The proposed program to certify EHR 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, according to a letter by the College of Healthcare Information Management Executives (CHIME).
The healthcare organization wrote the letter in response to the notice of proposed rule-making on health IT permanent certification programs issued by the Office of the National Coordinator for Health IT (ONC).
According to CHIME, the government should focus adequate attention and resources to ensure the success of the program. “All certification efforts, whether provisional or permanent, need to focus on developing a program to approve clinical applications for achieving meaningful use criteria,” stated the letter. “In the immediate term, this will represent a significant effort.”
The permanent certification process anticipates using several authorized certification bodies (ACBs) to certify EHR products. “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,” the letter 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, according to the organization.
CHIME’s comments called 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,” CHIME stated.
Concerns were raised about how efforts by the National Institute of Standards and Technology (NIST) 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 stated.
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 health IT vendors to fully disclose functions for which their products are certified and fully disclose known compatibility issues; and
- ONC should provide sufficient time for vendors to seek recertification of products if a certifying body should lose its authority to certify products.
Responses to the proposed rule are due by May 10.