WASHINGTON – The American National Standards Institute (ANSI) has launched its program to approve organizations that want to certify electronic health records for meaningful use.
ANSI will accept applications through Oct. 7, with its first organization accreditations anticipated in 2012, the standards-setting group said in an Aug. 25 announcement.
The Office of the National Coordinator for Health IT named ANSI in June as the sole authorized accreditor of certifying bodies for the permanent certification program.
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.
Lance Hallenbeck, ANSI vice president for accreditation services, said it is “committed to build on the record of confidence established via public-private partnerships with many other government agencies relying on ANSI accreditation.”
ONC intends to establish a more thorough and permanent certification program to replace the temporary program, which sunsets at the end of this year. The permanent program offers features that will make health IT certification more comprehensive, transparent, reliable and efficient than the current processes used to approve EHRs, ONC has said.
The single accreditor (ONC-AA) is critical to the permanent certification program because that organization approves the organizations that will become ONC-authorized certification bodies (ONC-ACBs).
Those organizations in turn will verify that EHRs are able to perform the functions required for healthcare providers to meet meaningful use and qualify for Medicare and Medicaid incentives.
Under the permanent certification program, which is scheduled to begin 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.
To be accredited, potential certifying organization must demonstrate adherence to:
- ISO/IEC Guide 65, a standard developed by the International Organization for Standardization and International Electrotechnical Commission for requirements for bodies operating product certification systems
- International Accreditation Forum (IAF) guidance on how to apply ISO/IEC Guide 65
- ANSI Policy 102, the Manual of Operations for Accreditation of Product Certification Programs
- The Health IT Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health IT final rule, which was published in October 2010
[See also: Single vocab standard for each EHR reporting domain seen as 'momentous']
ONC has authorized six temporary testing and certifying bodies to approve EHRs and/or modules of selected health IT functions. Under the temporary program, more than 1,000 EHRs have been certified to date so that healthcare providers can purchase and deploy them to meet meaningful use requirements.
ONC has also described the potential consequences for improper conduct by its authorized accreditor and its process for corrective action.
