Governance, function and focus recommendations for a proposed Health IT Safety Center presented by a safety task force on behalf of the Office of the National Coordinator for Health IT won the endorsement of the agency's Health IT Policy Committee on Tuesday.
At the committee's monthly meeting, the task force--chaired by David Bates, senior vice president for quality and safety at Brigham and Women's Hospital in Boston--called for a public/private governance structure funded both by the ONC and via private means. It also reiterated the need for the center's activities to simultaneously avoid duplication and complement ongoing efforts, key tenets of the proposed health IT risk-based regulatory framework from which the safety center has materialized.
Another recommendation from the task force included the creation of an executive board comprised of 10 to 12 "decision-making" members that, within two years, could expand to be a larger, more inclusive entity. The board would include representation from all parts of the health IT spectrum, including consumers, hospital IT leaders and vendor institutions.
Concerns from "front-line providers"--such as doctors, nurses and pharmacists--would drive the bulk of the safety center's efforts, the task force said. Those efforts would address all types of health IT issues, including sociotechnical and technical issues, as opposed to just those concerning electronic health records.
While information used by the safety center would primarily be voluntary--something Bates said would be challenging--he pointed to strategies employed by the Federal Aviation Administration's Aviation Safety Information Analysis and Sharing initiative as "especially relevant" and valuable.
"What ASIAS does is they nationally aggregate the safety data from individual airlines, they look at multiple data streams and bring that data together," Bates said. "They are very much data driven ... their approach is non-punitive ... and they are viewed by the industry as a trusted third partner."
Like ASIAS, the health IT safety center, the task force said, should be a learning entity, and not charged with regulatory or enforcement responsibilities.
Industry reaction to the regulatory framework--and thus, the safety center--outlined in the report mandated by the Food and Drug Administration Safety and Innovation Act of 2012 currently is under review. The Bipartisan Policy Center, as well as the American Medical Association, both lauded the idea of the center, with the latter calling a collaborative government and industry initiative to share data on safety issues "a strong framework to build on."
Even the American Hospital Association, which largely criticized the FDASIA report, said such a collaborative effort would "underscore the need to address patient safety holistically."