FDA to Release mHealth Final Guidance by October

The FDA plans to release the final guidance regarding the regulation of mHealth applications by October, Christy Foreman, director of the FDA’s device evaluation division, told a subcommittee of the House Energy and Commerce Committee during a hearing series, March 19-21, according to a Chicago Tribune report.

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The hearing series was held by three House subcommittees to discuss the role of technology in the healthcare industry and discuss the impact of possible FDA regulation of smartphones, tablets and mobile applications through the Patient Protection and Affordable Care Act.

Ms. Foreman said that the agency’s goal is to foster technological innovation while protecting patient safety. The FDA would not regulate the sale or general consumer use of mobile devices, she added, according to the report.

More Articles on mHealth Regulation:

New Legislation Would Regulate Data Collection by mHealth App Developers
New Bill Spurs mHealth, HIT Innovation
HIMSS, mHealth Regulatory Coalition Submit Comments to FDA on Mobile Medical Apps

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