Mobile App Clarity

November 20, 2013 by InTouch Health

Mobile apps in healthcare have become so ubiquitous that there are now several magazines that cover nothing else. They contain little or no news about hospitals and providers – just info on the latest healthcare apps for your smartphone. It leaves people with the impression that tomorrow’s healthcare will be delivered entirely on the run, with doctors making clinical decisions on the golf course or at a rock concert.

Fortunately, the FDA recently took steps to mute some of the exuberance about healthcare mobile apps. The organization has ruled that these apps fall into two broad categories: passive ones (used mainly for education and information-sharing) and active ones that require FDA Class II medical device clearance.

In the FDA’s view, apps that are designed for things like surgery training or patient education don’t have anything to do with real-time patient care. The same is obviously true for the vast array of business and administrative apps that perform things like billing or physician scheduling.

Even in the active category, most mobile apps are pretty limited tools compared to the Class II devices used in telemedicine. Most of these apps are designed for doctors who are already physically en route to the hospital. For example, there are now smartphone apps that let obstetricians view a baby’s fetal heart rate in real-time as they head for the delivery room. Likewise, a cardiologist can get a real-time look at a patient’s ECG transmitted from an ambulance. But that’s a far cry from the peri-operative and post-surgical precision that telemedicine brings to high-acuity environments.

The FDA has made it crystal clear that most healthcare apps are not – and never will be – worthy of medical device clearance. And those that do meet the criteria fall far short of delivering what’s needed for active patient monitoring in high-acuity settings. There’s no danger of tablets replacing telemedicine networks anytime soon.