1、December 2016 English price group 13No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 35.240.60; 35.240.80!%r“2595779
2、www.din.deDIN EN ISO 17523Health informatics Requirements for electronic prescriptions (ISO 17523:2016);English version EN ISO 17523:2016,English translation of DIN EN ISO 17523:2016-12Medizinische Informatik Anforderungen an elektronische Verschreibungen (ISO 17523:2016);Englische Fassung EN ISO 17
3、523:2016,Englische bersetzung von DIN EN ISO 17523:2016-12Informatique de sant Exigences applicables aux prescriptions lectroniques (ISO 17523:2016);Version anglaise EN ISO 17523:2016,Traduction anglaise de DIN EN ISO 17523:2016-12www.beuth.deDocument comprises 25 pagesDTranslation by DIN-Sprachendi
4、enst.In case of doubt, the German-language original shall be considered authoritative.12.16 DIN EN ISO 17523:2016-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 17523:2016) has been prepared by WG 6 “Pharmacy and medicines business” of Technical Committee ISO/TC
5、215 “Health informatics in collaboration with Technical Committee CEN/TC 251 “Health informatics (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-07-03 AA Terminologie
6、 Section 7 Medizinische Informatik. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 8601 DIN ISO 8601 ISO 11238 DIN EN ISO 11238 ISO 11239 DIN EN ISO 11239 ISO 11240 DIN EN ISO 11240 ISO 11615 DIN EN ISO 11615 ISO 11616 DIN EN ISO 1161
7、6 ISO/TS 16791 DIN CEN ISO/TS 16791 National Annex NA (informative) Bibliography DIN EN ISO 11238, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances DIN EN ISO 11239, Health informati
8、cs 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 packaging DIN EN ISO 11240, Health informatics Identification of medicinal produc
9、ts Data elements and structures for unique identification and exchange of units of measurement DIN EN ISO 11615, Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated medicinal product information DIN EN ISO 11616
10、 Health informatics Identification of medicinal products Data elements and structures for unique identification and exchange of regulated pharmaceutical product information DIN CEN ISO/TS 16791, Health informatics Requirements for international machine-readable coding of medicinal product package i
11、dentifiers DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17523 June 2016 ICS 35.240.80 English Version Health informatics - Requirements for electronic prescriptions (ISO 17523:20
12、16) 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/CENELEC
13、 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 t
14、o 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 offici
15、al 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, N
16、orway, 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 exp
17、loitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17523:2016 EForeword . 3Introduction . 51 Scope . 62 Normative references 63 Terms and definitions . 74 Conformance . 84.1 Generic conformance . 84.2 Data element conformance 95 General information .
18、95.1 Structure of this International Standard 95.2 Usage of this International Standard . 95.3 Use cases, actors, processes . 95.4 Information objects 115.4.1 Prescription .115.4.2 Related information objects 116 Requirements for electronic prescriptions .116.1 Identification of the patient 116.2 Id
19、entity information of the prescribing healthcare professional .116.3 Identification of the prescribed medicinal product .126.4 Compliance to medicinal product dictionaries 126.5 Product use information 126.6 Authentication of the electronic prescription .126.7 Data elements . 12Annex A (normative) D
20、ata elements13Annex B (informative) Examples of elements and implementations of electronic prescription .19Bibliography .23Contents PageEN ISO 17523:2016 (E) DIN EN ISO 17523:2016-12 2European foreword . 3European foreword This document (EN ISO 17523:2016) has been prepared by Technical Committee IS
21、O/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 the latest by Dec
22、ember 2016, and conflicting national standards shall 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 pat
23、ent rights. 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 Republic of Macedonia,
24、 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 17523:2016 has been approved by CEN as E
25、N ISO 17523:2016 without any modification. EN ISO 17523:2016 (E) DIN EN ISO 17523:2016-12 3 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 o
26、ut 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 the work. ISO c
27、ollaborates 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 different app
28、roval 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 document may be the
29、 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/patents). Any
30、 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 WTO principles in th
31、e Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 215, Health informatics.EN ISO 17523:2016 (E) DIN EN ISO 17523:2016-12 4 IntroductionModern healthcare is rapidly advancing and relying on electronic c
32、ommunications. 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 to set up International Standards that in
33、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 prescriptions can somehow be synchronized between pre
34、scribers 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 patient, including all relevant information with
35、 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 the other hand is truly international. The
36、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 this legislation (preferably without needi
37、ng 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” has to comply with that of national legis
38、lations 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 trust in healthcare professionals. Requirem
39、ents 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 sends the electronic prescription to the local
40、 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 messages related to electronic prescriptions, fa
41、cilitating 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 professionals) comply with legislation, regulation
42、s 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 legislations.EN ISO 17523:2016 (E) DIN EN ISO 1752
43、3:2016-12 5 1 ScopeThis International Standard specifies the requirements that apply to electronic prescriptions. It describes generic principles that are considered important for all electronic prescriptions.The scope of this International Standard is constrained to the content of the electronic pr
44、escription itself, the digital document which is issued by a prescribing healthcare professional and received by a dispensing healthcare professional. The prescribed medicinal product is to be dispensed through an authorized healthcare professional with the aim of being administered to a human patie
45、nt. Other messages, roles and scenarios (e.g. validation of a prescription, administration, medication charts, EHR of the patient, reimbursement of care and dispensed products) are out of scope of this International Standard, because they are more or less country or region specific, due to differenc
46、es in culture and in legislation of healthcare. However, requirements and content of electronic prescriptions within the context of jurisdictions have a relationship with these scenarios. The way in which electronic prescriptions are made available or exchanged also fall outside the scope of this In
47、ternational Standard.This International Standard is applicable to electronic prescriptions of medicinal products. Although other kinds of products (e.g. medical devices, wound care products) can be ordered by means of an electronic prescription, the requirements in this International Standard are ai
48、med at medicinal products that have a market authorization and at pharmaceutical preparations which are compounded in a pharmacy. An electronic prescription is an information 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.).2 Normative referencesThe following documents, in whole
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