The regulatory framework for artificial intelligence-based medical devices needs to be improved to ensure transparency and protect patients’ health, says Sara Gerke, the Richard W. & Marie L. Corman Scholar at the University of Illinois Urbana-Champaign and expert in the ethical and legal challenges of artificial intelligence for health care. Gerke argues that the Food and Drug Administration should prioritize the development of labeling standards for AI-powered medical devices in much the same way that there are nutrition facts labels on packaged food.
Gerke spoke to the Illinois News Bureau about her new paper, recently published in the Emory Law Journal, “A comprehensive labeling framework for AI/ML-based medical devices: From AI Facts labels to a front-of-package AI labeling system — Lessons learned from food labeling.”