New rule would give ONC power to better enforce EHR certification

March 5, 2016

The federal government announced Tuesday proposed rules that would give its Office of the National Coordinator for Healthcare Technology (ONC) greater oversight to ensure that certified electronic health records (EHR) can actually fulfill the functions physicians need them to, especially when it comes to interoperability.

The federal government announced Tuesday proposed rules that would give its Office of the National Coordinator for Healthcare Technology (ONC) greater oversight to ensure that certified electronic health records (EHR) can actually fulfill the functions physicians need them to, especially when it comes to interoperability.

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Physicians know a gulf exists between what a system is certified to do and what it can actually do in practice. Especially when it comes to matters pertaining to interoperability-exchanging records with other providers or getting notified when a patient has been released from the hospital-many EHRs can’t really do what their certification says.

More news this week: Donald Trump unveils seven-point healthcare reform planThe proposed rule, which is open for comments until May 2, gives ONC the power to review certified EHRs to ensure they meet the standards, provides more regulatory oversight over the certificating groups and pushes for greater transparency by releasing surveillance and testing results to provide physicians with “valuable information about the overall performance of certified health IT.”

The goal is ensure that when EHR products go to market, these “products are actually working as billed,” Karen DeSalvo, MD, the national coordinator who runs ONC, said during a Tuesday media event at HIMSS 2016 in Las Vegas.

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“The proposed rule furthers our ability to address and correct non-conformities found in certified health IT products from the initial testing phase through implementation in healthcare settings,” reads an ONC news release.

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These non-conformities-essentially the system issues that hinder usability for physicians and other providers-would be better addressed under the proposed rule by allowing ONC to work with the vendors on an action plan to address the issues or, if necessary, suspend or revoke certification. But that punitive action is not the goal, said Elise Sweeney Anthony, JD, acting director of ONC’s office of policy.

“Our goal is to work with developers,” Anthony said. “Our goal is not to get to decertification."

Farzad Mostashari, MD, the former ONC coordinator, weighed in on the proposed rule during a talk at HIMSS later on Tuesday, calling it a big deal and a major tool for ONC to use to ensure EHR systems do what physicians need and what they are actually certified for.

“Do we need government regulation? I would say we certainly need enforcement of the regulations we already have,” Mostashari said. “That’s why the rule that dropped today from ONC is so important. … If there is a vendor not doing the right thing, we can reach directly. We don’t need to go through the certification body or the testing body. This is a big deal.”

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