1、November 2010DEUTSCHE NORM Normenausschuss Medizin (NAMed) im DINPreisgruppe 11DIN 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!$j21“1711514www.din.deDDIN EN ISO 215
2、49-8Medizinische Informatik Patientendaten auf Karten im Gesundheitswesen Teil 8: Verweise (ISO 21549-8:2010);Englische Fassung EN ISO 21549-8:2010Health informatics Patient healthcard data Part 8: Links (ISO 21549-8:2010);English version EN ISO 21549-8:2010Informatique de sant Donnes relatives aux
3、cartes de sant des patients Partie 8: Liens (ISO 21549-8:2010);Version anglaise EN ISO 21549-8:2010Alleinverkauf der Normen durch Beuth Verlag GmbH, 10772 Berlin www.beuth.deGesamtumfang 17 SeitenDIN EN ISO 21549-8:2010-11 Nationales Vorwort Dieses Dokument enthlt unter Bercksichtigung des Prsidialb
4、eschlusses 13/1983 den englischen Original-text der internationalen Norm ISO 21549-8, Ausgabe Juni 2010. Diese Norm wurde im ISO/TC 215 Health Informatics“ (Sekretariat: ANSI, USA) erarbeitet und wurde parallel im CEN/TC 251 Medizinische Informatik“ (Sekretariat: NEN, Niederlande) abgestimmt. Der Fa
5、chbereich 7 Medizinische Informatik“ und insbesondere die Mitarbeiter des Arbeitsausschusses NA 063-07-05 AA Karten“ des Normenausschusses Medizin (NAMed) im DIN haben an der Erarbeitung mitgewirkt. Zusammenfassung Diese Internationale Norm gilt fr Verfahren, in den Patientendaten auf Basis von Gesu
6、ndheitskarten gespeichert oder mit Referenz auf diese transportiert werden. Diese Norm legt eine Methode fest, den Zugriff auf verteilte Patientendaten und / oder Verwaltungsinformatio-nen unter Verwendung von Gesundheitskarten zu erleichtern. Sie legt die Struktur und Elemente von Quer-verweisen“ f
7、est, wie sie blicherweise auf Gesundheitskarten gespeichert werden und wie sie Querverweise auf individuelle Patientenakten sowie auf deren Unterelemente darstellen. Zugriffskontrollmechanismen, Datenschutzmechanismen, Zugriffsmethoden und andere Sicherheitsdienste liegen nicht im Anwendungs-bereich
8、 dieses Teils der Norm ISO 21549. Begriff in englisch Begriff in deutsch reference information that provides the unambiguous identification of a certain part of a distributed record Referenz Information, die die eindeutige Identifikation eines bestimmten Teils einer verteilten Akte bereitstellt link
9、age information data set that provides the complete information to locate the resource of a certain part of a distributed record Verweisinformation Datensatz, der die vollstndige Information zur Lokalisierung einer Ressource eines bestimmten Teils einer verteilten Akte, bereitstellt ISO OID organiza
10、tion code unique worldwide organization code defined and managed following the ISO/IEC 9834 series of International Standards ISO OID Organisationscode einheitlicher weltweiter Organisationscode festgelegt und verwaltet nach der Internationalen Normenreihe ISO/IEC 9834 Uniform Resource Identifier co
11、mpact sequence of characters which identifies an abstract or physical resource einheitlicher Identifikator fr Ressourcen kompakte Sequenz von Zeichen zur Identifikation einer abstrakten oder physikalischen Ressource Uniform Resource Locator standardized address used for referring to resources by the
12、ir location einheitlicher Zeiger auf Ressourcen standardisierte Adresse fr den Verweis auf eine Ressource hinsichtlich des Ortes ihrer Ablage Uniform Resource Name location-independent standardized label identifying an object by its name serving as persistent, location-independent resource identifie
13、r einheitlicher Name fr Ressourcen ortsunabhngiger, standardisierter Kennsatz zur Identifizierung eines Objektes mittels seines Namens zur Verwendung als persistenter, ortsunabhngiger Identifikator einer Ressource 2 DIN EN ISO 21549-8:2010-11 Fr die im Abschnitt 2 zitierten Internationalen Normen wi
14、rd im Folgenden auf die entsprechenden Deutschen Normen hingewiesen: ISO 21549-2 siehe DIN EN ISO 21549-2 ISO 21549-4 siehe DIN EN ISO 21549-4 DIN EN ISO 21549-8, Medizinische Informatik Patientendaten auf Karten im Gesundheitswesen besteht aus: Teil 1: Allgemeiner Aufbau Teil 2: Gemeinsame Elemente
15、 Teil 3: Klinische Daten Kerndatensatz Teil 4: Klinische Daten - Erweiterter Datensatz Teil 5: Identifikationsdaten Teil 6: Verwaltungsdaten Teil 7: Medikationsdaten Teil 8: Verweise Nationaler Anhang NA (informativ) Literaturhinweise DIN EN ISO 21549-2, Medizinische Informatik Patientendaten auf Ka
