HIMSS’ EHR Association (EHRA)—a trade association of electronic health record (EHR) vendors— has written a letter to the Office of the National Coordinator for Health IT (ONC), urging the agency to reconsider its voluntary 2015 EHR certification criteria.
In February, ONC announced the new and optional 2015 edition criteria, designed to provide vendors flexibility in upgrading their systems while providing a peak at what the 2017 edition will contain. Those proposals represented 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, the agency said. “The proposed 2015 edition EHR certification criteria reflect ONC’s commitment to incrementally improving interoperability and efficiently responding to stakeholder feedback,” Karen DeSalvo, M.D., national coordinator for health IT, said at that time. “We will continue to focus on setting policy and adopting standards that make it possible for health care providers to safely and securely exchange electronic health information and for patients to become an integral part of their care team.”
However, in the letter to DeSalvo, the EHRA said that more frequent certification is not desirable and would be costly. “While framed in the NPRM (notice of proposed rulemaking) preamble as being responsive to and addressing EHR developers’ challenges created by uncertain regulatory timelines, this proposed rule focused on a 2015 certification edition and proposing a more frequent certification cadence does not in fact address this issue. In particular, the proposed rule specifically does not respond to our repeated requests for final rules and all supporting materials and tools at least 18 months in advance of when providers and others expect certified products to be available,” the letter stated.
EHRA recognizes that the 2015 certification requirements would be voluntary for the meaningful use program and that there would be no hard deadline for implementation, but remains “very concerned about market expectations of availability of certified electronic health record technology (CEHRT) in an unrealistic timeframe, possibly driven by other government programs that point to the 2015 certification.” The letter requests that ONC at least re-label this as the “2016” edition to provide some semblance of reality in terms of expectations by other federal agencies and EHR users as to when some of the final proposed functionality might be implemented.
Further in the letter, EHRA says that “the stated intention to move to more frequent certification, and this NPRM in particular (in the parts outlining 2015 certification requirements), moves in the opposite direction from our request for adequate time to deliver high quality software, and for our customers to prepare to use it in a meaningful and safe way. It also runs counter to our strong belief that post-2014 certification should be highly focused on interoperability and build on Stage 2 criteria rather than introducing new functional criteria.”
Additionally, the EHRA expressed concern about the compressed timeline for continued improvements to the electronic clinical quality measure process, which "does not allow adequate time to ensure that the critical improvements already underway to the clinical quality measures development, testing, and implementation process continue to advance, and are not compromised by rapidly changing standards and requirements that are only just evolving."
In conclusion, the EHRA says it strongly urges ONC not to include the proposed unified clinical decision support/ clinical quality measures standards for 2017 CEHRT. “We urge ONC and CMS to consider a more incremental approach to the eventual implementation and adoption of these standards, ensuring that each one has been fully tested and piloted prior to requiring adoption by all EHRs.”