Republican leaders in a U.S. House of Representatives committee are asking the Office of the National Coordinator for Health Information Technology (ONC) for clarification on its plans to regulate health IT.
In their June 3 letter to ONC national coordinator Dr. Karen DeSalvo, Fred Upton (R-MI), Marsha Blackburn (R-TN), Joseph Pitts (R-PA), and Greg Walden (R-OR) from the Energy and Commerce Committee said they are unclear regarding under what statutory authority ONC is pursuing new enhanced regulatory activities.
The authors referenced the April report by the U.S. Food and Drug Administration (FDA), ONC, and the Federal Communications Commission (FCC) that proposed a risk-based regulatory framework for health IT. That proposal also suggested that ONC create a Health IT Safety Center for the purposes of regulating software and other health IT products. In addition, the ONC 2014 budget suggests it will impose a new user fee on health IT vendors and developers to support ONC's certification and standardization activities, according to the Republican letter.
To better understand DeSalvo's perspective on ONC's role in these areas, the Republicans are asking the following:
- When the authorization for the Medicare and Medicaid meaningful use incentive program expires, under what statutory authority does ONC believe it is able to regulate health IT and electronic health records, particularly in (but not limited to) nonmeaningful-use areas?
- The FDA is provided with the authority to regulate medical devices by the Federal Food, Drug, and Cosmetic Act. What similar authority does ONC point to, going forward, to participate in regulatory activities in coordination with the FDA and the FCC?
- To what extent does ONC's notice of proposed rulemaking (NPRM) on 2015 Edition EHR Certification represent a broader shift in focus from coordinating and promoting efforts related to interoperability, privacy, security, and quality reporting criteria, to the regulation of data collection, functionality requirements, and other areas where market forces are more likely to promote innovation and efficiency?
- What role does ONC plan to play moving forward on issues including but not limited to health IT safety and electronic health record certification requirements? How will the recommendations of ONC's Federal Advisory Committee guide these plans? Will ONC's role be limited to the scope of these recommendations?
The full letter can be found here.
