Fed agencies aim for mHealth regulatory balance

From the mHealthNews archive
By Diana Manos

If the estimate comes true, by 2015 some 500 million people will be using mobile health apps worldwide. At such a fast pace of development, what agency could possibly regulate them all?

Right now the Food and Drug Administration, the Office of the National Coordinator for Health IT and the Federal Communications Commission all have a hand in some portion of regulation, even as Congress vies for possibly the greatest role by passing mHealth legislation. Until there is definitive mandated law, how will the various federal entities combine their efforts to avoid duplication and streamline the process for developers?

That question will inevitably be top of mind as a host of federal officials present at this year’s HIMSS Media mHealth Summit, and just like on Capitol Hill, folks will be gathering to grasp what the future may hold in this regulatory arena.

During a half-day workshop on Sunday, December 8, a panel of 13 policy experts will tackle the legal aspects of mHealth, delivering advice and insight on the FDA and FCC’s regulation of mHealth, HIPAA concerns and other regulatory issues.

Then, on Monday, December 9, private sector experts will use a town hall format to discuss the latest developments, including the FDA’s Safety and Innovation Act (FDASIA) working group involving the FDA, ONC and FCC; the joint work group on Telehealth; the White House Rural HIT Initiative and others. 

“I think we share a philosophy with the FDA to encourage innovation and not slow down an industry that’s being created,” said Lygeia Ricciardi, director of the ONC's Consumer eHealth Program, in an interview with Government Health IT, “and at the same time give some guidance and assurance to consumers.”

The ONC intends to host a Town Hall on Consumer Engagement on Tuesday, Dec. 10, at 1 p.m. And on Wednesday, December 11, at 8:30 a.m., FDA Commissioner Margaret Hamburg is slated to discuss in a keynote address the significance and background of the FDA’s September 23 guidance on mobile medical apps within the broader context of patient care and public health challenges.

Indeed, the FDA, FCC and ONC are all trying to strike a balance between enabling mHealth innovation and protecting patients via regulation.

“In actuality, regulation — when it’s done right — should not only help protect and promote the health of a community, but it also should help advance stability and economic health,” Hamburg explained in a speech earlier this year. “Smart regulation allows us to deliver the promise of science in the service of patients, healthcare providers, academics — and yes, industry, too.”


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