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AIDAVA Policy Brief

i~HD and AIDAVA co-publish policy brief on AI-powered scaling of EHDS

By i~HD

September 07, 2026

The European Institute for Innovation through Health Data (i~HD) and the AIDAVA project have co-prepared a policy brief on how the European Health Data Space (EHDS) can be implemented in a scalable and economically sustainable manner.

The policy brief and its accompanying Technical Evidence Paper are the product of roundtable discussions held with stakeholders from patient groups, hospitals, decision-makers, and industry. The document contains five calls-to-action that address five interdependent conditions for success, guided by the roundtables.

Calls-to-action

  • Technology: Test and expand
  • Governance: A European health data semantic strategy
  • Preparation: Capacity building and workforce preparation
  • Infrastructure: Define a Sustainable Data Infrastructure Funding Model
  • Coordination: EU and national action aligned with the regulatory framework

Technology: Test and expand

Support additional clinical use cases and national implementation pilots, involving multiple data holders, real governance frameworks, real data access use cases, in at least 3–5 Member States through dedicated EU funding calls. Recommended priority entry points are electronic health record (EHR)-to-electronic data capture (EDC) clinical trial enablement and patient matching for pharma; federated registry population for clinical research.

Governance: A European health data semantic strategy

Establish an EU Health Data Semantic Strategy including: (a) governance and sustainable public funding for a shared Simplified Upper Level Ontology (SULO or equivalent) as an EU public asset; (b) formal engagement of HL7, SNOMED International, CEN/TC 251 and other international Standards Development Organisations to develop mappings based on agreed, shared semantics and to enable cost-effective, AI-powered mapping; and (c) open licensing for all EU-funded semantic assets.

Preparation: Capacity building and workforce preparation

Invest in tools and the needed set of skills to enable this change; establish an EU open-source ecosystem, ensuring shared tools and semantic assets are accessible to all Member States regardless of their starting point.

Infrastructure: Define a Sustainable Data Infrastructure Funding Model

A paradigm shift is needed toward treating health data infrastructure as a pre-competitive national asset — co-funded by public Member States/EU budgets, industry and research bodies. A clear economic model with ROI articulated for each stakeholder group (hospitals, pharma, regulators, patients) must be developed and adopted by decision-makers.

Coordination: EU and national action aligned with the regulatory framework

Coordinated EU and national action is needed, in line with the AI Act, MDR, and the Biotech Act's data quality accelerator provisions, with strong involvement of Standards Development Organisations as governance partners. The EHDS Board, eHealth Network, and AI Office should establish a joint regulatory learning mechanism, including AI Act regulatory sandboxes, to resolve open qualification and governance
questions for AI-enabled health data infrastructure.

Learn more and read the Policy Brief