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Thursday, February 25, 2010

Notes on Certification

One of the questions I get asked a lot is "What version of C32, C83 and C80 specifications" should I be using to meet the certification requirements in the IFR.  The HITSP Care Management and Health Records TC waited to see what the Standards and Certification interim rule would look like BEFORE we finished updates to them.  The HITSP Panel Approved 2.0 releases of C83 and C80 were written AFTER we saw the rule, and contain provisions in them that SUPPORT that rule.  Prior Panel Approved versions (e.g., 1.1) of these specifications DO NOT contain these provisions.  So, if you want the best that HITSP has to offer for certification under meaningful use, use the 2.0 versions of the HITSP C80 and C83 specifications in your CCD implementations.  Take note: the CCHIT Comprehensive Certification still talks about Version 1.1.

The other question I get asked about a lot is what certification will look like, or how it will work.  I still don't know, because we haven't yet seen the promised rules.

Certification is a critical component for HIT products that must be completed BEFORE providers can take advantage of incentive payments.  It's nearly the end of February and we are still waiting on the proposed rule for Certification for Meaningful use.  This has a pretty significant impact in a couple of ways:

1.  The proposed rule will likely have a 30-60 day comment period.
2.  That will be followed by at least a 30 day period to consolidate comments and generate a final rule.
3.  That final rule will likely have a 30 day period before it goes into effect.
4.  Certifying organizations will need to align their processes with the certification final rule...
5.  Which may include certification of the certifiers...
6.  Finally, products will need to complete certification...

If each of these steps is required, and takes at least a month, we are still six months away from having certified products under meaningful use.  That means maybe this summer we could see certified products.
Yes, CCHIT is going to certify products -- twice if it needs to, once to see if they meet requirements under the current IFR, and a second time if needed to address any gaps.  That certification isn't the same without the finished certification process regulation.

We are told to expect a Final Rule based on feedback to the Interim Final Rule this Spring (April - June).  That Final Rule could change certification requirements, although any major changes seem to be pretty unlikely.  Finally, the rule for Meaningful Use Incentives could also be finalized this spring, which could effect any sort of additional certification that goes over and above the Meaningful Use certification requirements.  That means that step 4 will require synchronization with the Final Rules, which could mean certified products would be available in the fall.

At our current rate, EHR products could still be certified before the end of this year, but not if we keep adding delays.   I've heard recently that ONC wants to get public input on certification processes before they even public a proposed rule, which could delay things further.

Because of the way these processes work in government, it's very difficult to get any idea of what is going on.   During the development of regulation, the government basically acts like a black hole for information.  Lots of it may be going in, but nothing comes out until they are done.  I understand the need for this, but I very much wish that a SCHEDULE could be published so that the industry would have some idea what is happening.  A high level schedule with planned (but not promised) dates conveys very little about what is being done, but at least helps the industry to plan. 

At this time, I'm expecting another "Vacation Surprise" from HHS and ONC just like I got for Christmas last year.


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