Overview
CEN ISO/TS 5499:2024 - Health informatics: Core principles for harmonizing therapeutic indications terms and identifiers defines common principles for creating, assessing, selecting and maintaining maps between terminological resources used to describe and code IDMP therapeutic indications. The Technical Specification focuses on harmonization, map quality, reliability, reproducibility and long‑term maintenance to support interoperable exchange of indication data across regulators, industry, healthcare and research.
Key topics and requirements
- Scope and audience: Guidance intended for global regulators, pharmaceutical/biopharma companies, CROs, implementers of IDMP, healthcare providers, standards organizations, software vendors and patients.
- Terminologies covered: Practical considerations for mapping between commonly used vocabularies such as SNOMED CT, MedDRA, ICD, MeSH and other national/regional term sets.
- Mapping principles: Requirements for map creation and validation, including prerequisites, mapping processes, best practice conventions, documentation and stakeholder engagement aligned to specific use cases.
- Use‑case driven mapping: Emphasis that maps must be developed and evaluated against clear use cases (e.g., regulatory submissions, coded labelling, clinical trials, pharmacovigilance, registries, EHR integration).
- Maintenance principles: Core maintenance topics such as quality assurance, reproducibility, governance, versioning and reliability of map sets to ensure ongoing utility.
- Implementation guidance: Practical annexes and examples for implementing the IDMP therapeutic indications data model and for exchanging coded indication data between regulators and industry.
Applications and practical value
- Regulatory exchange and submissions: Enables consistent coding of therapeutic indications for IDMP data exchange between regulators and manufacturers, improving automated review and label harmonization.
- Clinical trials & drug development: Supports standardized capture of indication concepts used in protocol design, trial registries and evidence synthesis (PICO).
- Pharmacovigilance & safety monitoring: Improves signal detection and assessment by linking adverse event data to coded therapeutic indications across datasets.
- EHR and real‑world evidence: Facilitates mapping between clinical problem lists and medicinal product indications to support prescribing decisions, off‑label detection and registries.
- Software and terminology implementers: Provides governance and quality principles for vendors building terminology map sets, APIs, and IDMP‑compliant systems.
Related standards
- ISO 11615 (Identification of Medicinal Products - IDMP): conceptual data model referenced throughout for clinical particulars and therapeutic indications.
- Other ISO/CEN health informatics standards (e.g., terminology and interoperability guidance) are complementary for full implementation.
This Technical Specification is essential for anyone implementing IDMP‑based indication coding, developing terminology maps, or managing cross‑system exchange of therapeutic indication data. Keywords: IDMP, therapeutic indications, terminology mapping, SNOMED CT, MedDRA, pharmacovigilance, regulatory submission, EHR.