New Bill Would Limit FDA Regulation of Health IT

A bill introduced into the Senate this week seeks to limit the Food and Drug Administration’s ability to regulate certain health IT products.

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Introduced by Sens. Deb Fischer (R-Neb.) and Angus King (I-Maine), the Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 would remove FDA oversight from health IT products not used for diagnostic purposes, including electronic health records and many medical devices and mobile apps.

“The PROTECT Act increases regulatory efficiency over health IT to promote innovation, expand consumer access to information and improve patient safety,” said Rep. Fischer in a news release. “Current law is in desperate need of a makeover, and I’m pleased to work with Senator King on this commonsense solution.”

This bill mirrors the SOFTWARE Act, introduced in the House last October by Rep. Marsha Blackburn (R-Tenn.).

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