Tag Archives: medical

FDA might tax and regulate mobile apps, but that’s not the worst part

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We’ll just do it the old fashioned way.

Medical applications are approved and regulated by the federal Food and Drug Administration (FDA). An agency representative [recently told a congressional committee](https://searchhealthit.techtarget.com/news/2240180401/Congress-explores-potential-regulation-of-mobile-health-apps) that rules regarding mobile medical apps are coming later this year.

Over the course of a week, three separate committees heard a wide range of helpful advice on how best to regulate, or not, mobile medical applications and devices. Taxes were also an issue. The Affordable Care Act – Obamacare – puts a 2.3% tax on medical devices. Depending on the circumstances, mobile medical applications could be hit. Most of those testifying believed it wouldn’t extend to smart phones and tablets that run the apps or to purchases from retail app stores. Not everyone was convinced, though.

The real problem isn’t regulation and taxes as such. It’s uncertainty over what the rules will be, how those rules will be enforced and how long it’s going to take to find out. At last fall’s MobileCon show, Eric Topol, a cardiologist at Scripps Translational Science Institute, said the FDA is a bottleneck for innovators.

Unregulated medical devices are potentially damaging. But so is a lack of innovation. And uncertainty makes or breaks innovation. Too much of it and entrepreneurs back off. It doesn’t matter if they’re uncertain about market share or technical brilliance or government regulation. Once enough uncertainty accumulates, the balance tips towards, say, the next Angry Birds. Stay within the comfort zone, though, and money, talent and energy goes to making healthier lives for everyone.

“We have some things today, but you have to think that in future years we’ll have some things are really incredible,” Topol said.