Medical Artificial Intelligence

In late February 2020, the European Commission published a white paper on artificial intelligence (AI)a and an accompanying report on the safety and liability implications of AI, the Internet of Things (IoT), and robotics.b In the white paper, the Commission highlighted the "European Approach" to AI, stressing "it is vital that European AI is grounded in our values and fundamental rights such as human dignity and privacy protection." In April 2021, the proposal of a Regulation entitled "Artificial Intelligence Act" was presented.2 This Regulation shall govern the use of "high-risk" AI applications which will include most medical AI applications. Referring to the above-mentioned statement, this Viewpoint aims to show European fundamental rights already provide important legal (and not merely ethical) guidelines for the development and application of medical AI.7 As medical AI can affect a person's physical and mental integrity in a very intense way and any malfunction could have serious consequences, it is a particularly relevant field of AI in terms of fundamental rights.