ONC Will Continue To Seek Funding for Health IT Safety Center
April 16, 2015 in News
On Wednesday, Office of the National Coordinator for Health IT officials said that a proposed Health IT Safety Center cannot begin operating before 2017 because Congress has not appropriated funding for the project, Politico‘s “Morning eHealth” reports (Pittman et al., “Morning eHealth,” Politico, 4/16).
HHS had requested $5 million for the project in its fiscal year 2016 budget (Slabodkin, Health Data Management, 4/16).
HHS — directed by the Food and Drug Administration Safety and Innovation Act — last April released a draft report that included a proposed strategy and recommendations for creating a risk-based health IT regulatory framework, and suggested the creation of the safety center.
In a letter responding to the draft report, 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 lawmakers noted that the Federal Food, Drug and Cosmetic Act gives FDA the authority to regulate medical devices and questioned ONC’s statutory authority (iHealthBeat, 6/4/14).
Further, the Congressional Research Service in a January memorandum to the committee wrote, “[I]t is very difficult to ascertain the precise contours of ONC’s proposed safety center because of both the somewhat cryptic nature in which the Health IT Safety Center has been described thus far by the agency and because of the tentative nature of the proposal.”
Official: ONC Will Continue To Seek Funding
At the HIMSS15 conference this week, ONC Office of Clinical Quality and Safety Acting Director Andrew Gettinger said the agency will continue to seek funding for the center.
Gettinger noted that the funding holdup could be the result of a misunderstanding. He said, “[W]e are not proposing that the safety center would be a regulatory agency.” He added that the center was “conceived as a public-private partnership” with a “pretty independent board” made up of various stakeholders (Health Data Management, 4/16). In addition, he noted, “The center will be a convener that will examine safety themes and issue reports and fund research and synthesize the research that’s available” (“Morning eHealth,” Politico, 4/16).
According to Gettinger, a roadmap clarifying the center’s role is expected to be ready by May or early June (Health Data Management, 4/16). He said he expects the roadmap could improve the chances that Congress will fund the project (“Morning eHealth,” Politico, 4/16).