Mobile Health Apps: The Intersection Between Innovation and Regulation

Oct 07, 2013

If it detects heart rhythm abnormalities, your iPhone is an ECG, says the FDA. With the FDA releasing their final rules for mobile medical app development, a number of self-proclaimed software geeks become the newly anointed medical device developers - having to abide by strict regulatory standards and guidance.

In the eyes of the FDA, a defibrillator is a defibrillator even when it looks like a smartphone. Therefore the FDA will oversee these products, giving developers a clear path forward in securing regulatory clearance for their products.

For clarity, the FDA will be be “focusing its oversight on mobile medical apps” that are intended to be used as an accessory to a regulated medical device OR transform a mobile platform into a regulated medical device.

In short, software and hardware developers fearing innovation will be stifled through regulatory oversight, and need to recognize the horizon that just opened up. With the convergence of technology and healthcare comes the possibility of keeping people well and informed, delivering care to underserved populations around the globe. It is clear that innovation within the healthcare industry has just gotten started.

At Ximedica we continue to help a plethora of new technologies come to market under clear guidelines and preparing for FDA submission. Equally so, we are seeing a rise in existing platforms making their devices enabled for the mobile world. In all cases, there are significant advantages for operators - particularly as the rise of home health continues.