Expert: FDA’s MAUDE Database Can’t Track Bias In AI/ML Health Tech

FDA’s Manufacturer and User Facility Device Experience database is insufficient in monitoring bias in artificial intelligence and machine learning health technologies, according to experts, as federal agencies and lawmakers scramble to monitor the rapid expansion of AI/ML systems in the health care sector . FDA and the Federal Trade Commission are in the process of drafting new regulatory requirements to eliminate bias in AI/ML technologies bias before and after devices and software are on market as the technologies’ use in...