Challenges Abound In Creating Regulatory Framework For Mobile Medical Apps, Health IT
This article was originally published in The Gray Sheet
FDA plans to release guidance for mobile medical apps ahead of a larger regulatory framework on health information technology, according to an agency official.
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A new public stakeholder group met for the first time to begin efforts to advise government agencies on developing a health IT regulatory framework, setting itself an August 7 deadline for final recommendations.
On the last day of hearings by three House Energy and Commerce subcommittees March 19-21, CDRH Office of Device Evaluation Director Christy Foreman largely reiterated FDA’s previously stated approach to regulating mobile medical apps. Meanwhile, Energy and Commerce Committee Vice Chair Marsha Blackburn, R-Tenn., hinted at legislation on the issue
The legislation, awaiting the signature of the president, will bring greater scrutiny of device center activities by Congress and industry.