The legal regulation of artificial intelligence in the European Union: A practical guide for radiologists

The European Union is taking the lead globally on the regulation of Artificial Intelligence (AI) and developing important legislation, namely the AI Act. The purpose of this article is to describe this regulation and examine three implications that will affect radiologists. In relation to the 'risk approach', AI applications in radiology will be classified as high risk, thus necessitating compliance with a series of requirements and obligations. Secondly, 'effective radiologist supervision' involves establishing supervision-automation levels, defining an appropriate degree of authority, and determining how AI recommendations will be documented in the radiological report. Finally, this article examines the different forms of 'legal liability' that radiologists may incur in the event of a diagnostic error made by combined radiologist-artificial intelligence. (c) 2024 SERAM. Published by Elsevier Espana, S.L.U. All rights reserved.