FDA Releases Mobile M2M Regulations

9/25/2013
It’s no secret M2M is changing healthcare. Connected technology allows doctors and nurses to connect with their patients remotely, and it also provides easy access to a variety of data, thus ensuring convenience.

Naturally, the U.S. Food and Drug Admin. (FDA), www.fda.gov, has a vested interest in this technology, and what it offers to consumers. Thus, this week the organization issued a finalized guidance document for developers of mobile medical apps, which outlines the FDA’s tailored approach to mobile M2M.

For the majority of mobile apps, the FDA intends to be discreet about enforcing requirements under the Federal Drug and Cosmetics Act, as most pose minimal risks to consumers. Instead, the organization will focus on regulating apps which could harm patients if they do not work as intended.


“Some mobile apps carry minimal risks to consumers or patients, but others can carry significant risks if they do not operate correctly,” says Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA’s tailored policy protects patients while encouraging innovation.”

The FDA is focusing its efforts on two types of apps:

• Those intended to be used as an accessory to a regulated medical device.
• Apps that can transform a mobile platform into a regulated medical device.

Apps under FDA review will be evaluated using the same standards the agency applies to other medical devices. The FDA does not regulate the sale or consumer use of smartphones or tablets, nor does it regulate mobile app distributors.

The FDA is likely wise to take a hard look at medical apps, considering the potential they have in treating illnesses and injuries. Case in point: Allegheny Health Network, www.alleghenyhealthnetwork.com, announced this week that it will be making use of C3 Logix concussion testing capabilities. This technology allows for the tracking of a patient’s dynamic vision reflexes, their ability to focus on moving objects, their motor skills, and balance via an iPad application.

As the iPad is strapped to a patient’s back, the app collects data via an accelerometer and gyroscope to asses postural stability.

“By examining balance and other critical elements of concussion assessment that aren’t factored into existing diagnostic tools, C3 Logix is taking concussion evaluation to the next level,” says Edward Snell, director of Allegeny General Hospital’s Primary Care Sports Medicine Fellowship and Sports Concussion Clinic. He added: “C3 Logix’s comprehensive evaluation also will be extremely beneficial to physicians in developing personalized care plans to help each patient gradually and safely resume physical activity and eventually return to play.”

Mobile medical apps obviously have the potential to make a tremendous difference in the treatment and prevention of serious medical ailments. The question is, where will the next great mobile medical app surface?

Want to tweet about this article? Use the hashtag #M2M, #healthcare




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