1、PD CEN ISO/TS 17251:2016Health Informatics - Businessrequirements for a syntaxto exchange structured doseinformation for medicinalproducts (ISO/TS 17251:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06PD CEN ISO/TS 17251:2016 PUBLISHED DOCUMENTNational forewordT
2、his Published Document is the UK implementation of CEN ISO/TS17251:2016.The 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 pu
3、rport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016. Published by BSI StandardsLimited 2016ISBN 978 0 580 84765 3ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligatio
4、ns.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 31 July 2016.Amendments issued since publicationDate Text affectedTECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 17251 July 2016 ICS 35.240.80 English Ver
5、sion Health Informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2016) Informatique de sant - Exigences daffaire pour une syntaxe dchange dinformations de dose structure pour les produits mdicaux (ISO/TS 17251:2016) Medizinisch
6、e Informatik - Geschftsanforderungen an eine Syntax zum Austausch von Dosisinformationen fr Arzneimittel (ISO/TS 17251:2016) This Technical Specification (CEN/TS) was approved by CEN on 10 July 2016 for provisional application. The period of validity of this CEN/TS is limited initially to three year
7、s. 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 EN and to make the CEN/TS available
8、 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 national standards bodies of Austria, Belg
9、ium, 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, Slovakia, Slovenia, Spain, Sweden, Switze
10、rland, 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 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national
11、 Members. Ref. No. CEN ISO/TS 17251:2016 EPD CEN ISO/TS 17251:2016CEN ISO/TS 17251:2016 (E) 3 European Foreword This document (CEN ISO/TS 17251:2016) has been prepared by Technical Committee ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
12、 secretariat of which is held by NEN. 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 Internal Regulation
13、s, the national standards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, It
14、aly, 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/TS 17251:2016 has been approved by CEN as CEN ISO/TS 17251:2016 without any modification. PD CE
15、N ISO/TS 17251:2016ISO/TS 17251:2016(E)Foreword ivIntroduction v1 Scope . 12 Terms and definitions . 13 Conformance . 24 Business requirements for structured dose instructions . 34.1 General . 34.2 Use cases 34.3 Elements of a dose instruction 34.4 Information requirements 44.4.1 General 44.4.2 Infr
16、astructure . 54.4.3 Text representation . 54.4.4 Administration amount 54.4.5 Route/site of administration . 54.4.6 Timing of dose event(s) . 64.4.7 Conditional administration . 74.4.8 Patient-specific information 74.4.9 Ancillary information . 8Bibliography 9 ISO 2016 All rights reserved iiiContent
17、s PagePD CEN ISO/TS 17251:2016ISO/TS 17251:2016(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 normally carried out through ISO technical committees. Each
18、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 collaborates closely with the International
19、 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 approval criteria needed for the different ty
20、pes 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 subject of patent rights. ISO shall not be
21、 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 trade name used in this document is informa
22、tion 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 the Technical Barriers to Trade (TBT) see the
23、following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 215, Health informatics.iv ISO 2016 All rights reservedPD CEN ISO/TS 17251:2016ISO/TS 17251:2016(E)IntroductionThe requirements for the exchange of structured dose instructions are intended to be
24、 independent of any technology standard or software platform and have been developed with the aim of specifying the necessary clinical and business requirements precisely and unambiguously. Implementation of the requirements within a suitable medium designed to support communication of healthcare in
25、formation can provide support to clinicians and their applications in storing, retrieving, using, and above all, communicating dose instructions information to other clinicians, their applications, and most importantly, to the patient.The primary audiences for this Technical Specification are softwa
26、re developers building clinical IT systems. ISO 2016 All rights reserved vPD CEN ISO/TS 17251:2016PD CEN ISO/TS 17251:2016Health informatics Business requirements for a syntax to exchange structured dose information for medicinal products1 ScopeThis Technical Specification specifies the business req
27、uirements for the structured content of structured or semi-structured dose instructions for recording dose instructions in the electronic health record (EHR), supporting clinical decision support, and in exchanging medication orders, as applicable to primary, secondary and tertiary care.NOTE See 2.9
28、, note to entry, regarding the use of “medication order” and “prescription”.Comprehension of dose instructions by the patient is an overarching consideration for patient safety and the best patient outcomes. Related factors are discussed, but are not part of the primary scope.This Technical Specific
29、ation does not define an information model, except to the extent that those information model concepts are necessary to define business requirements.Outside the scope of this Technical Specification are: the functionality of health, clinical and/or pharmacy systems; other kinds of content of health,
30、 clinical or pharmacy systems that are needed to support the whole process of health care providers, such as: wide range of knowledge about medicines that would be handled in drug knowledge databases and decision support systems; the complete medical record (EHR); a medicinal product dictionary.2 Te
