1、Health informatics Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016) PD CEN ISO/TS 19256:2017 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword T h i s P u b l i s h e d D o c u m e n t i s t h e U K i m p l e
2、m e n t a t i o n o f C E N I S O / T S 1 9 2 5 6 : 2 0 1 7 . It is identical to ISO/TS 19256:2016. 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 secreta
3、ry. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017. Published by BSI Standards Limited 2017 ISBN 978 0 580 84766 0 ICS 35.240.80 Compliance with a British Standard cann
4、ot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 March 2017. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD CEN ISO/TS 19256:2017TECHNICAL SPECIFICATION S
5、PCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 19256 March 2017 ICS 35.240.80 English Version Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016) Informatique de sant - Exigences pour les systmes de dictionnaires de produits mdica
6、ux pour les soins de sant (ISO/TS 19256:2016) Medizinische Informatik - Anforderungen an Arzneimittelverzeichnisse im Gesundheitsbereich (ISO/TS 19256:2016) This Technical Specification (CEN/TS) was approved by CEN on 23 January 2017 for provisional application. The period of validity of this CEN/TS
7、 is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in the same way as for an
8、EN and to make the CEN/TS available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN members are the nationa
9、l 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, Norway, Poland, Portugal, Romania, Serbia
10、, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by an
11、y means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 19256:2017 E PD CEN ISO/TS 19256:2017CEN ISO/TS 19256:2017 (E) 2 Contents Page European foreword . 3 PD CEN ISO/TS 19256:2017CEN ISO/TS 19256:2017 (E) 3 European foreword The text of ISO/TS 19256:2016 has been prepared by Techn
12、ical Committee ISO/TC 215 “Health informatics” of the International Organization for Standardization (ISO) and has been taken over as CEN ISO/TS 19256:2017 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held by NEN. Attention is drawn to the possibility that some
13、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 Internal Regulations, the national standards organizations of the following countries are bound to announ
14、ce this Technical Specification: 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, Norway, Poland, Portugal, Roma
15、nia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 19256:2016 has been approved by CEN as CEN ISO/TS 19256:2017 without any modification. PD CEN ISO/TS 19256:2017 ISO/TS 19256:2016(E)Foreword v Introduction vi 1 Scope . 1
16、 2 Normative references 2 3 T erms and definitions . 2 4 Abbreviated terms 9 5 Boundary between MPD-systems and IDMP , ancillary information to build an MPD- system and local implementation. 9 5.1 Boundary between MPD-systems and IDMP 9 5.2 Boundary between MPD-systems and ancillary information to b
17、uild an MPD-system . 9 5.3 Boundary between MPD-systems and local implementation 9 5.4 Content of the MPD-systems in terms of product coverage 10 5.5 Definition of Medicinal Product Dictionary MPD-systems 10 5.6 Benefits of the Technical Specification 10 5.7 Target users for the Technical Specificat
18、ion .10 6 Positioning of Medicinal Product Dictionary Systems for Healthcare .11 6.1 Base materials for MPD-systems 11 6.1.1 Relation with ISO IDMP standards 12 6.1.2 Relation with health/clinical/pharmacy information systems, decision support, EHR and dose instructions 13 6.1.3 Relation with EHR-S
19、FM 14 6.2 Use cases for requirements for an MPD-system .14 6.2.1 Prescribing use case . 15 6.2.2 Dispensing use case . .15 6.2.3 Administration use case .15 6.2.4 Recording medication history use case .15 6.2.5 Reconciling medication list use case .15 6.2.6 Ordering and supply chain (logistics) use
20、case 16 6.2.7 Analysis, statistics, and pharmacoepidemiology use case 16 6.2.8 Electronic data exchange of medicinal product information between healthcare systems and/or related systems, i.e. reporting use case 16 6.2.9 Reimbursement use case .16 6.2.10 Clinical research use case 16 6.2.11 Tracking
21、 and tracing for patient and public safety use case .17 6.2.12 Pharmacovigilance use case17 6.2.13 Patient safety through linking personal data with the decision support system on medicinal products use case 18 6.2.14 Migration use case .18 7 The Functional Requirements for MPD-systems 18 7.1 Introd
22、uction .18 7.2 Goal of an MPD system 19 7.3 Normative content 19 7.3.1 Content of regulated medicinal products 19 7.3.2 Prescription .23 7.3.3 Dispensing 23 7.3.4 Administration 24 7.3.5 Recording and reconciliation .24 7.3.6 Order and supply chain and logistics 25 7.3.7 Analysis, statistics, pharma
23、coepidemiology, and clinical research .25 7.3.8 Ensuring patient safety through linking personal data with the decision support system on medicinal products .27 7.3.9 Interaction with reimbursement systems 27 ISO 2016 All rights reserved iii Contents Page PD CEN ISO/TS 19256:2017 ISO/TS 19256:2016(E
24、)7.3.10 Interaction of MPD-systems with pharmacovigilance systems 27 7.3.11 Data exchange and technical functions .28 7.4 Governance 29 7.5 Maintenance .30 7.5.1 Regular maintenance processes of the MPD-system .30 7.5.2 Interaction with regulatory information .31 7.6 Localization .32 Annex A (inform
25、ative) IDMP series in c ont e xt , serving this T echnical Specification33 Bibliography .35 iv ISO 2016 All rights reserved PD CEN ISO/TS 19256:2017 ISO/TS 19256:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO memb
26、er bodies). The work of preparing 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, government
27、al and non-governmental, in liaison 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
28、are described in the ISO/IEC Directives, 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 (see www.iso.org/directives). Attention i
