Mobile Health developers, meet the FDA

File under: Patient Engagement

During the last SXSW Interactive conference in Austin, we saw many exciting mobile health applications touting functionality that could monitor vital signs, remind patients when to take their meds, and give caregivers remote access to their loved ones. Many of these health apps were coming out of the same digital shops and start-up incubators that spawned mobile games and popular iPhone tools. What was missing, however, was an appreciation for the fact that the target consumers were also somebody’s patients. Mobile apps that could somehow influence care are no longer discretionary diversions, they are medical devices.

At least that’s what the FDA declared this morning. “The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in a prepared release. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”

Mobile apps that turn a smartphone into an ECG machine to detect abnormal heart rhythms, for example, could become a regulated device requiring FDA approval. It seems there were a few of those in Austin and later at the Mobile Health 2011 conference in Palo Alto.

For all the new developers who saw a lucrative mobile health app market but didn’t stop to consider the challenges of a highly regulated healthcare industry, I’ve got news for you. If you want to build an app that will make a real difference in the health of consumers, you will need to get as good at managing paperwork and legal forms as you are writing lean code.

A good place to start learning the FDA’s definition of a mobile medical application is right here.

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