iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

CEN ISO/TS 19256:2017

(Main)

Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)

Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)

ISO/TS 19256:2016 defines the required characteristics for any MPD-system to support use cases in healthcare.
These characteristics include the medication concepts, identifiers and relationships to form a kind of structure that supports the use cases.

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)

Zdravstvena informatika - Zahteve za slovarje zdravil v sistemih zdravstvenega varstva (ISO/TS 19256:2016)

Standard ISO/TS 19256:2016 določa zahteve za slovarje zdravil v sistemih zdravstvenega varstva (MPD) za podporo pri uporabi v zdravstvu.
Te značilnosti vključujejo koncepte zdravil, identifikatorje in odnose, ki tvorijo določeno strukturo, ki podpira primere uporabe.

General Information

Status
Published
Publication Date
21-Mar-2017
ICS
35.240.80 - IT applications in health care technology
Technical Committee
CEN/TC 251 - Medical informatics
Drafting Committee
CEN/TC 251/WG 1 - Information models
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
22-Mar-2017
Completion Date
22-Mar-2017
Ref Project
SIST-TS CEN ISO/TS 19256:2017 - Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)

Buy Standard

TS CEN ISO/TS 19256:2017 - BARVETS CEN ISO/TS 19256:2017 - BARVE
PreviousNext
Technical specification
TS CEN ISO/TS 19256:2017 - BARVE
English language
46 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


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
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

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 .
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

CEN
EN ISO 21549-7:2024(Main)
Health informatics - Patient healthcard data - Part 7: Medication data (ISO 21549-7:2024)
SIST EN ISO 21549-7:2024

This document applies to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810.
This document specifies the basic structure of the data contained within the medication data object, but does not specify or mandate particular data sets for storage on devices.
The purpose of this document is for cards to provide information to other health professionals and to the patient or its non-professional caregiver.
It can also be used to carry a new prescription from the prescriber to the dispenser/pharmacy in the design of its sets.
Medication data include the following four components:
—     medication notes: additional information related to medication and the safe use of medicines by the patient such as medication history, sensitivities and allergies;
—     medication prescriptions: to carry a new prescription from the prescriber to the dispenser/pharmacy;
—     medication dispensed: the records of medications dispensed for the patient;
—     medication references: pointers to other systems that contain information that makes up medication prescription and the authority to dispense.
The following topics are beyond the scope of this document:
—     physical or logical solutions for the practical functioning of particular types of data cards;
—     how the message is processed further “downstream” of the interface between two systems;
—     the form which the data takes for use outside the data card, or the way in which such data is visibly represented on the data card or elsewhere.
NOTE            Not only does the definition of “medicinal products” differ from country to country, but also the same name can relate to entirely different products in some countries. Therefore, it is important to consider the safety of the patient when the card is used across borders.
This document describes and defines the Medication data objects used within or referenced by patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).
This document does not describe nor define the common objects defined within ISO 21549-2.

  • Standard
    51 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 21860:2024(Main)
Health Informatics - Reference standards portfolio (RSP) - Clinical imaging (ISO 21860:2020)
SIST EN ISO 21860:2024

This document establishes the Reference Standards Portfolio (RSP) for the clinical imaging domain (as defined in Clause 4).
An RSP lists the principle health information technology (HIT) standards that form the basis of implementing and deploying interoperable applications in the target domain.
An RSP includes a description of the domain, a normative list of standards, and an informative framework for mapping the standards to example deployment use cases.
The lists do not include standards that are specifically national in scope.
The primary target audience for this document is policy makers (governmental or organizational), regulators, project planners and HIT managers. This document will also be of interest to other stakeholders such as equipment and HIT vendors, clinical and health information management (HIM) professionals and standards developers.
The intended usage of this document is to inform decisions about selecting the standards that will form the basis of integration projects in geographic regions or healthcare organizations. For example:
—     What standards to use for capturing/encoding/exchanging certain types of information
—     What standards to use for interfaces between the devices and information systems that support information capture, management, exchange, processing and use
—     What standards to use for specific use cases/deployment scenarios
The selected standards, and/or corresponding RSP clauses, might be useful when drafting project specifications.

