New final EHR certification rule drops

ONC says it's responding to stakeholder feedback
By Bernie Monegain
12:25 PM
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ONC and HHS issued a final rule today that they say will give EHR makers, health IT developers, providers and consumers more flexibility and clarity when it comes to certification of the 2014 Edition criteria.

[See also: ONC proposes 2015 certification criteria]

The new rule makes for more leeway with regard to 2014 criteria, while abandoning the controversial voluntary 2015 Edition criteria first proposed this past February.

"In consideration of public comment received on the proposed rule," the HHS/ONC announcement said, the final rule provides "alternative certification criteria and approaches for the voluntary certification of heath IT."

[See also: EHRA has complaints about 2015 criteria]

"This final rule reflects ONC's commitment to continually improve the certification program and respond to stakeholder feedback," ONC chief Karen DeSalvo, MD, said in a news release. "It provides more choices for health IT developers and their customers, including new interoperable ways to securely exchange health information. It also serves as a model for ONC to update its rules as technology and standards evolve to support innovation."

The new final rule will be published in the federal register on September 11.

It reflects changes to previously published EHR certification requirements, but changes nothing affecting reporting on the measures for meaningful use Stage 2, which has received hard pushback from many healthcare organizations.

In the executive summary, the agencies describe the purpose for the action for this new final rule and a "new approach."

The rule notes that ONC and HHS had given many reasons for adoption of the 2015 Edition criteria.

"We still believe that many of these reasons remain valid," agency officials write. "However, upon consideration of public comment, further reflection of ONC goals and timelines, and a desire to adhere to the administration’s principles embodied in Executive  Order (EO) 13563, we have not adopted the Proposed Voluntary Edition.

"Rather, we have adopted a small subset of our original proposals in the Proposed Voluntary Edition as optional 2014 Edition EHR certification criteria and made revisions to 2014 Edition EHR certification criteria (also referred to as the '2014 Edition Release 2' or '2014 Edition Release 2 EHR certification criteria') that provide flexibility, clarity, and enhance health information exchange; and administrative proposals (i.e., removal of regulatory text from the Code of Federal Regulations) and proposals for the ONC HIT Certification Program that provide improvements."

The intent, ONC and HHS officials say, is to make the program "more effective and less burdensome in achieving regulatory objectives. This final rule introduces multiple means to reduce regulatory burden, increase regulatory flexibility for stakeholders, and promote further innovation."

See the 187-page final rule here (PDF).