29、s drawn to the possibility that some of the 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/o
30、r on the ISO list of patent declarations received (see www.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 as
31、sessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 215, Health informatics. ISO 2016 All rights reserved v PD CEN ISO/TS
32、 19256:2017 ISO/TS 19256:2016(E) Introduction This introduction contains the following topics: a) What is a Medicinal Product Dictionary system? b) What are the use cases and who are the stakeholders? c) What are the benefits for the different stakeholders? d) What are the core functional requiremen
33、ts for an MPD-system for healthcare? The main target audience is the developers and service providers of MPD-systems, and those who contract such developers and service providers. The goal of MPD Systems is to offer various parties in healthcare a complete overview of available medicinal products in
34、 such a way the (elements of the) concepts and the descriptions and medicinal product identifiers can be used in a variety of other healthcare information systems. The principle for this Technical Specification is that the global unique IDs of IDMP (Identification of Medicinal Products) shall be mai
35、ntained in any MPD-system. Medicinal products play an important role in healthcare. There are many (thousands of) medicinal products and each medicinal product has many characteristics (attributes), both defining and non- defining. The development and use of medicinal products is highly regulated; c
36、urrently the way to define information about them is guided by the ISO IDMP standards. Furthermore, many healthcare providers, institutions and enterprises are involved in the use of medicinal products. Each of these actors uses information systems in which information on medicinal products is store
37、d and exchanged. These information systems need an MPD-system to accurately and consistently identify medication concepts in the form(s) that fulfill their use cases. An MPD-system establishes a consistent representation of medication concepts (set of identifiers) at various levels of detail and wit
38、h meaningful relationships between the concepts, in order to support parts of several processes in healthcare in which medication plays a role. This Technical Specification describes a Medicinal Product Dictionary system in that way, that the concepts, identifiers and the relationships form a kind o
39、f structure that supports the use cases; together with the description of how this structure supports the use cases and what is needed for that. The MPD-system is further described from within an architecture in which it is connected to other parts of healthcare information systems. Cultural differe
40、nces in the practice and delivery of care and national legislation require electronic MPD- systems that meet specific local, regional or national needs. Each MPD-system is designed to support a particular set of use cases, which helps to determine the functional requirements which must be met by suc
41、h systems. These functional requirements will then, in turn, determine the specific collection of medication abstractions which must be identified, defined and related to each other within the MPD-system. Each medicinal product in the MPD-system is described in terms of a specific subset of all poss
42、ible defining and non-defining information elements, which together enable it to support one or more specific use case(s). The concepts are formally defined in terms of their characteristics and relationships with other concepts according to the ISO IDMP Standards, in particular ISO 11615, ISO 11616
43、 and ISO 11238. Relationships between each of these medicinal product entries give the MPD- system the potential to support interoperability between use cases, processes, information systems, organizations and jurisdictions. The anticipated stakeholders of this Technical Specification include health
44、care providers that have responsibilities in selecting appropriate MPD-systems, software vendors, governments, pharmaceutical companies, wholesalers, payers, drugs regulatory authorities, and patients / patients organizations. In general, this Technical Specification supports the following business
45、goals: It provides information to MPD-system developers, to help them design MPD-systems which are better able to meet the ISO IDMP standards and the needs of multiple use cases;vi ISO 2016 All rights reserved PD CEN ISO/TS 19256:2017 ISO/TS 19256:2016(E) It facilitates accuracy and consistency of t
46、he use of concepts and terms according to the ISO IDMP standards in the MPD-systems; It increases the potential for consistency between MPD-systems around the world; It reduces redundancy of data collection and governance; It provides the foundations for future international standards, which help to
47、 enable interoperability between medication use cases, information systems, and jurisdictions involved in cross-border healthcare; It might reduce the cost of developing and maintaining medicinal product dictionaries systems. The Technical Specification is partly based on the following terminologies
48、 / databases: - The Australian Medicinal Terminology (AMT); - NHS dictionary of medicines and devices (DM+D); - Singapore Drug Database; - SNOMED CT; - Dutch G-Standaard from Z-Index (and Pharmabase from Healthbase) (NEN 7507); - ISO/TR 22790, Health informatics Functional characteristics of prescri
49、ber support systems. ISO 2016 All rights reserved vii PD CEN ISO/TS 19256:2017 Health informatics Requirements for medicinal product dictionary systems for health care 1 Scope This Technical Specification defines the required characteristics for any MPD-system to support use cases in healthcare. These characteristics include the medication concepts, identifiers and relationships to form a kind of structure that supports the use cases. In order to support the use cases, an MPD-system needs to: be comprehensive and exhaustive as far
