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REALM Building a shared, real-world evidence base thatenables evaluation of AI-powered medical software

REALM
  • Connects real-world health data from across Europe through a secure, federated infrastructure to evaluate AI-based medical device software (MDSW)
  • Develops a standardised evaluation methodology and regulatory toolbox covering clinical performance, robustness, ethics and legal compliance
  • Keeps a transparent, blockchain-based record of medical AI models throughout their lifecycle
  • Generates privacy-preserving synthetic data and digital twins to test algorithms where real data is scarce
  • Trains regulators, HTA bodies and industry through the REALM Academy to apply these tools in practice
  • RISE, together with EURICE, co-leads REALM's management, communication and stakeholder engagement, and steers the project's exploitation and sustainability planning"

What the project is about

AI is increasingly built into medical software, but regulators and health technology assessment bodies often lack standardised, real-world evidence to judge whether these tools are safe, fair and effective once deployed. REALM addresses this by connecting real-world health data from across Europe through a secure, federated infrastructure, paired with a common evaluation methodology for AI-driven medical device software. Data quality checks, explainable AI, synthetic data and blockchain-based tracking are brought together in one toolbox, helping the sector move from one-off approvals to ongoing, evidence-based oversight.

Why it matters

Software-based medical devices are changing faster than the evidence used to evaluate it, just as the EU AI Act, the European Health Data Space and stricter MDR post-market rules raise the bar for manufacturers and regulators alike. REALM turns these new requirements into practical, reusable tools: shared standards, federated data access and monitoring that make compliance faster and less costly. For regulators, HTA bodies and medical software developers across Europe, this means faster, more consistent and more trustworthy decisions about which AI tools reach patients – and stay safe once they do.

Our role in the project

  • Co-leading the project's overall management and governance with EURICE and overseeing financial monitoring and periodic reporting.
  • Driving communication and dissemination, running the monthly Communication Committee and helping shape REALM's outreach across Europe.
  • Supporting delivery of the REALM Academy, shaping agendas, lining up speakers, organising logistics and collecting feedback.
  • Coordinating the collection and analysis of stakeholder feedback to steer REALM's tools and training toward real regulatory needs.
  • Guiding exploitation and sustainability planning for the project's key results, including IP management pathways.
Our role in the project

Want to know more?

Visit Health Innovation Ecosystem to explore other projects related to digital health, advanced terappries and health systems innovations.

Project Facts & Figures

Full title
Real-world-data Enabled Assessment for heaLth regulatory decision-Making
Programme
Horizon Europe & sub-programmes
Duration
48 months (January 2023 – December 2026)
Budget
EUR 6,659,650.00
Project website
http://www.realm-ai.eu