FDA clarifies how it will regulate digital health and artificial intelligence

The Food and Drug Administration has issued new guidelines on how it will regulate mobile health software and products that use artificial intelligence to help doctors decide how to treat patients.

The guidelines, contained in a pair of documents released Thursday morning, clarify the agency’s intent to focus its oversight powers on AI decision-support products that are meant to guide treatment of serious or critical conditions, but whose rationale cannot be independently evaluated by doctors.