How can you be sure a medical app actually works?

The FDA-approved MyVisionTrack test has the ability to track vision loss in patients with retinal disorders. Patient Daniel Agnew, who has diabetic retinopathy, uses the device to differentiate between circles on the screen.

Your smartphone will see you now: the wild west of medical apps

If you take a virtual stroll through the iTunes store or Google Play, you will find nearly a hundred thousand health apps – everything from fitness trackers to blood glucose monitors. Out of all these apps, only about 100 have been cleared by the Food and Drug Administration. Some lawyers are calling for more regulation.

Nathan Cortez went to law school in Silicon Valley. He wears a black Fitbit bracelet and his iPhone is stocked with apps like WebMD. But some apps scare him.

“I’ve got an app that you can use to record your heartbeat or bowel sounds,” he says. “And it spits out a diagnosis. Just the thought you can hold your cell phone up to your chest and receive a serious diagnosis of a heart problem is a little mind blowing.”

Scary diagnoses

Cortez is a law professor at SMU in Dallas. He outlined the potential dangers of medical apps in an editorial in the New England Journal of Medicine. And while Cortez talks about hypothetical dangers, he has real life examples of malfunctioning apps.

For example, a rheumatoid arthritis app created by Pfizer in 2011: “It was basically a calculator,” he says, “trying to calculate a score for how severe your rheumatoid arthritis is.”

And it wasn’t working.

“In that case, you may have seen treatment decisions made based on erroneous calculations.”

The blood glucose app from drug company Sanofi was recalled because it miscalculated insulin doses.

Right now the FDA categorizes apps on three levels of risk. It only has jurisdiction over the riskiest products, and does not even review all of those.

Why? Cortez says it’s mainly politics, and a fear of stifling innovation.

The FDA is sensitive to accusations of over-regulation. This month the agency announced even more exemptions for mobile health products that allow users to track, log, trend, and share data with doctors. New rules clear Apple’s product HealthKit, an app to track everything from blood pressure to lung capacity, from regulation.

The regulatory hurdle 

In the past decade, the FDA has confirmed the medical claims of roughly 100 apps, or .1 percent of what’s out there. One app that has been cleared is called My Vision Track.

MyVision Track App 

“We believe that a regulatory approved medical app costs you about 10 times as much and takes about 10 times as long as doing one that’s not regulated,” says creator Mike Bartlett, with Richardson-based company Vital Art and Science Inc.

Bartlett had to organize multiple months-long clinical studies to prove that My Vision Track can monitor the progress of retinal diseases such as macular degeneration. But he’s not upset about the expensive, arduous process.

“I would be very cautious about using something that’s unproven,” Bartlett says. “And we know that there are vision tests that absolutely don’t work.”

Regulators walking a fine line

Regulators are walking a fine line between letting snake oil salesmen roam free and discouraging legitimate developers.

Chuck McCoy, head of North Texas Angels Network, says so far he hasn’t heard complaints from investors about too much red tape.

“The FDA over regulates in many areas,” he says, “but if you are going to make clinical claims about a device, there has to be some scientific basis for those claims.”

So far, the FDA has taken a fairly lenient view of the medical app ecosystem, says Dr. Chandra Duggirala, a physician with the San Mateo Medical Center. Last year, he made an experimental device for Type 2 diabetes with promising early results. But he wasn’t able to secure funding that would have brought it to market. Duggirala says the lenient stance could change once people start using medical apps that don’t just track, but also diagnose health conditions.

“So far, not many medical apps are hugely popular in a way that would attract FDA attention," he says. "Once that happens, I’m sure there will be some regulatory hurdles for everybody to cross."

Most entrepreneurs agree the FDA over-regulated medical devices. Now, the question is whether they’re under-regulating mobile medical apps.

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