The U.S. Food and Drug Administration is actively watching app stores for apps that it deems fill a medical purpose with an eye toward regulating them, according to Bradley Merrill Thompson, an attorney specializing in health care issues. Thompson said even smartphone apps require FDA approval, just like other medical “devices,” and the determination if an app requires federal approval is strictly the FDA’s call. Apps such as iStethoscope for the iPhone (featured today in the Telegraph) and Instant Heart Rate for Android may find themselves facing a regulatory process much like other medical devices such as glucose monitors, which could stymie innovation and put the kibosh on plans to use smartphones for health monitoring.
iStethoscope uses the iPhone’s microphone to monitor the user’s heartbeat, while Instant Heart Rate uses the camera on an Android phone to serve the same function. These aren’t the first apps to appear for medical-related purposes, and they won’t be the last, So at what point will the FDA step in and put the clamps down on such apps? According to Thompson, it isn’t clear which apps might trigger FDA scrutiny.
While the iStethoscope app doesn’t make any medical diagnoses from the heartbeats detected, other apps have clearly entered the diagnostic realm. One computer program listens to coughs to determine the underlying cause, and this program can (and probably will) be ported to a smartphone app. We’ve already covered apps that listen to sensors on a patient to track vital signs, and medical researchers are actively working on smartphone apps that analyze blood or saliva samples for monitoring the condition of patients with HIV and malaria.
Some uses of these apps are more involved in the medical process than a simple stethoscope app, but where is the line drawn? In an article written last year, Thompson notes the FDA could even regulate cell phones used for medical purposes. He points out that once a program is committed to computer media, “media with the code written on it is enough of a ‘thing’ for FDA to regulate.”
I spoke with Thompson to get his take on what we can expect from the FDA. While the FDA expects developers to pursue agency approval for apps with a medical purpose, he made it clear the FDA is not relying on that to happen:
The FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.
FDA involvement will complicate the app development process; developers will have to be aware that their app might warrant an FDA approval process, and if so, if it’s worth continuing with the project. As the distribution vehicle for apps, app stores will need to be aware of the implications FDA involvement brings to the process. Some apps may be rejected by the store because of potential federal scrutiny. On the positive side, smartphones have become so powerful, and apps so useful, we may be seeing some outstanding medical uses emerge. Panels at our Mobilize conference in just a few weeks will be looking at issues for app developers, perhaps this will be raised.