Nathan Cortez is one of Americas leading experts on the relatively new frontier of mobile health or mHealth, the use of mobile devices like smartphones and tablets for health or medical purposes.
But its not because he wears a black Fitbit bracelet and his iPhone is stocked with apps like WebMD and a slew of the nearly hundred thousand other health apps available.
Its because Cortez is a law professor at Southern Methodist University in Dallas, and he has become a walking encyclopedia on the largely unregulated multi-billion-dollar business of apps, claiming to provide everything from cardiac measurements to sonograms.
“Most consumers take mobile health app claims at face value, says Cortez, who studied law at Stanford practical in the heart of Californias Silicon Valley, and think that because they’re available through a trusted retailer like the iTunes Store, they must have been reviewed by the FDA, which isn’t usually the case.
To the contrary, argues Cortez–who in a New England Journal of Medicine article has outlined the potential dangers of medical apps–some frighten the technology daylights out of him.
Ive 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.
Or consider the rheumatoid arthritis app that Pfizer put out in 2011.
It was basically a calculator trying to calculate a score for how severe your rheumatoid arthritis is, says Cortez and it didnt work.
In that case, you may have seen treatment decisions made based on erroneous calculations.
Then there was a diabetes app produced by Sanofi Aventis in 2012 that was recalled because it miscalculated insulin dosages.
In the New England Journal of Medicine article, Cortez writes that more oversight is needed by the U.S. Food and Drug Administration (FDA) to ensure consumer confidence and safety.
I found the FDA was using the same approach it was 20 years ago, being very tentative, says Cortez, who was a co-author of a study on mHealth apps. It wasnt aggressively pursuing products, it was kind of taking baby steps and nervous about its jurisdiction and expertise.
As a result, of the hundred thousand mobile health or mHealth apps on the market, the article claims only about 100 have been approved by the FDA.
Consumers will be spending a lot of money on these products, and venture capital is flying into the industry, wrote Cortez, who is associate dean of research at the SMU law school.
It is a booming industry expected to grow from $2.4 billion last year to $26 billion in 2017.
“Although the vast majority of mHealth products are very low-risk, some apps make promises they can’t fulfill, and others make errors that could harm patients,” Cortez writes.
Its been using a statute from 1976, Cortez says of the FDAs approach to regulating mHealth technology, but its getting old and its getting outdated. With the kind of crazy innovations over the last several decades, I think the FDA needs some updated statutory authority from Congress to be more sensitive with these technologies.
Congress has considered but not passed several bills intended to give the FDA more power to regulate the mHealth industry, including the idea of a new federal Office of Wireless Health Technology.
I think if the FDA doesnt provide meaningful oversight, youre going to have a lot of products that just dont work, says Cortez. Congress is pushing the FDA and agencies to not over-regulate but the real problem is the opposite direction, its under-regulating the market in the long term.
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