Health Informatics - Business requirements for a syntax to exchange structured dose information for medicinal products (ISO/TS 17251:2016)

ISO/TS 17251:2016 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, as 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 discussed, but are not part of the primary scope.
It 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 ISO/TS 17251:2016 are:
- the functionality of health, 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;
- the complete medical record (EHR);
- a medicinal product dictionary.

Medizinische Informatik - Geschäftsanforderungen an eine Syntax zum Austausch von Dosisinformationen für Arzneimittel (ISO/TS 17251:2016)

Informatique de santé - Exigences d'affaire pour une syntaxe d'échange d'informations de dose structurée pour les produits médicaux (ISO/TS 17251:2016)

Zdravstvena informatika - Poslovne zahteve za sintakso za izmenjavo strukturiranih podatkov odmerkov za zdravila (ISO/TS 17251:2016)

ISO/TS 17251:2016 določa poslovne zahteve za strukturirano vsebino strukturiranih ali polstrukturiranih navodil za odmerke za shranjevanje navodil za odmerke v elektronski zdravstveni zapis (EHR), zagotavljanje podpore za klinično odločanje ter uporabo v izmenjavi naročil zdravil, kot se uporabljajo v primarni, sekundarni in terciarni oskrbi.
OPOMBA: Glej točko 2.9, opomba k izrazu, v zvezi z uporabo izrazov »naročilo zdravila« in »recept«.
Bolnikovo razumevanje navodil za odmerke je najpomembnejši vidik za zagotavljanje njegove varnosti in najboljših rezultatov zdravljenja. Obravnavani so povezani dejavniki, ki pa niso del primarnega področja uporabe.
Standard ne določa informacijskega modela, razen v obsegu, v katerem so ti koncepti informacijskega modela potrebni za opredelitev poslovnih zahtev.
Naslednji vidiki ne spadajo na področje uporabe standarda:ISO/TS 17251:2016:
– funkcionalnost zdravstvenih, kliničnih in/ali lekarniških sistemov;
– druge vrste vsebin zdravstvenih, kliničnih ali lekarniških sistemov, ki so potrebne za zagotavljanje podpore za celoten postopek ponudnikov zdravstvenih storitev, kot so:
– širok obseg znanja o zdravilih, vključenih v podatkovnih zbirkah znanja o zdravilih in sistemih za zagotavljanje podpore za sprejemanje odločitev;
– celovit elektronski zdravstveni zapis;
– slovar zdravil.

General Information

Status
Published
Publication Date
28-Nov-2016
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
29-Jul-2016
Due Date
03-Oct-2016
Completion Date
29-Nov-2016

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SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 17251:2017
01-februar-2017
Zdravstvena informatika - Poslovne zahteve za sintakso za izmenjavo
strukturiranih podatkov odmerkov za zdravila (ISO/TS 17251:2016)

Health Informatics - Business requirements for a syntax to exchange structured dose

information for medicinal products (ISO/TS 17251:2016)

Medizinische Informatik - Geschäftsanforderungen an eine Syntax zum Austausch von

Dosisinformationen für Arzneimittel (ISO/TS 17251:2016)

Informatique de santé - Exigences d'affaire pour une syntaxe d'échange d'informations

de dose structurée pour les produits médicaux (ISO/TS 17251:2016)
Ta slovenski standard je istoveten z: CEN ISO/TS 17251:2016
ICS:
11.120.10 Zdravila Medicaments
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST-TS CEN ISO/TS 17251:2017 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN ISO/TS 17251:2017
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SIST-TS CEN ISO/TS 17251:2017
CEN ISO/TS 17251
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
July 2016
TECHNISCHE SPEZIFIKATION
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 santé - Exigences d'affaire pour une Medizinische Informatik - Geschäftsanforderungen an

syntaxe d'échange d'informations de dose structurée eine Syntax zum Austausch von Dosisinformationen für

pour les produits médicaux (ISO/TS 17251:2016) 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 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 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 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR 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 Ref. No. CEN ISO/TS 17251:2016 E

worldwide for CEN national Members.
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CEN ISO/TS 17251:2016 (E)
Contents Page

European Foreword ...................................................................................................................................................... 3

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SIST-TS CEN ISO/TS 17251:2017
CEN ISO/TS 17251:2016 (E)
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

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 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, 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/TS 17251:2016 has been approved by CEN as CEN ISO/TS 17251:2016 without any

modification.
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SIST-TS CEN ISO/TS 17251:2017
TECHNICAL ISO/TS
SPECIFICATION 17251
First edition
2016-07-01
Health informatics — Business
requirements for a syntax to exchange
structured dose information for
medicinal products
Informatique de santé — Exigences d’affaire pour une syntaxe
d’échange d’informations de dose structurée pour les produits
médicaux
Reference number
ISO/TS 17251:2016(E)
ISO 2016
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SIST-TS CEN ISO/TS 17251:2017
ISO/TS 17251:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of

the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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ISO/TS 17251:2016(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Terms 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 requirements ............................................................................................................................................................ 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

Bibliography ................................................................................................................................................................................................................................ 9

© ISO 2016 – All rights reserved iii
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ISO/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 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 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 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 is 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/or

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

assessment, as well as information about ISO’s 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.
iv © ISO 2016 – All rights reserved
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Introduction

The requirements for the 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 suitable 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.

The primary audiences for this Technical Specification are software developers building clinical IT

systems.
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SIST-TS CEN ISO/TS 17251:2017
TECHNICAL SPECIFICATION ISO/TS 17251:2016(E)
Health informatics — Business requirements for a syntax
to exchange structured dose information for medicinal
products
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, as 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 discussed, 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, 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;
— the complete medical record (EHR);
— a medicinal product dictionary.
2 Terms and definitions
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 administration, 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 instructions in a consistent, computable format

2.3
structured information

information assembled from predefined concepts (vocabulary or code set) using an organizational

scheme (information model)
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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 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

“signā”.

Note 2 to entry: In the context of this Technical Specification, “sig” had the same meaning as “dose instructions”

(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 the

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, 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 context 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 represent 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.
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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 the 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 the 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 r
...

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