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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill Of Health

APRIL 4, 2024

Cross-sectoral EU laws First and foremost, the product as a whole must comply with the Medical Device Regulation (MDR) and the specific norms incorporated therein, as well as with GDPR requirements and ESG considerations, just to name a few. AI regulation has, for the most part, been sectoral rather than cross-sectoral.

Regulations 113
Regulations Accountability Health Data Patient Safety 113
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What’s on the Horizon for Health and Biotech with the AI Executive Order

Bill Of Health

NOVEMBER 17, 2023

By Adithi Iyer Last month, President Biden signed an Executive Order mobilizing an all-hands-on-deck approach to the cross-sector regulation of artificial intelligence (AI). Some questions that are less than an eventuality: is now too soon for sweeping AI regulations?

Biotechnology 99
Biotechnology Regulations Patient Safety Health Data 99
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