Four Republican Congressmen on the House Committee on Energy and Commerce sent a letter this week to Karen DeSalvo, M.D., the National Coordinator for Health Information Technology, questioning the Office of the National Coordinator for Health IT's (ONC) overall regulatory authority.
The line of questioning comes in light of an April 2014 report from the ONC and other federal agencies which aimed to provide guidance on health IT products to help determine a) what the product does and b) what risk it has to patients who will use it. Using this report as its basis, the Congressman expressed concern that the ONC would create a Health IT Safety Center so they could regulate software and health IT products.
The four Congressmen who wrote the letter with the Committee are Chairman Fred Upton (R-MI), Health Subcommittee Chairman Joe Pitts (R-PA), full committee Vice Chairman Marsha Blackburn (R-TN), and Communications and Technology Subcommittee Chairman Greg Walden (R-OR).
“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 Congressman write in the letter to Dr. DeSalvo.
The Congressmen explain that the ONC was created to perform duties consistent with the development of a national health information infrastructure, but note that does not specify regulatory oversight. They say that in the ONC’s announced restructuring from this past week, there is an “Office of Standards and Technology.” They want to understand how the agency can carry out certain functions in this regard without overstepping its statutory authority.
It asks DeSalvo what statutory authority over health IT ONC believes it will have when the Medicare and Medicaid Incentive program expires and what role ONC plans to play in Health IT safety and EHR certification requirements in the future.
“Fostering and promoting better integration of technology, innovation, and health care has been a central tenet of the committee’s 21st Century Cures initiative. Members are concerned that another layer of bureaucracy could hamper such efforts,” the Congressmen say in a press release.
Upton and other Committee members have advocated on the behalf of less regulation in health IT before. Last year, the Committee conducted hearings on health information technologies, and potential regulations and taxes on smartphones, tablets, and mobile apps.