Less than a week after the Office of National Coordinator for Health IT disclosed restructuring plans, some Congressman want Dr. Karen DeSalvo to explain where the ONC gets the power to regulate health IT companies. A letter to DeSalvo raised questions over the ONC’s plans to set up a Health IT Safety Center to regulate software. It also expressed concerns over the ONC’s 2014 budget plans to impose a user fee on health IT vendors and developers to support the ONC’s certification program.
Authors of the letter to DeSalvo included Republican members of the House Committee on Energy and Commerce — its chairman, U.S. Rep Fred Upton of Michigan; U.S. Rep Joe Pitts of Pennsylvania, who chairs the Subcommittee on Health; U.S. Rep. Marsha Blackburn of Tennessee; and U.S. Rep. Greg Walden of Oregon, the chairman of the Subcommittee for Communications and Technology.
Here were some of the most pointed questions in the letter:
“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?
When the authorization for the Medicare and Medicaid 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) non-Meaningful Use areas?”
Regulatory issues surrounding mobile health tools have been an ongoing source of debate on Capitol Hill. As DeSalvo seeks to make her mark on the office, particularly in advancing interoperability, there seems to be no avoiding a debate on what the limits of government regulation should be.
