CEN ISO/TS 19256:2017

SLOVENSKI STANDARD
01-julij-2017
Zdravstvena informatika - Zahteve za slovarje zdravil v sistemih zdravstvenega
varstva (ISO/TS 19256:2016)
Health informatics - Requirements for medicinal product dictionary systems for health
care (ISO/TS 19256:2016)
Medizinische Informatik - Anforderungen an Arzneimittelverzeichnisse im
Gesundheitsbereich (ISO/TS 19256:2016)
Informatique de santé - Exigences pour les systèmes de dictionnaires de produits
médicaux pour les soins de santé (ISO/TS 19256:2016)
Ta slovenski standard je istoveten z: CEN ISO/TS 19256:2017
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TS 19256
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
March 2017
TECHNISCHE SPEZIFIKATION
ICS 35.240.80
English Version
Health informatics - Requirements for medicinal product
dictionary systems for health care (ISO/TS 19256:2016)
Informatique de santé - Exigences pour les systèmes de Medizinische Informatik - Anforderungen an
dictionnaires de produits médicaux pour les soins de Arzneimittelverzeichnisse im Gesundheitsbereich
santé (ISO/TS 19256:2016) (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 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, Serbia, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 19256:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO/TS 19256:2016 has been prepared by Technical 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 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, 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.
TECHNICAL ISO/TS
SPECIFICATION 19256
First edition
2016-06-01
Health informatics — Requirements
for medicinal product dictionary
systems for health care
Informatique de santé — Exigences pour les systèmes de dictionnaires
de produits médicaux pour les soins de santé
Reference number
ISO/TS 19256:2016(E)
©
ISO 2016
ISO/TS 19256:2016(E)
© 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
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ii © ISO 2016 – All rights reserved

ISO/TS 19256:2016(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms 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 build 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 Specification .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 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 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 and tracing for patient and public safety use case .17
6.2.12 Pharmacovigilance use case.17
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 Introduction .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, pharmacoepidemiology, 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/TS 19256:2016(E)
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 .
...