Mainz – As the EU AI Act introduces new regulatory requirements for medical AI, hospitals and neuroradiology departments face questions about compliance, liability, and the potential impact on innovation.
"For us in clinical use, the most important question is, is my AI a so-called high-risk AI system or not?" said Dr. Joel Kohler of Heidelberg University Hospital.
In a video interview at neuroRAD 2026 in Mainz, Kohler explained how the AI Act interacts with the EU Medical Device Regulation, what the distinction between AI providers and deployers means for hospitals, and why the new legislation does not directly resolve questions of clinical liability.
He also discussed proposed regulatory changes, the risk of overlapping requirements, and the importance of keeping innovation focused on patient care. "Ideally, this should not stop us from working with AI and finding the best solution for patients," he said.
