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

Congratulations to UCD School of Medicine’s Jaka Potočnik on his recently published paper with University of Ljubljana’s Damjan Fujs. The paper is titled ‘Navigating uncharted waters: select practical considerations in radiology AI compliance with the EU AI Act’ and was published by npj Digital Medicine.

Jaka and Damjan discuss the landscape surrounding radiology artificial intelligence (AI) and the European Union's AI Act. They touch on a few practical issues in achieving compliance and highlight that any deployed AI-enabled solution should promote the Fundamental Rights specified in the Charter. Throughout the commentary, they challenge the AI Act and its limited, overly general guidance, which allows multiple interpretations of critical aspects.

Among other topics briefly addressed in the commentary are:

• Identifying risks pertinent to AI solutions in radiology
• Quantifying training dataset representativeness and completeness
• Training dataset considerations for a location- and task-specific AI-enabled solution impacting millions of patients
• Post-market monitoring, also known as post-market surveillance, including timely detection of covariate and concept shifts (they do not mention novelty detection, but acknowledge it is as equally important)
• The fact that current AI research demonstrates feasibility only in very limited contexts
• The need for greater regulatory clarity.

Without standardised 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.

Read online (opens in a new window)here.