SIST-TS CEN ISO/TS 19256:2017 PDF

Name: SIST-TS CEN ISO/TS 19256:2017 — Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)
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Health informatics - Requirements for medicinal product dictionary systems for health care (ISO/TS 19256:2016)

Название (английский):

SIST-TS CEN ISO/TS 19256:2017

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 46
Дата публикации:: 31 мая 2017 г.
Издание:: ISO/TS 19256:2016
ICS:: 35.240.80

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Описание (английский):

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.

Abstract

Похожие стандарты

Другие стандарты SIST

Overview

CEN ISO/TS 19256:2017 (identical to ISO/TS 19256:2016) is a Technical Specification in health informatics that defines required characteristics for medicinal product dictionary (MPD) systems used in healthcare. It specifies how medication concepts, identifiers and relationships should be structured to support common clinical and administrative use cases. The document targets developers and service providers of MPD-systems and organizations that procure or integrate them into clinical systems.

Key topics and technical requirements

Definition and scope of MPD-systems: Establishes what an MPD-system is and its boundary relative to local implementations and regulatory IDMP information.

Core content requirements: Normative content for regulated medicinal products and representation of medication concepts at multiple levels of detail.

Identifiers and relationships: Emphasizes maintenance of global unique IDs from the IDMP family to ensure consistent identification across systems.

Use-case driven requirements: Functional coverage aligned with real-world workflows (prescribing, dispensing, administration, recording, reconciliation, ordering/supply chain, analysis, reporting).

Data exchange & technical functions: Requirements for interoperability between MPD-systems, EHRs, decision support, pharmacovigilance and reimbursement systems.

Governance, maintenance and localization: Processes for regular updates, interaction with regulatory information, lifecycle management and adapting content to local needs.

Patient safety and decision support: Linking personal data with medicinal product decision support and pharmacovigilance interactions.

Practical applications

MPD-systems built to ISO/TS 19256 support:

Safe and consistent prescribing, dispensing, and administration in clinical settings.

Accurate medication histories, medication list reconciliation, and clinical decision support.

Interoperable electronic data exchange between EHRs, pharmacy systems, national registers and regulatory bodies.

Analytics, pharmacoepidemiology, reimbursement processing, clinical research and pharmacovigilance reporting.

Supply chain, ordering and tracking/tracing workflows that rely on standardized product identification.

Related standards

ISO IDMP series (Identification of Medicinal Products) - the Technical Specification requires MPD-systems to maintain IDMP global unique identifiers and align with IDMP concepts for regulatory interoperability.

This guidance helps organizations achieve consistent, interoperable and safety-focused medicinal product data across healthcare systems. Keywords: health informatics, medicinal product dictionary, MPD-system, ISO/TS 19256, IDMP, EHR interoperability, pharmacovigilance.

SIST-TS CEN ISO/TS 19256:2017 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards

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