EN ISO 21549-3-2014 en Health informatics - Patient healthcard data - Part 3 Limited clinical data《健康信息学 病人健康卡数据 第3部分 受限的临床数据(ISO 21549-3 2014)》.pdf

1、BSI Standards PublicationBS EN ISO 21549-3:2014Health informatics Patienthealthcard dataPart 3: Limited clinical dataBS EN ISO 21549-3:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO21549-3:2014. It supersedes BS EN ISO 21549-3:2004 which iswithdrawn.Th

2、e 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 necessaryprovisions of a contract. Users are resp

3、onsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 79144 4ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards

4、 Policy and Strategy Committee on 28 February 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21549-3 February 2014 ICS 35.240.80 Supersedes EN ISO 21549-3:2004English Version Health informatics - Patient healthcard data - Part 3: Li

5、mited clinical data (ISO 21549-3:2014) Informatique de sant - Donnes relatives aux cartes de sant des patients - Partie 3: Donnes cliniques limites (ISO 21549-3:2014) Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 3: Kerndatensatz der klinischen Daten (ISO 21549-3:201

6、4) This European Standard was approved by CEN on 13 December 2013. 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

7、 references concerning such national standards may be obtained on application to the CEN-CENELEC 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 responsibility of

8、 a CEN member into its own language and notified to the CEN-CENELEC 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, Former Yugoslav Republic of Mac

9、edonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EU

10、ROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21549-3:2014 EBS EN ISO 21549-3:2014EN ISO 21549-3:2014 (E) 3 Foreword This docu

11、ment (EN ISO 21549-3:2014) 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, either by pu

12、blication of an identical text or by endorsement, at the latest by August 2014, and conflicting national standards shall be withdrawn at the latest by August 2014. 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

13、 shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 21549-3:2004. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgi

14、um, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzer

15、land, Turkey and the United Kingdom. Endorsement notice The text of ISO 21549-3:2014 has been approved by CEN as EN ISO 21549-3:2014 without any modification. BS EN ISO 21549-3:2014ISO 21549-3:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction vi1 Scope . 12 Normative refer

16、ences 13 Terms and definitions . 24 Symbols and abbreviated terms . 25 Basic data object model for a healthcare data card - Patient healthcard data object structure . 26 Basic data objects for referencing 36.1 Overview 36.2 Coded data 36.3 Device and data security attributes 36.4 Accessory attribute

17、s . 37 Limited clinical data . 47.1 General . 47.2 The limited emergency data set . 47.3 Immunization details. 57.4 Blood grouping and transfusion record 67.5 The extended emergency data set 7Annex A (normative) ASN.1 Data definitions 9Bibliography .11BS EN ISO 21549-3:2014ISO 21549-3:2014(E)Forewor

18、dISO (the International Organization 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

19、 committee has been established 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 elec

20、trotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was d

21、rafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). 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

22、 rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not co

23、nstitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe

24、committee responsible for this document is ISO/TC 215, Health informatics.This second edition cancels and replaces the first edition (ISO 21549-3:2004), which has undergone a minor revision. The following changes have been made. Foreword: mention of CEN collaboration is removed. Scope:. first line i

25、s reworded. Normative references: references that are not cited normatively are moved to the Bibliography. Clause 5: paragraph after Figure 1 is reworded. Subclause 7.1: last sentence before Figure 2 is reworded. Clauses 6, and 7: the figures are renumbered sequentially and references to figures and

26、 tables are added. Clause 7: the class ExtendedEmergencyData is moved from Part 4 to Part 3. Bibliography: dates from the references are removed where not applicable.ISO 21549 consists of the following parts, under the general title Health informatics Patient healthcard data: Part 1: General structu

27、re Part 2: Common objects Part 3: Limited clinical data Part 4: Extended clinical data Part 5: Identification dataiv ISO 2014 All rights reservedBS EN ISO 21549-3:2014ISO 21549-3:2014(E) Part 6: Administrative data Part 7: Medication data Part 8: Links ISO 2014 All rights reserved vBS EN ISO 21549-3

