EN ISO 21549-4-2014 en Health informatics - Patient healthcard data - Part 4 Extended clinical data《健康信息学 病人健康卡数据 第4部分 开放临床数据(ISO 21549-4 2014)》.pdf

1、BSI Standards PublicationBS EN ISO 21549-4:2014Health informatics Patienthealthcard dataPart 4: Extended clinical dataBS EN ISO 21549-4:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO21549-4:2014. It supersedes BS EN ISO 21549-4:2006 which iswithdrawn.T

2、he 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 res

3、ponsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 79146 8ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandard

4、s Policy and Strategy Committee on 28 February 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21549-4 February 2014 ICS 35.240.80 Supersedes EN ISO 21549-4:2006English Version Health informatics - Patient healthcard data - Part 4: E

5、xtended clinical data (ISO 21549-4:2014) Informatique de sant - Donnes relatives aux cartes de sant des patients - Partie 4: Donnes cliniques tendues (ISO 21549-4:2014) Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 4: Erweiterter Datensatz der klinischen Daten (ISO 2

6、1549-4:2014) 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 bibli

7、ographical 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 respons

8、ibility of 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 Repub

9、lic of Macedonia, 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 NORMAL

10、ISATION EUROPISCHES 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 21549-4:2014 EBS EN ISO 21549-4:2014EN ISO 21549-4:2014 (E) 3 Foreword

11、 This document (EN ISO 21549-4:2014) 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, ei

12、ther by publication 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/

13、or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 21549-4:2006. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Aust

14、ria, Belgium, 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, Swede

15、n, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 21549-4:2014 has been approved by CEN as EN ISO 21549-4:2014 without any modification. BS EN ISO 21549-4:2014ISO 21549-4:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction vi1 Scope . 12 Norma

16、tive references 13 Terms and definitions . 24 Symbols and abbreviated terms . 25 Basic data object model for a healthcare data card . 25.1 Patient HDC data object structure 25.2 Basic data objects for referencing 36 Functional requirements on card information for extended clinical data 46.1 Overview

17、 of supported uses 46.2 Clinical message transfer between healthcare parties . 47 Extended clinical data . 47.1 General . 47.2 The clinical event description 57.3 The mapped clinical message. 6Annex A (normative) ASN.1 Data definitions . 8Annex B (informative) Rationale of extended clinical data str

18、ucture . 9Annex C (informative) Type and subtype of clinical event .14Bibliography .17BS EN ISO 21549-4:2014ISO 21549-4:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Internatio

19、nal Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO

20、, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part

21、 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention is drawn to the possibility that some of the elements

22、 of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent 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. w

23、ww.iso.org/patentsAny trade name used in this document is information given for the convenience of users and does not constitute an endorsement.The committee responsible for this document is ISO/TC 215, Health informatics.This second edition cancels and replaces the first edition (ISO 21549-4:2006),

24、 which has undergone a minor revision. The following changes have been made. Foreword: mention of CEN collaboration is removed. Scope: first paragraph is reworded. Scope: requirements “shall“ are replaced by “are“ in the third paragraph. Normative references: references that are not cited normativel

25、y are moved to the Bibliography. Terms and definitions, subclause 3.1: the second sentence is removed. Clause 5: paragraph after Figure 1 is reworded. Clause 7: references to figures and tables are added; the class ExtendedEmergencyData is moved to Part 3. Annexes B and C: requirements “shall“ are r

26、eplaced by “should“. Annex B, subclause B.2: syntax errors are corrected. Bibliography: created to list all the documents cited that are not in the normative references.ISO 21549 consists of the following parts, under the general title Health informatics Patient healthcard data: Part 1: General stru

27、cture Part 2: Common objects Part 3: Limited clinical data Part 4: Extended clinical data Part 5: Identification data Part 6: Administrative dataiv ISO 2014 All rights reservedBS EN ISO 21549-4:2014ISO 21549-4:2014(E) Part 7: Medication data Part 8: Links ISO 2014 All rights reserved vBS EN ISO 2154

28、9-4:2014ISO 21549-4:2014(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 de

29、vices 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 ope

30、rational 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

31、 carried out at a number of sites using patient transportable computer readable devices.The advent of remotely accessible databases 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 digit

32、al signatures to remote systems via networks.With the growing use of data cards for practical everyday healthcare delivery, the need has arisen for a standardised data format for interchange.The person related data carried by a data card can be categorised in three broad types: identification (of th

33、e device itself and the individual to whom the data it caries relates), administrative and clinical. It is important to realize that a given healthcare data card “de facto” has to contain device data and identification data and may in addition contain administrative, clinical, medication and linkage

34、 data.Device data are defined to include: identification of the device itself; identification of the functions and functioning 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 rel

35、ated.Administrative data may include: complementary person(s) related data; 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 health events; their appraisal and labellin

36、g 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 level” Object Modelling Technique (OMT) has

37、 been applied with respect to the definition of healthcare data card data structures.This part of ISO 21549 describes and defines the Extended Clinical Data objects used within or referenced by patient held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).vi ISO 2014 All

38、rights reservedBS EN ISO 21549-4:2014ISO 21549-4:2014(E)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 viiBS EN ISO 21549-4:2014BS EN ISO 21549-

39、4:2014Health informatics Patient healthcard data Part 4: Extended clinical data1 ScopeThis part of ISO 21549 is applicable to situations in which clinical data additional to the limited clinical data defined in ISO 21549-3 is recorded on or transported by patient healthcare data cards compliant with

40、 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 extended clinical data, but does not specify or mandate particular data sets for storage on devices.In order to facilitate interoperability

41、, 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 are drawn from the list of objects (some of which are extensible) as provided in Clause 5. These are used in conjunction with other data defined in

42、other parts of this International Standard.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. Security functions and r

43、elated 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. Access control services which may depend on acti

44、ve 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 to it according to this part of ISO 21549).The fo

45、llowing 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 systems; the form which data takes for use outside the

46、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. For dated references, only the edition cited appli

47、es. 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 Part 2: Common objectsISO 21549-3, Health informatics

48、Patient healthcard data Part 3: Limited clinical dataINTERNATIONAL STANDARD ISO 21549-4:2014(E) ISO 2014 All rights reserved 1BS EN ISO 21549-4:2014ISO 21549-4:2014(E)3 Terms and definitionsFor the purposes of this document the terms and definitions given in ISO 21549-1, ISO 21549-2, ISO 21549-3 and

49、 the following apply.3.1clinical informationinformation about a patient, relevant to the health or treatment of that patient, that is recorded by or on behalf of a healthcare professionalSOURCE: ENV 16133.5healthcare partyorganization or person responsible for the direct or indirect provision of healthcare to an individual, or involved in the provision of healthcare-related servicesSOURCE: ENV 16133.9relaying agentparty agreed to be acting as an intermediary, communicating messages between the reques