Congressional White Paper Recommends a Sector-by-Sector Approach to Regulating Artificial Intelligence

Senate Health Committee ranking Republican Bill Cassidy (LA) released a white paper on September 6 suggesting Congress refrain from crafting a government-wide approach to overseeing artificial intelligence and only step in when an agency’s oversight falls short, such as filling gaps in U.S. Food and Drug Administration’s (FDA) ability to regulate artificial intelligence (AI) as a medical device.

This white paper came days after Senate Majority Leader Chuck Schumer (D-NY) announced he will hold a series of bipartisan forums in coming weeks on AI issues spanning all government sectors to build a basis for future AI/machine learning (ML) legislation. Cassidy’s interest in a sector-by-sector approach to regulating comes as health technology stakeholders weigh in on ways the FDA and the Centers for Medicare and Medicaid Services (CMS) could build off their current authority to regulate the growing use of AI/ML in health care. Cassidy said he is also interested in who carries the liability if AI malfunction or goes wrong.

According to Cassidy, AI poses two foundational challenges to FDA’s current regulatory framework for medical devices. First, products that incorporate AI software face varying degrees of premarket regulatory scrutiny on whether companies meet the statutory definition of a medical devices or are subject to a statutory carve out for FDA’s enforcement policy for certain products. Second, FDA’s review of the safety and effectiveness of devices applies to a specific product at a specific moment in time, which are not designed for products that incorporate AI to improve over time.