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But as computer code took on more complex tasks, like spotting specious moles and quantifying blood flow, their duties began to accelerate. Software developers needed months, not years, to make it to the market. And there were a lot of them. It got harder to match pace. And then came artificial intelligence.

Today, machine learning powers more and more medical device software. And because it is always learning and improving, it is constantly changing products on the fly. For most regulators, an ever-changing algorithm is their worst nightmare. But Patel is one of those rare Washington bureaucrats who’s also a fervently optimistic futurist. And he’s got big plans to get federal regulators off Washington time and up to Silicon Valley speeds.

To do that, the FDA is creating a new unit dedicated strictly to digital health. Patel will be hiring 13 engineers—software developers, AI experts, cloud computing whizzes—to prepare his agency to regulate a future in which health care is increasingly mediated by machines. (He’s using funds generated by the medical device division’s user fee system, which is the FDA’s only other revenue stream besides congressional appropriations.) He’s also got plans to reimagine the path these machines will take to regulatory approval.

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