EHNAC: Certain changes would bolster ONCs certification rules
The Electronic Healthcare Network Accreditation Commission (EHNAC), a non-profit standards development organization and accrediting body, has submitted comments to the Notice of Proposed Rulemaking (NPRM) regarding the proposed establishment of certification programs for health IT by the Office of the National Coordinator (ONC) for Health IT, Department of Health and Human Services.
The Farmington, Conn.-based commission’s comments focus on the definition of an Authorized Testing and Certification Body in the NPRM, testing versus certification, temporary and permanent certification guidelines, the facility requirement for a certifier and program timing, among other things.
According to the NPRM, the temporary certification program would allow the National Coordinator to authorize organizations 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 ACBs related to surveillance of certified EHR technology, and include the potential for certification bodies authorized by the National Coordinator to certify other types of health IT besides complete EHRs and EHR modules.
EHNAC’s recommendations would enable EHNAC to be designated as an HIE certifier without being an EHR certifier.
The commission’s comments also addressed the NPRM imperative for a temporary program. EHNAC recognizes the need for efficient development of an accreditation/certification program, but 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.
EHNAC also recommended that:
The Farmington, Conn.-based commission’s comments focus on the definition of an Authorized Testing and Certification Body in the NPRM, testing versus certification, temporary and permanent certification guidelines, the facility requirement for a certifier and program timing, among other things.
According to the NPRM, the temporary certification program would allow the National Coordinator to authorize organizations 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 ACBs related to surveillance of certified EHR technology, and include the potential for certification bodies authorized by the National Coordinator to certify other types of health IT besides complete EHRs and EHR modules.
EHNAC’s recommendations would enable EHNAC to be designated as an HIE certifier without being an EHR certifier.
The commission’s comments also addressed the NPRM imperative for a temporary program. EHNAC recognizes the need for efficient development of an accreditation/certification program, but 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.
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 should allow more time 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.