Members of the House Energy and Commerce Committee continue to challenge the Office of the National Coordinator for Health Information Technology’s statutory authority to regulate HIT.

At a July 17 joint hearing of the Subcommittee on Communications and Technology and Subcommittee on Health, committee vice-chairman Marsha Blackburn (R-Tenn.) expressed her disappointment with ONC in failing to address the concerns of committee members sent in a June 3 letter to National Coordinator for Health IT Karen DeSalvo, M.D., which accused the agency of overstepping its regulatory authority over HIT.

Last month, lawmakers called into question a proposed risk-based HIT regulatory framework released in April that recommended ONC, in collaboration with FDA, FCC, and the Agency for Healthcare Research and Quality, create a Health IT Safety Center--a public-private entity to convene stakeholders to assure that risks are minimized and patient safety is protected. 

“We got a response recently and we felt like they really don’t know where they have that authority,” Blackburn said at the hearing, referring to a July 8 letter from DeSalvo to Rep. Fred Upton (R-Mich.), chairman of the House Energy and Commerce Committee. “Like so many times, agencies get into mission creep. And, it concerns us.”

The congresswoman described the system of regulations for health IT as “misguided.” Blackburn in October 2013 introduced a bill--the SOFTWARE Act--to amend the Federal Food, Drug, and Cosmetic Act and to limit the FDA's authority.

“We feel like the FDA wants to regulate our medical app products as medical devices, and they’re not,” she said in the hearing. “Congress in its infinite wisdom decided in 1996 to update the FDA statute by creating the definition of a medical device in order to differentiate it from drugs. Before that time, there was no statutory difference between the two. So, just like drugs, software is not a medical device.”

Blackburn’s bill would establish three categories of software--clinical, health and medical--with the two former software types not subject to regulation under the proposed legislation. Similarly, Jonathan Niloff, M.D., chief medical officer and vice president of McKesson Connected Care and Analytics, testified before the committee regarding the need for a new risk-based regulatory framework that is specific to health IT.

McKesson has endorsed a HIT regulatory framework recommended in a 2013 Bipartisan Policy Center report which included three categories of health IT according to potential risk to the patient and the opportunity for clinical intervention. “We believe Congress should amend the Food, Drug and Cosmetic Act to establish guidelines defining each of these categories of health IT and then oversee implementation of these guidelines by federal agencies,” said Niloff. “Specifically, the Act should be updated to provide clarity that clinical and administrative software should not be regulated as a medical device.”   

Blackburn argued that it is vital that FDA and ONC work with the committee to come up with a regulatory framework so that “low- and moderate-risk items can proceed to the marketplace and things that are invasive and high risk have the oversight of the FDA and that clarity is provided for this nation’s innovators.”

However, Rep. Henry Waxman (D-Calif.), Ranking Member of the House Energy and Commerce Committee, made the case that the current system of HIT regulations is fostering a climate of innovation. “It’s not a coincidence that we’ve seen all of this innovation with FDA and the FCC offering important guidance and using their enforcement discretion wisely,” said Waxman. “We should legislate only where appropriate and necessary, otherwise we risk jeopardizing the integrity of a system that is already functioning quite well.”  

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