You might not have been prescribed a mobile app yet, but you may soon be.
In addition to prescription drugs and prescribed behavioral changes, mobile health applications (referred to as mHealth apps), are dramatically expanding the reach and efficacy of a visit to the clinic. For that reason, mHealth has come under the microscope by public and private regulatory groups.
Many mHealth apps currently on the market resemble DiabetesManager, a prescription-app from WellDoc. The app first tracks and collects information from the patient by way of smartphone app, basic phone, home computer, and wireless glucose monitors. For this app the tracked variables include food, blood-sugar and other medications. That information is synthesized and transformed into a clinical recommendation sent over to the doctor for review. But it also makes real-time feedback to the patient, recommending what to eat if their blood sugar is too low.
Where prescription apps break from our current understanding of apps is their price — DiabetesManager has an unabashed $100 price tag. But they differ in two other respects. Because these apps can deal with matters of life and death (which is not quite the case with Angry Birds), their regulation by the industry of federal government is imminent. Second, and in part because of the hefty cost, insurance companies are stepping in to cover them on plans. Some of these factors are interrelated. The apps are expensive because they're covered by insurance. They're covered by insurance because they're regulated. You get the point.
These developments beg the question: Just how do you regulate a mobile app?
The FDA just held three days of discussion on this very topic. In so doing, they mostly determined what wouldn't be regulated. For example, tablets and smartphones will not be considered medical devices just because they can run prescription apps, app stores and developers will not be considered medical device manufacturers, and apps will not be forced to seek re-approval for small updates. Moreover, any apps that contribute to Electronic Health Records or act as personal health monitors will not be regulated.
But this doesn't put apps in the clear. In the last 16 years, the FDA has reviewed about 100 mHealth apps. While their stance toward apps is in developed, the agency has postured toward regulating any apps that do meet their definition of a medical device, or “an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man, or intended to affect the structure or any function of the body.”
While somewhat limiting, this definition still presents a wide net for potential review, so the FDA has leaned toward a policy of “selective-enforcement” without pinning down what criteria will be used in selecting sample apps or developers. As a result, companies are themselves submitting their apps for review, in hopes that an FDA-approved app will fetch a higher price and invite insurance coverage. For an mHealth developer, self-enforcement is also a way to beat the rush to FDA review. While it currently takes an average 143 days to gain FDA-approval for all review submissions, selectively-enforced apps get approved in an about 67 days.
Overall, the FDA seems committed to regulating a fraction of apps for the converse of why some developers are seeking FDA review — should there be a program malfunction, the company's liability can get perceptually transferred to the FDA. So as not to take heat for the limitless ways in which apps can misfire, the agency strategy is to only regulate those that absolutely need review. This group will most likely include only those apps classified as “Class II” or “Class III,” or are actively involved in reporting a wound and treating a wound, respectively. By applying the medical device definition and classifying apps using existing standards, the idea is to essentially find which mobile apps can be treated and reviewed as medical devices. Whatever guidelines are developed, it's unlikely they won't set out anything new so much as they'll set a guide determining which apps can be forced into the existing FDA framework for regulation.
Where full guidelines by the FDA can be released as early as mid-April or as late October, some industry groups are already trying to fill the market for granting apps regulatory credibility. One such firm is Happtique, which operates like the Better Business Bureau to certify apps as safe through their own process.
But even if mHealth apps are regulated, there will be lingering concerns. After all, the prescription drug system has its own Pandora's Box of frustrations. As Dr. Leslie Kernisan of The Health Care Blog rightly points out, apps may suffer from all the same problems: apps may be over-prescribed because they're well marketed by advertising campaigns, patients may demand them whether or not they're needed, they may contribute to their own kind of side effect or treatment interactions, they can add to the prescription-burden of patients who already have too many treatments to keep up with, and so on.
With 60,000 health-based apps currently available, and a market expected to be worth of $26 billion by 2017, there's a clear need for the FDA to figure a workable solution to the quick evolution of mHealth. Unfortunately, there's no app for that.