STAT+: As the FDA clears a flood of AI tools, missing data raise troubling questions on safety and fairness
Artificial intelligence is the fastest-growing frontier in medicine, but it is also among the most lawless. U.S. regulators have approved more than 160 medical AI products in recent years based on widely divergent amounts of clinical data and without requiring manufacturers to publicly document testing on patients of different genders, races, and geographies, a STAT investigation has found.
The result is a dearth of information on whether AI products will improve care or trigger unintended consequences, such as an increase in incorrect diagnoses, unnecessary treatment, or an exacerbation of racial disparities.
