One of the few bright spots in the current economy is sales of smartphones, tablet computers, and e-readers. Led by three U.S. companies -- Apple, Google (Android), and Amazon -- the worldwide market for these gadgets is expected to reach $190 billion this year. Driving much of the growth is a rapidly expanding universe of "apps" that offer exciting new capabilities such as helping patients manage their diabetes and letting physicians pull up CT scans from any location.
Now the U.S. Food and Drug Administration wants to apply the brakes to this growth market. The FDA released draft guidelines for regulating mobile medical applications on July 19, 2011 and is giving the public ninety days to comment. If the FDA goes through with its plan, it could undermine the very things that make mobile medical apps so attractive to small developers: low entry cost and quick time-to-market.
The FDA portrays this attempt to expand its fiefdom as uncontroversial. The FDA's Dr. Jeffrey Shuren told MobiHealthNews.com, "These are the devices we have been regulating all along and just because they are on a mobile platform doesn't mean we should be regulating differently." But that's not quite true. While some of the first mobile apps merely emulate products already on the market, most deliver added functionality. The ultimate goal is to create something that didn't exist before -- to transform the mobile device into an Internet gateway for a body area network of health sensors.
Or as the FDA's Bakul Patel explains it: since standalone stethoscopes are already regulated, apps that turn iPhones into stethoscopes should also be regulated. But that should raise questions about whether FDA regulation of stethoscopes is even necessary. It's hard to conceive of someone being injured by a stethoscope. And surely FDA officials aren't better-qualified to evaluate stethoscopes than the medical professionals who use them day in and day out. Besides, if we don't think physicians are competent enough to purchase decent-quality stethoscopes, then why should we think that they are competent enough to use them properly?
The FDA knows how crucial the first regulations are to conquering new markets. In 1989, the FDA proposed to regulate PC-based medical applications, but the market took off so quickly and in so many directions that the effort had to be abandoned. So this time around, the FDA is trying to establish a regulatory regime for mobile medical apps earlier in the market's evolution.
Once regulations are established, they spread like weeds. The FDA downplays the proposed regulations as only affecting a tiny slice of the larger mobile health apps market. "We are starting off with the very small tip of the pyramid," said the FDA's Bakul Patel. The draftguidelines focus on mobile apps that work with already regulated medical devices, mobile appsthat turn handheld gadgets into medical devices, and mobile apps that generate recommendations about a patient's diagnosis or treatment. But notice that the FDA has not ruled out regulatingmobile apps for fitness, medical reference, or hospital billing further down the road.
The FDA hasn't identified a single case in which a patient has been harmed by a mobile medical app. Instead, the FDA is warning that small screen size, lower contrast ratio, uncontrolled ambient light, and use of the apps by ordinary consumers pose new risks. That may be true, but all products and users have limitations, so there are always going to be risks. The purpose of regulation should be to eliminate only clearly unacceptable risks. Because it's also true that one size does not fit all: the mobile platform's limitations may be acceptable to customers for whom mobility and low price are more important.
The FDA should seize the opportunity afforded by mobile medical apps to try a completely different approach. Instead of deciding which products live and which products die, the FDA should focus on testing and reviewing mobile medical apps. By running products by panels consisting of vendors, medical professionals, and consumers, the FDA could provide timely, valuable, and balanced feedback.
We've been hearing about how the U.S. has fallen behind Europe and Asia in key technologies for the past two decades, so it's gratifying to learn that we are leading the burgeoning smartphone, tablet, and e-reader markets. The worst thing the FDA could do now is slap mobile medical app developers with new fees and regulations.
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