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ONC’s New Leader Defends Agency’s Role in EHR Oversight

September 20, 2016
by Rajiv Leventhal
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In a meeting with health IT press on Sept. 19, Vindell Washington, M.D., new National Coordinator for Health IT, defended the Office of the National Coordinator for Health IT’s (ONC) role in overseeing and reviewing electronic health records (EHR) and other health IT products.

For some background, earlier this year at HIMSS16 in Las Vegas, the U.S. Department of Health and Human Services (HHS) and ONC proposed a new rule that would aim to further enhance the safety, reliability, transparency, and accountability of certified health IT for users. The “ONC Health IT Certification Program: Enhanced Oversight and Accountability” proposed rulemaking  would modify the ONC Health IT Certification Program to reflect the widespread adoption of certified EHRs and the rapid pace of innovation in the health IT market, according to an HHS press release at the time. 

The rule would focus on three key areas: Direct Review, enabling ONC to directly review certified health IT products, including certified EHR systems, and take necessary action to address circumstances such as potential risks to public health and safety; Enhanced Oversight, increasing ONC oversight of health IT testing bodies; and Greater Transparency and Accountability, making identifiable surveillance results of certified health IT publicly available.

In May, comments from health IT stakeholders on the rule became public, with concerns stemming regarding ONC’s ability to perform the above actions. The Health IT Now Coalition, for one, said it is “a significant overstep of regulatory authority.” Meanwhile, the College of Healthcare Information Management Executives (CHIME) commented that “The authority ONC is citing under the PHSA [Public Health Service Act] contains such an expansive and exhaustive list that we are concerned that addressing it will exceed ONC’s resources.” ONC is expected to issue the final rule in the near future.

Yesterday, in a small briefing with health IT trade press, Washington said that while he couldn’t comment on specific of the rule as it is in the process of becoming finalized, the concept behind the regulation is to “make sure that the products providers are using to care for folks meet certain standards, and as that matures, and you’re in the second or third cycle, the structure behind it needs to mature as well.” Washington added that ONC “needs a little ability to do direct oversight of actual certification,” noting that the agency has “left optimal oversight into the testing that goes along with the certification, and “we want transparency on the surveillance side.” He said, “It’s fairly driven by a maturation of the program and a maturation of the environment.”

What’s more responding to criticism that the rule is an overstep of ONC’s authority, Washington said “It falls within the realm of ONC’s role as initially defined. We have relationships with certifying and testing bodies, but at the time that was the right structure for that current level of maturity. Making that choice at that point of time didn’t narrow the possible implementation strategies that could be used in the future.” He added, “That was a delegation that was done for that particular time in the market, and I would say rightly so.”

Washington further noted when pressed again about Congressional backlash to the rule, particularly with a new Administration forthcoming, “If we were in a different environment, we might think differently. At this point in time, though, I can’t imagine a space where ONC’s role would be anything less than vital to the Administration’s priorities around these things.” He added, “There is a long opportunity in front of us to push these interoperability measures and standards for it, to push for information sharing. The certification rule is a way to ensure that providers, whether it’s their first second or third EHR that they’re purchasing, have full faith and confidence in their capabilities to care for patients.”

In the briefing with reporters, Washington also spoke about ONC’s priorities going forward, namely its core goal of improving health data sharing through a variety of initiatives. Healthcare Informatics’ story on the rest of Washington’s conference call can be read here.

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