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From Health Law Daily, September 12, 2014

HHS revises 2014 Edition EHR criteria and waits for 2015

By Bryant Storm, JD

The HHS Office of the National Coordinator for Health Information Technology (ONC) has introduced changes to the 2014 Edition electronic health records (EHR) certification criteria in lieu of adopting its proposed 2015 voluntary edition of EHR certification criteria. Instead of adopting the more expansive changes in the 2015 edition, HHS revised ten optional and two revised certification criteria, all of which have origins in the 2014 edition. The changes in the new edition, known as “2014 Edition Release 2,” are intended to “provide flexibility, clarity, and enhance health information exchange” in a way that will benefit providers, developers, health information technology, and consumers (Final Rule, 79 FR 54430, September 11, 2014).

Criteria. The optional changes to the EHR certification criteria include dividing ‘‘computerized provider order entry’’ (CPOE) criterion into three separate certification criteria based on differing provider capabilities, including medication, laboratories, and diagnostic imaging. Additionally, the final rule makes changes to the transport standards and the transitions of care certification criterion. The revised changes include a revision to the “view, download, and transmit to 3rd party” certification criterion as well as a revision to the safety-enhanced design’’ (SED) certification criteria that includes the now optional CPOE criteria. Each of the changes is designed to reduce the regulatory burden on stakeholders (see, CMS finalizes revisions to the permanent certification program for HIT, August 28, 2012).

ONC HIT Certification. Under the ONC HIT Certification program, HHS is, among other changes, eliminating the concept of “Complete EHR” to enhance flexibility and compliance. The final rule also indicates that HHS has adopted an updated standard for the accreditation of ONC Authorized Certification Bodies (ACBs), in order to better align itself with standards already used in the industry.

Costs. HHS believes the economic costs of final rule to develop and prepare EHR technology to be tested and certified in accordance with the new criteria will be relatively small, in part because HHS anticipates releasing a 2015 edition of EHR certification criteria next year. The total average cost estimate for 2014 and 2015, the two years that the standards are projected to be in effect, is $4.38 million. In part the cost savings stem from the fact that eligible professionals (EPs), eligible hospitals (EHs), critical access hospitals (CAHs), and technology developers are not obligated to recertify their products to the 2014 Edition Release 2 standards.

2015 edition. The changes adopted by the final rule are minor when compared to the proposed voluntary 2015 Edition HER certification criteria. Although the proposed 2015 Edition adopted around 60 percent of the 2014 Edition, it did propose to make significant changes by implementing a few new certification criteria, clarifying regulatory text, adopting voluntary consensus standards, and restructuring certification criteria to clarify it for stakeholders (see, 2015 Edition EHR certification criteria to be voluntary, HHS proposes, February 26, 2014). The final rule indicates that after reviewing public comments to the 2015 Edition proposal and reviewing ONC goals, HHS decided not to roll out a new edition.

Naming. In light of confusion posed by several HHS proposals and final rules regarding EHR certification criteria, HHS announced in the final rule that it intends to only supply a year to the name of a final rule, when that final rule represents a new certification criteria edition. Therefore, when HHS issues it’s anticipated 2015 Edition EHR it will be labeled as 2015, because that will be the year in which it was issued. Similarly, the current revisions are labeled as “2014 Edition Release 2” because they represent a revision of the EHR certification criteria edition released in 2014. Editions will no longer reference effective dates in titles because the prior naming practice reportedly led to confusion among stakeholders.

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