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CHIME Issues Comments on the Permanent Certification Process NPRM
Date:5/1/2010

Responding in its comments to ONC on proposed regulations for the permanent certification program, the College of Healthcare Information Management Executives (CHIME) calls for sufficient capacity and consistency.

Ann Arbor, MI (Vocus) May 1, 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.

Responding in its comments to proposed regulations for the permanent certification program, the College of Healthcare Information Management Executives (CHIME) said the effort is important for fostering the use of electronic health records, and the government should focus adequate attention and resources to ensure the success of the program.

CHIME’s comments are in response to a Notice of Proposed Rule-Making issued by the Office of the National Coordinator for Healthcare IT. Responses to the proposed rule are due by May 10.

“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 on 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 Office of the National Coordinator for Healthcare IT, which will oversee the program, must accurately assess how much capacity is needed to ensure the certification program approves applications in a timely manner.

“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 also is 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.”

CHIME also re-emphasized positions it stated in its previous comments on the temporary certification program:

 
  • ONC needs to ensure that the temporary program is harmonized so it coordinates with the permanent program.
  • Regulations need to specify what constitutes a self-developed EHR.
  • ONC should require changes in certification requirements only when necessary to meet meaningful use evolution, not just because a set period of time has passed.
  • ONC needs to design an overall approach that enables the rapid analysis of currently certified programs to defuse uncertainty while providing a quick, yet thorough review of products.
  • Regulations should require HIT vendors to fully disclose functions for which their products are certified and fully disclose known compatibility issues.
  • ONC should provide sufficient time for vendors to seek recertification of products if a certifying body should lose its authority to certify products.

To access CHIME’s letter filed with ONC, please visit: http://www.cio-chime.org/advocacy/CHIME_Permanent_certification_comment-April_29.pdf

About CHIME
The College of Healthcare Information Management Executives (CHIME) is an executive organization dedicated to serving chief information officers and other senior healthcare IT leaders. With more than 1,400 CIO members and over 70 healthcare IT vendors and professional services firms, CHIME provides a highly interactive, trusted environment enabling senior professional and industry leaders to collaborate; exchange best practices; address professional development needs; and advocate the effective use of information management to improve the health and healthcare in the communities they serve.

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