Certified Electronic Health Records

Certification Status

Electronic health record (EHR) systems used by providers to achieve meaningful use will be required to meet Health and Human Services (HHS) certification requirements.

In early March 2010, the Office of the National Coordinator (ONC) published a Notice of Proposed Rule Making (NPRM) for certification. It outlines the proposed approach for establishing a temporary and then permanent certification program to test and certify electronic health records (EHRs).

The proposed certification program is intended to enable physicians and hospitals to adopt certified EHRs in time to qualify for meaningful use incentives. This phased approach is also recognition by the ONC that the rule-making process will take time, and is a bridge to an ongoing program of testing and certification of health IT.

Under the first temporary certification process, the ONC will authorize organizations to assume many of the responsibilities that will eventually be fulfilled under the permanent certification program. The rule proposes transitioning much of the responsibility for testing and certification to private sector organizations once the permanent certification program is established.

McKesson's Achieve HIT/Stimulus Program Office is evaluating the certification NPRM and will submit comments by the 30-day comment period. However, it is important to note that at this time there is no recognized certification process available today for vendors, and there is no certification body formally recognized by HHS.

Two types of certification for EHR systems were outlined in the Interim Final Rule (IFR) on certification published on Jan. 13, 2010:

  • For a complete EHR, in which all components of the system must be certified (27 objectives for physicians; 23 objectives for hospitals)
  • For certified EHR modules, including any service, component or combination that meets the definition of a certified EHR. HHS is not calling for "certified combinations," but that each module has been certified according to the applicable certification criteria.

McKesson recently submitted our comments on the:

Moving Forward

To help the industry move forward in the absence of final rules, the Certification Commission for Health Information Technology (CCHIT) used the 2011 meaningful use objectives along with proposed measures to create two kinds of certification programs. These programs are based on CCHIT's interpretation of preliminary regulatory documents from the federal government. However, those regulatory documents are subject to change before the initiation of the HITECH incentive program.

The HITECH incentive program will require use of an EHR that was certified by a federally-recognized certifying body. Although CCHIT will undoubtedly seek such recognition, the federal government has not yet recognized any certifying body for HITECH. McKesson is closely following the CCHIT methodology as a proxy. Once there is clear guidance, we plan to certify our EHR solutions under the process defined by the Department of Health and Human Services (HHS)

With the mid-March release of the NPRM for Certification, CCHIT is re-evaluating its certification offerings. Leaders from McKesson are participating in the process and closely monitoring CCHIT requirements. However, while it is important to achieve full CCHIT certification, McKesson's priority is to provide an EHR that meets the HHS certification criteria.

Still to Be Determined

While the recent rules provided clarity on a number of issues, there is still much information and many processes yet to be defined for (EHR) vendors, including:

  • What will be the application process, functionality requirements, testing process and timeline for application certification?
  • Who will be authorized to certify EHR software?

As McKesson's team gains more insight into outstanding issues and questions, and as the rules are finalized, we will provide further updates.