Senator Bill Cassidy Introduces PATIENT AI Act to Reform FDA Software Device Review
U.S. Senator Bill Cassidy, Chairman of the U.S. Senate Health, Education, Labor, and Pensions Committee, has released a discussion draft of the Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act, or PATIENT AI Act. This proposed legislation aims to update the premarket review process for software devices by the Food and Drug Administration (FDA). The draft introduces new categories for devices: 'integrated devices,' which combine software functions with other components, and 'software-based devices,' primarily achieving their medical purpose through software. Key provisions include a voluntary preliminary premarket review for individual components of integrated devices, a risk-based approach for software-based devices, and the allowance for predetermined change control plans (PCCPs) during FDA review. Additionally, the bill proposes an accredited third-party review program for low- to moderate-risk software-based devices and a voluntary pilot progr...