Legal Experts Call For More Regulation Of Mobile Health Apps

Veronica Thomas
CommonHealth Intern

Want to hypnotize yourself thin? There's an app for that. Want to monitor your heart rate without buying another gadget? There's an app for that too. With the emergence of countless mobile health applications, smartphones are quickly transforming health care at our fingertips.

Mobile health—“mHealth”—apps have the potential to help promote healthy behaviors, expand health care access, and manage costs. But in order to protect the safety of consumers, health law experts say there needs to be more regulation by the Food and Drug Administration.

According to the new report, just published in the New England Journal of Medicine, only about 100 out of 100,000 mHealth apps available on the market have been FDA-approved.

Many mobile health developers, however, worry that FDA oversight will hinder creativity and growth. The FDA approval process can cost tens of thousands of dollars and take months or even years to complete. Before committing time and money to FDA endorsement, many developers first look to consumers for a stamp of approval.

From the study's press release:

"Consumers will be spending a lot of money on these products, and venture capital is flying into the industry," says the article's lead author, SMU Dedman School of Law Associate Dean of Research Nathan Cortez, adding that by 2017 mHealth apps are expected earn $26 billion— 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 authors note. An under-regulated mobile health industry could create "a Wild West" market, says Cortez, who has conducted extensive research into FDA regulation of mobile health technologies.

While consumers might trust that iTunes and Android would only sell legitimate health apps cleared by the FDA, that just typically isn't the case, Cortez says.

As with drugstore vitamins and weight-loss products claiming to "shrink your waist in 7 days," most of these products have not been thoroughly tested and evaluated by outside experts.

Also from the press release:

"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," Cortez notes, pointing out that life-threatening technical mistakes are not only possible – they also have occurred.

The authors note that Congress has introduced many bills to strengthen FDA control over mHealth apps, including the proposed creation of a new Office of Wireless Health Technology. On the other hand, there are also more conservative bills that limit the authority of the FDA in the mHealth market.

In the press release, Cortez responds to opponents' concerns that increased FDA oversight will inhibit innovation and growth:

The conventional wisdom is that FDA regulation will stifle innovation, and that's a very short-term way to think about this," Cortez says. "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 contends.

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