The Office of the National Coordinator for Health Information Technology’s plan to establish a $5 million Health IT Safety Center remains up in the air due to Congress’ refusal to authorize funds for the center.

“It is not funded—that’s a reality,” Andrew Gettinger, M.D., acting director of ONC’s Office of Clinical Quality and Safety, told Health Data Management at HIMSS15 in Chicago. “We would like it to be funded. We have put it in our budget. We will continue to put it in our budget.”

Also See: Inherent Risks of Health IT, EHRs Putting Patients in Peril

The $5 million for the Health IT Safety Center was part of the Department of Health and Human Services’ $92 million budget request for ONC in fiscal year 2016. Had the agency secured the funding, Gettinger said that ONC would have “stood up” the Health IT Safety Center next year, “but Congress chose not to fund it.”

Gettinger, who previously worked as a policy fellow in the office of Senator Orrin Hatch (R-Utah) and knows the legislative process, believes the problem is that “there’s been some real misinformation out there” about the Health IT Safety Center. Contrary to what some members of Congress argue, “we are not proposing that the safety center would be a regulatory agency,” he insisted. “It’s conceived as a public-private partnership” that would be established with a cooperative agreement and “there would be a pretty independent board” made up of a wide variety of stakeholders.     

However, a January 2015 memorandum from the Congressional Research Service (CRS) to the House Committee on Energy and Commerce questioned ONC’s legal authority to in fact create such a Health IT Safety Center. “The plain language of the HITECH Act appears to foreclose any regulatory role for the Safety Center,” according to CRS. “After all, the HITECH Act specifically limits the authority provided under the Act, in that the statute cannot be construed to ‘require a private entity to adopt or comply with a standard’ proposed by ONC and promulgated by HHS.”

In addition, the CRS memo questions ONC’s legal authority to “establish a Health IT Safety Center that takes on the more modest role of a clearinghouse or a public-private partnership,” arguing that ONC “cannot legally engage in such activity without an affirmative grant of authority from Congress.”

Gettinger, however, claims that ONC’s view of the CRS memo is that “despite how well written that paper was, it missed some of our statutory authority.”

Providing Clarity

In April 2014, ONC along with the Federal Communications Commission and Food and Drug Administration jointly released a draft risk-based framework for health IT mandated by FDASIA that included a proposal for ONC to create a Health IT Safety Center described in the agencies’ report as a “public-private entity” that would “convene stakeholders in order to focus on activities that promote” HIT, with the ultimate goal of creating a “learning system” that “avoids regulatory duplication and leverages and complements existing and ongoing efforts.”

The FDASIA report states that the Health IT Safety Center “will require a strong governance mechanism and involvement by participants in programs and activities” that establish a “broad and engaged stakeholder membership and leadership base” focusing on “high-value issues” with respect to HIT, as well as analyzing the “best available data and evidence” pertaining to HIT safety while developing “priority goals and measures that align with broader patient safety goals and initiatives” and providing safety education.

But, the CRS memo notes that “it 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.” CRS calls ONC descriptions and discussions of the proposed Health IT Safety Center “vague and imprecise” at times, while “even hinting at the possibility that the Center would have some type of regulatory role, such as having the power to establish governing rules for the HIT industry.”

To help clarify what the Health IT Safety Center will actually encompass, ONC in the fall of 2014 awarded a contract to RTI International to—among other activities—develop a roadmap that defines the focus, functions, governance and value of the center. In December 2014, RTI announced the members of a task force—including safety researchers, patient advocates, providers, vendors, patient safety organizations, insurers, and government officials—that will help draft the roadmap, which Gettinger said will be completed by May or early June.

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