The Mobile MIM app for the iPad and iPhone. It took the FDA two years to clear this software, and it's one of only a handful of apps that have gone through this process. (Photo: MIM Software)

Mark Cain got his big break on June 9, 2008. The chief technology officer at a little-known medical software company, MIM Software, Cain was invited onstage at Apple’s Worldwide Developer Conference to promote his company’s iPhone app, a way for doctors to view incredibly detailed scans of their patients.

It was a cool demo of what the iPhone’s great graphics and touchscreen interface could really do. With hordes of international press looking on, Cain moved through a three-dimensional iamge of a human body, toggling between a CT scan and a PET scan.

Even today, Cain remembers the demo fondly, both because of the attention that Apple lavished on his company, and because the MIM software really stood out amongst all of the other iPhone software displayed at the event. “It was like play games, keep track of your friends, play games, diagnose cancer, play games,” he remembers.

But the fun was short lived. Two months after the demo, the U.S. Food and Drug Administration told MIM Software to remove their app from Apple’s store, saying it needed to be cleared for medical use. That process took more than two years. And it cost about $150,000.

But that’s not what bugs Cain. What bothers him is that there are so many other medical imaging apps out there — many of them similar to Mobile MIM — that are being bought and sold without FDA supervision. Or at least, it appears that way. “It’s one thing to have the approval of Apple,” he says. “It’s another thing to have the approval of the FDA.”

For the FDA — the agency responsible for keeping medial devices safe — MIM Software was one step along the tightrope as the agency looks to regulate the burgeoning field of software written for mobile devices such as the iPad. Just as consumers have brought their iPhones and iPads into the enterprise, consumer devices are creeping into the medical world. Doctors are getting exciting new ways to do their work remotely; consumers are getting new tools that help them take charge of their own health.

It’s an exciting time, but all of this change has made things tricky for the FDA, an agency that is more at home regulating blood pressure cuffs and stethoscopes than mobile software. Today, there are thousands of mobile medical apps, most written for the iPad or the iPhone. According to the FDA, only a handful of them are cleared for medical use.

“This is the wild west,” says Bradley Thompson, a partner with Epstein Becker Green, and an expert on FDA regulations. “The thing that is so hard for the FDA to grapple with is there are just so many apps out there.”

According to Bakul Patel, a policy advisor with the FDA who is working on mobile app regulation policy, there are more than 15,000 medical apps available for download. Apple has taken an everything-but-the-kitchen-sink approach to curating its App Store Medical section, lumping software that uses the iPhone’s camera to measure your heart rate next to medical imagery viewers like MIM’s product and astrological and baby naming apps.

Thompson advises clients on FDA regulations for a living. At present, his job is pretty tricky, whenever his client happens to be a mobile app maker. “I have all these companies coming to me wanting to do the right thing and I have to somehow advise them when I now full well the FDA isn’t enforcing the rules.”

Right now, companies can choose to undergo the cumbersome FDA clearance process — Cain says it cost MIM Software about $150,000 — in hopes that they’ll have an advantage if the FDA does step into the App Store. Or, as the vast majority are choosing to do, they can go to market quickly without any government paperwork.

The FDA issued some preliminary guidelines for software makers in July. It made it clear that it has no plans to regulate tablets and phones themselves as medical devices. Instead, it will look at the software. But those preliminary guidelines are expected to be finalized next year. Until then, FDA is developing policy rather than enforcing the market. “We don’t want to just come in really, really strong where we discourage people doing these things,” says Patel. “But by the same token we want to encourage people to do the right thing.