Tuesday, March 2, 2010

Certification Programs NPRM Issued

David Blumenthal announced the release today of the notice of proposed rule making for Certification Programs for Complete EHR's and EHR Modules.  Excerpts from the ONC's summary include:

Certification of EHR Technology will provide assurance to purchasers and other users of health IT that an EHR system offers the necessary technological capability, functionality, and security to meet meaningful use criteria.

The Notice of Proposed Rulemaking (NPRM) proposes establishment of two certification programs for the purposes of testing and certifying health IT, one temporary and one permanent.

NIST is developing a test method and infrastructure that will be used by testing laboratories in the testing component of both certification programs.

Certified EHR technology is a requirement for providers to receive incentive payments for the adoption and meaningful use of EHRs under the Medicare & Medicaid Incentives Program. 

An initial set of standards, implementation specifications, and certification criteria for Complete EHRs and EHR Modules was also published in a related Interim Final Rule.
The temporary certification program provides for ONC to authorize organizations to test and certify Complete EHRs and/or EHR Modules.  The goal is to assure availability of Certified EHR Technology prior to the reporting period in which health care providers may seek the incentive payments available under Medicare and Medicaid.

The second proposal establishes a permanent certification program to replace the temporary certification program. 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 ends 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 anticipates issuing separate final rules for each of the programs.

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