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Real-world-data enabled assessment
for health regulatory decision-making

REALM Academy Workshop: From Data Federation to Medical AI Model Evaluation 14 April 2026 | Brussels, Belgium

The REALM Academy invites stakeholders from across the European health data and AI ecosystem to an in-person workshop dedicated to trustworthy AI evaluation in healthcare, spanning the full journey from federated real-world data to transparent AI model assessment.

As artificial intelligence increasingly enters clinical and regulatory decision-making, there is a growing need for robust, scalable, and legally compliant evaluation frameworks. The REALM project addresses this challenge by developing and demonstrating a federated European infrastructure that enables the evaluation of AI models on real-world health data while respecting data protection, governance, and national constraints.

This workshop will provide participants with a practical and conceptual understanding of the REALM approach, including how federated data infrastructures enable cross-border AI evaluation without centralising sensitive data; how common data models and standards support interoperability and reuse; and how AI models can be evaluated and documented in a transparent and reproducible manner to support trust and regulatory readiness.

In addition, we will demonstrate the REALM workflow through a realistic use case, showcasing the user journey of AI developers and manufacturers, from model onboarding and claim definition to transparent evaluation and evidence generation. We will also consider the perspective of regulators, and illustrate how the outputs of REALM provide valuable, trustworthy evidence to support regulatory assessment and decision-making.

Drawing on experiences from REALM national nodes and platform demonstrations, the workshop will connect technical implementation, data governance, and the European regulatory landscape, including alignment with the AI Act and the European Health Data Space (EHDS). The event is designed to be interactive and cross-disciplinary, fostering dialogue on future collaboration, uptake, and capacity building through the REALM Academy.

This workshop is intended for representatives from:

  • AI as Medical Device Manufacturers
  • Hospitals, University Medical Centres, and clinical data providers
  • Data Protection Officers and legal/compliance teams
  • Clinical research units, biobanks, imaging and laboratory infrastructures
  • National and EU health authorities and initiatives
  • Data hubs, federated networks, and European real-world data (RWD) partners

Please complete the following registration form to confirm your participation in the workshop. The information provided will be used to organize the event and ensure that your preferences are accommodated.

Date: 14th April 2026

Venue: HOEK 38
Rue de Louvain 38, 1000 Brussels, Belguim

Places are limited: 40 participants.