The House Energy and Commerce Committee sent a letter to National Coordinator for Health Information Technology Karen DeSalvo, M.D., challenging ONC for overstepping its statutory authority to regulate health IT. 

The letter, signed by full committee Chairman Fred Upton (R-Mich.), Health Subcommittee Chairman Joe Pitts (R-Penn.), full committee Vice Chairman Marsha Blackburn (R-Tenn.), and Communications and Technology Subcommittee Chairman Greg Walden (R-Ore.), calls into question a proposed risk-based regulatory framework for health IT released April 3 by the Food and Drug Administration, Federal Communications Commission, and ONC. 

Specifically, legislators object to the report's draft recommendation that ONC, in collaboration with FDA, FCC, and the Agency for Healthcare Research and Quality, would create a Health IT Safety Center--a public-private entity to convene stakeholders in order to assure that health IT risks are minimized and patient safety is protected. 

"That report, released in April 2014, suggests that the Office for 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," states the letter. "However, 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."

ONC was legislatively mandated in 2009 as part of the Health Information Technology for Economic and Clinical Health Act (HITECH Act). At HIMSS14 in late February, Doug Fridsma, ONC's Chief Science Officer and Director of the Office of Science and Technology, lamented that the ONC budget had returned to its historic funding level of $60 million annually--the same amount the office received when it was first formed. The HITECH Act provided $2 billion to ONC between 2009 and 2013 to support health IT infrastructure, policy and standards, education and other activities. Yet, with HITECH Act funding expiring, ONC appears to be looking for alternative revenue streams.

“Late last week, ONC announced a leadership structure that, among other things, creates an Office of Standards and Technology,” states the committee in a written statement. “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.”

In its letter to DeSalvo, committee members asked ONC to answer several questions including: 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) Meaningful Use areas?

Tom Leary, vice president for government relations at HIMSS, commented that these are “reasonable questions for Congress in light of the on-going discussion of a regulatory framework for health IT and the recently released FDASIA report." Leary said the best health IT strategy is one that "ensures patient safety without stifling the kind of innovation that supports healthcare transformation.”

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