Interoperability Standards
Technical formats, models and terminologies enabling data exchange and reuse across the biotech, pharma and health ecosystem. Complementary to compliance frameworks — often referenced or mandated by them.
Standards vs regulatory frameworks
Interoperability standards define the HOW (format, syntax, semantics). Regulatory frameworks define the WHAT and WHY (legal obligations, governance, audit). A single project may be subject to GDPR (framework) while implementing FHIR R4 (standard) to exchange patient data.
Interoperability: the prerequisite for AI in health and life sciences
Artificial intelligence is transforming biomedical research — but its promises can only materialise if data is accessible, structured and comparable. Yet in life sciences and health, data is scattered across dozens of systems with incompatible formats: EHRs, LIMS, ELNs, genomic platforms, imaging devices.
Without interoperability, every AI model is trained in a silo. With open standards (FHIR for clinical data, CDISC for trials, OMOP CDM for real-world data), data can flow, be compared and feed robust AI models — in compliance with regulatory requirements.
Constellab implements these standards natively
The Constellab platform natively supports FHIR R4/R5, CDISC ODM/CDASH/SDTM, OMOP CDM, DICOM and HL7 v2/v3. Data can enter from any source format and be exported in the standard required by each partner or regulatory authority — without manual re-conversion.
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Showing 9 of 9 standards
| Standard | Type | Domain | Active version | Regulatory link | Description | Organisation |
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