16、rten im Gesundheitswesen Teil 2: Gemeinsame Elemente DIN EN ISO 21549-4, Medizinische Informatik Patientendaten auf Karten im Gesundheitswesen Teil 4: Klinische Daten Erweiterter Datensatz 3 DIN EN ISO 21549-8:2010-11 4 Leerseite EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21549-8 June
17、2010 ICS 35.240.80 English Version Health informatics Patient healthcard data Part 8: Links (ISO 21549-8:2010) Informatique de sant Donnes relatives aux cartes de sant des patients Partie 8: Liens (ISO 21549-8:2010) Medizinische Informatik Patientendaten auf Karten im Gesundheitswesen Teil 8: Verwei
18、se (ISO 21549-8:2010) This European Standard was approved by CEN on 26 May 2010. 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 b
19、ibliographical references concerning such national standards 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 translation under the responsibil
20、ity 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 of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
21、 Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: A
22、venue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21549-8:2010: EEN ISO 21549-8:2010 (E) 2 Contents PageForeword3Introduction .41 Scope 52 Normative references 53 Terms and definitions .54 Sy
23、mbols and abbreviated terms 65 Requirements.66 Structure .6Annex A (normative) ASN.1 Data definitions .9Annex B (informative) Examples .11B.1 Usage 11B.2 Example 11Bibliography 13DIN EN ISO 21549-8:2010-11 EN ISO 21549-8:2010 (E) 3 Foreword This document (EN ISO 21549-8:2009) has been prepared by Te
24、chnical 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, either by publication of an identical text or by endorsement, at
25、 the latest by December 2010, and conflicting national standards shall be withdrawn at the latest by December 2010. 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 a
26、ny 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 Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hung
27、ary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 21549-8:2009 has been approved by CEN as a EN ISO 21549-8:2010 without any modific
28、ation. DIN EN ISO 21549-8:2010-11 EN ISO 21549-8:2010 (E) 4 Introduction The ISO 21549 series of International Standards is intended to replace the European Prestandard ENV 12018 adopted by CEN in 1995. This series of International Standards provides data structures and definitions for data objects
29、on patient data cards. Healthcare becomes more and more integrated and is changing from having a local character to being regional and with increasing mobility even international. Typically, patients health history consists of many service episodes distributed over time and space. Sometimes patients
30、 are getting services from separate service providers at the same time. Each service provider such as hospital, health centre, and physician has his own local patient record system. Thus the patients health data is more and more over specialities and space inside one country and worldwide. Patients
31、can be better cared for if the health professional in charge has access to the patients most recent data. Physicians at different locations have to be able to simultaneously see and edit a patient record from remote locations. This requires, on the one hand, information systems that are able to comm
32、unicate and, on the other hand, standardised methods to locate the information. The Internet which is able to distribute information to geographically-distant users offers a secure technological solution for handling electronic patient records. However, it is necessary to access the data required in
33、 an easy and timely way. Not only does this mean that the relevant information has to be made available by its authors; but also that it has to be retrieved from a mass of irrelevant information whenever and wherever needed. Patient data is especially sensitive and a secure basic infrastructure is a
34、bsolutely necessary. Therefore, besides the secure transmission of data the persons handling the record, for example health professionals and or the patients have to be to identified and authenticated. Further services like integrity and privacy protection, accountability, accessibility etc. need to
