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CCHIT's IFR Stage 1 Certification Programs
(Update Note: We have reviewed the Notice of Proposed Rulemaking regarding certifying bodies, and we feel confident about our prospects of becoming accredited. We plan to file an application with the Office of the National Coordinator as soon as it is ready to accept them.)
The Commission"s CCHIT Certified® Comprehensive IFR Stage 1 certification program and its more limited Modular IFR Stage 1 certification program, both formerly entitled "2011" programs, now align with the Interim Final Rule (IFR) issued by the U.S. Department of Health and Human Services (HHS) on January 13, 2010, effective February 12, 2010.
We have identified and analyzed the gaps between our existing criteria and the Stage 1 IFR. More details on those gaps can be found in the following documents:
- CCHIT IFR Stage 1 Certification Criteria Gap Analysis - Eligible Providers - Jan 19 2010
- CCHIT IFR Stage 1 Certification Criteria Gap Analysis - Hospitals - Jan 19 2010
- CCHIT IFR Stage 1 Certification Criteria Gap Analysis - Security - Jan 19 2010
The CCHIT Certified® Comprehensive IFR Stage 1 certification program includes a rigorous inspection of integrated EHR functionality, interoperability, and security in addition to requiring full compliance with HHS criteria and standards supporting the meaningful use objectives required to qualify for incentives under the American Recovery and Reinvestment Act of 2009 (ARRA). As part of the process, successful use is verified at live sites and, for Ambulatory EHRs, product usability is rated. Products must be fully compliant with both sets of criteria.
The Modular IFR Stage 1 program is limited to a modular inspection of applicable HHS criteria and standards to support the IFR Stage 1 incentives under ARRA. EHR technology may meet all or just some of the requirements. Integration of the modules to support meaningful use is the responsibility of the healthcare provider applying for ARRA incentives. A new labeling system, Certification Facts, describes which meaningful use objectives are supported by the technology.
The IFR Stage 1 certification component of both programs is considered preliminary because the definitions of meaningful use,the criteria and standards, and the process for accrediting certifying bodies have not yet been finalized by HHS.
We will continue to update our certification materials and test tools to accommodate changes. Our program staff is committed to working directly with certification applicants during this transition to ensure they have the information they need to prepare for an inspection.
The Commission expects the criteria and standards changes during finalization will be minimal, and will perform incremental testing of products if necessary to certify they meet the final Stage 1 ARRA requirements expected in the spring of 2010.