 21549-6:2008: EForeword This document (EN ISO 21549-6:2008) has been prepared by Technical Committee ISO/TC 215 “Health informatics“ in collaboration with Technical Committee CEN/TC 251 “Health

11、 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 October 2008, and conflicting national standards shall be withdrawn at the latest by October

12、2008. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organi

13、zations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Rom

14、ania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21549-6:2008 has been approved by CEN as a EN ISO 21549-6:2008 without any modification. BS EN ISO 21549-6:2008iii Introduction With a more mobile population, greater healthcare delivery i

15、n the community and at patients homes, together with a growing demand for improved quality of ambulatory care, portable information systems and stores have increasingly been developed and used. Such devices are used for tasks ranging from identification, through portable medical record files, and on

16、 to patient-transportable monitoring systems. The functions of such devices are to carry and to transmit person-identifiable information between themselves and other systems; therefore, during their operational lifetime they may share information with many technologically different systems which dif

17、fer greatly in their functions and capabilities. Healthcare administration increasingly relies upon similar automated identification systems. For instance prescriptions may be automated and data exchange carried out at a number of sites using patient transportable computer readable devices. Healthca

18、re funding institutions and providers are increasingly involved in cross-region care, where reimbursement may require automated data exchange between dissimilar healthcare systems. Administrative data objects may require linkage to external parties responsible for their own domains which are not wit

19、hin the scope of this part of ISO 21549. For instance, cross-border reimbursement of healthcare services are usually regulated by law and intergovernmental agreements which are not subject to standardization. The advent of remotely accessible data bases and support systems has led to the development

20、 and use of “Healthcare Person” identification devices that are also able to perform security functions and transmit digital signatures to remote systems via networks. With the growing use of data cards for practical everyday healthcare delivery, the need has arisen for a standardized data format fo

21、r interchange. The person-related data carried by a data card can be categorised in three broad types: identification (of the device itself and the individual to whom the data it carries relates), administrative and clinical. It is important to realise that a given healthcare data card “de facto” ha

22、s to contain device data and identification data and may in addition contain administrative, clinical, medication and linkage data. Device data are defined to include: identification of the device itself; identification of the functions and functioning capabilities of the device. Identification data

23、 can include: unique identification of the device holder (and not information of other persons!). Administrative data can include: complementary person(s) related data; identification of the funding of healthcare, whether public or private, and their relationships, i.e. insurer(s), contract(s) and p

24、olicy(ies) or types of benefits; identification of other persons as a part of the insurance contract (e.g. a family contract); other data (distinguishable from clinical data) that are necessary for the purpose of healthcare delivery. BS EN ISO 21549-6:2008ivClinical data may include: items that prov

25、ide information about health and health events; their appraisal and labelling by a healthcare provider; related actions planned requested or performed. Medication data may include: a record of medications received or taken by the patient; copies of prescriptions including the authority to dispense r

26、ecords of dispensed medication; records of medication bought by the patient; pointers to other systems that contain information that makes up an electronic prescription and the authority to dispense. Because a data card essentially provides specific answers to definite queries whilst having at the s

27、ame time a need to optimize the use of memory by avoiding redundancies “high level” Object Modelling Technique (OMT) has been applied with respect to the definition of healthcare data card data structures. Patient data cards may offer facilities to: a) communicate prescription information from one h

28、ealthcare person to another healthcare person such as to a healthcare agent or healthcare organization; b) provide indexes and/or authority to access prescription information held other than on the patient data card. This part of ISO 21549 describes and defines the administrative data objects used w

29、ithin or referenced by patient held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1). This part of ISO 21549 does not describe and define the common objects defined within ISO 21549-2 even though they are referenced and utilized within this document. BS EN ISO 21549-6:200

30、81Health informatics Patient healthcard data Part 6: Administrative data 1 Scope This part of ISO 21549 is applicable to situations in which administrative data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. This pa

31、rt of ISO 21549 specifies the basic structure of the data contained within the data object administrative data, but does not specify or mandate particular data sets for storage on devices. The detailed functions and mechanisms of the following services are not within the scope of this part of ISO 21

32、549, although its structures can accommodate suitable data objects elsewhere specified: the encoding of free text data; security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integ

