A Pathway from Law to Care: How the Artificial Intelligence Act, the Medical Device Regulation, and the Public Procurement Directive Can Contribute to Ensuring Quality in Healthcare.
Artificial intelligence (AI) is increasingly embedded in healthcare delivery, and when systems are scaled across clinical workflows, errors may have system-wide consequences. The Artificial Intelligence Act (AIA) and the Medical Device Regulation (MDR) establish important safety requirements for AI-based medical device...