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June 26, 2012

Health apps under the microscope

Explosion of offerings puts tech industry, regulators at odds on effectiveness, approval process and safety concerns
IPI expert referenced: Merrill Matthews | In The News | Media Hit
  Washington Post

By Dina ElBoghdady

Three tries. More than two years. And roughly $150,000.

That's what it took for MIM Software to get theFood and Drug Administration'sclearance for a smartphone application that physicians can use to view MRIs and other medical images.

"It was 2008 when we first tried," said Mark Cain, the Ohio firm's chief technology officer. "They didn't know what questions to ask, and neither did we. … But at some point, they had to be thinking, 'How many more people will be lined up behind these guys?'"

Cain's was among the first apps cleared by the FDA. Since then, medical apps have flooded onto millions of smartphones, offering consumers the opportunity to check their heart rate, identify a pill in their medicine cabinet or even scan moles for skin cancer. Soon, if a firm called AliveCor gets its way, they might even be able to get an EKG by pressing a smartphone to their chest.

The gee-whiz factor can astonish and alarm.

A defect in apps that essentially turn a phone or tablet into a medical device could prove problematic or life-threatening: The app might not work as it should.

For instance, what if lighting or contrast issues distort an X-ray viewed on a smartphone or tablet?

That's why federal regulators lurched into action a year ago, offering their thinking on how to police this vast new frontier. Just as they were putting the finishing touches on a plan, lawmakers intervened. The Senate moved to put the plan on hold after tech firms convinced lawmakers that more government oversight would stifle innovation and cost jobs.

This month, Congress gave the FDA the green light to proceed with a push to define exactly which apps require government attention. But lawmakers also ordered the Obama administration to come up with a strategy that balances public interest with innovation in the years to come. The task is daunting, given the warp speed of technology.

It's a classic showdown between Washington regulators charged with safeguarding the public's health and a freewheeling tech industry that prizes agility and first-to-market bragging rights.

"There are two completely different mindsets," said Merrill Matthews, a resident scholar at the Institute for Policy Innovation. "The app people think: Where is there a need and how do I fill it? And the FDA thinks: Where is there a problem and how can I control it?"

Mobile apps, with their extraordinary reach, have the power to transform health care. Half of cellphone users in the United States have smartphones such as the iPhone or Android software-based devices, which can deliver care to their hands and potentially do so at a lower cost. Using smartphones and wireless tablets as diagnostic tools or monitoring devices could reduce emergency room visits.

For software developers, especially cash-strapped startups, there's an enormous amount riding on whether the FDA steps up enforcement.

"The FDA approval process adds months, if not years, and potentially millions of dollars to what it takes to bring a solution to the market," said Liz Boehm, a director at ExperiaHealth, a consulting firm.

Medical apps exploded onto the scene in 2010 and have grown by about 150 percent each year since, according to MobiHealthNews, which tracks Apple's iTunes store, where many apps debut. Consumers can choose about 13,000 of these apps; 5,000 more are marketed to medical professionals.

Although the FDA regulates certain medical software, the agency wants to update its thinking now that smartphones have juiced the apps market.

A year ago, the agency proposed policing only a subset of those apps, ones that use supplemental attachments to transform a mobile platform into a medical device and others that act as accessories to an already regulated medical device.

Rather than overseeing all medical apps, agency officials said they want to limit regulation to a slice of the market and take a pass on low-risk apps, such as calorie counters, said Bakul Patel, an FDA policy adviser.

Software-makers, on the other hand, see an agency that regulates next to nothing in the mobile apps space taking a sudden interest in regulating more. The FDA proposal, they say, is vague and leaves many questions unanswered. For instance, given that apps can be updated daily, does a software developer have to seek FDA approval for each update?

Among the critics is an industry group called the Health IT Now Coalition.

"The issue here is that they're really using a process for approval of these mobile apps that was basically created when the 5-inch floppy disk was the latest technology," said Joel White, the group's executive director.

Dirk Hobbs, chief executive of Medical Voyce Sciences and Multimedia, said the FDA's plan is ambiguous and he doesn't know whether the apps his firm is developing would be regulated. The apps aim to speed communication among medical professionals in different facilities.

"This is just going to slam the brakes on an innovative sector that includes tons of small businesses like mine," said Hobbs, who expressed his concerns to Sen. Michael Bennet, D-Colo.

Bennet and Sen. Orrin Hatch, R-Utah, wrote a provision, inserted in a broader FDA funding bill, that would have delayed the FDA proposal by forcing the agency to first reach agreement with other regulators about how to handle these apps.

In a compromise reached by House and Senate lawmakers, Congress has allowed the FDA to press ahead. But it also directed the agency to work on a report with other regulators that would lay out an appropriate framework to promote innovation and protect patient safety.

Former FDA Deputy Commissioner Scott Gottlieb, who researches medical trends as a fellow at the American Enterprise Institute, said he is disappointed. If consumers can track their blood-sugar levels using pen and paper, he said, why should the government have to clear an app that does the same thing more reliably?

Gottlieb said that software developers should be suspicious because regulators have a tendency to tighten their grip on industries as they develop.

"If they perceive a power vacuum," he said, "they'll step in and regulate more and more."



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