33、rity protection, and authentication of persons and devices related to these functions; access control services that may depend on active use of some data card classes such as microprocessor cards; the initialization and issuing process (which begins the operating lifetime of an individual data card,

34、 and by which the data card is prepared for the data to be subsequently communicated to it according to this part of ISO 21549). The following topics are therefore beyond the scope of this part of ISO 21549: physical or logical solutions for the practical functioning of particular types of data card

35、; how the message is processed further downstream of the interface between two systems; the form which data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere. 2 Normative references The following referenced documents are indispens

36、able 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 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Cou

37、ntry codes BS EN ISO 21549-6:20082 ISO 20302, Health informatics Health cards Numbering system and registration procedure for issuer identifiers ISO 21549-1, Health informatics Patient healthcard data Part 1: General structure ISO/IEC 7816-6, Identification cards Integrated circuit cards Part 6: Int

38、erindustry data elements for interchange ISO/IEC 8824-1, Information technology Abstract Syntax Notation One (ASN.1): Specification of basic notation Part 1 ISO/IEC 8825-1, Information technology ASN.1 encoding rules: Specification of Basic Encoding Rules (BER), Canonical Encoding Rules (CER) and Di

39、stinguished Encoding Rules (DER) Part 1 ISO/IEC 10646, Information technology Universal Multiple-Octet Coded Character Set (UCS) 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 21549-1 apply. 4 Symbols and abbreviated terms ASN.1 Abstract Syntax Nota

40、tion One BER Basic Encoding Rules CRT Cardholder Related Template ID Identifier NET National Extensions Template UCS Universal Multiple-Octet Coded Character Set UML Unified Modelling Language UTF8 UCS Transformation Format 8 5 Definition of the administrative data set 5.1 In order to facilitate int

41、eroperability, whenever an application is built for use in the healthcare domain in compliance with this part of ISO 21549, data items required for that application shall be drawn from the list of objects (some of which are extensible) as provided in 5.2. These shall then be used in conjunction with

42、 other data defined in other parts of ISO 21549. To differentiate between the administrative data set of this part of ISO 21549 and other data sets of ISO 21549, the administrative data set should primarily contain data for identification of the funding institutions of healthcare and their relations

43、hips i.e. insurers, contracts and policies or types of benefits. The administrative data set should include data (distinguishable from clinical data) that are necessary for the purpose of healthcare delivery. 5.2 Table 1 shows the definition of Administrative data in tabular form according to the AS

44、N.1 basic notation and basic encoding described in ISO/IEC 8824-1 and ISO/IEC 8825-1, respectively. The corresponding ASN.1 definition is given in Annex A. In the ASN.1 definition the ASN.1 data type UTF8String is used for the coding of alphanumeric data elements. Since the UTF8 encoding uses 1 to 6

45、 bytes for each character, the number of storage bytes which should be provided by the card may be greater than the denoted length in characters. The use of UTF8 should be restricted to a limited international character set, since it BS EN ISO 21549-6:20083does not make sense to provide each country

46、 with the unfamiliar character set of another country. The formation of this international character set as a subset of the Universal Character Set (UCS) is a subject for discussion. Figure 1 shows the UML class diagram. An overview of the template structure is given in Figure 2. Figure 1 UML class

47、diagram Table 1 Specification of individual entities within the Administrative data set Tag L Value Data type Notes 65 Var. Cardholder related template Tag of cardholder related data, defined in ISO 7816-6 Tag L Value Data type Notes 90 2 Issuing state ID number (2 characters) AN Mandatory DO; Alpha

48、-2-Code (see ISO 3166-1) 91 x Name of the institution (2-45 characters) AN Mandatory DO 92 4-10 Identification number of the institution N Mandatory DO; definition according to national regulations The number should follow ISO 20302 93 x Insured person number (2-30 characters) AN Optional DO; only p

49、resent, if this identification number of the person depends on the funding institution. 94 8 Expiry date N Mandatory DO; basic date format (see ISO 8601): YYYYMMDD 73 Var. National extensions template Optional; tag of discretionary data objects; the template should only be present if one or more additional data objects used by the issuing country follow. (see ISO 7816-6) Tag L Value Data type Notes Additional country-specific data objects not defined in this standard. BS EN ISO 21549-6:20

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