The Office of the National Coordinator for Health IT (ONC) today released a notice of proposed rulemaking (NPRM) for the establishment of two certification programs for purposes of testing and certifying health IT—one temporary and one permanent.
Certification of health IT will provide “assurance to purchasers and other users that an EHR system, or other relevant technology, offers the necessary technological capability, functionality and security to help them meet the meaningful use criteria established for a given phase,” according to ONC. “Providers and patients must also be confident that the electronic health IT products and systems they use are secure, can maintain data confidentially and can work with other systems to share information.”
To this end, the NPRM proposes:
* A temporary certification program to assure the availability of certified EHR technology prior to the date on which health care providers seeking the incentive payments would begin to report demonstrable meaningful use of certified EHR technology.
* A permanent certification program to replace the temporary certification program.
The first proposal within the NPRM would establish a temporary certification program whereby then national coordinator would authorize organizations to test and certify complete EHRs and/or EHR modules. This would assure the availability of certified EHR technology prior to the reporting period in which healthcare providers may seek the incentive payments available under the Medicare and Medicaid EHR Incentives Program demonstrating meaningful use of certified EHR technology, according to ONC.
The second proposal within the certification program NPRM would establish a permanent certification program to replace the temporary certification program, the office said. 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 related to the surveillance of certified EHR technology, and would include the potential for certification bodies authorized by the national coordinator to certify other types of health besides complete EHRs and EHR modules.
The temporary program would end once the permanent certification program is established and at least one certification body has been authorized by the national coordinator.
The public comment period for the temporary certification program will be open for 30 days after publication. The public comment period for the permanent certification program will be open for 60 days after publication. While two certification programs are described in this proposed rule, ONC said it anticipates issuing separate final rules for each of the programs.
ONC said it consulted with the National Institute of Standards and Technology (NIST) on developing the proposed certification programs, and will continue to consult and collaborate with NIST during the implementation and operational phases of both temporary and certification programs. NIST is developing a test method and infrastructure that will be used by testing laboratories in the testing component of both certification programs, according to the office.
To inform the rulemaking processes, ONC said it received recommendations from the HIT Policy Committee (a federal advisory committee), and input from technical subject matter experts, healthcare providers, and other stakeholders.