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.
“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.”
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 explains, “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.”
Or the blood glucose app drug company Sanofi recalled because it was miscalculating insulin doses.
Right now the FDA categorizes apps on three levels of risk. It only has jurisdiction over the riskiest products, and doesn’t review all of those.
Why? Cortez says it’s mainly politics, and a fear of stifling innovation.
The FDA is sensitive to accusations of overregulation. 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% of what’s out there. One app that’s been cleared is called My Vision Track.
“We believe that a regulatory approved medical app costs you about ten times as much and takes about ten 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 Fine Line
Regulators are walking a fine line between letting snake oil salesman roam free and shooing away legitimate developers.
Chuck McCoy, head of North Texas Angels Network, says so far he hasn’t heard complaints from investors about too much sticky red tape.
“The FDA over regulates in many areas,” he says, “but if you are going to in fact 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. 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, once that happens I’m sure there will be some regulatory hurdles for everybody to cross,” he says.
Duggirala knows, last year he made an experimental device for type two diabetes with promising early results. He wasn’t able to secure funding that would have brought it to market.
Most entrepreneurs agree the FDA overregulated medical devices. Now, the question is whether they’re under-regulating mobile medical apps.