  • Standard
    59 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN ISO/TS 5499:2024(Main)
Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers (ISO/TS 5499:2024)
SIST-TS CEN ISO/TS 5499:2024

The objective of this document is to establish common principles for the creation, assessment, selection and maintenance of maps between terminological resources used to describe and code IDMP therapeutic indications for investigational and medicinal products, medical devices, combination products, biologics and companion diagnostics. Core maintenance principles, such as reliability, reproducibility and quality assurance of the maps for future indication terminology use, are also discussed. The intended audience for this document includes:
a)       Global regulators, pharmaceutical/biopharmaceutical companies, Clinical Research Organizations (CROs) and universities/scientific institutes involved in the development, authorization and marketing of medicinal products
b)       Implementers of IDMP seeking more information about coding of Therapeutic Indications
c)        Healthcare providers
d)       Standards Organizations
e)       Implementers and software vendors developing and implementing terminology map sets
f)         Patients

  • Technical specification
    32 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN ISO/TS 14265:2024(Main)
Health informatics - Classification of purposes for processing personal health information (ISO/TS 14265:2024)
SIST-TS CEN ISO/TS 14265:2024

This document defines a set of high-level categories of purposes for which personal health information can be processed: collected, used, stored, accessed, analysed, created, linked, communicated, disclosed or retained. This is in order to provide a framework for classifying the various specific purposes that can be defined and used by individual policy domains (e.g. healthcare organisation, regional health authority, jurisdiction, country) as an aid to the consistent management of information in the delivery of health care services and for the communication of electronic health records across organisational and jurisdictional boundaries.
Health data that have been irreversibly de-identified are outside the scope of this document, but since de-identification processes often includes some degree of reversibility, this document can also be used for disclosures of de-identified and/or pseudonymised health data whenever practicable.
This classification, whilst not defining an exhaustive set of purposes categories, provides a common mapping target to bridge between differing national lists of purpose and thereby supports authorised automated cross-border flows of EHR data.

  • Technical specification
    20 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 18104:2023(Main)
Health informatics - Categorial structures for representation of nursing practice in terminological systems (ISO 18104:2023)
SIST EN ISO 18104:2024

This document specifies the characteristics of categorial structures, representing nursing practice. The overall aim of this document is to support interoperability in the exchange of meaningful information between information systems in respect of nursing diagnoses, nursing actions and nurse sensitive outcomes. Categorial structures for nursing diagnoses, nursing actions, nurse sensitive outcomes and associated categories support interoperability by providing common frameworks with which to
a)       analyse the features of different terminologies, including pre- and post-coordinated expressions, those of other healthcare disciplines, and to establish the nature of the relationship between them,[3][4][5][6][7][8]
b)       develop terminologies for representing nursing diagnoses, nursing actions,[9][10][11][12] and nurse sensitive outcomes,
c)        develop terminologies that are able to be related to each other,[3][8][13] and
d)       establish relationships between terminology models, information models, including archetypes, and ontologies in the nursing domain.[14][15][16][45]
There is early evidence that the categorial structures can be used as a framework for analysing nursing practice,[17] for developing nursing content of electronic record systems,[18][19] document the value of nursing services provided and to make nursing’s contribution visible[16][36][47][50].

  • Standard
    45 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 21549-5:2023(Main)
Health informatics - Patient healthcard data - Part 5: Identification data (ISO 21549-5:2023)
SIST EN ISO 21549-5:2024

This document describes and defines the basic structure of the identification data objects held on healthcare data cards, but it does not specify particular data sets for storage on devices.
This document does not apply to the detailed functions and mechanisms of the following services (although its structures can accommodate suitable data objects elsewhere specified):
—    security functions and related services that are likely to be specified by users for data cards depending on their specific application, e.g. confidentiality protection, data integrity protection and authentication of persons and devices related to these functions;
—    access control services;
—    the initialization and issuing process (which begins the operating lifetime of an individual data card, and by which the data card is prepared for the data to be subsequently communicated to it according to this document).
Therefore, this document does not cover:
—    physical or logical solutions for the practical functioning of particular types of data card;
—    the forms that data take for use outside the data card, or the way in which such data are visibly represented on the data card or elsewhere.

