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.

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.

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.

The Food and Drug Administration is creating a digital health unit within its Center for Devices and Radiological Health in an effort to develop internal technical expertise, and streamline the agency's software review process and regulation of medical devices. "Because it's such an emerging area, having a centralized unit in the Center Director's Office is important for coordination on digital health topics and having consistency in applying policies," says Bakul Patel, associate director of digital health in the FDA's CDRH. Also See: FDA's medical device arm ramps up HIT strategies The digital health unit will be established in the CDRH's Office of the Center Director as part of the next iteration of the Medical Device User Fee Amendments, under which the FDA is authorized to collect user fees from medical device manufacturers. In exchange for those fees, FDA commits to meeting certain performance goals, such as reviewing submissions within specified timeframes. The medical device users fees, which must be reauthorized every five years, expire in September.