The idea for the center originated in a proposed strategy and framework for the regulation of health IT products, co-written by the ONC, the Food and Drug Administration and the Federal Communications Commission. The Health IT Safety Center, run by the ONC in conjunction with other government agencies, would bring together industry representatives to discuss best practices and promote health IT safety.
However, some Republican lawmakers have claimed the center would actually act as a regulatory body and would therefore be outside the ONC’s purview. In a June letter to National Coordinator Karen DeSalvo, MD, four ranking GOP leaders wrote, “[It] is not clear to us under what statutory authority ONC is now pursuing these enhanced regulatory activities.” The letter also says the ONC’s 2014 budget, which includes a new, $1 million entry for user fees to support the ONC’s health IT regulatory activities, suggests the regulatory activities would “impose a new user fee on health IT vendors and developers to support ONC’s certification and standardization activities.”
Dr. DeSalvo quickly responded, saying the center will not perform regulatory functions and therefore is well within the ONC’s authority. In a letter, Dr. DeSalvo points to the original language of the HITECH Act, which grants the ONC authority to “perform a broad range of duties” that “promote a more effective marketplace, greater competition [and] greater systems analysis,” including, she writes, a center that would promote the safe use of health IT products.
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