Top-ranking Republican Congressmen have begun to question whether the ONC has the authority to open a new center, which the lawmakers say would regulate health IT software and products and possibly impose fees on IT vendors.
In April, the ONC, the Federal Communications Commission and the Food and Drug Administration released a proposed strategy and framework for the regulation of health IT products. The proposed recommendations are the result of a provision of the FDA Safety and Innovation Act, signed into law in 2012, which requires the three agencies to work together to develop a regulatory strategy that promotes innovation while protecting patient safety.
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 write, "[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."
The letter's signatories — Fred Upton (R-Mich.), Joseph Pitts (R-Pa.), Marsha Blackburn (R-Tenn.) and Greg Walden (R-Ore.) — end the letter by calling on the ONC to clarify its regulatory authority both for the proposed center and other initiatives in the future.
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