REALM at the CSMD-Horizon Conference

Janaki Raman Rangarajan from VPH Institute and Vincent Uyttendaele from the University of Liège represented the REALM project at the recent CSMD-Horizon Conference, a key European forum dedicated to shaping the regulatory landscape for Artificial Intelligence as a Medical Device (AIaMD).

The event gathered clinical experts, notified bodies, regulators, and technology developers to address one of the most pressing challenges in the field - evidence generation for AI-based medical tools.

A highlight of the conference was the session on Regulatory Sandboxes, where Miguel Amador presented insights from European AI sandbox initiatives. The UK MHRA’s AI Airlock pilot further underscored challenges around the acceptance of AI-generated synthetic data, a topic closely aligned with ongoing discussions within the REALM federated sandbox platform.

Expert speakers also clarified the clinical evidence pathway for machine learning models and software as a medical device. Tom Melvin detailed the use of early feasibility studies for AI/software devices, while Amie Smirthwaite’s use cases demonstrated the persistent difficulty around 'classification' of these devices. Furthermore, Elisabeth Oltmanns and her team probed ambiguities surrounding the benefit-risk ratio and crucial validation data considerations for AI.

Overall, the conference offered REALM valuable engagement with regulatory and industry stakeholders interested in leveraging its sandbox framework to support AIaMD development and evidence-based regulatory innovation.