Digital Health , AI and the FDA

The FDA is getting ready to go digitial and embrace AI. Interesting times ahead, when scientists, bureaucrats and technologists try to work together in the new emerging work.

https://sharpbrains.com/blog/2017/05/30/the-fda-creates-new-digital-health-unit-to-reimagine-regulatory-paths-in-the-age-of-scalable-ai-enhanced-innovation/

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 through the metal detector. Patel’s not yet sure exactly how it would work, but it’s one of the ideas he’s toying with and running by industry stakeholders.”