USA – Gottlieb Defends Digital Health Approach

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Wednesday defended the agency’s approach to regulating digital health apps following the de novo classification and clearance of two software applications that add atrial fibrillation detection capabilities to the Apple Watch 4.

Unlike with traditional medical devices, where FDA would review the device and its software components, the agency’s approach for medical apps focuses on the software rather than the platform the software runs on.

“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,” Gottlieb writes.

Gottlieb says this approach allows FDA to get digital health technologies to market more efficiently and will encourage more developers to move into the health space and to fulfill the aims of the agency’s Digital Health Innovation Action Plan