Decoding Digital Health: Conversation with Dr. Bernardo Bizzo, Mass General Brigham AI

In this episode of Decoding Digital Health, Christine Moundas interviews Dr. Bernardo Bizzo, a Senior Director at Mass General Brigham AI and Assistant Professor of Radiology, about the development, validation, and implementation of AI and machine learning in healthcare. Dr. Bizzo discusses Mass General Brigham's role as a device manufacturer, their AI CRO, and the FDA's regulatory framework for AI-based medical devices, including the 510k pathway and special controls like performance assessments and reader studies. The conversation explores the potential of AI to enhance diagnostic accuracy and efficiency, the challenges of achieving return on investment, and the promising emergence of foundation models and generative AI in healthcare. Dr. Bizzo emphasizes the need for high-quality healthcare data to train these models and suggests an expansion of the FDA's regulatory authority to include AI applications beyond traditional medical devices.