Providers, vendors await EHR certification guidelines

Without overdue federal electronic health record certification guidelines, the health IT community can’t move forward with work to achieve meaningful use for its EHR systems.

Even though members of the health IT community have had some time to absorb that meaningful use criteria and technology

standards are needed in their electronic health record systems, they’re still waiting for the last piece of the IT puzzle -- EHR certification -- before moving ahead in earnest to comply with federal 2011 requirements.

The Office of the National Coordinator (ONC) had planned to release a notice of proposed rulemaking in January outlining the EHR certification process, computerized point of entry and other health applications. That rule would be the last component of a three-part federal approach to health IT implementation. It follows the release of the meaningful use proposed rule and ONC’s companion interim final rule that governs standards and specifications for software that supports meaningful use. The last rule is expected to explain how organizations become certifying bodies, and vendors will have to ensure their products are certified by the groups officially recognized by the ONC. Like the previous two rules, this EHR certification rule is subject to public comment and official review before it becomes final.

A spokeswoman for the ONC said the agency expects to release the rule in the “near future,” but did not have an exact date.

One organization, the Certification Commission for Health Information Technology (CCHIT), has been certifying vendor systems for several years; at one time it was the only officially recognized certifying body. Indeed, providers who are gearing up to meet the 2011 deadline for beginning meaningful use say they are looking for CCHIT-certified vendors to help them.

Last year, however, the ONC said it wanted to make the certification process more competitive, and Austin, Texas-based IT testing firm Drummond Group Inc. announced plans to certify EHRs.

Still, neither CCHIT nor Drummond can go forward with its EHR certification program until the ONC has released the rule. Further complicating things, a third body, the National Institute of Standards and Technology recently announced its intention to develop its own EHR certification system.

In the meantime, Drummond is developing its certifying program with the help of industry stakeholders, and CCHIT is positioning itself to continue to be recognized as a certifying body.

The commission has announced that it’s updating its two electronic records programs to comply with the ONC’s standards-and-specifications interim final rule. That rule goes into effect Feb. 12, and CCHIT wants to ensure that providers and vendors have enough time to implement technology that meets the 2011 criteria, said Sue Reber, a spokeswoman for the organization. “That’s what we’re reacting to,” she said.

CCHIT began to assemble its plan to certify EHRs according to meaningful use criteria last year, before the U.S. Department of Health & Human Services determined which of those criteria would be required for 2011. Now that the meaningful use rule and standards final rule are out, the commission can align its certification program with federal requirements, Reber said.

The organization has a modular program for vendors to meet the minimum federal requirements for Stage 1 implementation, which begins in 2011, as well as a more comprehensible certification process for vendors that want to meet even greater requirements, Reber said.

While the rule will open up certification to become more competitive, CCHIT is confident that whatever the ONC releases, the process will be fair enough that the organization can reapply to become an officially recognized body. “We have a hard time believing they would exclude us,” Reber said.

We feel a great deal of empathy with providers who want to qualify for this program.

Sue Reber, spokeswoman, Certification Commission for Health Information Technology

Some software developers also seem mostly unworried about what might happen under the rule. “Obviously we have concerns, and they could do something stupid,” said Fred Trotter, a medical software developer and director of the Liberty Health Software Foundation, which advocates open source application development. However, because CCHIT is working with the developer community now and because there might be an option for open source developers to start their own certification body, “I do not think there will be a problem,” he said.

The Drummond Group has been hearing from vendors since it announced it would develop an EHR certification program in November, said Beth Marrow, the firm’s president and chief operating officer. Drummond is conducting stakeholder interviews to determine its software testing plan.

Drummond already works with other federal agencies to test applications; this work includes a testing system for the software management of controlled substances with the U.S. Drug Enforcement Administration. The firm views testing for conformance with federal meaningful use requirements and for levels of interoperability in health care as an extension of that work, said Kyle Meadors, a principal of test processes at Drummond.

It’s not just about meeting meaningful use criteria, Meadors said: “You have to lay the groundwork first.” Timing is of the essence, Drummond said. Until the ONC explains the criteria for becoming a certifying body, the firm’s programs are on hold, Marrow said. “We’re working, but we’re waiting.”

Until the meaningful use rule is finalized and the EHR certification rule has been released, reviewed and finalized, it’s challenging for providers to move forward with software decisions.

If providers want to qualify for financial incentives starting in 2011, they have to begin implementing certified systems soon, CCHIT’s Reber said. “We feel a great deal of empathy with providers who want to qualify for this program.”

Let us know what you think about the story; email Jean DerGurahian, News Writer.

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