As Committee Pursues Policies to Foster Health Care Innovation, Leaders Question Agency Plan to Increase Health IT Regulation and Fees

June 3, 2014

Members Question Authority and Rationale for Expanded Regulatory Approach, Underscore Commitment to Safe and Innovative New Approaches for Technology in Health Care

WASHINGTON, DC – House Energy and Commerce Committee leaders today sent a letter to Karen DeSalvo, National Coordinator for Health Information Technology in the Department of Health and Human Services Office of the National Coordinator (ONC), questioning the ONC’s authority to expand its regulatory role in the Health IT space. The leaders are concerned that a report released in April 2014 “suggests that the Office of the National Coordinator for Health Information Technology would, among other things, 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.”

The leaders write, “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 Office of the National Coordinator was legislatively established in 2009 as part of the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of 2009. Late last week, ONC announced a leadership structure that, among other things, creates an Office of Standards and Technology. As the ONC is poised to reorganize itself, committee leaders want to better understand how the agency believes it can carry out a host of new functions amid concerns that it might be overstepping its statutory authority. 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 letter was signed by full committee 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).

Read the complete letter online here.