The increasing use of artificial intelligence (AI) threatens our fundamental rights, including the right to privacy and non-discrimination. These risks also hold true when it comes to the use of AI in the healthcare sector. Currently, the European Union (EU) is making its first attempt at providing a regulatory framework for AI in the AI Act. In its current version, the AI Act only covers AI medical devices which are covered by the EU Medical Devices Regulation.
Our latest fact sheet compares both regulatory frameworks (the AI Act and the Medical Devices Regulation) and provides recommendations on how to address the remaining gaps when it comes to health-related AI.