The new EU Regulation on Artificial Intelligence requires us to rethink the design and development of health research with AI systems. The casuistry is complex. While some of these systems are classified as high-risk, others are expressly excluded from the scope of the Regulation. This seminar will address, on the one hand, the different legal scenarios that we may face in health research with AI and, on the other hand, the confluence of data protection, medical devices and artificial intelligence regulations. This systematisation will help us in practice to implement the new obligations introduced by the (EU) Regulation on AI as soon as possible.
Guillermo Lazcoz (Sun,) studied this question.