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Report: Booming Mobile Health App Market Needs More FDA Oversight

Less than 1% of mobile health apps are agency-approved

Smart phones and mobile devices are poised to revolutionize health care in the U.S., offering mobile health (mHealth) apps capable of providing everything from cardiac measurements to sonograms.

While the potential exists to broaden the access to medical treatment and to control costs, several health law experts say in a new report published in the New England Journal of Medicine that more oversight is needed by the FDA to ensure consumer confidence and safety. Out of approximately 100,000 mHealth apps on the market, only about 100 have been cleared by the FDA, while opponents see the FDA as a deterrent to innovation — and profits.

“Consumers will be spending a lot of money on these products, and venture capital is flying into the industry,” said lead author Nathan Cortez of the Southern Methodist University School of Law. Cortez added that mHealth apps are expected to earn $26 billion by 2017 — up from $2.4 billion in 2013.

The FDA needs “additional funding and in-house technical expertise to oversee the ongoing flood of mHealth products,” the article notes. An under-regulated mobile health industry could create “a Wild West” market, said Cortez, who has conducted extensive research into FDA regulation of mobile health technologies.

“Most consumers take mobile health app claims at face value, and think that because they’re available through a trusted retailer like the iTunes store, they must have been reviewed by the FDA, which isn’t usually the case,” Cortez said.

“Although the vast majority of mHealth products are very low-risk, some apps make promises they can’t fulfill, and others make errors that could harm patients,” he added, pointing out that life-threatening technical mistakes are not only possible — they have occurred.

One of several examples cited in the study includes Sanofi Aventis’ 2012 recall of a diabetes app that miscalculated insulin dosages.

Several Congressional bills have been proposed to strengthen FDA jurisdiction over mHealth products, with one proposing the creation of a new Office of Wireless Health Technology within the administration, the article notes. Meanwhile, more restrictive bills have been introduced to keep the FDA from regulating “clinical software,” stating that “applying a complex regulatory framework could inhibit future growth and innovation in this promising market.”

Cortez commented: “The conventional wisdom is that FDA regulation will stifle innovation, and that’s a very short-term way to think about this. Most Silicon Valley firms aren’t used to much federal regulation, and internet technologies have been subject to very little federal oversight.”

If dangerous errors and disproven product benefits are allowed to proliferate, “some very useful products will be undermined by widespread consumer distrust,” Cortez remarked.

“We’re trying to push lawmakers to empower the FDA, not hamstring it,” he said. “Clarity will help the industry create products [that are] more helpful than harmful.”

Sources: Medical Xpress; July 28, 2014; and NEJM; July 24, 2014.

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