Navigating uncharted waters: select practical considerations in radiology AI compliance with the EU AI Act.

Potočnik, Jaka; Fujs, Damjan · NPJ Digit Med · 2025

expert_opinion · Level V

Where this comes from

Abstract

Artificial intelligence (AI) is transforming traditional medicine, particularly in radiology. Its integration across patient care stages has made it increasingly ubiquitous. The European Union’s (EU) AI Act will additionally regulate AI-enabled solutions within the EU. However, without standardized guidelines, the Act’s flexibility poses practical challenges for providers and deployers, leading to inconsistencies in meeting requirements for high-risk systems like radiology AI, potentially impacting patients’ fundamental rights and safety.