On 12 March 2026, the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) issued a Joint Opinion (the “Joint Opinion”) on the proposed European Biotech Act […]
The European Commission (Commission) released its Digital Omnibus package, which aims to streamline and recalibrate certain aspects of the fast-growing body of EU digital regulations, on November 19, 2025. Rather […]
On November 19, 2025, the European Commission officially adopted a proposal for the Digital Omnibus package. Specifically, the Digital Omnibus package consists of two legislative proposals, a Digital Omnibus on AI and […]
On January 21, 2025, the European Health Data Space Regulation (EHDS) was formally adopted by the Council of the European Union. This marks the near-final step in the adoption process, […]
Digital health AI technologies are transforming the advancement of drug development and healthcare delivery at an unprecedented speed, backed by governments facilitating the momentum to improve healthcare for their growing […]
Globally, the rapid advancement of artificial intelligence (AI) and machine learning (ML) raises fundamental questions about how the technology can be used. Drug approval authorities are now also taking part […]
The European Union is moving closer to adopting the first major legislation to horizontally regulate artificial intelligence. Today, the European Parliament (Parliament) reached a provisional agreement on its internal position […]