Commission recommends voluntary technology certification programs

June 10, 2010

A proposal by the U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology to establish a temporary program to certify electronic health record systems, followed by a permanent program, has elicited formal comments from the Electronic Healthcare Network Accreditation Commission.

A proposal by the U.S. Department of Health and Human Services Office of the National Coordinator (ONC) for Health Information Technology to establish a temporary program to certify electronic health record (EHR) systems, followed by a permanent program, has elicited formal comments from the Electronic Healthcare Network Accreditation Commission (EHNAC).

The ONC's proposed temporary certification program would allow the ONC to authorize bodies to test and certify EHRs and/or EHR modules. The permanent certification program would separate the responsibilities for performing testing and certification, introduce accreditation requirements, and establish requirements for certification bodies authorized by the ONC related to surveillance of certified EHR technology. It would also include the potential for certification bodies authorized by the ONC to certify other types of HIT in addition to complete EHRs and EHR modules.

The EHNAC, a non-profit standards development and accrediting body, expressed concern that the proposal defines ONC-authorized certification bodies in such a way as to exclude the EHNAC and other entities from consideration of health information exchange (HIE) certifiers. The EHNAC's recommendations would enable EHNAC to certify HIEs without being an EHR certifier.

"Because of our 15 years of experience in the development of accreditation criteria and in certifying organizations against those criteria, we feel that EHNAC is uniquely qualified to provide insight as the industry looks toward achieving certification and accreditation guidelines and best practices," says Lee Barrett, executive director of EHNAC.

The EHNAC also recommended that the temporary program instead be viewed as a pilot program, providing proof of concept or demonstration of the requirements for a permanent accreditation/certification program. The ONC should evaluate the outcome of the program after a year, then issue a proposal for the design of a permanent program, the EHNAC recommends. Doing so would provide industry participants with experience and thereby would encourage more informed comments to be provided for the permanent program, according to the EHNAC.

EHNAC also recommended that:

a certified testing program should not be considered a necessary requirement for certification of products;

the ONC either should eliminate the need for certifiers to establish a physical presence of their own or, conversely, allow for certifiers to establish a "virtual" office for conducting certification;

the ONC should allow more time before this fall for organizations to develop accreditation/certification programs, even on a temporary basis, thereby encouraging more candidates to apply to be temporary certification organizations; and

no unannounced visits should occur. They tend to raise more issues than they address, according to the EHNAC. Organizations should be given sufficient time to schedule and prepare for site visits.