Lawmakers question ONC's regulatory authority
Four members of the House Energy and Commerce Committee, in a letter to National Coordinator for Health IT Karen DeSalvo, question the office's regulatory authority, as outlined in the recently proposed strategy and draft recommendations for a health IT risk-based framework.
The letter expresses concern about ONC's plans to "regulate software and other health IT products" via a Health IT Safety Center called for in the Food and Drug Administration Safety and Innovation Act report, released jointly in April by ONC, FDA and the Federal Communications Commission.
The legislators--Fred Upton (R-Mich.), Joe Pitts (R-Pa.), Marsha Blackburn (R-Tenn.) and Greg Walden (R-Ore.)--also point out that ONC's most recent budget suggests that the agency will require health IT vendors and developers to pay a user fee to support certification and standardization efforts.
DeSalvo and ONC this past week unveiled plans to streamline the agency's efforts--which include cutting its offices from 17 to 10--in part, she said, because federal funds will soon dry up.
"It is not clear to us under what statutory authority ONC is now pursuing these enhanced regulatory activities, including the levying of new user fees on health IT," the legislators say.
The committee members add, in an accompanying announcement, that the agency appears to be "overstepping" that authority.
"Fostering and promoting better integration of technology, innovation and healthcare has been a central tenet of the committee's 21st Century Cures initiative," the announcement says. "Members are concerned that another layer of bureaucracy could hamper such efforts."
The committee poses four questions to DeSalvo, including:
- Under what statutory authority will ONC regulate health IT beyond the expiration of the Medicare and Medicaid Meaningful Use incentive programs?
- What authority will ONC have to participate in regulatory activities in coordination with the FDA and FCC?
- How does the proposed rule on 2015 edition electronic health record certification represent a shift from "coordinating and promoting" health IT efforts--including interoperability and privacy and security--to regulating data collection and functionality requirements?
- What role will ONC play in efforts such as health IT safety and EHR certification moving forward? Will the agency's role be limited to the scope of recommendations provided by its federal advisory committees?
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