STAT February 23, 2023
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Industry fumes as FDA increases AI tool regulation
Health tech companies are in a tizzy. After years of letting companies roll out software tools to guide patient care with little oversight, the Food and Drug Administration is taking a tougher stance.
In September, the FDA announced its intentions to regulate many of these AI-powered clinical decision support tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the move. Earlier this month,...
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