35、 be addressed as well. Health cards can help to provide the necessary security in the sensitive health domain including data integrity and data protection. They enable authentication for data on the card and can also provide links to several additional data objects to be held elsewhere. Health cards
36、 may contain both a subset of critical clinical data stored on the card itself and links to data distributed nationally or worldwide over many medical information systems. DIN EN ISO 21549-8:2010-11 EN ISO 21549-8:2010 (E) 5 1 Scope This part of ISO 21549 defines a way to facilitate access to distri
37、buted patient records and/or administrative information using healthcards. It defines the structure and elements of links” typically stored in healthcards and representing references to individual patients records as well as to subcomponents of them. Access control mechanisms, data protection mechan
38、isms, access methods and other security services are outside the scope of this part of ISO 21549. 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
39、 edition of the referenced document (including any amendments) applies. ISO 21549-2:2004, Health informatics Patient healthcard data Part 2: Common objects ISO 21549-4:2006, Health informatics Patient healthcard data Part 4: Extended clinical data HL7v3, Health Level Seven Messaging Standard Version
40、 3, Normative Edition 2006 IETF RFC 3986, Uniform Resource Identifier (URI): Generic Syntax 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 reference information that provides the unambiguous identification of a certain part of a distributed
41、record 3.2 linkage information data set that provides the complete information to locate the resource of a certain part of a distributed record 3.3 ISO OID organization code unique worldwide organisation code defined and managed following the ISO/IEC 9834 series of International Standards. 3.4 Unifo
42、rm Resource Identifier compact sequence of characters that identifies an abstract or physical resource. 3.5 Uniform Resource Locator standardised address used for referring to resources by their location. 3.6 Uniform Resource Name location-independent standardized label identifying an object by its
43、name serving as persistent, location-independent resource identifier DIN EN ISO 21549-8:2010-11 EN ISO 21549-8:2010 (E) 6 4 Symbols and abbreviated terms OID Object Identifier URI Uniform Resource Identifier URL Uniform Resource Locator URN Uniform Resource Name XML eXtended Markup Language 5 Requir
44、ements Typically, organisations are using internal data object identification systems for patient data records and images (e.g. DICOM numbering system consisting of an ISO OID organisation code, a local archiving code and accumulative yearly number). The data object identifiers may be globally uniqu
45、e (as DICOM identifiers of studies, series and frames) or locally unique (as laboratory accession numbers). References to these data objects enable access to data objects that cannot be handled by use of the Healthcard itself (e.g. for reasons of timing or storage capacity). The logical structure of
46、 these references should be compatible with the structure of references used in messages sent between healthcare information systems. 6 Structure A link consists of the following data elements (see Figure 1): URI contains the physical reference (e.g. an internet/email address) and the unique ID (OID
47、 or proprietary ID) labelling the referenced data. Description gives a short characterisation of the kind of data. Accessory specifies who stored the data and the date the link was created. Moreover it may contain the author and the date of collection of the data. URI description accessory Reference
48、 Linkage Information Figure 1 Schematic representation of a link URI represents the Reference part of a Link. Additional linkage information is provided by the optional sections description and constraints. The constraints elements are used according to the specification for accessory attributes in
49、ISO 21549-2 of this standard. The proposed structure of healthcard links data area intended for storage of internal and external references is shown below in Figure 2 as UML class diagram. DIN EN ISO 21549-8:2010-11 EN ISO 21549-8:2010 (E) 7 CodingScheme+codeIdentifier : OCTET STRING(SIZE(6) 1+codeLength : INTEGER 1+comment : OCTET STRING(SIZE(20) 01Reference+label : UTF8String 01+language : CodedData 01+use : CodedData 0*+mediaType : CodedData 01+refer
