1、BSI Standards PublicationBS EN ISO 21549-2:2014Health informatics Patienthealthcard dataPart 2: Common objectsBS EN ISO 21549-2:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO21549-2:2014. It supersedes BS EN ISO 21549-2:2004 which iswithdrawn.The UK pa
2、rticipation 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 responsible
3、 for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 79149 9ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy
4、 and Strategy Committee on 28 February 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21549-2 February 2014 ICS 35.240.80 Supersedes EN ISO 21549-2:2004English Version Health informatics - Patient healthcard data - Part 2: Common ob
5、jects (ISO 21549-2:2014) Informatique de sant - Donnes relatives aux cartes de sant des patients - Partie 2: Objets communs (ISO 21549-2:2014) Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 2: Gemeinsame Elemente (ISO 21549-2:2014) This European Standard was approved
6、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 references concerning such national st
7、andards 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 a CEN member into its own language and
8、 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 Macedonia, France, Germany, Greece, Hungar
9、y, 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 EUROPISCHES KOMITEE FR NORMUNG CEN-CENELE
10、C 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 21549-2:2014 EBS EN ISO 21549-2:2014EN ISO 21549-2:2014 (E) 3 Foreword This document (EN ISO 21549-2:2014) has been pre
11、pared 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 publication of an identical text or by en
12、dorsement, 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 shall not be held responsible for iden
13、tifying any or all such patent rights. This document supersedes EN ISO 21549-2:2004. 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, Croatia, Cyprus, Czech Re
14、public, 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, Switzerland, Turkey and the United Kingdom. En
15、dorsement notice The text of ISO 21549-2:2014 has been approved by CEN as EN ISO 21549-2:2014 without any modification. BS EN ISO 21549-2:2014ISO 21549-2:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14 Sym
16、bols and abbreviated terms . 35 Basic data object model for a healthcare data card - Patient healthcard data object structure . 36 Basic data objects for referencing 36.1 Overview 36.2 Internal links . 46.3 Coded data 46.4 Accessory attributes . 67 Device and data security attributes 97.1 General .
17、97.2 Specific data cards security services-related data objects . 9Annex A (normative) ASN.1 data definitions 13Bibliography .15BS EN ISO 21549-2:2014ISO 21549-2:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member
18、 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 established has the right to be represented on that committee. International organizations, governmental
19、 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.The procedures used to develop this document and those intended for its further maintenance are
20、 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 drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives). Attention is d
21、rawn 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 rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or o
22、n 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 constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assess
23、ment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information.The committee responsible for this document is ISO/TC 215, Health informatics.This second edition cancels and replaces the firs
24、t edition (ISO 21549-2:2004), which has undergone a minor revision. The following changes have been made. Foreword: mention of CEN collaboration is removed. Scope: first paragraph is reworded. Normative references: references that are not cited normatively are moved to the Bibliography. Terms and de
25、finitions: unused terms are removed. Symbols and abbreviated terms: unused abbreviated terms are removed. Subclause 6.3.2, Table 2: data type of codeIdentifier is corrected to match ASN.1 definition. Clauses 5, 6, and 7: the figures and tables are renumbered sequentially, references to the figures a
26、nd tables are added. 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 structure Part 2: Common objects Part 3: Limited clinical data Part 4: Extended
27、 clinical data Part 5: Identification dataiv ISO 2014 All rights reservedBS EN ISO 21549-2:2014ISO 21549-2:2014(E) Part 6: Administrative data Part 7: Medication data Part 8: Links ISO 2014 All rights reserved vBS EN ISO 21549-2:2014ISO 21549-2:2014(E)IntroductionThis part of ISO 21549 provides data
28、 structures and definitions for limited clinical data for use within patient-held healthcare data cards.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 care, portable information syst
29、ems 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 person-identifiable information
30、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 similar automated identification syste
31、ms. For instance prescriptions may be automated and data exchange carried 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
32、dissimilar healthcare systems.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 and transmit digital signatures to remote systems via networks.With the gro
33、wing 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 categorized in three broad types: identification (of the device itself and the individual to whom the data it ca
34、rries 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, prescription and linkage data.Device data is defined to include: identificatio
35、n 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 related.Administrative data may include: complementary per
36、son(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; other data (distinguishable from clinical data) that are necessary for the purpose of healthcare delivery.Clinical d
37、ata may include: items that provide information about health and health events; their appraisal and labeling by a healthcare provider (HCP); related actions planned requested or performed.vi ISO 2014 All rights reservedBS EN ISO 21549-2:2014ISO 21549-2:2014(E)Because a data card essentially provides
38、 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 Modeling Technique (OMT) has been applied with respect to the definition of healthcare data card data structures.Data in the four categories above sh
39、are many features. For instance, each may need to include ID numbers, names and dates. Some information may also have clinical as well as administrative uses. Therefore it has been considered inadequate to provide a simple list of items carried by healthcare data cards without applying a generic org
40、anization, based upon the existence of basic data elements. These may be defined by their characteristics (e.g. their format), and from them compound data objects may be constructed; several such objects may also share attributes.This part of ISO 21549 describes and defines the Common Data objects u
41、sed within or referenced by patient held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).These data objects are utilized in all forms of healthcare data cards and are used to construct compound data objects as defined in Parts 3 to 8 of ISO 21549. ISO 2014 All rights res
42、erved viiBS EN ISO 21549-2:2014BS EN ISO 21549-2:2014Health informatics Patient healthcard data Part 2: Common objects1 ScopeThis part of ISO 21549 establishes a common framework for the content and the structure of common objects used to construct data held on patient healthcare data cards. It is a
43、lso applicable to common objects referenced by other data objects.This part of ISO 21549 is applicable to situations in which such data is 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 t
44、he basic structure of the data, but does 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 spe
45、cified): the encoding 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
46、these functions; access control services which may depend 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 subsequent
47、ly communicated 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 be
48、tween two systems; the form which data takes for use outside the data card, or the way in which such data is 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
49、 application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 21090:2011, Health informatics Harmonized data types for information interchange3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.INTERNATIONAL STANDARD ISO 21549-2:2014(E) ISO 2014 All rights reserved 1BS EN ISO 21549-2:2014ISO 21549-2:2014(E)3.1countrycode that identifies the country of ori
