I started reading the Certification NPRM this morning around 10:00. The first thing I did was bookmark the rule, which you can find here. I finished that around 10:50. It's now 11:40 and I'm done reading the regulation text starting on page 146 of the NPRM. I can see the fingerprints of NIST on this document. It is remarkably clear and I have only a few comments on the entire proposed rule:
1. Kudus to the government for using standards! The new rule uses international standards: ISO/IEC Guide 65:1996 (General requirements for bodies operating product certification systems) and ISO/IEC 17025:2005 (General requirements for the competence of testing and calibration laboratories) to describe the requirements of certification and testing organizations. But shouldn't these documents be incorporated into the rule by reference along with the location where they can be obtained?
2. As proposed, the sunset of the temporary certification program begins as soon as the first permanent certification body is announced by ONC. I would prefer to see a set end date for the temporary certification program. Deadlines produce results, and a clear end date would provide incentives for organizations to be ready for the permanent program.
3. I'm not terribly sure about the value of two accreditation process, one for testing bodies and the other for certification bodies. I understand the disctinction between testing and certification, but wonder if it is necessary to have two separate accredited bodies as part of the certification process. There is a great deal of overlap in the requirements to be accredited for either and an expectation that at least some organizations will do both. It seems as if having two accrediting processes could increase certification costs without providing much additional value.
4. This is really just a minor nit: In two places the rule talks about the effect of revocation of status for a certifying body on the certifications that it issued. This can be found in sections §170.470 and §170.570, both titled: Effect of revocation on the certifications issued to complete EHRs and EHR modules. I'd like to see text in the rule that says that if a certification is called into question that the orginization whose recieved it is entitled to a refund of fees paid for certification. After all, if you paid for something and got a defective item, you should be entitled to get your money back.
5. NVLAP (National Voluntary Laboratory Accreditation Program) is never defined or expanded in the regulation text itself.
This is one I'm not going to worry about. If the rule goes final as written, I'll still be happy with it. Thanks again NIST!
P.S. NIST is publishing the test methods that are cited in the NPRM and is seeking public comment on those also. Take a look at the first wave.
P.P.S. The PDF I bookmarked was the "corrected" rule that Brian Ahier mentions on his blog.
P.P.P.S. Updated to fix broken links.