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Medicine Is Going Digital. The FDA Is Racing to Catch Up

May 24, 2017


WHEN BAKUL PATEL started as a policy advisor in the US Food and Drug Administration in 2008, he could pretty much pinpoint when a product was going to land in front of the reviewers in his division. Back when medical devices were heavy on the hardware—your pacemakers and your IUDs—it would take manufacturers years to get them ready for regulatory approval. FDA reviewers could keep up pretty well.

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.

For technology giants getting into the health care game, the timing couldn’t be better. Last year Google’s venture capital arm (which manages around $2.4 billion) spent one-third of its investments in the health care space. Its spinoffs Calico and Verily are pursuing ambitious projects like smart contact lenses, Project Baseline—oh, and beating death. Apple, in addition to its wellness through wearables play, is already working closely with the FDA on an app to diagnose Parkinson’s. And IBM is employing its artificial intelligence engine, Watson, to do everything from treating cancers to discovering new drugs.

Read the Full Story at the Source: Medicine Is Going Digital. The FDA Is Racing to Catch Up | WIRED


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