Medical Apps Will Only Rarely Be Regulated By The FDA

The FDA has set out its plans to regulate medical and health-related apps on mobile devices: It'll be gentle.

Among the most popular categories mobile apps, medical apps have been a little controversial from the start because quackery and unsubstantiated claims can be hard to tell apart from serious apps. This fact caused the FDA to look into the matter, potentially with a goal of regulating which apps reached the public, much as it regulates other sources of medical data. The Agency has now said it will indeed step in and limit health apps—but only a few of them, under certain conditions.

In particular the Agency says it's going to pay the most attention to apps that perform a bit like traditional medical devices—such as those that connect to a peripheral to enable ultrasound scans or perform heart monitoring. This sort of app could potentially cause a risk to a patient, and that's what the FDA wants to prevent. Health apps like fitness step-counters won't be regulated.

The FDA says it'll look at the apps case by case, and there's going to be no expensive clinical trial required even if the app does resemble a traditional medical device. When the iPhone and its kin arrived on the scene, one of its most promising and oft-ignored capabilities was interfacing with third party devices to either share information or sample the world in a clever way. Recently, thanks to efforts like the FitBit as part of the "quantified self" movement, the smartphone really is becoming more of a personal data "hub" than a mere communications device.

[Image via Flickr user: Jason Howie]

Add New Comment

0 Comments