The ONC has responded to criticism from Republican lawmakers over a proposed health IT safety center, asserting the agency does have the authority to create a non-regulatory body under the HITECH Act.
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. Part of the proposed strategy is the formation of the Health IT Safety Center, run by the ONC in conjunction with other government agencies, to bring together industry representatives to discuss best practices and promote health IT safety.
The original proposal describes the center as a public-private entity that would "convene stakeholders in order to focus on activities that promote health IT as an integral part of patient safety with the ultimate goal of assisting in the creation of a sustainable, integrated health IT learning system that avoids regulatory duplication and leverages and complements existing and ongoing efforts."
However, Republican lawmakers are claiming the center would actually act as a regulatory body, overstepping the ONC's bounds. In a 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."
Now, Dr. DeSalvo has responded, saying the center will not perform regulatory functions and therefore is well within the ONC's purview. 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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