Remove Biotechnology Remove Health Data Remove Integration Remove Regulations
article thumbnail

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

Bill Of Health

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.

article thumbnail

From Regulation to Innovation: The Impact of the EU AI Act on XR and AI in Healthcare

Bill Of Health

However, integrating XR and AI into healthcare comes with ethical, legal and liability challenges. This includes addressing potential specific AI-related risks—such as biases, discrimination, and data poisoning—as well as ensuring data security and privacy, and delineating liability for failures or harm caused by these technologies.