31、rms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1dose instructionsinstructions pertaining to the medication, which describe the amount of medication per dose, method of administration, the frequency or interval of dose, associated instructions for do
32、sing or skipped doses, and other associated parameters necessary for appropriate administration of the medication2.2dose syntaxstructured dose instructionsstructured set of data elements which represent the dose instructions in a consistent, computable format2.3structured informationinformation asse
33、mbled from predefined concepts (vocabulary or code set) using an organizational scheme (information model)TECHNICAL SPECIFICATION ISO/TS 17251:2016(E) ISO 2016 All rights reserved 1PD CEN ISO/TS 17251:2016ISO/TS 17251:2016(E)2.4unstructured informationinformation assembled from narrative words and w
34、ord fragments, following either casual conventions or language-specific grammatical rules2.5semi-structured informationinformation containing both structured content and unstructured content2.6sigdirections to be written on a package or label for the use of the patientNote 1 to entry: Sig (sometimes
35、 written as SIG) appears to be an acronym, but is an abbreviation of the Latin term “sign”.Note 2 to entry: In the context of this Technical Specification, “sig” had the same meaning as “dose instructions” (see 4.1).2.7storage and handling informationinformation provided to the patient/caregiver reg
36、arding the appropriated conditions to maximize the shelf life of the medicinal productNote 1 to entry: While essential information, this does not directly relate to administration and is not within the scope of this Technical Specification.2.8medication orderdocumented instruction on intended therap
37、y for an individual person with a medicinal product issued by an authorized health professionalNote 1 to entry: There is no inherent limitation on the setting for the medication order (inpatient, ambulatory, etc.).SOURCE: ISO/TR 22790:20072.9prescriptiondirections created by an authorized health pro
38、fessional to instruct a dispensing agent regarding the preparation and use of a medicinal product or medicinal appliance to be taken or used by a subject of careNote 1 to entry: In the context of this Technical Specification, “prescription” or “medication order” could be used. We have chosen to use
39、“medication order”. In this sense, we imply that “medication order” is inclusive of “prescription.”SOURCE: ISO/TR 22790:20072.10message syntaxstructured set of data elements which represent the medication order in a consistent computable format3 ConformanceSystems that create or consume electronic m
40、edication orders can claim conformance to this Technical Specification when it fulfils all requirements in Clause 4.2 ISO 2016 All rights reservedPD CEN ISO/TS 17251:2016ISO/TS 17251:2016(E)4 Business requirements for structured dose instructions4.1 GeneralThe business requirements for structured do
41、se information shall focus on the primary goal of ensuring that the patient receives the appropriate medication dose at the appropriate time in a consistent manner. In addition to the patient-centric aspects, certain information is required to achieve this goal. The following requirements address bo
42、th patient and information aspects.NOTE The following conformance statements refer to either, or both, the message syntax and the dose syntax. Requirements which are not unique to the dose instructions, or useful in other components of a medication order, are described as part of the “message syntax
43、”. Requirements which are specific to the dose instructions are described as part of the “dose syntax”.4.2 Use casesDose instructions serve the following use cases. Indicating the right dosage during prescribing. Recording the indicated dosage in the EHR: to be used in clinical decision support syst
44、ems, like dose checking; exchange of information between health care providers. Indicating comprehensible dose instructions on the patient label in order to make clear how to use the medicine. Comprehension may not be a component of the dose instructions specifically, but comprehension does influenc
45、e the presentation of the instructions to the patient. Patient comprehension information shall be present in the medication order in some manner such that the dispenser can create appropriate instructions for the patient or caregiver.4.3 Elements of a dose instructionBased on the use cases, the elem
46、ents of a dose instruction include the following. Text representation. The purpose of this Technical Specification is to specify requirements for structured dose instructions. However, some parts of a dose instruction cannot be captured in structured information. To support a human readable text of
47、the whole dose instruction of a certain medicine, a textual representation of the whole dose instructions will remain an important element. This textual representation includes both the structured and the unstructured part of the dose instruction. Also, if a scenario occurs which prevents the struct
48、ured content from being produced, the textual representation is then necessary for communicating the dose instruction. The structured content and the textual content, if both are present, shall agree, neither omitting nor adding any significant content between the two. Amount of medication to be adm
49、inistered at each dose event. This may be comprised of a number of units of presentation (e.g. “1 tablet”) or a number and unit of measure (e.g. “5 ml”, “500 mg”). Calculated amounts (e.g. “50 mg/kg body weight) may be appropriate in some cases, however an explicit amount is generally preferred over an implied amount. The administered amount may vary over time (e.g. tapered dose) or relative to other parameters (e.g. insulin sliding scale). The administered amount may be a range (1 to 2 tablets). The administered amount should be qu
