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Health Beat: Health apps: The regulation conversation

Published On: May 31 2013 02:40:10 PM EDT   Updated On: May 31 2013 06:03:14 PM EDT

You may have seen your doctor use his smart phone the last time you were in the office.

You may have seen your doctor use his smart phone the last time you were in the office. That's because more and more medical apps are coming out on the market. Now the question is, should they be regulated?

Some experts project more than 50 billion app downloads in the United States in 2013. While most of us use apps for entertainment or exercise, some health apps now serve a much more serious purpose.

For example, there's an app to spot ear infections, one that turns your phone into a mobile heart monitor, and even one in the works that helps detect tumors.


More and more doctors are using their smartphones and tablets as tools to help patients.

Dr. Brian Rothman, an anesthesiologist and medical director at Vanderbilt University Medical Center, can observe up to four operating rooms at once with Vigivu. The app he helped create allows him to keep track of patients’ medication and vital signs and get notifications if those vitals go out of range.

“We have such a demand to be everywhere for our patients.  It brings information to me," said Rothman.

Some people, however, question the safety and privacy of health apps.

“I think we need to be cautious," said Debbie Gregory, senior clinical consultant with Smith Smeckman Reid Inc. "How are we going to regulate these? Who’s going to be regulated?"

Three days of FDA hearings were recently held to debate what medical apps should be regulated. 

"While many mobile apps carry minimal risks, others can pose significant risks to patients if they don’t operate correctly," said a woman who testified at the hearings.

The agency proposed regulating a small subset of health apps that turn mobile devices into medical devices. For example, an app that allows smartphones to take a diabetic’s blood glucose reading may have to get approval, but apps considered low-risk, like those containing general medical information, will not be regulated.

The FDA plans to put the new health app regulations in place by Oct. 1.

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