All told, there are about 27,000 unique health apps available on Apple and Google app stores, of which 7,000 are meant to be used by health care professionals, according to Jarrin.

But a survey by mobihealthnews found the FDA has cleared fewer than 80 apps by its 510(k) regulatory process, even though about 5 percent could be considered medical devices and thus subject to FDA oversight, he said.

"We're looking for clarity from the agency," Jarrin said, pointing out that the industry most wanted to see clear-cut examples of low-risk apps it would consider devices, but did not plan on regulating.

What's the reason for the FDA's delay? Thompson, speaking as a self-described "nerdy lawyer," speculated that the FDA was taking its time to come up with the "final definition for all time" answer to app regulations, but was having problems because the industry moves too fast to keep up with.

"What they need to do is get a final version out there, and use the guidance process to update it periodically," he said. A previous discussion between the FDA and industry representatives suggested creating a website where they could give real-time guidance updates, he said.

Taxing matters

A big worry was how, and if, the medical device tax, which was created by the Affordable Care Act, would affect the industry. Rep. Greg Walden, an Oregon Republican who chairs the subcommittee, wondered if the tax would lead future entrepreneurs away from medical apps into making another Angry Birds instead.

"The specter of costly and time-consuming regulation, to say nothing of the 2.3 excise tax, looms large over this industry," he said.

Jonathan Spalter, chairman of Mobile Future, argued that the excise tax, should it be applied to apps regulated as devices, would "stifle innovation."

The memo for the meaning also raised a more dire prospect, of whether smartphones or even networks would be subject to the medical device tax or other regulations.

But Rep. Henry Waxman, a Democrat from California, said the FDA in its draft guidance clarified that it had no intention of regulating app stores or smartphones, and that most health apps would not be subject to the device tax because of a retail exemption, included in the ACA and which applies to products like contact lenses and wheelchairs sold directly to the consumer.

Role for FDA

Most of the panelists seemed to welcome the FDA to take a role in regulating apps, rather than shunting off responsibility to another agency or even creating a new one just for mHealth. "We favor sticking with the agency," Thompson said. In fact, Thompson in his testimony encouraged the FDA to step up enforcement on some products, such as a recently announced home urinalysis product that will let consumers use their iPhone camera to help interpret the results of a urine test strip.

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