Home > EHR, FDA, radiation safety > Energy and Commerce Health Subcommittee Hearing on FDA Oversight of Mobile Apps and Other Software

Energy and Commerce Health Subcommittee Hearing on FDA Oversight of Mobile Apps and Other Software

On November 19, the House Energy and Commerce Health Subcommittee held a hearing on “Examining Federal Regulation of Mobile Medical Apps and Other Health Software.” Dr. Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health; Dr. J. Leonard Lichtenfeld, Deputy Chief Medical Officer, American Cancer Society; and assorted representatives of the health IT industry participated as witnesses.

The hearing was primarily focused on the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013 (HR 3303), a bill that would codify certain aspects of FDA’s guidance on mobile medical applications while adding restrictions on FDA’s regulatory authority over certain types of software. FDA’s concern is that the current version of the bill would remove the agency’s existing authority over diagnostic software such as electronic blood glucose meters, computer-aided detection (CAD), and more.

As of this writing, the SOFTWARE Act only has 7 cosponsors and no Senate counterpart.

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Categories: EHR, FDA, radiation safety
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