DeSalvo defends health IT safety center, ONC

Amid concerns among House Energy and Commerce Committee legislators that a proposed health IT safety center would engage in unauthorized regulatory activities, National Coordinator for Health IT Karen DeSalvo, MD, MPH, MSc, defended the center, describing it as a “coordinating body.”

The formation of a health IT safety center was among recommendations in ONC, the FDA and the Federal Communications Commission’s draft report, “Proposed Strategy and Recommendations for a Risk-Based Framework,” in April.

“The report did not propose that the health IT safety center would have the authority to regulate health IT. The draft report recommends that no new or additional areas of FDA oversight are needed,” DeSalvo wrote in a letter to lawmakers.

Also, the ONC chief clarified that the Obama administration’s fiscal year 2015 budget did not include a user fee program to pay for the agency’s certification program. Also, it stressed that the statutory authorities for the Medicare and Medicaid EHR incentive programs are separate from that of ONC, and that its major authorities are establishing a voluntary certification program for health IT and building infrastructure to promote health data exchange.

Responding to questions from Congress on its role in the future, DeSalvo wrote that the agency “plans to focus on developing and implementing an interoperability roadmap, supporting care transformation and establishing a framework to support appropriate use of health data to further meaningful consumer engagement, system-level quality and safety of care, improvements in the public’s health and advancements in science.”

She welcomed an in-person discussion to address these matters.

Also this month, the Health IT Policy Committee approved recommendations from its subgroup, the Safety Task Force, that the center should serve as a central point for a learning environment, complement existing systems, facilitate reporting and promote transparent sharing of information regarding patient safety. It also recommended a public-private governance structure, which should sit outside of government but be resourced at least in part by the ONC.