  • Standard
    17 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO/IEEE 11073-10419:2023(Main)
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
SIST EN ISO/IEEE 11073-10419:2023

This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.
This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

  • Standard
    135 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 17117-1:2023(Main)
Health informatics - Terminological resources - Part 1: Characteristics (ISO 17117-1:2018)
SIST EN ISO 17117-1:2023

ISO 17117-1:2018 defines universal and specialized characteristics of health terminological resources that make them fit for the purposes required of various applications. It refers only to terminological resources that are primarily designed to be used for clinical concept representation or to those parts of other terminological resources designed to be used for clinical concept representation.
ISO 17117-1:2018 helps users to assess whether a terminology has the characteristics or provides the functions that will support their specified requirements. The focus of this document is to define characteristics and functions of terminological resources in healthcare that can be used to identify different types of them for categorization purposes. Clauses 4 and 5 support categorization according to the characteristics and functions of the terminological resources rather than the name.
NOTE       Categorization of healthcare terminological systems according to the name of the system might not be helpful and has caused confusion in the past.
The target groups for this document are:
a)    organizations wishing to select terminological systems for use in healthcare information systems;
b)    developers of terminological systems;
c)    developers of terminology standards;
d)    those undertaking independent evaluations/academic reviews of terminological resources;
e)    terminology Registration Authorities.
ISO 17117-1:2018 contains general characteristics and criteria with which systems can be evaluated.
The following considerations are outside the scope of this document.
-      Evaluations of terminological resources.
-      Health service requirements for terminological resources and evaluation criteria based on the characteristics and functions.
-      The nature and quality of mappings between different terminologies. It is unlikely that a single terminology will meet all the terminology requirements of a healthcare organization: some terminology providers produce mappings to administrative or statistical classifications such as the International Classification of Diseases (ICD). The presence of such maps would be a consideration in the evaluation of the terminology.
-      The nature and quality of mappings between different versions of the same terminology. To support data migration and historical retrieval, terminology providers can provide maps between versions of their terminology. The presence of such maps would be a consideration in the evaluation of the terminology.
-      Terminology server requirements and techniques and tools for terminology developers.
-      Characteristics for computational biology terminology. Progress in medical science and in terminology science will necessitate updating of this document in due course.

  • Standard
    38 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 11239:2023(Main)
Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO 11239:2023)
SIST EN ISO 11239:2023

This document specifies:
—     the data elements, structures and relationships between the data elements required for the exchange of information, which uniquely and with certainty identify pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products;
—     a mechanism for the association of translations of a single concept into different languages, which is an integral part of the information exchange;
—     a mechanism for the versioning of the concepts in order to track their evolution;
—     rules to help regional authorities to map existing regional terms to the terms created using this document, in a harmonized and meaningful way.

  • Standard
    37 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
CEN ISO/TS 20440:2023(Main)
Health informatics - Identification of medicinal products - Implementation guidelines for ISO 11239 data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging (ISO/TS 20440:2023)
SIST-TS CEN ISO/TS 20440:2023

This document describes data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging.
Based on the principles outlined in this document, harmonised controlled terminologies will be developed according to an agreed maintenance process, allowing users to consult the terminologies and locate the appropriate terms for the concepts that they wish to describe. Provisions to allow for the mapping of existing regional terminologies to the harmonised controlled terminologies will also be developed in order to facilitate the identification of the appropriate terms. The codes provided for the terms can then be used in the relevant fields in the PhPID, PCID and MPID in order to identify those concepts.
This document is intended for use by:
—    any organization that might be responsible for developing and maintaining such controlled vocabularies;
—    any regional authorities or software vendors who want to use the controlled vocabularies in their own systems and need to understand how they are created;
—    owners of databases who want to map their own terms to a standardized list of controlled vocabularies;
—    other users who want to understand the hierarchy of the controlled vocabularies in order to help identify the most appropriate term to describe a particular concept.
This document does not specify a particular terminology for the implementation of ISO 11239.

  • Technical specification
    53 pages
    English language
    sale 10% off
    e-Library read for
    1 day