A Final Rule on Permanent Certification Program

The Office of the National Coordinator for Health IT has released a final rule establishing the permanent certification program for the meaningful use incentive program. The rule introduces several significant changes from the temporary program currently in use.

Participants in the federal EHR adoption program, which opened yesterday, must use health IT that has been approved specifically for the program.

The most notable change under the permanent program will be a separation of powers in approving organizations to test and certify health IT products. Approval for each function occurs in a multi-step process run by differing organizations.

The National Institute of Standards and Technology will accredit organizations to test products. Those organizations must use tools and procedures either approved or developed by NIST.

ONC will designate one organization to approve other organizations to certify health IT products. This accrediting organization will be known as the ONC-Approved Accreditor. It will be selected every three years through a competitive process.

All organizations receiving certification accreditation will apply to ONC for status as ONC-Approved Certification Bodies, or ONC-ACBs. They will be required to renew their status every three years.

Organizations currently approved to test and certify products under the temporary program are not automatically approved for the permanent program. They must receive accreditation under the new process.

It will be possible for an organization to receive approval to both test and certify products.

“Gap Certification” and Sunsetting the Temporary Program

The permanent program also will feature “gap certification,” allowing products that have been certified previously to be tested only on new or revised criteria as they are established. This should speed the process as stage 2 and 3 criteria are rolled out.

The permanent program is scheduled to begin January 1, 2012, which has been ONC’s intention since it announced the temporary program. However, the launch will be delayed as necessary if all the pieces are not in place. The temporary program will be sunsetted when the permanent program launches.

Products certified under the temporary program will not be affected by the transition to the permanent program. However, they will require certification for new functionality required under later stages of the meaningful use program.

Publication of the final rule is forthcoming in the Federal Register. For now, ONC has released a prepublication copy on its Web site, where it offers additional information on the program. (The final rule is available here.)

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