FDA and Wireless Medical App Manufacturers Square Off

FDA and Wireless Medical App Manufacturers Square Off

April 17th, 2012 // 1:03 pm @ jmpickett

An onslaught of mobile health technology has forced an arranged marriage between smartphone app makers and the Food and Drug Administration — because someone had to regulate them.

There’s just one problem: Many of the tech wizards aren’t used to FDA supervision. And now, both sides are struggling to figure out how to live with each other.

Last year, the FDA suggested some ground rules: If you make an app that claims to diagnose or treat a medical condition, then you need to show that it’s safe and effective before you sell it, just as other medical-device makers do.

That seemed reasonable enough to the traditional medical-device industry, which is well-versed in the ways of the FDA. But the requirements — data on effectiveness, possibly clinical trials — have gobsmacked some software developers who are used to working in the fast-paced, relatively unregulated wilds of the Internet.

“That’s culture clash,” said Bradley Thompson, an attorney who works with the mHealth Regulatory Coalition, which is pushing FDA to relax some of its proposed restrictions on health-related apps. “We get calls from consumer electronics firms all the time, where speed is everything. … I spend a huge amount of time explaining what it means to be in regulated territory, what it means to be FDA-regulated.”

Bakul Patel, the FDA policy adviser who’s leading the efforts on app and wireless device regulation, says the agency is having to help a lot of tech people make the adjustment.

“The audience that we are addressing is extremely broad: people who know FDA law like the back of their hand, and people on the consumer end, or [information technology] end, who are just getting into health care,” Patel said.

It’s a regulatory clash that grew out of a burgeoning revolution in medical technology. Thousands of health-related apps are on the market already. Some help people manage their diets or workouts or take their pulse. FDA has said it doesn’t intend to regulate such “health and wellness” apps.

But others, including one designed to help doctors read imaging scans on a portable device, need to show FDA that they work — an expensive and time-consuming endeavor that has shocked parts of the app development world.

In its draft guidance to industry last year, FDA said “the interpretation of imaging scans on a mobile device could be affected by the smaller screen size, lower contrast ratio and uncontrolled ambient light of the mobile platform; FDA intends to take these limitations into account.”

In at least one case, the agency took those considerations into account and approved an iPad radiology app by MIM Software last year.

Marketing is another major issue. Thompson and others would like to be able to advertise their wares — apps designed to help people lose weight, for instance — with claims that they might also reduce the risk for conditions such as heart disease or diabetes. Those ads would be based on established medical claims about the benefits of exercise, if not the effectiveness of the app itself.

The initial guidance from FDA suggested that apps advertised that way would draw agency scrutiny. But Patel, in an interview, suggested that an app could make such claims if it were registered with the FDA along with some scientific literature supporting its claims.
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“We’re trying to come up with a policy that addresses some of the concerns people have and provides clarity,” Patel said. What the agency is trying to avoid, for instance, are the bad actors who might claim a device that shocks you “is good to use as a pacemaker.”

But the marketing and other issues — including whether an app that is used with a medical device is automatically a medical device “through guilt by association” — have led to the showdown, Thompson said.

The mHealth Coalition has asked FDA to delay finalizing the draft guidance on these controversial points, saying the agency should continue to work through the issues until they have a sturdy framework that can accommodate the rapid pace of innovation in the sector.

Thompson expects FDA to announce it will do that later this spring or in the summer, while providing final guidance on the general points of agreement. FDA declined to comment on the timing, but Patel said the agency was working to finalize its guidance on mobile health apps.

But the mobile apps are not the only advancing technologies FDA is struggling to keep pace with. It’s also wrestling with a proliferation of devices that can provide automated clinical decision support to physicians, such as implantable devices that regularly gauge — and transmit — key measures for chronic diseases, such as blood sugar for diabetes and pressures in heart failure patients.

Some of these devices could allow doctors and support staff to remotely monitor large chronic-disease populations and adjust their therapies in advance of a major health event, proponents say.

Such “remote, actionable diagnostics” could greatly reduce costs and improve the care of chronic disease, complications from which account for about 80 percent of health care spending, said Joseph Smith, chief medical and science officer at the West Wireless Health Institute in California and policy director of the West Health Policy Center in Washington, D.C.

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