• PD CEN ISO/TS 19256:2017

    Current The latest, up-to-date edition.

    Health informatics. Requirements for medicinal product dictionary systems for health care

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-03-2017

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Abbreviated terms
    5 Boundary between MPD-systems and IDMP, ancillary
      information to build an MPD-system and local implementation
    6 Positioning of Medicinal Product Dictionary Systems
      for Healthcare
    7 The Functional Requirements for MPD-systems
    Annex A (informative) - IDMP series in context, serving
            this Technical Specification
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes the required characteristics for any MPD-system to support use cases in healthcare.

    Scope - (Show below) - (Hide below)

    This Technical Specification 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.

    In order to support the use cases, an MPD-system needs to:

    • be comprehensive and exhaustive as far as possible – unless all medicinal products that are in scope are included, other systems cannot fully rely on the MPD-system to supply the necessary information, and some amount of duplicated registration of information will still be necessary;

    • contain the information in a consistent and appropriate structure according to the ISO IDMP Standards (as described in this Technical Specification) and with an appropriate level of detail.

    Outside the scope of this Technical Specification are:

    • the functionality of health, clinical and/or pharmacy systems;

    • the other kinds of content of health, clinical or pharmacy systems that are needed to support the whole process of healthcare providers, like:

      • the wide range of knowledge about medicines, which would be handled in drug knowledge databases and decision support systems,

      • the medication record,

      • the dose instructions;

    • in terms of products:

      • traditional Chinese medicines,

      • medical devices, such as for medication administration [this Technical Specification focuses on administration devices that are intended for correct administration of the medicinal product only (see ISO11615)],

        NOTE An administration device can be an integral part of an immediate container or a closure.

      • veterinary medicines.

    The purpose of this Technical Specification is to provide a set of functional requirements for systems handling details about medicinal products and the relationships between them for the purpose of supporting healthcare.

    General Product Information - (Show below) - (Hide below)

    Committee IST/35
    Document Type Standard
    Publisher British Standards Institution
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 18308:2011 Health informatics — Requirements for an electronic health record architecture
    CEN/TS 15699:2009 Health informatics - Clinical knowledge resources - Metadata
    ISO 1087-1:2000 Terminology work Vocabulary Part 1: Theory and application
    ISO 13119:2012 Health informatics — Clinical knowledge resources — Metadata
    ISO 13940:2015 Health informatics — System of concepts to support continuity of care
    ISO 11615:2017 Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated medicinal product information
    ISO/HL7 27953-2:2011 Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR
    ISO 21549-7:2016 Health informatics — Patient healthcard data — Part 7: Medication data
    ISO 21090:2011 Health informatics — Harmonized data types for information interchange
    ISO 11240:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of units of measurement
    ISO 11238:2012 Health informatics Identification of medicinal products Data elements and structures for the unique identification and exchange of regulated information on substances
    ISO 11616:2017 Health informatics — Identification of medicinal products — Data elements and structures for unique identification and exchange of regulated pharmaceutical product information
    ISO 19115-1:2014 Geographic information — Metadata — Part 1: Fundamentals
    ISO 17523:2016 Health informatics — Requirements for electronic prescriptions
    ISO/HL7 10781:2015 Health Informatics — HL7 Electronic Health Records-System Functional Model, Release 2 (EHR FM)
    ISO 704:2009 Terminology work — Principles and methods
    ISO/TS 17439:2014 Health informatics Development of terms and definitions for health informatics glossaries
    ISO 11239:2012 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
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