Because not all medical apps have a life or death baring on users lives, the FDA has decided to take a “enforcement discretion” approach – meaning that while this official guidance exists and should be followed for the most part, it won’t be fully enforced for all medical related apps. (Please note that I am in no way a lawyer and if you’re concerned about the effect this will have on your app you should talk to a professional.)
Still, with some medical mobile apps being so intricately tied to user health – and the healthcare they receive – it’s important for the FDA to pay attention. From the FDA press release:
Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it. …
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The FDA is careful to point out that they don’t regulate the use or distribution of smartphones or mobile apps. But there are some cases they will be paying attention to, specifically ones that move apps out of the world of causal use and into the realm of legitimate medical device. From the press release:
- are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional 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; or
- transform a mobile platform into a regulated medical device – for example, 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.
Mobile medical apps that undergo FDA review will be assessed using the same regulatory standards and risk-based approach that the agency applies to other medical devices.
If you develop or test medical mobile apps, give the press release and/or FDA guidance a read. Part of being a good tester is being thorough, so it’s crucial that you stay up to date with big developments like this.