Wes Rishel

In Practical Concerns re: Certification Recommendation I drew from the experience with CCHIT to identify issues that must be dealt with in certifying EHRs for various programs created under the ARRA. I further suggested that these issues are compounded by the “waterfall” process recommended by the HIT Policy Committee, wherein one organization (ONC) determines certification criteria and other organizations actually implement certification programs.

I immediately received an e-mail response suggesting that the waterfall approach is mandated by the HITECH portion of ARRA. Specifically at Section 13101 it amends The Public Health Service Act to add Sec 3004 giving the process for adoption of endorsed recommendations; adoption of initial set of standards, implementation specifications, and certification criteria.

While only lawyers can interpret legalese, as a layman it seems pretty clear that 13101 dictates a process wherein the HIT Standards Committee ends up enumerating specific requirements for certification. This only slightly changes what I wrote however. ONC must recognize that it has only two choices for certification:

• Be precise and uniform not only on what is certified but also how, or
• Expect that multiple certifiers will be driven by market forces to “race to the bottom,” giving the most benefit of the doubt to vendors they can get away with.

If it chooses the former, it should determine what level of support the HIT Standards Committee needs to work out the details on how. I would urge it to look at the CCHIT experience for at least one working methodology and resource estimate.

Alternatively, I have not actually found language in the HITECH act that requires multiple certifiers. That seems to be a recommendation of the HIT Policy Committee. The ONC should at least consider whether the heavyweight approach used for ISO 9001 and the like is really required.

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