1、BS EN ISO 21549-7:2016Health informatics Patienthealthcard dataPart 7: Medication data (ISO 21549-7:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 21549-7:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 2
2、1549-7:2016. It supersedes BS EN ISO 21549-7:2007 which iswithdrawn.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purp
3、ort to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82702 0 ICS 35.240.80 Compliance with a British Standard cannot confer immunity from legal obliga
4、tions.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21549-7 December 2016 ICS 35.240.80 Supe
5、rsedes EN ISO 21549-7:2007English Version Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2016) Informatique de sant - Donnes relatives aux cartes de sant des patients - Partie 7: Donnes de mdication (ISO 21549-7:2016) Medizinische Informatik - Patientendaten auf
6、Karten im Gesundheitswesen - Teil 7: Medikationsdaten (ISO 21549-7:2016) This European Standard was approved by CEN on 12 December 2016. 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
7、 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 version
8、 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, Czec
9、h 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. EU
10、ROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21549-7:20
11、16 EBS EN ISO 21549-7:2016EN ISO 21549-7:2016 (E) 3 European foreword This document (EN ISO 21549-7:2016) 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 E
12、uropean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by June 2017, and conflicting national standards shall be withdrawn at the latest by June 2017. Attention is drawn to the possibility that some of the elemen
13、ts of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 21549-7:2007. This document has been prepared under a mandate given to CEN by the European Commission and the Europ
14、ean Free Trade Association. 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, Denmark, Estonia, Finland, Former Yugoslav Republ
15、ic 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 notice The text of ISO 21549-7:2016 has been ap
16、proved by CEN as EN ISO 21549-7:2016 without any modification. BS EN ISO 21549-7:2016ISO 21549-7:2016(E)Foreword ivIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 24 Abbreviated terms 55 Basic data object model for a healthcare data card . 65.1 Patient healthcard data obj
17、ect structure 65.2 Basic data objects for referencing 65.2.1 Overview . 65.2.2 Coded data . 65.3 Device and data security attributes 75.4 Accessory attributes . 76 Functional requirements on card information for prescriptions . 76.1 Overview of supported uses 76.2 Carry a prescription from prescribe
18、r to the dispenser 76.2.1 General 76.2.2 Prescription set . 86.2.3 Who . 86.2.4 What . 86.2.5 Times 96.2.6 How . 96.3 Card information on dispensed prescriptions . 96.4 Medication notes . 97 Medication data 107.1 General 107.2 “MedicationNotes” class. 117.2.1 General. 117.2.2 “MedicationHistory” cla
19、ss . 127.2.3 “MedicationRelevantCharacteristics” class 137.2.4 “KnownMedicationRisks” class 147.3 “MedicationPrescriptions” class . 157.4 “MedicationsDispensed” data object 237.5 MedicationReferences . 30Annex A (normative) ASN.1 data definitions 32Annex B (informative) Example of medication notes .
20、48Bibliography .50 ISO 2016 All rights reserved iiiContents PageBS EN ISO 21549-7:2016ISO 21549-7:2016(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 norma
21、lly 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, also take part in th
22、e 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 1. In particular the
23、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 drawn to the possibility that some of the elements of this documen
24、t 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 (see www.iso.org/p
25、atents).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 assessment, as well as information about ISOs adherence to the World Tra
26、de Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 215, Health informatics.This second edition cancels and replaces the first edition (ISO 21549-7:2007), which has been t
27、echnically revised with the following changes: medication notes definition in Clause 1 is modified; the list of definitions in Clause 3 is shortened and several definitions are corrected and clarified; the list of abbreviation in Clause 4 is shortened; an explanation is added in 5.1 why MedicationDa
28、ta is modelled as a direct child of the PatientHealthcardData; “healthcare person” in 6.2.3 is replaced by “healthcare professional”; “factor of the quantity” in 6.2.4 is replaced by “quantity units”; “medication history” in 6.4 is changed to “medication notes” in the title and an explanation of a m
29、ajor use is modified; in Clause 7, all the names of attributes in the tables are harmonized with the class diagrams. The term “data object” is replaced by “class”. Additional comments are included in the tables. For implementers convenience, the fragments of ASN.1 definitions are gathered together i
