The draft framework, the ONC reply stated, “did not propose that the Health IT Safety Center would have the authority to regulate health IT.” Indeed, recommendations a workgroup presented to the agency last week did not envision a regulatory or enforcement role for the center, backing up the ONC's claims.
Further, the letter continued, the ONC is authorized to perform a “broad range of duties” through the Health Information Technology for Economic and Clinical Health (HITECH) Act, the bill that kicked off the meaningful-use program in 2009, to develop a “nationwide health information technology infrastructure.”
The agency is authorized to establish voluntary certification programs for health IT, and is also allowed to adopt standards, implementation specifications and certification criteria through rulemaking, the letter said.
The ONC's response did not entirely satisfy Rep. Marsha Blackburn, (R-Tenn.), who introduced the SOFTWARE Act last fall, legislation meant to deregulate the health-IT market. During a hearing Thursday, Blackburn stated that the reply was incomplete, because it did not address what authority the agency had to regulate health-IT products.
The administration's regulatory plan “relies upon ONC to regulate some of these products, but in my estimation, lacks the statutory authority to do so,” Blackburn said, calling the plan an incipient “regulatory disaster.”
Blackburn concluded that it would be necessary for the Food and Drug Administration and the ONC to work with her and her colleagues, including Rep. Gene Green (D-Texas), on the Energy & Commerce Committee. The committee, or at least Republicans on the committee, are worried about the potential of mission creep, said a source on the Energy & Commerce Committee, and the committee intends to continue pursuing the matter.
Follow Darius Tahir on Twitter: @dariustahir