Food and Drug Administration (FDA)

The United States’ regulatory regime may not be clear or flexible enough to ensure the safety of AI-powered medical devices. Physicians and other health professionals believe that U.S. regulators have approved AI-powered medical products without proper oversight or disclosure.

The United States paved the way to regulate AI systems in healthcare. The U.S. Food and Drug Administration (FDA) interpreted existing rules that govern health-related software to include some machine learning algorithms.

U.S. government approval of medical AI products is on the upswing — but information about how such systems were built is largely unavailable. The U.S. Food and Drug Administration (FDA) has approved a a plethora of AI-driven medical systems.

Institutional hurdles to AI for medicine began to fall, setting the stage for widespread clinical use of deep learning in medical devices and treatments. DeepMind’s AlphaFold model determined the three-dimensional shape of a protein in just hours.