Health Law Highlights

The FDA and the Future of AI Oversight

From Manatt, Phelps & Phillips, LLP, by Nicholas Bath Jr., Rachel Sher, Daniel Weinstein:

The U.S. Government Accountability Office (GAO) issued a report in January 2024 highlighting challenges faced by the U.S. Food and Drug Administration (FDA) in effectively regulating artificial intelligence (AI) and machine learning (ML) in medical devices and other emerging health care technologies. The report emphasized the need for clear regulations that balance safety, transparency, consumer protection, and innovation, especially considering the rapid evolution of AI/ML technology and its potential applications and risks.

Over the past five years, federal regulation of AI/ML has increased, particularly in the health care sector. In 2023, the FDA issued its first-ever AI/ML device draft guidance, aiming to provide a forward-thinking approach to the development of machine learning-enabled device software functions.

Despite the FDA’s efforts, the approach to AI/ML regulation has been criticized as uncoordinated and overly broad, potentially hindering technology development and rollout, and causing confusion among stakeholders. State legislators, regulators, and medical boards are beginning to introduce state-level policy, adding to the regulatory complexity.

Given the legislative gridlock, some stakeholders have proposed a novel approach to ensure the safety and effectiveness of AI/ML-enabled medical devices through public-private assurance laboratory partnerships. These labs would be testing grounds to validate and monitor AI/ML in medical devices. The proposal, while controversial, is expected to garner more attention in the coming months as the Congressional Bipartisan AI Task Force develops its comprehensive report and policy proposals to bolster the federal government’s ability to regulate AI/ML.