Draft guidance on the Food and Drug Administration's role in regulating electronic health records and other health IT products is expected by the end of March.
The Food and Drug Administration Safety and Innovation Act, signed into law in 2012, requires the FDA, in consultation with the Federal Communications Commission and the ONC, to develop a strategy and recommendations for a framework to promote innovation and protect patient safety. A workgroup was formed in early 2013 to formulate guidance on the issue.
At HIMSS 14, the director of the FDA's Center for Devices and Radiological Health announced next month's internal deadline, while stressing the draft guidance's role not as a definitive rule, but as the start of a conversation.
The scope of FDA regulation for health IT products has been discussed recently in Congress. The Preventing Regulatory Overreach To Enhance Care Technology Act of 2014, introduced this month in the Senate, would remove FDA oversight from health IT products not used for diagnostic purposes, including EHRs and many medical devices and mobile apps. This bill mirrors the SOFTWARE Act, introduced in the House last October.
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