Highlights

Artificial intelligence as a medical device in radiology

Artificial intelligence as a medical device in radiology

This paper analyses the state of AI regulation in the context of medical device development, and strategies to make AI applications safe and useful in the future. The focus is on the legal framework regulating medical devices and data protection in Europe and in the United States, assessing developments that are currently taking place.

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