EHR accreditation body proposes strengthening draft certification rules

FARMINGTON, Conn. – The Electronic Healthcare Network Accreditation Commission (EHNAC), a non-profit standards development organization and accrediting body, recently submitted detailed comments to the Notice of Proposed Rulemaking (NPRM) regarding the proposed establishment of certification programs for health information technology by the Office of the National Coordinator (ONC) for Health Information Technology, Department of Health and Human Services. EHNAC’s comments and suggestions focus on the definition of an Authorized Testing and Certification Body (ONC-ACB) in the NPRM, testing versus certification, the facility requirement for a certifier, program timing, unannounced visits, the temporary program, and lastly, Guide 65 and ISO requirements.

Under the authority of Section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health Act (HITECH), the ONC issued a NPRM that would establish a temporary certification program, followed by a permanent certification program to replace the temporary certification program.

According to the NPRM, the temporary certification program would allow the National Coordinator to authorize organizations, ONC-ATCBs to test and certify Complete EHRs and/or EHR Modules. The permanent certification program would separate the responsibilities for performing testing and certification; introduce accreditation requirements; establish requirements for certification bodies authorized by the National Coordinator, ONC-ACBs, related to surveillance of Certified EHR Technology; and would include the potential for certification bodies authorized by the National Coordinator to certify other types of health information technology besides Complete EHRs and EHR Modules.

A primary concern for EHNAC is that the definition of ONC-ACB as presented in the NPRM will eliminate EHNAC and other entities from consideration if the Secretary designates these organizations to certify Health Information Exchanges (HIEs). EHNAC’s recommendations would enable EHNAC to be designated as an HIE certifier without being an EHR certifier.

“EHNAC’s response to the ONC’s NPRM on certification came about as a result of the diligent analysis and compelling discussion among EHNAC commissioners and members,” noted Lee Barrett, executive director of EHNAC. “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.”

EHNAC’s comments also addressed the NPRM imperative for a temporary program. While the submitted comments recognized the need for efficient development of an accreditation/certification program, the Commission recommended that this effort be viewed as a pilot, providing proof of concept or demonstration of the requirements for a permanent accreditation/certification program. Ultimately, EHNAC recommends that ONC evaluate the outcome of the temporary program after one year, then issue an NPRM for the design of a permanent program, allowing industry participants experience and therefore encouraging more informed comments to be provided for the permanent program.

On behalf of its members and contributing stakeholders, EHNAC also recommended that:

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

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

ONC allow more time before the fall of 2010 for organizations to develop accreditation/certification programs, even on a temporary basis, therefore encouraging more candidates to apply to be the temporary certification organizations.

There should be no unannounced visits (which tend to raise more issues than they address), and that organizations should be given sufficient time to schedule and prepare for site visits.

Source: The Electronic Healthcare Network Accreditation Commission