Bridging the Regulatory Gaps for AI Medical Devices The New Layer ...
summary
Explains how the AI Act sits on top of MDR/IVDR and GDPR and where responsibilities actually land: use MDR procedures and ISO 14971 risk/benefit logic for clinical evaluation, map AI Act Article 13 transparency and interpretability to existing device information duties, and rely on harmonized standards plus QMS evidence to demonstrate high‑risk compliance. Flags two concrete gaps: generative models deployed clinically without device conformity and research‑exclusion ambiguity under Article 2.6, plus practical patient consent and oversight failures despite hundreds of AI devices already on the market.
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chapters (9)
- 0:00AI medical device regulation intro
- 4:01Privacy and standardization in AI Act
- 11:00AI in biomedical research ethics
- 20:40Data governance under AI Act
- 27:47Transparency requirements for AI devices
- 38:39Generative AI in mental health debate
- 51:48Patient consent with AI systems
- 1:02:00Regulatory gaps and patient trust
- 1:19:02Q&A
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