Gottlieb Describes FDA’s Approach to Digital Health Products

Digital health technology is “an area of intense focus” at the FDA, FDA Commissioner Scott Gottlieb said, in a statement defending the agency’s FY2019 budget request for digital health activities.

He said the agency’s recent marketing authorization for two medical apps for Apple’s newest watch marked a significant step in the agency’s approach to the development of digital health.

“The FDA’s approach to digital health isn’t to regulate the every-day health and lifestyle uses of consumer devices, but rather to focus our resources on reviewing more sophisticated medical apps that sit on top of this general purpose hardware — the functions that have greater ramifications for patient health and where ensuring safety and efficacy of the application is critical,” Gottlieb said.