1、BSI Standards PublicationBS EN ISO 21549-1:2013Health informatics Patient healthcard dataPart 1: General structureBS EN ISO 21549-1:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO21549-1:2013. It supersedes BS EN ISO 21549-1:2004 which iswithdrawn.The U
2、K 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 respons
3、ible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 76632 9ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Po
4、licy and Strategy Committee on 31 July 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21549-1 June 2013 ICS 35.240.80 Supersedes EN ISO 21549-1:2004English Version Health informatics - Patient healthcard data - Part 1: General struc
5、ture (ISO 21549-1:2013) Informatique de sant - Donnes relatives aux cartes de sant des patients - Partie 1: Structure gnrale (ISO 21549-1:2013) Medizinische Informatik - Patientendaten auf Karten im Gesundheitswesen - Teil 1: Allgemeiner Aufbau (ISO 21549-1:2013) This European Standard was approved
6、by CEN on 2 June 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 standar
7、ds 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 noti
8、fied 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, Hungary, Ic
9、eland, 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 Management Cent
10、re: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21549-1:2013: EBS EN ISO 21549-1:2013EN ISO 21549-1:2013 (E) 3 Foreword This document (EN ISO 21549-1:2013) has been prepared by Technic
11、al 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 th
12、e latest by December 2013, and conflicting national standards shall be withdrawn at the latest by December 2013. 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 any
13、or all such patent rights. This document supersedes EN ISO 21549-1:2004. 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 Republic, Denm
14、ark, 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. Endorsement no
15、tice The text of ISO 21549-1:2013 has been approved by CEN as EN ISO 21549-1:2013 without any modification. BS EN ISO 21549-1:2013ISO 21549-1:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Symbols and abbr
16、eviated terms . 25 Basic data object model for a healthcare data card Patient healthcard data object structure . 25.1 Overview 25.2 Device data . 25.3 Identification data 25.4 Administrative data 35.5 Clinical data . 35.6 Links . 35.7 Medication data 35.8 Patient healthcard security data 3Bibliograp
17、hy 4BS EN ISO 21549-1:2013ISO 21549-1:2013(E)ForewordISO (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 membe
18、r 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, also take part in the work. ISO collaborates closely with the International Elec
19、trotechnical Commission (IEC) on all matters of electrotechnical standardization.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
20、 by the technical committees are circulated to the member bodies for voting. Publication 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 r
21、ights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 21549-1 was prepared by Technical Committee ISO/TC 215, Health informatics.This second edition cancels and replaces the first edition (ISO 21549-1:2004), which has undergone a minor revision. The following cha
22、nges have been made. Foreword: the title of Part 7 was changed to “Medication data”. Scope: the restriction “This part does not apply to multi-application cards” was deleted and other wording was improved. Normative references: ISO 21549, Parts 2 to 8, were added. Clause 5: the title of ISO 21549-7
23、was changed to “Medication data” in the text and in Figure 1, and references to ISO 21549, Parts 2 to 7, were reworded to shorten them.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
24、3: Limited clinical data Part 4: Extended clinical data Part 5: Identification data Part 6: Administrative data Part 7: Medication data Part 8: Linksiv ISO 2013 All rights reservedBS EN ISO 21549-1:2013ISO 21549-1:2013(E)IntroductionWith a more mobile population, greater healthcare delivery in the c
25、ommunity 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 devices are used for tasks ranging from identification, through portable medical records, and on to patient-
26、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 operational lifetime they may share information with many technologically different systems which differ greatly i
27、n their functions and capabilities.Healthcare administration increasingly relies upon similar automated identification systems. For instance prescriptions may be automated and data exchange carried out at a number of sites using patient-transportable computer readable devices. Healthcare insurers an
28、d providers are increasingly involved in cross-region care, where reimbursement may require automated data exchange between dissimilar healthcare systems.The advent of remotely accessible databases and support systems has led to the development and use of “Healthcare Person” identification devices t
29、hat 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, the need has arisen for a standardized data format for interchange.The person-related data carried by a data c
