1、PD CEN ISO/TS 17251:2016 Health Informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2016) BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06PD CEN ISO/TS 17251:2016 PUBLISHED DOCUMENT National f
2、oreword This Published Document is the UK implementation of CEN ISO/TS 17251:2016. 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 secretary. This publicat
3、ion does not purport 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 2016 ISBN 978 0 580 84765 3 ICS 35.240.80 Compliance with a British Standard cannot confer immunit
4、y from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 July 2016. Amendments issued since publication Date Text affected TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 17251 July 201
5、6 ICS 35.240.80 English Version 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
6、/TS 17251:2016) Medizinische 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 limi
7、ted 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 EN and t
8、o 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 national standa
9、rds 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, Slovakia, Slov
10、enia, 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 2016 CEN All rights of exploitation in any form and by any means reserved
11、 worldwide for CEN national Members. Ref. No. CEN ISO/TS 17251:2016 EPD CEN ISO/TS 17251:2016 CEN 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
12、251 “Health informatics” the 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
13、-CENELEC Internal Regulations, 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, H
14、ungary, 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/TS 17251:2016 has been approved by CEN as CEN ISO/TS 17251:2016 wit
15、hout any modification. PD CEN ISO/TS 17251:2016ISO/TS 17251:2016(E)Foreword iv Introduction v 1 Scope . 1 2 T erms and definitions . 1 3 Conformance . 2 4 Business requirements for structured dose instructions . 3 4.1 General . 3 4.2 Use cases 3 4.3 Elements of a dose instruction 3 4.4 Information r
16、equirements 4 4.4.1 General 4 4.4.2 Infrastructure . 5 4.4.3 Text representation . 5 4.4.4 Administration amount . . 5 4.4.5 Route/site of administration . 5 4.4.6 Timing of dose event(s) . 6 4.4.7 Conditional administration . 7 4.4.8 Patient-specific information 7 4.4.9 Ancillary information . 8 Bi
17、bliography 9 ISO 2016 All rights reserved iii Contents PagePD CEN ISO/TS 17251:2016ISO/TS 17251:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is norma
18、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
19、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
20、 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 docum
21、ent 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
22、/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 the WTO p
23、rinciples 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.iv ISO 2016 All rights reservedPD CEN ISO/TS 17251:2016ISO/TS 17251:2016(E) Introduction The requirements for t
24、he exchange of structured dose instructions are intended to be 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 suit
25、able medium designed to support communication of healthcare information 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. Th
26、e primary audiences for this Technical Specification are software 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 product
27、s 1 Scope This Technical Specification specifies the business requirements 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, a
28、s applicable to primary, secondary and tertiary care. NOTE See 2.9, 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 discu
29、ssed, but are not part of the primary scope. This Technical Specification 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
30、, clinical and/or pharmacy systems; other kinds of content of health, 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; t
31、he complete medical record (EHR); a medicinal product dictionary. 2 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 2.1 dose instructions instructions pertaining to the medication, which describe the amount of medication per dose, method of admi
32、nistration, the frequency or interval of dose, associated instructions for dosing or skipped doses, and other associated parameters necessary for appropriate administration of the medication 2.2 dose syntax structured dose instructions structured set of data elements which represent the dose instruc
33、tions in a consistent, computable format 2.3 structured information information assembled 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 172
34、51:2016(E) 2.4 unstructured information information assembled from narrative words and word fragments, following either casual conventions or language-specific grammatical rules 2.5 semi-structured information information containing both structured content and unstructured content 2.6 sig directions
35、 to be written on a package or label for the use of the patient Note 1 to entry: Sig (sometimes 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
36、” (see 4.1). 2.7 storage and handling information information provided to the patient/caregiver regarding the appropriated conditions to maximize the shelf life of the medicinal product Note 1 to entry: While essential information, this does not directly relate to administration and is not within th
37、e scope of this Technical Specification. 2.8 medication order documented instruction on intended therapy for an individual person with a medicinal product issued by an authorized health professional Note 1 to entry: There is no inherent limitation on the setting for the medication order (inpatient,
38、ambulatory, etc.). SOURCE: ISO/TR 22790:2007 2.9 prescription directions created by an authorized health professional 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 care Note 1 to entry: In the contex
39、t of this Technical Specification, “prescription” or “medication order” could be used. We have chosen to use “medication order”. In this sense, we imply that “medication order” is inclusive of “prescription.” SOURCE: ISO/TR 22790:2007 2.10 message syntax structured set of data elements which represe
40、nt the medication order in a consistent computable format 3 Conformance Systems that create or consume electronic medication 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 17251:20
41、16(E) 4 Business requirements for structured dose instructions 4.1 General The business requirements for structured dose 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 th
42、e patient-centric aspects, certain information is required to achieve this goal. The following requirements address both 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 t
43、he dose instructions, or useful in other components of a medication order, are described as part of the “message syntax”. Requirements which are specific to the dose instructions are described as part of the “dose syntax”. 4.2 Use cases Dose instructions serve the following use cases. Indicating the
44、 right dosage during prescribing. Recording the indicated dosage in the EHR: to be used in clinical decision support systems, 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
45、the medicine. Comprehension may not be a component of the dose instructions specifically, but comprehension does influence 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
46、 appropriate instructions for the patient or caregiver. 4.3 Elements of a dose instruction Based on the use cases, the elements of a dose instruction include the following. Text representation. The purpose of this Technical Specification is to specify requirements for structured dose instructions. H
47、owever, some parts of a dose instruction cannot be captured in structured information. To support a human readable text of 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
48、both the structured and the unstructured part of the dose instruction. Also, if a scenario occurs which prevents the structured content from being produced, the textual representation is then necessary for communicating the dose instruction. The structured content and the textual content, if both ar
49、e present, shall agree, neither omitting nor adding any significant content between the two. Amount of medication to be administered 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 othe
