1、August 2008DEUTSCHE NORM Normenausschuss Medizin (NAMed) im DINPreisgruppe 8DIN Deutsches Institut fr Normung e.V. Jede Art der Vervielfltigung, auch auszugsweise, nur mit Genehmigung des DIN Deutsches Institut fr Normung e.V., Berlin, gestattet.ICS 35.240.80!$O2o“1441576www.din.deDDIN EN ISO 21549-
2、6Medizinische Informatik Patientendaten auf Karten im Gesundheitswesen Teil 6: Verwaltungsdaten (ISO 21549-6:2008);Englische Fassung EN ISO 21549-6:2008Health informatics Patient healthcard data Part 6: Administrative data (ISO 21549-6:2008);English version EN ISO 21549-6:2008Informatique de sant Do
3、nnes relatives aux cartes de sant des patients Partie 6: Donnes administratives (ISO 21549-6:2008);Version anglaise EN ISO 21549-6:2008Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 Berlin www.beuth.deGesamtumfang 12 Seiten2 Nationales Vorwort Diese Norm wurde in der WG 5 Health cards“ des
4、ISO/TC 215 Health informatics“ in Zusammenarbeit mit dem CEN/TC 251 Medizinische Informatik“ erarbeitet, dessen Sekretariat von NEN (Niederlande) gehalten wird. Der Fachbereich 7 Medizinische Informatik“ und insbesondere die Mitarbeiter des Arbeitsausschusses NA 063-07-05 AA Karten“ des Normenaussch
5、usses Medizin (NAMed) im DIN haben an der Erarbeitung mitgewirkt. Diese Norm enthlt unter Bercksichtigung des Prsidialbeschlusses 13/1983 die Englische Fassung der Internationalen Norm EN ISO 21549-6:2008. Fr die im Abschnitt 2 zitierten Internationalen Normen wird im Folgenden auf die entsprechende
6、n Deutschen Normen hingewiesen: ISO 21549-5 siehe DIN EN ISO 21549-5 ISO 3166-1 siehe DIN EN ISO 3166-1 Zusammenfassung: Diese Norm definiert eine Struktur fr Versicherungsdaten eines Patienten auf Karten im Gesundheitswesen. Die kostentrgerbezogenen Versicherungsdaten (Kostentrgerlndercode, Name de
7、s Kostentrgers, Kostentrgerkennung, Ende des Versichertenschutzes) knnen innerhalb des Gesundheitswesens auf einer Krankenversichertenkarte, einer Gesundheitskarte oder einer anderen Patientenkarte zum Einsatz kommen, um eine eindeutige Zuordnung von administrativen und klinischen Daten zum Patiente
8、n zu ermglichen. Die Datenstruktur stellt einen Mindestsatz von Datenelementen bereit, die insbesondere dazu geeignet ist, den Anspruch des Karteninhabers auf medizinische Leistungen in einem anderen Staat als dem Versicherungs- oder Wohnsitzstaat nachzuweisen. Die Versicherungsdaten knnen in Verbin
9、dung mit den Personenstamm-daten des Patienten (siehe DIN EN ISO 21549-5) im Ausland den Anspruch auf Kostenerstattung doku-mentieren und eine sptere Kostenbernahme durch den Kostentrger erleichtern. Bei der Erarbeitung wird des Weiteren groer Wert darauf gelegt, dass die in DIN EN ISO 21549-5 (Iden
10、ti-fikationsdaten) und DIN EN ISO 21549-6 (Verwaltungsdaten) enthaltenen Datenelemente und Definitionen sowohl mit den Personenstammdaten der Europischen Krankenversichertenkarte en: European health insurance card (EHIC) sowie mit den Versichertenstammdaten der deutschen elektronischen Gesund-heitsk
11、arte konform sind. Nationaler Anhang NA (informativ) Literaturhinweise DIN EN ISO 3166-1, Codes fr die Namen von Lndern und deren Untereinheiten Teil 1: Codes fr Lndernamen DIN EN ISO 21549-5, Medizinische Informatik Patientendaten auf Karten im Gesundheitswesen Teil 5: Identifikationsdaten DIN EN I
12、SO 21549-6:2008-08 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMEN ISO 21549-6April 2008 ICS 35.240.80English Version Health informatics Patient healthcard data Part 6: Administrative data(ISO 21549-6:2008) Informatique de sant Donnes relatives aux cartes de sant des patients Partie 6: Donnes ad
13、ministratives (ISO 21549-6:2008) Medizinische Informatik Patientendaten auf Karten im Gesundheitswesen Teil 6: Verwaltungsdaten (ISO 21549-6:2008) This European Standard was approved by CEN on 14 March 2008. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate th
14、e conditions for giving this EuropeanStandard 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 CEN Management Centre or to any CEN member. This European Standard exists i
15、n three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies
16、 of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Manag
17、ement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21549-6:2008: EEUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Foreword
18、 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 informatics” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, ei
19、ther 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 2008. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN an
20、d/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 organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republ
21、ic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21549-6:2008 has b
22、een approved by CEN as a EN ISO 21549-6:2008 without any modification. EN ISO 21549-6:2008 (E)2DIN EN ISO 21549-6:2008-08 Introduction With a more mobile population, greater healthcare delivery in the community and at patients homes, together with a growing demand for improved quality of ambulatory
