House committee questions authority of a DHHS staff division to regulate health IT

by Sheppard Mullin Richter & Hampton LLP
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Is the Office of the National Coordinator for Health Information Technology (ONC) overstepping its statutory authority in pursuing enhanced regulatory activity? A June 3, 2014 letter from the House Committee on Energy and Commerce to ONC explores this very question.[1]

The ONC is the primary federal entity tasked with formulating a strategy for and coordinating national efforts to implement a health information technology infrastructure. A staff division within the Department of Health and Human Services, the ONC was created in 2004 and became legislatively mandated by the Health Information Technology for Economic and Clinical Health Act in 2009.

In recent months the ONC, together with the Food and Drug Administration (FDA) and Federal Communications Commission (FCC), proposed a new risk-based regulatory framework for health IT.[2] One component of this plan is the creation of a Health IT Safety Center—a public-private entity tasked with engaging stakeholders on the development of an integrated health IT learning system—to be created by the ONC.

This Health IT Safety Center is a key concern of the House Committee, alongside elements of the ONC 2014 budget suggesting the imposition of new user fees on Health IT developers and vendors to support standardization and certification.[3]

Specifically, the letter asks four questions:

  • When the authorization for the Medicare and Medicaid Incentive program expires, under what statutory authority does ONC believe it is able to regulate health IT and electronic health records, particularly in (but not limited to) Meaningful Use areas?
  • What authority does ONC point to regarding participation in regulatory activities in coordination with the FDA and FCC?
  • To what extent does ONC’s Notice of Proposed Rulemaking on 2015 Edition EHR Certification represent a broader shift in focus from coordinating and promoting efforts related to interoperability, privacy and security, and quality reporting criteria, to the regulation of data collection, functionality requirements, and other areas where market forces are more likely to promote innovation and efficiency?
  • What role does ONC plan to play moving forward on issues including, but not limited to, Health IT safety and EHR certification requirements? How will the recommendations of ONC’s Federal Advisory Committees guide these plans? Will ONC’s role be limited to the scope of these recommendations?

A press release accompanying the letter explains that Committee members are concerned about the effects of bureaucracy on innovation and the integration of technology in healthcare.[4] This concern echoes an April 2014 letter to the ONC from the American Medical Association (AMA) in which the association advocated for simplified and less rigid Meaningful Use requirements, and recent recommendations by the Health IT Policy Committee Workgroup on Adoption/Certification regarding the complexity and scope of certification requirements. We are left wondering not only how the ONC will respond to the letter but, more broadly, how DHHS will respond to what appears to be growing expressions of discontent with federal health IT policy.

[1] The letter is available here.

[2] The April 2014 “Proposed Strategy and Recommendations for a Risk-Based Framework.”

[3] The ONC 2014 budget request is available here.

[4] The press release is available here.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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