ONC Issues 2015 Voluntary EHR Certification Criteria; Promises More Frequent and Dynamic Future Updates

by Leonardo M. Tamburello

The Office of the National Coordinator for Health Information Technology, (ONC) has issued proposed regulations concerning 2015 Voluntary EHR Certification Criteria, Interoperability Updates and Regulatory Improvements (the “2015 Edition”).  For EHR-based providers, the 2015 Edition is important for two reasons:  first, its requirements are voluntary.  Second, it signals dramatic change in the frequency and manner which ONC will issue future EHR certification criteria updates. 

These Proposed Regulations come in the wake of ONC’s decision in December 2013 to extend Stage 2 Meaningful Use (MU) through 2016 and delay Stage 3 (whose criteria remain in development) until at least 2017.  By making the 2015 EHR Certification Criteria voluntary, ONC has given providers a short respite during which they can catch their breath and insure that all Stage 2 MU criteria have been met.  To date, the most pervasive MU deficiency cited by auditors has been providers’ failure to meet the requirements of Core Measure 14 – Protect Electronic Health Information.  This measure requires that providers conduct a security risk analysis in accordance with 45 CFR 164.308(a)(1) and implement security updates as necessary and correct identified security deficiencies prior to or during the EHR reporting period. 

“The proposed 2015 Edition EHR certification criteria reflect ONC’s commitment to incrementally improving interoperability and efficiently responding to stakeholder feedback,” said Karen DeSalvo, M.D., M.P.H., national coordinator for health IT. “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.”

EHR developers that have certified EHR technology to the 2014 Edition do not need to recertify to the 2015 Edition for customers to participate in the Medicare and Medicaid EHR Incentive Programs. Similarly, health care 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. “This provides the opportunity for developers and health care providers to move to the 2015 Edition on their own terms and at their own pace,” said Dr. DeSalvo.

The 2015 Edition’s voluntary highlights include:

  • New certification criteria representing new functionality such as a certification criterion to support patient population filtering of clinical quality measures;
  • Enahanced interoperability with new or updated implementation specifications for several certification criteria, including transitions of care, clinical decision support, and a few related to public health reporting;
  • Improved interoperable exchange with policy revisions that changes the certification approach for transitions of care;
  • A path for the certification of “non-MU” EHR technology;
  • Codification of ONC regulatory guidance provided in Frequently Asked Questions issued since the 2014 Edition Final Rule;
  • Revisions to the 2014 Edition syndromic surveillance certification criterion;
  • Closer alignment with other HHS program policies (e.g., CLIA and clinical quality measure reporting) and to address Office of the Inspector General (OIG) recommendations;
  • To discontinue the “Complete EHR” definition and the issuance of Complete EHR certifications starting with the 2015 Edition; and
  • To solicit comment on new capabilities and standards-based requirements for potential future certification criteria (2017 Edition in support of MU Stage 3) to provide EHR technology developers advance visibility and time to react.

The 2015 Edition marks the first time ONC has proposed an edition of certification criteria separate from the “meaningful use” regulations. It also 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.

A final rule is expected by the summer of 2015.  Although compliance with it will be voluntary for the time being, it is expected that ONC will eventually make those requirements mandatory for all participating providers.  It is therefore recommended that EHR stakeholders make their concerns known to ONC so that they may be addressed in a final rule which is expected sometime in the summer of 2014.  Moreover, EHR users that want to best prepare for the coming more frequent updates to EHR requirements promised by ONC should consider upgrading their systems to comply with the 2015 Edition as soon as a final rule is announced.