HIT Consultant | Mobile Health Apps: If You Build Them, Will They Come?

It’s hard to find a pharma or medical device company these days that doesn’t have at least one mobile app in development. And now that, as of February 2015, the U.S. Food and Drug Administration (FDA) has issued guidance on which apps need to be regulated and which ones don’t, it will be interesting to see if this almost exponential development trend continues.

In its guidelines, FDA outlined which mobile apps must apply for 510(k) certification – also known as a Premarket Notification (or PMN) – a requirement to market a medical device. In the mobile device category are those apps which function as a medical device; apps that control, support, or augment an existing medical device; and apps that transform a mobile platform into a medical device. Mobile apps that use patient data to provide diagnosis or treatment recommendations also require 510(k) submission.

Having to submit for these applications now changes the app development game. And many questions abound. For example, “Will it be worth [app designers’] investment in time and money?” asks Larry Stofko, Executive Vice President of the Innovation Institute. “Disruptive change can be painful,” he says, “but in the end, if we improve patient care, we’ll have accomplished what we set out to do.” More…