1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 21549-8:2010Health informatics Patienthealthcard dataPart 8: Links (ISO 21549-8:2010)BS EN ISO 21549-8:2010 BRITISH STANDARDNational forewordThis British Standard is th
2、e UK implementation of EN ISO21549-8:2010.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the neces
3、saryprovisions of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 58202 8ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Commi
4、ttee on 31 July 2010Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21549-8 June 2010 ICS 35.240.80 English Version Health informatics - Patient healthcard data - Part 8: Links (ISO 21549-8:2010) Informatique de sant - Donnes relatives au
5、x cartes de sant des patients - Partie 8: Liens (ISO 21549-8:2010) Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 8: Verweise (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 Reg
6、ulations 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 CEN Management Centre or to any CEN member. Thi
7、s 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 CEN Management Centre has the same status as the official versions. CEN members are
8、the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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,
9、 Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue 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
10、. No. EN ISO 21549-8:2010: EBS EN ISO 21549-8:2010EN ISO 21549-8:2010 (E) 3 Foreword This document (EN ISO 21549-8:2010) 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
11、 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 2010, and conflicting national standards shall be withdrawn at the latest by December 2010. Attention is drawn to the possibility
12、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 organizations of the following countries are bound
13、 to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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, Sw
14、eden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21549-8:2010 has been approved by CEN as a EN ISO 21549-8:2010 without any modification. BS EN ISO 21549-8:2010ISO 21549-8:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normativ
15、e references1 3 Terms and definitions .1 4 Abbreviated terms .2 5 Requirements.2 6 Structure.2 Annex A (normative) ASN.1 data definitions .5 Annex B (informative) Examples .7 Bibliography9 BS EN ISO 21549-8:2010ISO 21549-8:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organi
16、zation for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been establishe
17、d has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
18、International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Pub
19、lication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent
20、 rights. ISO 21549-8 was prepared by Technical Committee ISO/TC 215, Health informatics. ISO 21549 consists of the following parts, under the general title Health informatics Patient healthcard data: Part 1: General structure Part 2: Common objects Part 3: Limited clinical data Part 4: Extended clin
21、ical data Part 5: Identification data Part 6: Administrative data Part 7: Medication data Part 8: Links BS EN ISO 21549-8:2010ISO 21549-8:2010(E) ISO 2010 All rights reserved vIntroduction The ISO 21549 series of International Standards is intended to replace the European Prestandard ENV 12018 adopt
22、ed by CEN in 1995. This series of International Standards provides data structures and definitions for data objects 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. Typi
23、cally, a patients health history consists of many service episodes distributed over time and space. Sometimes patients 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. T
24、hus the patients health data is distributed more and more over specialities and space inside one country and also worldwide. Patients 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 simulta
25、neously see and edit a patient record from remote locations. This requires on the one hand, information systems that are able to communicate and, on the other hand, standardized methods to locate the information. The Internet, which is able to distribute information to geographically-distant users,
26、offers a securable technological solution for handling electronic patient records. However, it is necessary to access the data required in 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
27、a mass of irrelevant information whenever and wherever needed. Patient data are especially sensitive and a secure basic infrastructure is absolutely necessary. Therefore, besides the secure transmission of data, the persons handling the record, for example health professionals and/or the patients ha
28、ve to be identified and authenticated. Further services like integrity and privacy protection, accountability, accessibility etc. need to 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 en
29、able authentication for data on the card and can also provide links to several additional data objects stored elsewhere. Health cards 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 syst
30、ems. BS EN ISO 21549-8:2010BS EN ISO 21549-8:2010INTERNATIONAL STANDARD ISO 21549-8:2010(E) ISO 2010 All rights reserved 1Health informatics Patient healthcard data Part 8: Links 1 Scope This part of ISO 21549 defines a way to facilitate access to distributed patient records and/or administrative in
31、formation 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 mechanisms, access methods and other security servi
32、ces 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 edition of the referenced document (includin
33、g any amendments) applies. ISO 21549-2, Health informatics Patient healthcard data Part 2: Common objects ISO 21549-4, Health informatics Patient healthcard data Part 4: Extended clinical data HL7v3, Health Level Seven Messaging Standard Version 3, Normative Edition 2006 IETF RFC 3986, Uniform Resou
34、rce 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 record 3.2 linkage information data set that provides t
35、he complete information to locate the resource of a certain part of a distributed record 3.3 ISO OID organization code unique worldwide organization code defined and managed following the ISO/IEC 9834 series of International Standards 3.4 Uniform Resource Identifier compact sequence of characters wh
36、ich identifies an abstract or physical resource BS EN ISO 21549-8:2010ISO 21549-8:2010(E) 2 ISO 2010 All rights reserved3.5 Uniform Resource Locator standardized address used for referring to resources by their location 3.6 Uniform Resource Name location-independent standardized label identifying an
37、 object by its name serving as persistent, location-independent resource identifier 4 Abbreviated terms OID Object Identifier URI Uniform Resource Identifier URL Uniform Resource Locator URN Uniform Resource Name XML eXtended Markup Language 5 Requirements Typically, organizations are using internal
38、 data object identification systems for patient data records and images (e.g. DICOM numbering system consisting of an ISO OID organization code, a local archiving code and accumulative yearly number). The data object identifiers may be globally unique (as DICOM identifiers of studies, series and fra
39、mes) 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 these references should be compatible with the st
40、ructure 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 or proprietary ID) labelling the referenced data.
41、 Description gives a short characterization 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 Linkage information Figure 1 Schematic representa
42、tion 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 ISO 21549-2. BS EN ISO 21549-8:2010ISO 21549-8:20
43、10(E) ISO 2010 All rights reserved 3The proposed structure of healthcard links data area intended for storage of internal and external references is shown below in Figure 2 as a UML class diagram. +codeIdentifier : OCTET STRING(SIZE(6) 1+codeLength : INTEGER 1+comment : OCTET STRING(SIZE(20) 01Codin
44、gScheme+language : CodedData 01+use : CodedData 0*+mediaType : CodedData 01+reference : URI 0*+description : UTF8String 01+useablePeriod 0*+sizeReferenced : CodedData 01+purpose : CodedData 01+accessConditions : UTF8String 01ReferenceCodingSchemesUsedAccessoryAttributesReferencesLinks+schemeReferenc
45、e01101011*011*Figure 2 Patient healthcard links data structure This structure extends the structure of the object links defined in ISO 21549-2 with the following two optional objects. Object CodingSchemesUsed is defined in ISO 21549-2. It contains the identifiers and the short descriptions of the co
46、ding schemes used in the other parts of ISO 21549. Object References contains references to external data objects which may be complemented by a concise characterization of the kind of data and the AccessoryAttributes as specified in ISO 21549-2. Due to the different usage, references can be divided
47、 into the two subtypes: relay and standalone. Reference of type relay provides a kind of extension point for data objects stored on the healthcard itself. If there are additional data for a ClinicalEvent data object specified in ISO 21549-4 available from an external source, this can be referenced b
48、y use of an object Reference. A standalone reference is independent from other data objects on the healthcard and may be used discretely. The structure of the object Reference is derived from data type Encapsulated Data defined in Health Level Seven Reference Information Model and used in Health Lev
49、el Seven Clinical Document Architecture, Release Two. The attribute description is of type CWE (HL7 “Code With Exception”) and allows to have code only, code with text or text only. BS EN ISO 21549-8:2010ISO 21549-8:2010(E) 4 ISO 2010 All rights reservedTable 1 The specification of individual entities within object Reference Object name Object Type Multiplicity Comments label String 01 Information of the referenced data for display purposes (man-machine interface).