23、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 to patient-transportable monitoring systems. The functions of such devices are to carry and to transmit
24、person-identifiable information between themselves and other systems; therefore, during their operational lifetime they may share information with many technologically different systems which differ greatly in their functions and capabilities. Healthcare administration increasingly relies upon simil
25、ar 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. Healthcare funding institutions and providers are increasingly involved in cross-region care, where reimbursement
26、 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 within the scope of this part of ISO 21549. For instance, cross-border reimbursement of healthcare services
27、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 and use of “Healthcare Person” identification devices that are also able to perform security functions a
28、nd 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 for interchange. The person-related data carried by a data card can be categorised in three broad types: id
29、entification (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” has to contain device data and identification data and may in addition contain administrative, clinical, me
30、dication 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 can include: unique identification of the device holder (and not information of other persons!). Adminis
31、trative 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 policy(ies) or types of benefits; identification of other persons as a part of the insurance contract (e.g
32、. a family contract); other data (distinguishable from clinical data) that are necessary for the purpose of healthcare delivery. EN ISO 21549-6:2008 (E)3DIN EN ISO 21549-6:2008-08 Clinical data may include: items that provide information about health and health events; their appraisal and labelling
33、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 records of dispensed medication; records of medication bought by the patient; p
34、ointers 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 same time a need to optimize the use of memory by avoiding redundancies “high l
35、evel” 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 healthcare person to another healthcare person such as to a healthcare agent or
36、 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 within or referenced by patient held health data cards using UML, plain text an
37、d 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. EN ISO 21549-6:2008 (E)4DIN EN ISO 21549-6:2008-08 1 Scope This part of ISO 21549 is applicable to
38、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 part of ISO 21549 specifies the basic structure of the data contained within the data object administrative data, but does
39、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 21549, although its structures can accommodate suitable data objects elsewhere specified: the encoding of free text data; s
40、ecurity 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 integrity protection, and authentication of persons and devices related to these functions; access control services that may d
41、epend 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, and by which the data card is prepared for the data to be subsequently communicated to it according to this part of ISO
42、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; how the message is processed further downstream of the interface between two systems; the form which data take for use
43、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 indispensable for the application of this document. For dated references, only the edition cited applies. For undated references,
44、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: Country codes EN ISO 21549-6:2008 (E)5DIN EN ISO 21549-6:2008-08 ISO 20302, Health informatics Health cards Numbering system
45、 and registration procedure for issuer identifiers ISO 21549-1, Health informatics Patient healthcard data Part 1: General structureISO/IEC 7816-6, Identification cards Integrated circuit cards Part 6: Interindustry data elements for interchangeISO/IEC 8824-1, Information technology Abstract Syntax
46、Notation One (ASN.1): Specification of basic notation Part 1ISO/IEC 8825-1, Information technology ASN.1 encoding rules: Specification of Basic Encoding Rules (BER), Canonical Encoding Rules (CER) and Distinguished Encoding Rules (DER) Part 1ISO/IEC 10646, Information technology Universal Multiple-O
47、ctet 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 Notation One BER Basic Encoding Rules CRT Cardholder Related Template ID Identifier NET National Exten
48、sions 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 interoperability, whenever an application is built for use in the healthcare domain in compliance wit
49、h 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 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 identifi
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