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Washington Debrief: House Questions ONC’s Regulatory Ambitions

June 9, 2014
by Jeff Smith, Senior Director of Federal Affairs
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Jeff Smith, Senior Director of Federal Affairs

House Questions ONC’s Regulatory Ambitions

Key Takeaway: Republican leaders on the House Energy & Commerce Committee sent a letter to the Office of the National Coordinator for Health IT (ONC), questioning its authority to regulate health IT apart from Meaningful Use certification.

Why it Matters: Congressional scrutiny of ONC’s authority may dampen the agency’s ambitions to regulate patient safety and develop certification programs apart from MU. However, ONC should be able to easily justify most – if not all – of its ongoing activities to critics through statutory language established by the HITECH Act.

Since early last summer, ONC has been actively pursuing a range of activities beyond the grant programs established by the HITECH Act. In July 2013, ONC published its Patient Safety Surveillance & Action Plan, positioning the agency as the overseer of HHS activities related to health IT and safety. In December, the agency published an NPRM creating a voluntary 2015 Edition certification option, divorcing previous efforts from Meaningful Use. And most recently, ONC joined the FDA and the FCC in releasing a risk-based regulatory framework for health IT. Last week, Republican leaders from the House Energy & Commerce Committee asked under what authority ONC felt compelled to regulate such activities. “[I]t is not clear to us under what statutory authority ONC is now pursuing these enhanced regulatory activities,” Reps. Upton, Pitts, Blackburn and Walden said in a letter date June 3. Specifically, the E&C leadership asked for clarification on:

  • Certification authority, particularly in non-Meaningful Use areas
  • Authority to work with the FDA and FCC on patient safety
  • How the 2015 Edition NPRM represents a departure from previous Edition priorities, including interoperability, privacy and quality reporting criteria
  • The role ONC intends to play in the future in areas such as health IT safety and EHR certification, and how ONC will use its Federal Advisory Committees to inform the office’s work

While the House letter represents a new chapter of interaction between ONC and Congress, it will have an impact only if ONC inadequately addresses the letter’s underlying concerns.

Creating a Learning Health System

Key Takeaway: Last week the ONC published a white paper, outlining their 3-, 6- and 10-year plan for interoperability. The near-term focus will be on send, receive and query capabilities for existing systems; the mid-term will focus on connecting disparate parties in the care continuum, including individual patients; and the long-term plan will take steps toward creating a “learning health system.”

Why It Matters: Amid the ongoing restructuring of ONC and its Federal Advisory Committees, this high-level white paper joins the ranks of similar papers produced by ONC and other health IT industry stakeholders. With the policy direction set, the real work starts in efforts to translate the policy into action by focusing on the details of the technology and standards work.