EN ISO 17523-2016 en Health informatics - Requirements for electronic prescriptions《健康信息学电子处方的要求(ISO 17523 2016)》.pdf

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1、BS EN ISO 17523:2016Health informatics Requirements for electronicprescriptions (ISO 17523:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 17523:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO17523:2016. 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 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 79726 2ICS 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 31 July 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 17523 June 2016 ICS 35.240.80 English Version Health informatics - Requirements for electronic prescriptions (ISO 17523:2

5、016) Informatique de sant - Exigences applicables aux prescriptions lectroniques (ISO 17523:2016) Medizinische Informatik - Anforderungen an elektronische Verschreibungen (ISO 17523:2016) This European Standard was approved by CEN on 15 April 2016. CEN members are bound to comply with the CEN/CENELE

6、C 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 standards may be obtained on application to the CEN-CENELEC Management Centre or

7、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 notified to the CEN-CENELEC Management Centre has the same status as the offic

8、ial 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,

9、Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN 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 ex

10、ploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17523:2016 EBS EN ISO 17523:2016EN ISO 17523:2016 (E) 3 European foreword This document (EN ISO 17523:2016) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration w

11、ith 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 the latest by December 2016, and conflicting national standards s

12、hall be withdrawn at the latest by December 2016. 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 or all such patent rights. According to the CEN-CENELEC Interna

13、l 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 Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Irel

14、and, 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 17523:2016 has been approved by CEN as EN ISO 17523:2016 without any modification. BS EN

15、 ISO 17523:2016ISO 17523:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 Conformance . 34.1 Generic conformance . 34.2 Data element conformance 45 General information . 45.1 Structure of this International Standard 45.2 Usage of this International Stan

16、dard . 45.3 Use cases, actors, processes . 45.4 Information objects . 65.4.1 Prescription 65.4.2 Related information objects . 66 Requirements for electronic prescriptions 66.1 Identification of the patient . 66.2 Identity information of the prescribing healthcare professional 66.3 Identification of

17、 the prescribed medicinal product 76.4 Compliance to medicinal product dictionaries . 76.5 Product use information . 76.6 Authentication of the electronic prescription 76.7 Data elements 7Annex A (normative) Data elements. 8Annex B (informative) Examples of elements and implementations of electronic

18、 prescription .14Bibliography .18 ISO 2016 All rights reserved iiiContents PageBS EN ISO 17523:2016ISO 17523:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standar

19、ds 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, also take

20、 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 1. In part

21、icular 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 drawn to the possibility that some of the elements of

22、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 (see w

23、ww.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 assessment, as well as information about ISOs adherence to

24、the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 215, Health informatics.iv ISO 2016 All rights reservedBS EN ISO 17523:2016ISO 17523:2016(E)IntroductionModern healthcare is ra

25、pidly advancing and relying on electronic communications. Many countries already have or are in the process of developing electronic systems to contain and distribute personal data regarding healthcare, among which is exchange of electronic prescriptions. Therefore, it becomes increasingly important

26、 to set up International Standards that in the end will facilitate safe and reliable dispensing and administration of the prescribed product to the patient. Also, since international travelling has become integrated into daily life, it is important that electronic communications regarding prescripti

27、ons can somehow be synchronized between prescribers and dispensers in different jurisdictions.The most important question regarding electronic prescriptions is which information is required to accompany the electronic prescription in order to have exactly the intended medicine dispensed to the patie

28、nt, including all relevant information with regard to its correct and safe use. This International Standard provides the basic set of information requirements to support electronic prescription.While the organization of healthcare is national, the development and production of medicinal products on

29、the other hand is truly international. The market authorization is strictly legislated in jurisdictional specific directives and laws. Part of this legislation regulates prescribing and dispensing of medicinal products. Information systems in healthcare must be designed so that end-users comply with

30、 this legislation (preferably without needing to pay too much attention). An International Standard on electronic prescriptions may support the implementation of (international) legislation on medicinal products in health informatics. For instance, the definition of the term “electronic prescription

31、” has to comply with that of national legislations and multinational directives.The prescription written on paper has a deeply rooted cultural history for both healthcare professionals and patients. Using an electronic prescription instead of paper is a change that must be guided to ensure societys

32、trust in healthcare professionals. Requirements for the processing of electronic prescriptions can fulfil this need. An example of use in practice of this specification is the following: a general practitioner prescribes a medicinal product for a patient with the aid of an information system and sen

33、ds the electronic prescription to the local pharmacy where the patient picks up the medication a short while thereafter.The benefit of an International Standard on the requirements of an electronic prescription is that it can serve as a starting point and reference for all kinds of records and messa

34、ges related to electronic prescriptions, facilitating the communication between stakeholders and information systems.The intended audience for this International Standard is made up of the developers of standards and information systems, so that in using their products, end-users (healthcare profess

35、ionals) comply with legislation, regulations and expectations of society relating to the prescribing and dispensing of medicinal products. Specifically, this International Standard provides a basis for a common understanding of the data elements contained in an electronic prescription across legisla

36、tions. ISO 2016 All rights reserved vBS EN ISO 17523:2016BS EN ISO 17523:2016Health informatics Requirements for electronic prescriptions1 ScopeThis International Standard specifies the requirements that apply to electronic prescriptions. It describes generic principles that are considered important

37、 for all electronic prescriptions.The scope of this International Standard is constrained to the content of the electronic prescription itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal

38、 product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patient. Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products

39、) are out of scope of this International Standard, because they are more or less country or region specific, due to differences in culture and in legislation of healthcare. However, requirements and content of electronic prescriptions within the context of jurisdictions have a relationship with thes

40、e scenarios. The way in which electronic prescriptions are made available or exchanged also fall outside the scope of this International Standard.This International Standard is applicable to electronic prescriptions of medicinal products. Although other kinds of products (e.g. medical devices, wound

41、 care products) can be ordered by means of an electronic prescription, the requirements in this International Standard are aimed at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy. An electronic prescription is an information

42、object that authorizes a healthcare professional to legally dispense a medicinal product.This International Standard specifies a list of data elements that can be considered as essential for electronic prescriptions, depending on jurisdiction or clinical setting (primary healthcare, hospital, etc.).

43、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 applies. For undated references, the latest edition of the referenced document (including any amendm

44、ents) applies.ISO 8601, Data elements and interchange formats Information interchange Representation of dates and timesISO 11238, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substancesISO

45、11239, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packagingISO 11240, Health informatics Identification of m

46、edicinal products Data elements and structures for the unique identification and exchange of units of measurementISO 11615, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product informationISO 11

47、616, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated pharmaceutical product informationINTERNATIONAL STANDARD ISO 17523:2016(E) ISO 2016 All rights reserved 1BS EN ISO 17523:2016ISO 17523:2016(E)ISO 17090-1,

48、 Health informatics Public key infrastructure Part 1: Overview of digital certificate servicesISO/TS 16791, Health informatics Requirements for international machine-readable coding of medicinal product package identifiersISO/TS 22220, Health informatics Identification of subjects of health careISO/

49、TS 27527, Health informatics Provider identification3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1dispenserhealthcare professional authorized to dispense medicinal products3.2dispensingprocess of validation of the electronic prescription, preparation of the medicinal product, labelling, informing and handing the medication to the patient or administering healthcare professional3.3electronic prescriptione-prescriptionprescription (issued by electronic means) that complies