Hugh Harvey, founder of a consulting company focused on medical device regulation, joins T Cook, head of the Innovation Centre at Penn Radiology and AI expert. They discuss the intricate regulatory landscape for medical AI, contrasting Europe’s cautious approach with the U.S.’s entrepreneurial spirit. The duo emphasizes the need for rigorous evaluation processes, especially for lung nodule detection, and the growing challenges posed by AI in healthcare. They explore AI's transformative role in radiology and the need for collaboration to ensure safety and effectiveness.