The U.S. Food and Drug Administration (FDA) has issued final guidance for developers of mobile health (mHealth) applications, with the agency saying it intends to exercise “enforcement discretion” for most apps because they pose minimal risk to consumers.
Instead, the FDA says it will “focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.” This includes mHealth apps intended to be used as an accessory to a regulated medical device. For example, an app that allows a healthcare provider to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet.
Another area of FDA oversight will be apps that transform a mobile platform into a regulated medical device. An example of that is an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack. The apps that do undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.
“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
The debate over mHealth app regulation was the focus of hearings in May, in front of The Energy and Commerce Subcommittee. In it, the FDA promised that its policy on mobile medical apps will not include the regulation of consumers’ smartphones or tablets. It is uncertain how the mHealth community will react to this guidance, as they had expressed concern on possible regulation of medical smartphone apps during those hearings.
