The FDA creates new Digital Health unit to reimagine regulatory paths in the age of scalable, AI-enhanced innovation

— Medicine Is Going Digital. The FDA Is Racing to Catch Up (Wired): “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…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. …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 also got plans to reimagine the path these machines will take to regulatory approval… he envisions a model something more like the TSA security line at the airport: New developers or manufacturers with spotty track records would still have to take off their shoes and go through the body scanner. But trusted companies with demonstrated histories of excellence could keep their footwear and stroll throu...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Cognitive Neuroscience Health & Wellness Technology algorithm artificial intelligence Bakul Patel Brain-health devices digital health FDA machine-learning mobile health software wearables Source Type: blogs