As Developers Push the Envelope with Smartphone Apps, FDA May Step Up too
​[Posted on: Thursday, June 15, 2017]

Smartphone apps allow users to manage their own health and wellness; and FDA has taken a mostly hands off approach to regulating them. But with new apps being created to capture a variety of use and handling information to diagnose and potential help treat diseases, particularly neurological diseases, FDA may need to step in and regulate such apps more vigorously. FDA’s policy has been that when an app transforms a smartphone into a regulated medical device, it should be regulated as a Class II, 510k device. However, it is a hard decision because of the way such apps are being developed and intend to be used. A phone captures a variety of information via its microphone, accelerometers, location, camera and keyboards that can be used to monitor the user’s behavioral patters and changes therein. Information about changes in a user’s behavior such as frequency and speed of talking, talking differently, change in rhythm, syntax and movement, responsiveness to their contacts, social media behavior, location, sleep patterns, and other traits can be used to diagnose their mental and neurological health. And since such information is captured in real time and over a long period of time, it can lead to better, faster and more accurate diagnosis. This in turn can be used to alter behavior using connections and potentially interactions with therapists and doctors. Apps are being developed that collect all the above information and process through algorithms to help users self-diagnose and seek help. Apps are also being designed to “crowd-diagnose” where a group of individual members help each other understand and manage mental health issues. In many of these cases, the developers are pushing the envelope of a classical health management app, and getting closer to a medical device.  A smartphone app that detects a deteriorating state of mind would be closer to a diagnostic instrument, than a general health app. However, if the diagnosis involves the user’s friends and connections, and not therapists, it can be considered a general health app. It would depend on the claims made by the app’s developers that may solve the puzzle. An app promoted to diagnose and treat a disease will be regulated as a device otherwise not. There is another issue; the commercial viability of an app if it is regulated by the FDA. One of the key reasons, FDA decided to go for a hands off approach to regulating apps was because it was deemed that such regulation will practically kill the medical app industry where an individual developer may not have much financial incentive to develop such apps. After all, most apps are not expected to be covered by insurance and most cannot charge high fees to use their app. With stiff competition from similar apps, it is hard to justify adding on the burden of FDA regulation. But these new versatile diagnostic apps create a unique regulatory conundrum for FDA. Only time will tell which way FDA goes, and it will likely not take that long for this to unfold.