As we described in an earlier post, in February, the Office of the National Coordinator for Health Information Technology (ONC) published the proposed 2015 Edition of its Electronic Health Records (EHR) certification criteriaSee 79 Fed. Reg. 10880 (Feb. 26, 2014).  As the public comment period came to a close at the end of April, a number of industry groups submitted comments expressing concern about the proposal.

Unlike the 2014 Edition, the 2015 Edition would not be mandatory.  79 Fed. Reg. at 10880.  ONC intends for the 2015 Edition to be the beginning of its effort to update its EHR criteria more regularly, i.e., every 12 to 18 months.  79 Fed. Reg. at 10880-81.  ONC believes that a longer regulatory cycle is “sub-optimal” given the pace of technology, and more frequent certification criteria updates will allow faster response to stakeholder feedback and faster regulatory improvements.  See 79 Fed. Reg. at 10880-81.

The EHR industry appears to be resisting the idea of more frequent certification criteria, even voluntary criteria.  In its comments on the proposal, the Healthcare Information and Management Systems Society’s (HIMSS) Electronic Health Record Association (EHRA) argued that more frequent certification criteria “moves in the opposite direction from our request for adequate time to deliver high quality software” and “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.”

EHRA also expressed concern that market expectations or other federal programs could end up effectively requiring EHR developers to meet the proposed criteria in 2015.  The Telecommunications Industry Association (TIA) expressed similar concerns in its comments that “other associated federal programs and resulting regulations could reference or incorporate these voluntary requirements, thus subtly converting a voluntary program into a mandatory requirement.”  And HIMSS itself commented that it was “concerned that other federal programs and associated regulations (e.g., existing and new payment and delivery systems) could ‘pick up’ some or all of these requirements and incorporate them, thus turning a voluntary program into a mandatory program.”

The American Hospital Association (AHA) also criticized ONC’s focus on updating EHR criteria instead of other aspects of the EHR program that it views as more pressing.  The AHA argued that “[i]ntroducing voluntary regulatory compliance between cycles of rulemaking that impose mandatory compliance will complicate, rather than mitigate, the significant and ongoing challenges already faced by providers who must use certified EHRs in order to participate in the Medicare and Medicaid EHR Incentive Programs.”

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Covington Digital Health Team

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with…

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