Mobile Medical Apps: To Be Or Not Be Regulated
I think you're offering a very balanced (and correct) perspective here, Larry. Though the discussion about where to draw the line is and should be ongoing, It's not like medical app developers should have expected this area to go unregulated forever. All in all, it sounds like the FDA is being very lenient here. Unless your app directly changes a smartphone into a medical device (under existing requirements, I assume), or accesses a device that's already regulated (like an MRI machine), you're good to go. While some may bemoan the latter condition, since many of these functions could be totally innocuous (like something that collects data from the device while it's not connected to a patient), it's easy to see why it has to be this way for security reasons. An app that has access to one function on one medical device could gain access to others through accidental backdoors, etc.
One valid complaint I think people could have is how open the FDA is leaving this to their own interpretation, but this is a common complaint to any regulation. A quick look at the document shows some broad terminology - "the FDA intends to apply its regulatory oversight to... apps that are medical devices and whose functionality could pose a risk to a patient's safety if the mobile app were to not function as intended." On top of covering themselves a bit by saying what they 'intend' to do rather than what they 'will' do, it also leaves it up to the FDA what constitutes 'risk to safety' and 'functioning as intended'. You said that devices that don't offer specific treatment suggestions are exempt - does that mean devices that offer any treatment suggestions are regulated because of 'risk to safety'? That too seems like it could be broadley interpreted. All that said, I still think the FDA is being fair here.