mHealth Trials Are Happening, Without the Clinic

HIMSS' mHealth Summit began yesterday in Washington, D.C., and runs through tomorrow. Because it's in the capital, government policymakers are likely to be dazzled by slick vendor presentations and lofty statements about what mobile health technology can do now and will be doing soon.

Meanwhile, outside the Beltway, healthcare providers ponder all the promise and peril of putting sensitive patient information on an ever-proliferating array of gadgets, the vast majority of which merely have garden-variety security, authorization, and authentication controls. After the petabytes of data breached by lost or stolen laptops is subtracted, the good news is that so far, mHealth doesn't seem to account for very many scary stories of health data exposure. But that could change.

Looking over the mHealth Summit agenda, I was struck by the fact that the elephant in the room—government regulation—has no session devoted to it.

There is a clue, however. Another session is titled, "Pushing the Limits of Mobile Health—Can We Have Health and Healthcare Without Doctors?"

Two answers. First, of course we had health, ill health, and healthcare before there were doctors. I'm pretty sure no one wants to go back to that.

But more to the point, I'm sure mHealth will provide, and probably already has, examples of disease diagnosis and treatment that do not involve doctors. There are laws against practicing medicine without a license, of course. Lack of enforcement of these laws is due to the fact that no one apparently is being harmed by these apps.

The question has to be, will the mHealth apps of the future be accused of enabling medical practice without a license. Will someone suffer serious bodily harm or die because of an app?

I wish I could say with confidence that that day will never come. However, apps are getting smarter every month. I wish I could say the same about people, but despite the knowledge-spreading effect of social networks, there are too many examples of bogus science being spread that way to expect social networks alone to help the average patient to keep up with what's medically proven and what is quackery.

In other words, it's probably not a question of if healthcare apps will be regulated, but when, and which ones, and how much.

Drugs and medical devices go through rigorous discovery, testing, and clinical trial phases before doctors can begin prescribing them. The healthcare IT system must police itself or the same kind of requirements will be imposed, at some point, on some or all of the technology rushing to market. I do not hold out faith that the free market alone will be sufficient to do all the necessary policing.

Healthcare regulators are becoming technology regulators
If an adverse event happens, that free market could contract suddenly, and some of it could even go underground. Ironically, recent changes in the way technology gets distributed could make it easier for the FDA or other agencies to take action, but also to encourage that underground.

Windows 8, now shipping, has joined Apple's iOS and Google's Android in a new model of software distribution. These platforms' app stores make it easy for centralized control to be exercised over what apps run on these devices. If an app is shown to be the cause of an adverse event, we may witness the spectacle of the FDA ordering the removal of that app from the app store, and that would be that.

But would consumers try to jailbreak their phones to run banned healthcare apps? Stranger things have happened.

Now you may be shaking your head at this point, given that most healthcare apps are read-only or accept only a limited amount of input. If a patient or caregiver incorrectly enters a blood pressure or blood sugar reading into an app, the problem lies with them, and not with the app.

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.