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

REALM Academy Launches First In-Person Workshop on Medical AI Evaluation

The REALM project is pleased to announce its first in-person REALM Academy Workshop, 'Multi-Stakeholder Insights for Evaluating Medical AI,' scheduled for 5 November 2025, in Brussels, Belgium.

The event aims to bring together a diverse audience of regulators, health technology assessment (HTA) bodies, software manufacturers, and researchers to address one of the most pressing challenges in digital health: how to evaluate AI-enabled medical software in a way that is robust, transparent, and responsive to real-world needs.

Artificial intelligence is already transforming healthcare, from diagnostics to decision support, and its potential is growing rapidly. Yet, while technology advances at high speed, evaluation systems often struggle to keep pace with the complexity, risks, and real-world challenges of AI in medical contexts. This gap creates uncertainty for regulators, developers, and healthcare providers — and ultimately for patients who rely on safe and effective solutions.

The REALM project addresses this challenge by building a collaborative platform that offers all stakeholders a reliable environment for testing and evaluating software used in medical devices. By combining real-world data, medical expertise, and up-to-date legal guidance, REALM is creating a transparent, traceable, and secure framework that strengthens trust in medical AI and supports better decision-making across the lifecycle of these technologies.

A Full-Day Program of Exchange and Co-Creation

The workshop will open with a keynote introduction to the REALM project, outlining its pillars: developing better evaluation guidelines, building a practical toolbox (for bias detection, explainability, stability, and auditing), advancing standards and synthetic data use, and strengthening post-market monitoring.

A panel of experts will share insights from across the ecosystem, highlighting the expectations and challenges of HTA agencies, notified bodies, and industry. Their perspectives will frame the day’s central activities: hands-on, multi-stakeholder group sessions.

Participants will collaborate on drafting a “REALM evaluation playbook”, a practical framework capturing shared evaluation principles, stakeholder priorities, and lessons learned from REALM’s demonstrator use cases.

The afternoon will focus on refining the playbook, identifying key gaps, and translating discussions into a prioritized roadmap of improvements to REALM’s tools and guidelines.

Shaping the Future of Medical AI Evaluation

By engaging directly with experts and peers, participants will not only exchange knowledge but also actively contribute to shaping the evaluation frameworks that will support safe, effective, and trustworthy use of medical AI across Europe. Participation is free of charge, with attendance limited to 40 participants to foster meaningful discussion and interaction.

Event Details

  • Date: 5 November 2025
  • Location: TRACK Brussels, Vooruitgangstraat 76, 1030 Schaarbeek, Belgium

Registration: link