ISO/TS 19256:2016

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 2016
© ISO 2016, Published in Switzerland
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ii © ISO 2016 – All rights reserved

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
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 (informative) IDMP series in context, serving this Technical Specification.33
Bibliography .35
iv © ISO 2016 – All rights reserved

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.
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 requirements 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 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 maintained 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; currently 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 stored 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 with meaningful relationships between the concepts, in order to support
parts of several processes in healthcare in which medication plays a role. T
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