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FDA clarifies plans for mobile health regulation

Written by Anne DeGheest // 25 March 2013 // FDA,

Brian Horowitz in eWeek wrote a very nice article on upcoming FDA regulation. PLease find key extracts below:

The U.S. Food and Drug Administration plans to regulate medical devices connected to smartphones, but consumer devices such as the iPhone and app stores like iTunes and Google Drive will remain clear of oversight, an FDA official told the House of Representatives' Subcommittee on Oversight and Investigations on March 21."

[The] FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended," Christy L. Foreman, director of the FDA's Office of Device Evaluation at the Center for Devices and Radiological Health, told the congressional panel."

Consistent with this balanced approach, [the] FDA would not regulate the sale or general consumer use of smartphones or tablets," Foreman said.During three days of hearings on Capitol Hill, lawmakers explored how far mobile health app regulations by the FDA should go.

Mobile apps that measure patients' vital signs or control devices such as CT scanners will be regulated. Inaccurate programming of a drug infusion pump or a CT scanner could cause a drug or radiation overdose, Foreman explained." An inaccurate or malfunctioning mobile medical app that uses a sensor to diagnose skin cancer or to measure critically low blood oxygen levels in chronic lung disease patients could delay lifesaving diagnosis and treatment," she said.

Mobile apps that provide access to electronic health records (EHRs) will be free of regulation, according to Foreman.Wellness, fitness and medical resource apps will also not be regulated, noted Jennifer Kent, a research analyst at Parks Associates."Medical apps with low-risk to consumers, such as an e-book of medical information, will not be worth the FDA's time," Kent told eWEEK in an email.

"Peripherals and apps that turn a mobile device into a medical device in some way—a common example is using an iPhone as a wireless glucometer—will be regulated," said Kent.

When guidelines are finalized, the FDA will publish a list of apps on its Web site that have been approved by the agency, said Foreman. Secretary of Health and Human Services Kathleen Sebelius is required to submit recommendations for a "regulatory framework" that includes mobile medical apps by January 2014, according to Foreman.



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