Three tries. More than two years. And roughly $150,000.
That’s what it took for MIM Software to get the Food and Drug Administration’s clearance for a smartphone application that physicians can use to view MRIs and other medical images.
Ron Gutman is the CEO and founder of HealthTap, which creates mobile and Web applications with the goal of connecting individuals with medical professionals. Gutman spoke with the Washington Post’s Emi Kolawole about the power of turning doctors into health care information curators for the Web and on mobile.
(The Washington Post/None) - The explosion in medical apps.
“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?’ ”
His was, in fact, among the first apps cleared by the FDA. And since then, medical applications have flooded onto millions of smartphones, offering consumers the chance 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 may even be able to get an EKG by pressing iPhone to chest.
The gee-whiz factor can both astonish and alarm.
A defect in apps that essentially turn your phone or tablet into a medical device could prove problematic or even life-threatening: The app may not work as it should. For instance, what if lighting or contrast issues distort an X-ray that’s viewed on an iPhone or iPad?
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 agreed to put the plan on hold after technology firms argued that heightened oversight would stifle innovation and cost jobs.
On Monday night, a compromise was struck. Congress gave the FDA the green light to proceed with its push to define exactly which apps require its attention. But they 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 free-wheeling tech industry that prizes agility and first-to-market bragging rights.
“There are two completely different mind-sets,” said Merrill Matthews, a resident scholar at the Innovative Policy Institute. “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?”
Cost-saving potential
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 also cut back on emergency room visits.
For software developers, especially cash-strapped start-ups, there’s an enormous amount riding on whether the FDA steps up enforcement — and exactly how it plans to do it, industry analysts said.
“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. “That development process would put many of these guys out of business.”
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