What impact does the removal of the 2011 Edition EHR certification criteria and related standards, terms, and requirements from the Code of Federal Regulations (effective March 1, 2015) (79 FR 54447) have on the ONC Health IT Certification Program, health care providers, and health IT developers?
- ONC Health IT Certification Program
- ONC and NIST will archive the 2011 Edition Test Method (test procedures, tools and data). The Certified HIT Products List (CHPL) will maintain the 2011 Edition certified products in an active status until July 1, 2015, so that participants in HHS programs permitting the use of 2011 certified products (which also require a CMS EHR Certification ID) will be able to generate these IDs. Beginning in July 2015, these products will only be present in the CHPL download data file and will be marked as “retired.”
- As of March 1, 2015, NVLAP Accredited Testing Laboratories (ATLs) are no longer testing products for conformance to the 2011 Edition certification criteria.
- The ONC-Authorized Certification Bodies (ACBs) are working with their health IT developer clients to “retire” the 2011 Edition certifications they granted and are ceasing their related responsibilities, such as surveillance of the 2011 Edition certified health IT.
- Health Care Providers: From a health care provider perspective, the removal of the 2011 Edition will have varying impact on compliance with HHS programs.
- There is no impact on those providers participating in the Medicare and Medicaid EHR Incentive Programs. Prior to the 2011 Edition removal from the Code of Federal Regulations, CMS had already determined that health IT certified to 2011 Edition certification criteria would no longer be permitted for use in 2015 under the Medicare and Medicaid EHR Incentive Programs 1.
- There is no impact on providers of chronic care management (CCM) services. CCM services may be furnished during CY 2015 using health IT that has been certified to the 2011 Edition 2.
- Health IT Developers: Developers should be working with their ONC-ACB to formally retire the 2011 Edition certifications of their respective products. We also recommend that to be helpful to their customers, developers may consider communicating with their clients still actively using these products about the 2011 Edition being retired.
1. 79 FR 52913
2. 79 FR 67723-24