REALM Launches First HTA-focused Training on AI in Medical Software Evaluation

On 11–12 June, REALM hosted its first health technology assessment (HTA)-focused online training, bringing together HTA body representatives, regulators and evaluators from across Europe to explore the challenges of evaluating AI-based medical device software and how REALM is building practical tools to support them.

The two-day training combined insights into where we currently are with interactive discussion and feedback from the audience, led by REALM Academy coordinators Dr Anshu Ankolekar (Maastricht University) and Dr Rebekka Van Hoof (VITO).

Throughout Day 1, speakers unpacked key technical, regulatory, and ethical hurdles such as challenges with explainability and fairness in AI, GDPR compliance and the use of real-world data, evidence gaps in local validation, and the need for a unifying EU framework for consistent evaluation.

Participants engaged actively, sharing their own HTA challenges and helping shape future REALM directions.

Day 2 shifted focus to REALM’s tools, such as the data resources catalogue, regulatory toolbox, blockchain framework, and the living lab. Speakers demonstrated how these components can help streamline assessments, support compliance, and build trust in AI-enabled health technologies.

The training concluded with an open discussion where participants shared their needs and expectations, input that will directly shape future REALM development.

The upcoming REALM Academy events.

Stay tuned for future sessions by visiting REALM Academy.