2014 Archives

How can you be sure a medical app actually works?

Excerpt

The following is from the August 20, 2014, edition of NPR's Marketplace. Expertise for this story was provided by SMU Law Professor Nathan Cortez, who teaches and writes in the areas of health law, administrative law, and FDA law. 

August 25, 2014

By Lauren Silverman

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.”

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.

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