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FDA Assembles Team to Oversee AI Revolution in Health

Mobile health apps and wearable devices that use artificial intelligence to help diagnose or even treat medical conditions pose a new regulatory challenge for the U.S. Food and Drug Administration. The government agency has responded by starting to assemble a team of computer scientists and engineers to help oversee and anticipate future developments in AI-driven medical software.

This comes at a time when medical devices have evolved from fairly self-contained gadgets into implants and wearables that communicate wirelessly with medical software on separate computers or in the cloud. The definition of medical device has also stretched as smartphone apps and online services—often backed by machine-learning algorithms—promise to deliver medical diagnoses that once would have required a visit to a doctor’s office and specialized lab equipment. That is why the FDA aims to create a new digital health unit around people having both the technical expertise and industry experience to understand how machine learning AI and related subjects such as big data, cybersecurity, and cloud computing will all affect health care for Americans.

“We’re trying to get people who have hands-on development experience with a product’s full life cycle,” says Bakul Patel, the FDA’s associate director for digital health. “We already have some scientists who know artificial intelligence and machine learning, but we want complementary people who can look forward and see how this technology will evolve.”

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