30、ard can be categorized in three broad types: identification (of the device itself and the individual to whom the data it carries relate), 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
31、 addition contain administrative and clinical 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 t
32、o whom the data carried by the device are related.Administrative data may include: complementary person(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 (dis
33、tinguishable 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 labelling by a healthcare provider (HCP); related actions planned, requested or performed.Because a
34、 data card essentially provides specific answers to definite queries while at the same time there is a need to optimize the use of memory by avoiding redundancies, “high level” Object Modelling Technique (OMT) has been applied with respect to the definition of healthcare data card data structures. I
35、SO 2013 All rights reserved vBS EN ISO 21549-1:2013ISO 21549-1:2013(E)Data in the four categories above share 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 in
36、adequate to provide a simple list of items carried by healthcare data cards without applying a generic organization, 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 suc
37、h objects may also share attributes.vi ISO 2013 All rights reservedBS EN ISO 21549-1:2013INTERNATIONAL STANDARD ISO 21549-1:2013(E)Health informatics Patient healthcard data Part 1: General structure1 ScopeThis part of ISO 21549 defines a general structure for the different types of data to be defin
38、ed in other parts of ISO 21549 using UML notation. ISO 21549 defines data structures held on patient healthcards compliant with the physical dimensions of ID-1 cards, as defined by ISO/IEC 7810.2 Normative referencesThe following referenced documents are indispensable for the application of this doc
39、ument. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO/IEC 7810, Identification cards Physical characteristicsISO 21549-2, Health informatics Patient healthcard data Part 2: Common obje
40、ctsISO 21549-3, Health informatics Patient healthcard data Part 3: Limited clinical dataISO 21549-4, Health informatics Patient healthcard data Part 4: Extended clinical dataISO 21549-5, Health informatics Patient healthcard data Part 5: Identification dataISO 21549-6, Health informatics Patient hea
41、lthcard data Part 6: Administrative dataISO 21549-7, Health informatics Patient healthcard data Part 7: Medication dataISO 21549-8, Health informatics Patient healthcard data Part 8: Links3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1data obje
42、ctcollection of data that has a natural grouping and may be identified as a complete entity3.2healthcare data cardcard conformant to ISO 7816 (all parts) intended for use within the healthcare domain3.3patient healthcardhealthcare data card containing data related to a unique record person intended
43、for use within the healthcare domainNote 1 to entry: The term “patient” is not intended to determine that the record person is currently a subject of care.3.4recordcollection of data ISO 2013 All rights reserved 1BS EN ISO 21549-1:2013ISO 21549-1:2013(E)3.5record personindividual about whom there is
44、 an identifiable record containing person-related data4 Symbols and abbreviated termsUML Unified Modelling Language5 Basic data object model for a healthcare data card Patient healthcard data object structure5.1 OverviewA set of basic data objects have been designed to facilitate the storage of clin
45、ical data in a flexible structure, allowing for future application-specific enhancements. These tools should help the implementation of common accessory characteristics of stored data in a way that allows efficient use of memory, an important feature for many types of data cards.The classes shown in
46、 Figure 1 are defined in ISO 21549, Parts 2 to 8.Figure 1 Patient healthcard data: Overall structureThe content of this object-oriented structure is described below and intrinsically will also require the use of data objects defined within other parts of ISO 21549.NOTE This part of ISO 21549 is pure
47、ly applicable to patient healthcards containing health data. Data objects containing financial and healthcare reimbursement data are not defined within this part of ISO 21549.5.2 Device dataThis data object incorporates data specific to the device which is the patient data card itself. For instance,
48、 if the card is a “smart card”, this data object incorporates the unique identifiers of the manufacturers, the chip manufacturers, the card personalizers and the unique identifier of the device itself, as well as other pertinent data. This data object is technology specific and, as such, falls outsi
49、de the scope of this part of ISO 21549.5.3 Identification dataThis data object, as defined in ISO 21549-5, incorporates data that provide for the unique identification of the holder to whom the records relate.NOTE In some circumstances a “patient” data card may (in the case of a family insurance card) contain records related to more than one individual.2 ISO 2013 All rights reservedBS EN ISO 21549-1:2013ISO 21549-1:2013(E)5.4 Administrative dataThis data object, as defined in ISO 21549-6, inco
