Highlights

Artificial intelligence as a medical device in radiology: ethical and regulatory issues in Europe and the United States

Artificial Intelligence (AI) is a current trending and much debated topic, and also relevant to many medical fields, including radiology. AI brings numerous legal and ethical questions to the forefront. This paper analyses the state of AI regulation in the context of medical device development in both Europe and the United States.

Article: Artificial intelligence as a medical device in radiology: ethical and regulatory issues in Europe and the United States

Authors: Filippo Pesapane, Caterina Volonté, Marina Codari and Francesco Sardanelli