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.
"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 moved to put the plan on hold after tech firms convinced lawmakers that more government oversight would stifle innovation and cost jobs.
Last week, 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.