Lawmaker Continues To Question ONC’s Health IT Regulatory Power

July 21, 2014 in News

On Thursday, Rep. Marsha Blackburn (R-Tenn.) took issue with the Office of the National Coordinator for Health IT’s response regarding the agency’s authority to regulate health IT products, Modern Healthcare reports (Tahir, Modern Healthcare, 7/18).

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, ONC and the Federal Communications Commission.

In a June 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.”

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.

They asked National Coordinator for Health IT Karen 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 (iHealthBeat, 6/4).

ONC Response

In a letter dated July 8, DeSalvo wrote that under the HITECH Act, ONC has the authority to establish voluntary health IT certification programs, as well as issue rules to adopt:

  • Certification criteria;
  • Specifications for implementation; and
  • Standards.

However, ONC clarified that the draft framework “did not propose that the Health IT Safety Center would have the authority to regulate health IT” (Modern Healthcare, 7/18).

Blackburn’s Comments

During a joint hearing of the House Energy and Commerce Subcommittee on Communications and Technology and Subcommittee on Health, Blackburn said she was disappointed in ONC’s response (Slabodkin, Health Data Management, 7/18).

Blackburn called the draft regulatory framework a “regulatory disaster,” noting that it “relies upon ONC to regulate some of these products, but in my estimation, lacks the statutory authority to do so” (Modern Healthcare, 7/18).

In response to ONC’s July 8 letter, Blackburn said, “We felt like they really don’t know where they have that authority” (Reichard, CQ HealthBeat, 7/18).

Blackburn argued that FDA and ONC should work with the committee to develop a regulatory framework to ensure 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” (Health Data Management, 7/18).

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