mHealth Trials Are Happening, Without the Clinic

But that's today's apps. Tomorrow's apps will talk to an array of devices and sensors, some possibly inside the human body. Will all those devices and sensors be FDA-approved? Should they be? Many of them will require regular recalibration. Who will be managing that? Human beings are fallible. Can the technology be made self-calibrating? Or will the burden fall upon healthcare providers, who may find that their ACO status requires them to keep home health care devices in tune?

Then there's the dilemma of the regulators, if they suddenly find themselves charged with regulating 1s and 0s instead of just drugs and devices. To some extent, though, they already are in the software business.

Software technology is so malleable that it's unlikely that the clinical trial methodology we've used for drugs and devices could easily be adapted, or scaled, to regulate something like an app. Human factors often determine whether or not an app gets used correctly or not.

Perhaps, in the end, we'll just trust the technology as we do in so many other areas of life. Think of how modern jetliners couldn't fly without complex software systems managing the details. Self-driving cars have been sighted in my neighborhood in California. An amazingly tricky landing on Mars seemed like a piece of cake thanks to technology. Why shouldn't we trust more and more apps to manage our health?

Probably because nothing is more personal than one's health and well being. While the average app won't have the scientific might of the Jet Propulsion Laboratory behind it, we're going to be scrutinizing these apps even more closely. The trials are under way. They're just not happening in the clinic.

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