CHIME is “ … very concerned that the introduction of a two-stage approach for certification will prolong the current instability in the health IT marketplace, which exists because of the unfinalized status of meaningful use and certification regulations,” stated the organization in its comment letter to ONC regarding the Certification process NPRM.
“Above all else, providers need a stable marketplace in which vendors can quickly offer and support implementation of certified products,” the letter continued. “The introduction of two separate certification schemes – one temporary and one permanent – carries a risk of continuing the uncertainty and promoting needless product replacement in the marketplace.”
To mitigate uncertainty, CHIME called for the temporary process to be a provisional or interim one that builds on current certification strategies and is “harmonized” with the eventual permanent certification process.
In its comments, CHIME asserts that the certification process should be the responsibility of the vendor, and that the purpose of certification should be to provide healthcare providers and professionals with assurance that the product they are purchasing can help them achieve meaningful use.
“Regulations surrounding certification must uphold a clear dichotomy of responsibility – healthcare providers are responsible for meaningfully using electronic health records system and supporting technologies, while vendors of healthcare IT products must ensure their EHR systems meet the certification criteria to support providers in achieving meaningful use,” CHIME writes. “Any certification policy by federal agencies must actively reinforce this division of responsibility.”
In CHIME’s comments, it also calls for more specificity in language to define what constitutes a self-developed EHR. Current wording in the regulation suggests that any complete EHR or EHR module that’s modified by a healthcare provider or a contractor could require certification. CHIME states that EHR products often are adapted or adjusted for a variety of reasons, such as facilitating the exchange of data or to fit specific needs of organizations, and routine adaptations of certified systems should not need to be recertified.
CHIME’s comments also recommend that:
- HIT vendors fully disclose functions for which their products are certified and fully disclose known compatibility issues.
- In the event of a certification body losing its authority to certify products, vendors should have six months to recertify products, and providers should not be penalized for a change in a product’s certified status if they are still able to demonstrate the meaningful use of the technology.