The Food and Drug Administration announced Tuesday that it is developing a framework for regulating artificial intelligence products used in medicine that continually adapt based on new data.
It is the most forceful step the FDA has taken to assert the need to regulate a category of artificial intelligence systems whose performance constantly changes based on exposure to new patients and data in clinical settings.
The white paper describes criteria the agency proposes to use to determine when medical products that rely on artificial intelligence will require FDA review before being commercialized.
The paper is the first step in a monthslong process in which the FDA will collect input from the public and a variety of stakeholders in medicine before finalizing a policy on regulating adaptive AI systems.
Eric Topol, an expert in artificial intelligence at the Scripps Research Institute, said the white paper “Demonstrates careful forethought about the field” of artificial intelligence in medicine.
“Artificial intelligence has helped transform industries like finance and manufacturing, and I’m confident that these technologies will have a profound and positive impact on health care,” he wrote in his statement.
“I can envision a world where, one day, artificial intelligence can help detect and treat challenging health problems, for example by recognizing the signs of disease well in advance of what we can do today.”
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