30、n the new Annex A; explanation of MedicationNotes in 7.2.1 is modified; comments in Table 3 are modified; comments in Table 4 are modified; comments in Table 5 are modified; Example in 7.2.5 is moved to informative Annex B;iv ISO 2016 All rights reservedBS EN ISO 21549-7:2016ISO 21549-7:2016(E) Figu
31、res 7 and 8 are merged. Class “Prescriber” is defined as an attribute. The attribute “qualification” is replaced by the attribute “qualifier” having datatype “CodedData”. The attribute “medicinalProduct” is renamed as “prescribedMedicinalProduct”. The class “MedicinalProduct” is renamed as “Prescrib
32、edMedicinalProduct”. The class “ManufacturedMedicinalProduct” is renamed as “PrescribedManufacturedMedicinalProduct”. The class “MagistralMedicinalProduct” is renamed as “PrescribedMagistralMedicinalProduct”. Datatype of the attribute “strength” is replaced by “Strength”, the definition of this new
33、datatype is added. Datatype of the attribute “quantityOfMedicinalProduct” is replaced by “Quantity”. Datatype of the attribute “amountOfIngredient” is replaced by “Amount”. The class “AmountOfIngredient” is replaced by the class “Amount”; Figures 17 and 18 are merged. Class “Dispenser” is defined as
34、 an attribute. The attribute “dispensedMedicinalCode” is replaced by the attribute “dispensedMedicinalProduct” having new datatype “DispensedMedicinalProduct”. This new datatype is a generalization of the classes “DispensedManufacturedMedicinalProduct” and “DispensedMagistralMedicinalProduct”. The a
35、ttributes “strength”, “form”, manufacturerOfMedicinalProduct” are moved from the class “ActualDispensedItem” to the class “DispensedManufacturedMedicinalProduct”. The attributes “batchIdentifier”, “genericSubstitution” are moved from the class “DispensingInformation” to the class “DispensedManufactu
36、redMedicinalProduct”. Datatype of the attribute “quantityDispensed” is replaced by “QuantityToDispense”, so the class “QuantityDispensed” becomes unused and is deleted. The attributes “magistralMedicinalProductName” and “dispensedQuantity” are added to the class “DispensedMagistralMedicinalProduct”.
37、 The attribute “nameOfIngredient” is deleted from the class “DispensedIngredient”. Datatype of the attribute “quantityOfIngredient” is replaced by “Amount”. The attribute “nameOfContainerOrApplicationAid” is deleted from the class “DispensedContainerOrApplicationAid”; Figures 26 and 27 are merged; n
38、ew ASN.1 definition is added in Annex A.A list of all parts in the ISO 21549 series can be found on the ISO website. ISO 2016 All rights reserved vBS EN ISO 21549-7:2016ISO 21549-7:2016(E)IntroductionWith a more mobile population, greater healthcare delivery in the community and at patients homes, t
39、ogether 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 record files, and on to patient-transportable monitoring sys
40、tems.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 in their functions and capab
41、ilities.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 and providers are increasing
42、ly 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 Professional” identification devices that are also able to
43、 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 card can be categoriz
44、ed in three broad types: identification (of the device itself and the individual to whom the data it carries 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
45、 administrative, clinical, medication and linkage data.Device data is defined to include identification of the device itself, and identification of the functions and functioning capabilities of the device.Identification data may include unique identification of the device holder or of all other pers
46、ons to whom the data carried by the device are related.Administrative data may include the following: complementary person(s) related data; identification of the funding of health care, whether public or private, and their relationships, i.e. insurer(s), contract(s) and policy(ies) or types of benef
47、its; 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 labelling by a healthcare provider (HCP), and related actions planned requested
48、or performed.Medication data may include a record of medications purchased by the patient for self administration, copies of prescriptions including the authority to dispense records of dispensed medications,vi ISO 2016 All rights reservedBS EN ISO 21549-7:2016ISO 21549-7:2016(E) records of medicati
49、ons dispensed by a pharmacist to the patient, and pointers to other systems that contain information that hold medication data, either medication history or prescribed medicines, (or both) and in the case of prescribed medicines, the authority to dispense.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 been applied with respect to the definition of healthcare
