FDA maintains its focus on digital health in 2018

Scott Gottlieb
FDA Commissioner Scott Gottlieb, M.D., plans to continue overhauling the agency's approach to digital health. (FDA)

After what was widely viewed as a groundbreaking year for digital health oversight, the Food and Drug Administration plans to maintain its focus on easing the pathway for innovative technology and devices.

Advancing digital health is one of several priorities for FDA in the coming year, according to a 2018 Strategic Policy Roadmap released (PDF) by the agency on Thursday that identified four priority areas “that will be the focus of additional policy activity in 2018.”

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In particular, the FDA plans to publish finalized guidance clarifying when digital health technology falls under the FDA’s regulatory purview and when the agency plans to exercise enforcement discretion. Unsurprisingly, the agency also plans to advance its software precriticization program after launching a pilot program in September involving nine companies including Apple and Fitbit.

“By monitoring and managing chronic health conditions and dietary needs using consumer directed mobile apps and other mobile health tools, or using medical devices to connect digitally with medical professionals, consumers can take more effective control of their care and their medical information and clinicians can provide better medical care,” the road map stated. “Well-validated, digital technologies provide a significant opportunity to achieve all of these and similar goals.”

The FDA is coming off a year in which it unveiled a Digital Health Innovation Plan that was met with enthusiasm from industry experts, released new guidance on clinical decision support software and began recruiting a team of entrepreneurs to “help identify requirements and input for a new digital health paradigm.”