The EU AI Act and Medical Device Regulation with Andrea Biasiucci

Our guest is Dr. Andrea Biasiucci (https://www.linkedin.com/in/andreabiasiucci/) who is the CEO of confinis (https://www.confinis.com/), a worldwide medical device regulatory consulting company based in Switzerland. Dr. Biasiucci received his Ph.D. in Brain-Computer Interfaces from EPFL in Lausanne, and has been an AI-based neurotech innovator for over a decade. The video was recorded on Nov 22, 2023.

This is a follow up interview to a previous discussion recorded with Dr. Biasiucci for the Yale Medical Software Coursera Class: https://www.youtube.com/watch?v=OhK6AQ3Qyfk (June
2021).

Further Reading:

EU AI Act: https://artificialintelligenceact.eu/the-act/
Gilbert S, Harvey H, Melvin T, Vollebregt E, Wicks P. Large language model AI chatbots require
approval as medical devices. Nat Med [Internet]. Nature Publishing Group; 2023 Jun 30.
Available from: https://www.nature.com/articles/s41591-023-02412-6