Skip to main content

Success of certification process hinges on 'sufficient capacity, consistency'

By Molly Merrill , Associate Editor

The College of Healthcare Information Management Executives (CHIME) is calling for the government to focus  "adequate attention and resources" on the proposed program to certify electronic health technology in order to ensure its success. CHIME aired its concerns about the program in a letter sent Friday with its comments responding to the Notice of Proposed Rule-Making issued by the Office of the National Coordinator for Healthcare IT that's due May 10, 2010.

The proposed program to certify electronic health record technology will create challenges for the government in ensuring the process has sufficient capacity to handle demand in the early months of the program while achieving consistent results from the various organizations that will be certifying systems, said the Ann Arbor, Mich.-based organization.

"All certification efforts, whether provisional or permanent, need to focus on developing a program to approve clinical applications for achieving meaningful use criteria," CHIME's comment letter said. "In the immediate term, this will represent a significant effort."

In responding to whether certification should expand to other technologies, CHIME noted that the priority must be the EHR certification program. "To use a common analogy, this program needs to 'walk' and create an effective process for assuring products can help providers achieve meaningful use objectives, before it tries to 'run' by expanding scope beyond the immediate needs."

The permanent certification process anticipates using several Authorized Certification Bodies (ACBs) to certify EHR products. The ONC must accurately assess how much capacity is needed to ensure the certification program approves applications in a timely manner, CHIME said.

"It is crucial that sufficient certification capacity is available in the market to handle the demand for certification while ensuring that the need for quality and consistency is met," CHIME's comments stated. Organizations that prove themselves capable of certifying technology in the first, provisional certification stage should have their certifications carry forward into the permanent phase, thus providing important protections to those vendors and providers that have installed applications under the temporary process.

CHIME's comments call for careful design of any surveillance program that aims to assess the performance of certified products in actual care settings. "For clinical systems, it will be important that any type of surveillance activity to measure system safety not become overly prescriptive." The industry needs answers to a variety of questions about any potential surveillance effort, it said.

CHIME is also concerned about how efforts by the National Institute of Standards and Technology to oversee testing bodies for EHRs will coordinate the ONC's oversight of activities of certification bodies. "To provide assurance that the testing and certification processes will work together, we ask that ONC provide detailed information on how ONC and NIST will coordinate efforts."

To access CHIME's letter filed with ONC, click here.