DiscoverYale Certificate in Medical Software and Medical AI: Guest ExpertsThe EU AI Act and Medical Device Regulation with Andrea Biasiucci
The EU AI Act and Medical Device Regulation with Andrea Biasiucci

The EU AI Act and Medical Device Regulation with Andrea Biasiucci

Update: 2024-02-13
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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

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The EU AI Act and Medical Device Regulation with Andrea Biasiucci

The EU AI Act and Medical Device Regulation with Andrea Biasiucci

Yale Biomedical Informatics & Data Science