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.
Who should use this standard
- MPD-system developers and vendors
- EHR and clinical decision support implementers
- Healthcare IT architects and integrators
- Regulatory agencies, pharmacovigilance authorities and payers
- Hospitals, pharmacies and public health organizations seeking interoperable medicinal product data
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.
