On Tuesday, House Republicans sent a letter to National Coordinator for Health IT Karen DeSalvo questioning her office's authority to regulate health IT products as called for in a recently released draft report, The Hill reports (Al-Faruque, The Hill, 6/3).

Background

As directed by the Food and Drug Administration Safety and Innovation Act, HHS in April released a draft report that included a proposed strategy and recommendations for creating a risk-based health IT regulatory framework.

The draft report was developed by FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission (iHealthBeat, 4/3).

Letter Details

In the letter, Republican leaders on the House Energy and Commerce Committee wrote that the report "suggests that [ONC] would, among other things, create a Health IT Safety Center for the purposes of regulating software and other health IT products." The letter added that "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" (GOP letter, 6/3).

The lawmakers noted that the Federal Food, Drug and Cosmetic Act gives FDA the authority to regulate medical devices but questioned ONC's statutory authority.

In addition, the lawmakers asked DeSalvo to comment on the extent to which ONC is shifting from its focus on coordinating and promoting health IT to regulating the industry. They also asked for information on the office's role in developing requirements for health IT and electronic health record certification.

The letter was signed by:

• Committee Chair Fred Upton (R-Mich.);
• Vice Chair Marsha Blackburn (R-Tenn.);
• Health Subcommittee Chair Joe Pitts (R-Pa.); and
• Communications and Technology Subcommittee Chair Greg Walden (R-Ore.) (The Hill, 6/3).