In this episode, we delve into the realm of AI regulation and its impact on the future of medical AI innovation in UK. Joining me is the esteemed Professor Stephen Gilbert, a medical device regulatory science academic.

During our discussion, we explore:

• The necessity for innovative regulatory approaches in the AI domain
• The diverging paths of EU and US regulatory strategies
• Challenges posed by the EU MDR approach and its horizontal regulatory system
• Pioneering approaches to regulation, emphasising system rather than product-level oversight

Relevant publicatons:

https://www.jmir.org/2023/1/e43682

https://www.nature.com/articles/s41591-023-02412-6
https://www.sciencedirect.com/science/article/pii/S2949761223000421