The American National Standards Institute (ANSI) will be the sole authorized accreditor of organizations that want to certify electronic health records (EHR) for meaningful use under the permanent certification program for health IT.
ANSI oversees the creation and publication of standards and guidelines in many business sectors, including health care and technology. It offers accrediting programs for product and personnel certification and standards developers.
[Related: Would delaying Stage 2 of meaningful use ignite ICD-10 efforts?]
Approval of ANSI as the accrediting organization is one of the first steps in establishing a more thorough and permanent certification program by the Office of the National Coordinator for Health IT to replace the temporary program, which sunsets at the end of this year, ONC said in a June 9 announcement.
The permanent program offers features that will make health IT certification more comprehensive, transparent and reliable than the current processes used to approve EHRs, ONC said.
The single accreditor (ONC-AA) is critical to the permanent certification program because that organization approves the entities that will become ONC-authorized certification bodies (ONC-ACBs).
Those organizations in turn will verify that EHRs are able to perform the functions that are required for healthcare providers to meet meaningful use and qualify for Medicare and Medicaid incentives.
ONC has said it will select only one approved accreditation organization every three years through a competitive process to oversee certification bodies. ANSI could be approved again through that process.
Under the permanent certification program, which begins Jan. 1, 2012, the accreditor must assure that the authorized certification bodies follow consistent and reliable methods when they conduct surveillance of EHR vendor products after they receive certification.
Among its responsibilities, the accreditor must adhere to ISO/IEC 17011, a standard developed by the International Organization for Standardization that specifies the requirements for bodies that approve conformity assessment organizations, such as ONC’s authorized certification bodies.
The accreditor must also evaluate how certification organizations conform with ISO/IEC Guide 65, a standard for requirements for certifying bodies.
Currently, ONC has authorized six temporary testing and certifying bodies to approve EHRs and/or EHR modules of selected functions. Under the temporary program, more than 700 EHRs have been certified to date so that healthcare providers can purchase and deploy them for the first stage of meaningful use requirements.
In a recently published proposed rule, ONC described the potential consequences for improper conduct by its authorized accreditor and its process for corrective action.
