On February 26, 2014, 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.  According to ONC, the 2015 Edition adopts approximately 60 percent of the 2014 Edition criteria, with the roughly 40 percent of proposed changes falling into one of four categories: Clarifying Revisions, Standards Updates, Restructuring, and New Certification Criteria Proposals.  Id. at 10882.  Comments on the proposal are due by April 28, 2014.

The 2015 Edition will be voluntary.  Id. at 10880.  EHR technology developers whose products were certified as compliant with the 2014 Edition will not need to comply with the 2015 Edition.  Id.  Nor will providers need to upgrade their technology to comply with the 2015 Edition.  Id.

Instead, EHR developers and users will be permitted to move toward the new standards in the 2015 Edition at their own pace, id. at 10882, which may better position them to comply the mandatory 2017 Edition criteria.  As ONC explains, the 2015 Edition “provide[s] EHR technology developers with advance visibility and time to react to the potential requirements ONC is considering for our next planned rulemaking — the 2017 Edition certification criteria (which would be proposed to support meaningful use Stage 3 proposals).”  Id.  ONC may provide “gap certifications” for EHR technology that is certified as complying with the parts of the 2015 Edition that remain unchanged in the 2017 Edition.  Id.

The 2015 Edition is the beginning of ONC’s effort to update its EHR criteria more regularly, i.e., every 12 to 18 months.  Id. at 10880-81.  ONC determined that a longer regulatory cycle is “sub-optimal” in light of the pace of EHR technological developments.  See id.  ONC explains that it believes more frequently updating the criteria will enable it to

(A) Adapt our regulations to more effectively and efficiently respond to stakeholder feedback and to support HHS healthcare delivery reform and transformation programs that may seek to leverage health IT certification;

(B) Better our regulations by making “bug fixes” and other regulatory improvements as part of a more frequent rulemaking cycle;

(C) Chart a course toward enhanced interoperability, information exchange, quality improvement, patient engagement, and patient safety that gives health IT developers more ability to predict ONC’s potential next steps; and

(D) Deliver smaller, incremental regulatory requirements that are easier to integrate into software development cycles.

Id. at 10882.

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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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