We are 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 un-finalized status of meaningful use and certification regulations
Ann Arbor, MI (Vocus) April 9, 2010
The College of Healthcare Information Management Executives (CHIME) has released comments supporting the general concept of moving to a two-stage approach for creating a certification process for electronic health records.
However CHIME notes that significant questions still surround the creation of the approach, even though it offers a way to deal with the near-term need of accelerating the certification of EHR products. It’s essential to certify clinical technology quickly yet thoroughly, so that providers can implement applications that will enable them to receive stimulus funds for meaningful use of EHR technology.
“We are 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 un-finalized status of meaningful use and certification regulations,” read CHIME’s comments. “Above all else, providers need a stable marketplace in which vendors can quickly offer and support implementation of certified products.”
CHIME filed its comment letter on April 7 with the Office of the National Coordinator for Health Information Technology regarding the creation of a temporary certification program for health information technology.
While the regulation provides a short-term solution for certification and solves the need to approve applications quickly, it has the potential to maintain market instability, said CHIME, an Ann Arbor, Mich.-based executive organization with more than 1,400 CIOs and senior IT members.
“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,” CHIME’s comment letter read.
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 said. “Any certification policy by federal agencies must actively reinforce this division of responsibility.”
Speed in enabling the certification process to proceed is critical to the industry’s efforts to implement clinical systems that providers then need to use in a meaningful way. “We cannot emphasize enough the need for a mechanism that enables the rapid analysis of currently certified programs so that they can be deemed approved after testing against criteria needed to achieve meaningful use,” CHIME said.
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.
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 said. “A broad interpretation of modification by the agencies charged with enforcing a final regulation on this topic may require more providers to embark on the certification process than is necessary or effective,” the comments said.
CHIME’s comments also recommend that:
- Changes in certification requirements be made only when they are necessary to meet meaningful use evolution or advance interoperability, not just because a certain amount of time has passed.
- If CMS maintains the “adoption year” approach originally advanced in proposed regulations, providers should not be required to have products certified for capabilities not required in their current adoption year.
- Individual EHR modules be certified to ensure that they can communicate according to adopted standards, and that the interoperability of those modules as used by providers be deemed as certified.
- 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.
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.
# # #