GOP questions health software regulator’s authority

Top Republicans are questioning whether an office within the Health and Human Services Department has the authority to regulate software applications used in the health industry and impose user fees.

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In a Tuesday letter to Karen DeSalvo, national coordinator for health information technology (IT) at HHS, GOP leaders questioned whether the Office of National Coordinator (ONC) has the statutory authority to regulate health IT products based on a new report and whether it has the authority to receive user fees under its budget request. [READ THE LETTER.]

“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,” said the lawmakers on the House Energy & Commerce Committee.

They included Chairman Fred Upton (R-Mich.), Vice Chairman Marsha Blackburn (R-Tenn.), Health Subcommittee Chairman Joe Pitts (R-Pa.) and Communications and Technology Subcommittee Chairman Greg Walden (R-Ore).

The Food and Drug Administration is authorized to regulate medical devices under the Federal Food, Drug and Cosmetic Act, but the lawmakers want to know what similar authority ONC has.

They are also asking to what extent the office is moving from its focus on coordinating and promoting health IT to regulating the industry, and what role the office will play in developing requirements for health IT and electronic health records certification.