STAT

FDA clarifies how it will regulate digital health and artificial intelligence

The rules clarify the FDA's intent to focus its oversight on AI decision-support products meant to guide treatment of serious health conditions.
Source: FDA

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

Citiți o mostră, înregistrați-vă pentru a citi în continuare.

Mai multe de la STAT

STAT1 min cititeBiology
STAT+: Pharmalittle: Pfizer-BioNTech Vaccine Seems To Work Against Covid-19 Mutation; Sarepta Gene Therapy Shows Mixed Results
United Kingdom regulators cleared the Moderna Covid-19 vaccine, adding a third shot for emergency use against the pandemic as infections surge there.
STAT1 min cititeAmerican Government
STAT+: Pharmalittle: Biden Taps Kessler To Lead Operation Warp Speed; Trump Administration Seeks Term Limits On Top FDA, CDC Scientists
President-elect Joe Biden has chosen David Kessler to help lead Operation Warp Speed, the program to accelerate development of Covid-19 vaccines and treatments.
STAT1 min cititeMedical
STAT+: Pharmalittle: Pfizer And BioNTech Say Vaccine Is Effective Against Covid-19 Variant; U.S. To Join COVAX Initiative
The Pfizer-BioNTech Covid-19 vaccine appears to work just as well against a fast-spreading variant first identified in the U.K. as it does against earlier forms of the coronavirus.