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Mobile health apps undergo scrutiny by the FDA

AliveCor CEO Judy Wade demonstrates her company's new, FDA-approved heart monitoring device and application.
AliveCor CEO Judy Wade demonstrates her company's new, FDA-approved heart monitoring device and application.
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Mobile health apps are becoming more sophisticated. Some can take an EKG of your heart, measure your blood sugar level, and send the data to doctor. But who's making sure these apps are accurate and safe? The Food and Drug Administration is taking a closer look at mobile health devices and applications.

At the company AliveCor in downtown San Francisco, CEO Judy Wade turns her Apple iPhone sideways and presses her fingertips against the back of her phone case, where there are two sensors embedded in the case. Seconds later, an app on her phone begins measuring her heart rate as a series of wavy lines parade across her screen.

Wade's iPhone has become an EKG machine.

"[An EKG machine] is used to detect irregular heartbeats, as well as specific forms of heart issues like arrhythmia," Wade said. "What I think is one of the most amazing things about this is as soon as you're done, it's instantly transmitted to the cloud and available anywhere in the world to be analyzed and reviewed and read."

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Wade said a cardiologist who was testing the device, used it to treat a passenger on an airplane who was having chest pains.

"He actually used our device to detect that a person was having myocardial infarction," Wade said. "And they landed the plane, they did an emergency landing. The passenger survived."

Wade's app is exactly the kind of thing officials with the Food and Drug Administration think needs federal oversight before being allowed on the market. In other words, software that's used to diagnose patients or prescribe treatment says Bakul Patel. He's a senior policy advisor for the FDA's Center for Devices and Radiological Health which began regulating mobile health applications last year.

"When a technology could actually harm patients when it's not working right, we would be concerned about that," Patel said.

Patel says the agency will clarify what that means with final guidelines it aims to publish by early 2013. He says the FDA has no plans to regulate wellness apps that do things like count calories, remind you to take your pills, or measure the number of steps you've walked in a day.

"We're excited about the fact that such technologies are going to change behavior and eventually help patients manage their own health," Patel said. "So we are actually encouraging that."

Patel's reassurances haven't stopped app developers -- or their investors -- from worrying that FDA regulation could stifle innovation. Especially among start-ups that run on shoestring budgets.

San Francisco's Chinatown is where Rock Health has its headquarters. The group provides seed money, mentorship and other resources to promising mobile and web health entrepreneurs.

"A lot of entrepreneurs may be hesitant to invest their time and money into a product that they don't know will be regulated or not," Rock Health CEO Halle Tecco said. "It's very risky."

Tecco said developers overall, are happy with draft guidelines the FDA put out last year. She says they're hoping the FDA's final rules are clear and concise.

"And [won't] resemble what a drug would have to go through, but something that is more suitable for a software application," Tecco said.

That concern is shared by Silicon Valley Congressman Mike Honda. On Monday, Honda introduced legislation that would create a separate FDA office of wireless health technologies, to help ensure what he called "reasonable" regulation of mobile medical apps.

The FDA's Baruk Patel wouldn't comment on Honda's pending legislation, but says the agency has been taking steps to more efficiently process approvals.
"We're trying to be smart about this," Patel said. "We recognize the growth and we recognize the potential of mobile technologies."

Back at AliveCor, the company has just learned the FDA has approved its device for sale to medical professionals. Michael Righter handled AliveCor's application.
"I'm able to go on the FDA's website and register the device," Righter said. "From there, you're a real medical device company."

Righter said the FDA's response to his application came sooner than expected. Though preparing to submit the application took months of clinical trials and meeting other federal requirements.

"I've had experiences where it's gone beyond 90 days," Righter said. "This once came in I'm guessing, 75 days or so."

Doctors can now order AliveCor's-FDA approved-heart monitor. The company is hoping to get its next FDA clearance to sell the device over-the-counter in April.