1、BSI Standards PublicationBS EN ISO 21549-4:2014Health informatics Patienthealthcard dataPart 4: Extended clinical dataCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-
2、BS 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.The UK participation in its preparation was entrusted to TechnicalCommittee IST/35, Health informatics.A list of organi
3、zations 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 for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISB
4、N 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 theStandards Policy and Strategy Committee on 28 February 2014.Amendments issued since publicationDate Text affectedCopyright Bri
5、tish Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21549-4 February 2014 ICS 35.240.80 Supersedes EN ISO 21549-4:2006English
6、Version Health informatics - Patient healthcard data - Part 4: Extended 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 Gesundheitsw
7、esen - Teil 4: Erweiterter Datensatz der klinischen Daten (ISO 21549-4:2014) 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 nati
8、onal standard without any alteration. Up-to-date lists and bibliographical 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 ver
9、sion in any other language made by translation under the responsibility 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,
10、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, Switzerland, Turkey and United Kingdom
11、. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION 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-
12、4:2014 ECopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 21549-4:2014EN ISO 21549-4:2014 (E) 3 Foreword This document (EN ISO 21549-4:2014) has been prepared
13、 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 endorse
14、ment, 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 identifyi
15、ng 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: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republi
16、c, 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. Endorse
17、ment notice The text of ISO 21549-4:2014 has been approved by CEN as EN ISO 21549-4:2014 without any modification. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS
18、EN ISO 21549-4:2014ISO 21549-4:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction vi1 Scope . 12 Normative 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
19、 25.2 Basic data objects for referencing 36 Functional requirements on card information for extended clinical data 46.1 Overview 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 mappe
20、d clinical message. 6Annex A (normative) ASN.1 Data definitions . 8Annex B (informative) Rationale of extended clinical data structure . 9Annex C (informative) Type and subtype of clinical event .14Bibliography .17Copyright British Standards Institution Provided by IHS under license with BSI - Uncon
21、trolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS 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
22、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 and non-governmental, in liaiso
23、n 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 described in the ISO/IEC Direct
24、ives, 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. www.iso.org/directivesAttention is drawn to the possibility that some of th
25、e 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 on the ISO list of patent declarations r
26、eceived. www.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 2154
27、9-4:2006), 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
28、normatively 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 “sh
29、all“ are replaced 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: Ge
30、neral structure 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 reservedCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleN
31、o reproduction or networking permitted without license from IHS-,-,-BS EN ISO 21549-4:2014ISO 21549-4:2014(E) Part 7: Medication data Part 8: Links ISO 2014 All rights reserved vCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reprod
32、uction or networking permitted without license from IHS-,-,-BS EN ISO 21549-4:2014ISO 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 informa
33、tion systems 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 inf
34、ormation 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 identificat
35、ion systems. For instance prescriptions may be automated and data exchange 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 d
36、evices 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, the need has arisen for a standardised data format for interchange.The person related data carried by
37、a data card can be categorised 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 realize that a given healthcare data card “de facto” has to contain device data and identification data an
38、d may in addition contain administrative, clinical, medication and linkage 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 hol
39、der or of all other persons to whom the data carried by the device are related.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 provid
40、e information about health and health 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
41、by avoiding redundancies “high level” Object Modelling Technique (OMT) has 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 u
42、sing UML, plain text and Abstract Syntax Notation (ASN.1).vi ISO 2014 All rights reservedCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 21549-4:2014ISO 215
43、49-4:2014(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 viiCopyright British Standards Institution Provided by IHS under license with BSI - U
44、ncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 21549-4:2014Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-
45、,-,-BS EN ISO 21549-4:2014Health 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
46、cards compliant with 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 facilit
47、ate interoperability, 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 ot
48、her data defined in 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 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 devic
