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FDA’s new AI guidelines create uncertain future
The Food and Drug Administration roared into the week with a handful of dense documents that hold big implications for how it will oversee technology in health care. The most significant is the agency’s final guidance on what kinds of decision support software it intends to regulate, spelling out four criteria, pictured above, that determine whether things like AI software that flags medical conditions for doctors are considered diagnostic devices that must be reviewed by the agency.
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