A proposal for the 2015 Edition of electronic health record technology certification criteria was published today in the Federal Register by the Office of the National Coordinator for Health IT. Speaking at a HIMSS14 panel session, ONC's Federal Policy Division Director Steve Posnack said it has been about two years since there was proposed rulemaking for EHR technology certification criteria. However, that's about to change with the 2015 Edition, which signals a new approach.
Going forward, ONC intends to update certification criteria editions every 12 to 18 months in order to provide smaller, more incremental regulatory changes and policy proposals.
"We have learned that as health information technology continues to evolve, a two to three-year regulatory cycle is sub-optimal," states ONC's announcement. "Moreover, because these rulemakings have been less frequent, our regulations have had to take into account one to two years worth of industry effort prior to the rulemaking and established policy that anticipates industry readiness one to two years post-rulemaking. This approach has created cycles of significant peaks and valleys from a health I.T. development standpoint; resulted in missed opportunities to improve interoperability and programmatic alignment because of mismatched regulatory and standards balloting cycle timelines; and adversely affected EHR technology developers ability to strategically plan their development and product rollout processes due to uncertain regulatory timelines."
According to the proposal, compliance with the 2015 Edition is voluntary. EHR developers that have certified EHR technology to the 2014 Edition would not need to re-certify for customers to participate in the Medicare and Medicaid EHR Incentive Programs. In addition, healthcare providers eligible to participate in the Medicare and Medicaid EHR Incentive Programs would not need to upgrade to EHR technology certified to 2015 edition to have EHR technology that meets the Certified EHR Technology definition.
Similarly, ONC announced that in the future incremental rules would be voluntary "in an effort to intentionally give EHR technology developers more time to plan, develop, and implement updated EHR technology for their customers."
In proposing the 2015 Edition EHR certification criteria, ONC said it had three policy objectives: to enable a more efficient and effective response to stakeholder feedback; to incorporate bug fixes to improve on 2014 Edition EHR certification criteria in ways designed to make the rules clearer and easier to implement; and to reference newer standards and implementation specifications that reflect ONC's commitment to promoting innovation and enhancing interoperability.
"The proposed 2015 Edition EHR certification criteria include many improvements over the 2014 Edition EHR certification criteria," states the ONC announcement. "Yet, they do not entirely overhaul the full suite of certification criteria. From a 2014 Edition perspective, we are proposing to adopt roughly 60 percent of the 2014 Edition EHR certification criteria without change as part of the 2015 Edition."
The 2015 Edition's remaining certification criteria proposals fall into four general categories: clarifying revisions, standards updates, restructuring, and new certification criteria proposals. Among other provisions, the 2015 Edition proposes: new certification criteria on functionality to support patient population filtering of clinical quality measures; improved interoperability exchange for transitions of care and clinical decision support; a path for certification of non-Meaningful Use EHR technology; and closer alignment with other HHS program policies and OIG recommendations.
ONC will accept comments to the proposed rule through April 28. The final rule is expected to be out this summer.
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