Organizations that are allowed to certify technology in the temporary certification stage should have their certifications carry forward into the permanent phase, thus providing protections to vendors and providers that have installed applications under the temporary process, according to CHIME’s comments on the Permanent portion of the Certification Process NPRM.
CHIME also expressed concerns about the capacity of both programs to handle the influx of applications. “It is crucial that sufficient 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.
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.”
CHIME’s comments also 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.”
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