28、:2014ISO 21549-3:2014(E)IntroductionWith a more mobile population, greater healthcare delivery in 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 devic

29、es 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 person-identifiable information between themselves and other systems; therefore, during their operat

30、ional lifetime they may share information with many technologically different systems which differ greatly in their functions and capabilities.Healthcare administration increasingly relies upon similar automated identification systems. For instance prescriptions may be automated and data exchange ca

31、rried out at a number of sites using patient transportable computer readable devices. Healthcare insurers and providers are increasingly involved in cross-region care, where reimbursement may require automated data exchange between dissimilar healthcare systems.The advent of remotely accessible data

32、bases and support systems has led to the development 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, th

33、e need has arisen for a standardized data format for interchange.The person-related data carried by a data card can be categorized in three broad types: identification (of the device itself and the individual to whom the data it caries relates), administrative and clinical. It is important to realiz

34、e that a given healthcare data card “de facto” has to contain device data and identification data and may in addition contain administrative, clinical, prescription and linkage data.Device data are defined to include: identification of the device itself; identification of the functions and functioni

35、ng capabilities of the device.Identification data may include: unique identification of the device holder or of all other persons to whom the data carried by the device are related.Administrative data may include: complementary person(s) related data; identification of the funding of healthcare, whe

36、ther public or private, and their relationships i.e. insurer(s), contract(s) and policy(ies) or types of benefits ; other data (distinguishable from clinical data) that are necessary for the purpose of healthcare delivery.Clinical data may include: items that provide information about health and hea

37、lth events; their appraisal and labelling by a healthcare provider (HCP); related actions planned requested or performed.Because a data card essentially provides specific answers to definite queries while having at the same time a need to optimize the use of memory by avoiding redundancies, “high le

38、vel” Object Modelling Technique (OMT) has been applied with respect to the definition of healthcare data card data structures.vi ISO 2014 All rights reservedBS EN ISO 21549-3:2014ISO 21549-3:2014(E)This part of ISO 21549 describes and defines the Limited Clinical Data objects used within or referenc

39、ed 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 part of ISO 21549. ISO 2014 All rights reserved v

40、iiBS EN ISO 21549-3:2014BS EN ISO 21549-3:2014Health informatics Patient healthcard data Part 3: Limited clinical data1 ScopeThis part of ISO 21549 is applicable to situations in which limited clinical data are recorded on or transported by patient healthcards compliant with the physical dimensions

41、of ID-1 cards defined by ISO/IEC 7810.This part of ISO 21549 describes and defines the limited clinical data objects used in or referenced by patient healthcards using UML, plain text and abstract syntax notation (ASN.1).This part of ISO 21549 specifies the basic structure of the data contained with

42、in the data object limited clinical data, but does not specify or mandate particular data sets for storage on devices. In particular the data contained within the data objects in limited clinical data are intended to aid the delivery of emergency care, while being by themselves neither intended, nor

43、 fit for purpose, for the total of information provision for the delivery of emergency care.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 enc

44、oding of free text data; security functions and related services which are likely to be specified by users for data cards depending on their specific application, for example: confidentiality protection, data integrity protection, and authentication of persons and devices related to these functions;

45、 access control services which may depend on active use of some data card classes such as microprocessor cards; the initialisation 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

46、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 cards; how the message is processed further “downstream” of the interface between two syst

47、ems; the form which data takes for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application.

48、 For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 21549-1, Health informatics Patient healthcard data Part 1: General structureISO 21549-2, Health informatics Patient healthcard data Par

49、t 2: Common objectsINTERNATIONAL STANDARD ISO 21549-3:2014(E) ISO 2014 All rights reserved 1BS EN ISO 21549-3:2014ISO 21549-3:2014(E)3 Terms and definitionsFor the purposes of this document the terms and definitions given in ISO 21549-1 and ISO 21549-2 and the following apply:3.1confidentialityproperty that information is not made available or disclosed to unauthorized individuals, entities or processesSOURCE: ISO 7498-2:1989, definition 3.3.163.2data origin authenticationcorroboration that the source of da