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.
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