Last week, the Office of the National Coordinator for Health IT (ONC) issued a proposed rule containing voluntary certification criteria for electronic health record (EHR) systems in 2015. On Feb. 25 at HIMSS 2014, during a late-breaking session, ONC further explained the criteria.
This proposed rule marks the first time ONC has proposed an edition of certification criteria separate from the Centers for Medicare & Medicaid Services’ (CMS) meaningful use regulations. Jodi Daniel, ONC's director of the office of policy planning, reminded session attendees that compliance is voluntary and not at all tied to meaningful use. Rather, she said, it is designed to address bug issues and improve on 2014 criteria. Daniel said that 2017 edition criteria will come out later this year, and that will be connected with Stage 3. She added that in a way, this rule will provide as advanced thinking for the 2017 edition.
The proposals represent ONC’s new regulatory approach that includes more incremental and frequent rulemaking. This approach allows ONC to update certification criteria more often to reference improved standards, continually improve regulatory clarity, and solicit comments on potential proposals as a way to signal ONC’s interest in a particular topic area.
“We want regulations out on a more regular basis so you all can prepare,” Jacob Reider, M.D., ONC chief medical officer, said to the audience. “By reducing the quantity and the size of the regulatory burden, and increasing frequency, we’ll get more of a heads up for what will happen down the line. This equates to more innovation and greater stability,” he said.
In one major highlight of the 2015 edition, ONC is proposing to separate EHR “content” and “transport” capabilities, as well as “view, download, transmit to 3rd party” criteria, to expand health information exchange (HIE) services in part by making it easier for patients to choose where they want to send their information, said Steve Posnack, ONC’s director of federal policy.
In a recent blog post, John D. Halamka, M.D., CIO of the Boston-based Beth Israel Deaconess Medical Center, writes, “Separating the content and transport certification criteria is a good thing. The 2014 Edition which linked the two concepts proved to be very problematic in Massachusetts where the state HIE performs all of the Direct and XDR functions we need, so no EHR requires transport capabilities. Yet because EHRs had to be certified to do both content and transport interoperability, extra work and expense was incurred.”
In terms of bug fixes, Reider said that the only way to do a repair process is to have new regulations. “There are aging standards and challenges in regulations that some might consider bugs,” he said. “We aren’t perfect.”
To that end, ONC is proposing to split computerized physician order entry (CPOE) certification into three separate criteria, each focused on one of the three order types, so that developers can better tailor their products based on their customers’ needs, explained Posnack.
Also incorporated in the 2015 edition is the standards and interoperability (S&I) Framework's Health eDecisions work, which, according to ONC, “will address standards for the ability to exchange clinical decision support interventions.” Additionally, the new criteria proposes a way for non-meaningful use EHR systems to become certified.
The ONC officials all expressed the desire for public comment, as Posnack said that feedback will flow right into the writing process of the 2017 edition. The proposed rule will be published in the Federal Register on Feb. 26. ONC will accept comments on the proposed rule through April 28.
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