Legal Experts Call For More Regulation Of Mobile Health Apps

smartphone (Stephan Geyer/Flickr)

(Stephan Geyer/Flickr)

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. Continue reading

Take Two Aspirin And Download This App (At Your Own Risk)

Don’t be surprised if one day soon your doctor ends an appointment saying, “Here’s a prescription for a drug that will help, and download this app.”

Medical apps are turning our phones and tablets into exercise aides, blood pressure monitors and devices that transmit an EKG. But the proliferation of apps is way ahead of tests to determine which ones work.

Christine Porter is hooked on the My Fitness Pal app.

Christine Porter posts food, drink and exercise infofmation to her health app every day and says she's almost always honest. (Martha Bebinger/WBUR)

Christine Porter posts food, drink and exercise infofmation to her health app every day and says she’s almost always honest. (Martha Bebinger/WBUR)

In October, after deciding to lose 50 pounds, Porter started recording everything she eats or drinks and any type of exercise she does.

“It’s telling me I have about 1,200 calories remaining for the day,” Porter said. She took a long walk at lunch and built up some calorie credits so she wouldn’t have to skimp so much at dinner.

Porter heard about the app from her health coach at the Ambulatory Practice of the Future, a primary care clinic for Massachusetts General Hospital employees.

“I usually give patients a choice of several apps that might help them,” said health coach Ryan Sherman. “Some patients won’t even look at them and then others might say, ‘Oh, yeah, this could work for me.’ ”

Increasingly, Sherman says, patients are coming in, pulling out their phones and asking, “Hey, have you seen this one?” The options are both exciting and hard to manage.

“There’s a new one every day so it’s trying to keep up with that,” Sherman said. “And if there’s not one place to look that can be hard.”

Which is one reason doctors at this Mass General clinic are suggesting — but not prescribing — apps. It’s hard to know which of the roughly 40,000 choices work.

Experts who are trying to figure out which apps are safe and effective generally separate them into two categories: those that actually turn your phone into a medical device and everything else. Continue reading