2014 cert final rule strives for flexibility, interoperability

The Office of the National Coordinator for Health IT’s 2014 Edition Release 2 Final Rule provides more choices for health IT developers and their customers, including new interoperable ways to exchange health data, said Michael Lipinski, JD, Office of Policy at the ONC, during an Oct. 2 webinar.

The rule, published on Sept. 11, aims to provide gradual rulemaking so regulations get updated as technology and standards evolve. It is more flexibile and less comprehensive than the proposed rule released by the agency in February.

“We adopted a small subset of proposals--criteria we believe allows flexibility and clarity and enhances health information exchange,” said Lipinski.

Lipinski clarified that the ONC has changed its approach to the naming of its rules. In previous editions, EHR certification criteria were named for the first year the agency expected compliance. To avoid unrealistic expectations that certified products will be available by the edition year, now it’s named for the year the final rule is released, he said. “It’s not tied to any particular program, just when it was adopted.”

The final rule contains alternative certification criteria and certification approaches. Some areas in which the agency is allowing more flexibility are computerized provider order entry (CPOE); transitions of care (ToC); transition method; and clinical information reconciliation and incorporation.  

For example, under the rule, CPOE is broken down into three separate certification criteria—medications, laboratory and diagnostic imaging. As such, it allows an EHR developer to create adaptations for one of the three capabilities or certify to just one capability.

For ToC, HISPs and other health IT developers can now certify either the content capability or transport capabilities. The new rule adopts the Implementation Guide for Direct Edge Protocols v1.1 to promote interoperability and an EHR’s ability to reliably connect to a HISP, he said.

The rule also permits any electronic method of creating syndromic surveillance information for exchange to help organizations achieve the Meaningful Use syndromic surveillance objective for Stage 2.

In addition, the rule provides clarity as it allows test results from a previous certification for functionalities that have not changed in Release 2, subject to the discretion of an ONC-Authorized Certification Body (ONC-ACB). In other changes, the rule:

• Discontinued the “complete EHR” definition beginning with the next adopted edition of certification criteria.
• Adopted the ONC Certified IT certification and design mark (He noted that health IT developers do not have to use this mark).
• Adopted an updated standard for the accreditation of ONC-ACBs.

Moreover, he explained that the 2014 edition supports core objectives as well as menu objectives. “This gives you more flexibility so you don’t have to have EHR technology certified to everything,” according to Lipinski.

The agency plans to publish a proposed rule for the next edition of EHR certification this winter.

“We anticipate that the next edition of certification criteria will contain functionalities that will be required for the next stage of the EHR incentives program,” he said.