Thursday, May 5, 2011

Certification Retrospective Part 3 – Controversies Along the Way

Note: this blog post continues my discussion of experiences in CCHIT. The opinions are mine only and do not necessarily reflect the views of CCHIT or Siemens. Please bear this in mind especially considering that the topic is “Controversies”

From my last Certification Retrospective post, I promised to share lessons learned and some “agonizing controversies” we faced in the CCHIT Interoperability workgroup (IOWG). I thought I could do both in one post, but now realize that I’ll need a “Fourth Movement” after this. Each controversy could easily take up a post of its own, but I’ll try to squeeze them into this post, deferring Lessons Learned to Part 4.
  1. When should HITSP specs be incorporated into certification? Once HITSP was formed, it (not CCHIT) was designated to select standards. CCHIT, however, could decide when/if those standards would be certified, striking a difficult balance between supporting the federal strategy (HITSP was HHS-funded, CCHIT was partially HHS-funded) and yet being pragmatic. It would have been difficult to require EHRs to develop too much at once when certification was “all or nothing” and not modular. From working in both CCHIT and HITSP, CCHIT tended to give more weight to considerations such as market adoption and lead times, not just whether a suitable standard existed. I along with Jamie Ferguson were appointed to co -chair the 10-member HITSP-CCHIT joint working group, whose goal was to coordinate the work of HITSP and CCHIT and address how/when to include HITSP specs in certification. But some HITSP-selected standards were still in “trial implementation” with little adoption, and the approval of a standard (HL7, HITSP, or any other) didn’t mean it should be mandatory within a specific timeframe. And there were just so many of them to digest, let alone certify! Some people weren’t pleased, thinking that CCHIT should be a more aggressive “enforcement arm” of HITSP. In the end, we included more of HITSP in 2008 and 2009 certification criteria than ONC did in its 2011 certification criteria, most notably the HL7 2.5.1 Laboratory results with LOINC vocabulary starting in 2007, C32 CCD starting in 2008 (adding RxNorm, UNII, SNOMED CT vocabularies in 2009) and HITSP TP13 (IHE XDS.b – see point #2 below). But we also roadmapped (2-3 years out) most other HITSP specs when we published our 2009 criteria. I believe this was a sensible middle of the road approach. IMHO, if we had mandated many more HITSP specs in certification, there would be few or zero certified products today!
  2. Should certification require transport standards? Fourth & Ten – we’d better punt! Seriously, we debated this during 2008 and 2009. We recognized this as a glaring gap in interoperability, and wanted to make headway, realizing that lack of secure transport standards would hinder interoperability even if content were standardized. The Direct Project didn’t exist back then. We were aware of diverse ways that HL7 messages were transported, that IHE had defined SOAP-based web services for document transport, and that HITSP had selected many IHE specifications. Many vendors had already tested IHE Cross-Enterprise Document Sharing (XDS.b) at Connectathon. So the IOWG approved XDS.b as 2009 certification criteria (along with PIX/PDQ to support it). But the Board of Commissioners decided to designate these as optional interoperability criteria, not required for certification, because despite the IOWG’s recommendation and strong EHRA support, some commented against it. This was the one case I can recall where my workgroup’s recommendation was overridden by the Board, which I know was a tough decision since the Board usually didn’t do that. This was also a case where we were less aggressive in CCHIT than the EHR Association had proposed. EHRA had sometimes criticized CCHIT for not providing enough lead time, but in this case they were very disappointed that CCHIT had not required this in certification. This one still bothers me as a missed opportunity.
  3. Should we require discrete data import, and who owns that decision anyway? We felt that the main point of requiring standardized content formats and vocabularies, not just human readability/liquidity, was for the discrete data to be consumable. Following our “methodical march” mentioned in part 2, we thought in 2008 that the time had come to propose discrete data import (e.g., update your medication, allergy, or problem lists using data from other providers). But now we were into a “boundary condition.” Where did interoperability’s “turf” end and functionality begin? We had a series of “discrete data import” meetings between the IOWG and the Ambulatory and Inpatient Functionality workgroups. We recognized that data must not only be exchanged, it needs to be reconciled (medication reconciliation being an example), and that you can’t just “slam in” all meds, allergies, problems from many external sources to automatically update the active med/allergy/problem list. The functionality workgroups didn’t think the time was right to require such capability in certification for 2009 or 2010. But how were we going to keep making progress toward semantic interoperability? In the end, we proposed criteria to import very specific discrete data elements for medications, allergies, demographics, and immunizations (with problems to come later), as described in my last post. But we didn’t define the functionality, as long as the discrete data were stored somewhere. And in any case, reconciliation criteria would belong to the functionality workgroups, not the IOWG. I think this would have been a reasonable “baby step” but because of the change in certification that started in 2009, those roadmap criteria never had the chance to be certified. I hope that similar careful thought will go into decisions in ONC certification, whenever it gets to that point. End-to-end interoperability involves content creation, secure standardized transport, and content consumption, all of which should be considered holistically.
  4. Should we push the industry toward a single standard for clinical problems? This was really part of the broader topic of converging on a singular standard vocabulary for each type of data, but SNOMED CT for problems was the lightning rod topic for several reasons: a) the difficulties of getting physicians to create medical problem lists at all; b) ICD-9 diagnosis codes were already required for reimbursement and some physicians systems were built around ICD-9; c) ICD-10 was already complicating things by looming on the horizon; d) anything that imposed more work on physicians could hinder usability and adoption. So though SNOMED CT seemed a clear winner for an interoperable clinical vocabulary and was HITSP-endorsed, we received considerable pushback from some members of the other workgroups as to how fast SNOMED CT could be required. I was pleased that many in the IOWG stepped up to provide statistics and research facts such as analysis of mapping of ICD-9 to SNOMED CT and clarification that standard codes don’t have to be visible in the clinician’s UI. We knew this was a contentious issue, but staked out our positions in the 2009 roadmap and a Q&A document.
The above four were prototypical of the controversies we faced in content, vocabulary, and transport. I could go on with more examples. That’s part of the challenge of interoperability work, as evidenced by the fact that ONC and the HIT Standards Committee still have all of the above issues to ponder for Stages 2 and beyond. I should mention that one more big controversy arose in the very first year, when CCHIT was newly formed and struggling to figure out how to set the interoperability bar. Eyes were upon those first members to resolve the CDA vs. CCR debate. Unlike the four issues above, where we took a stand, we weren’t ready to force a decision in 2006, and then HITSP was formed by ONC to deal with such “standards harmonization” issues. So at least our punt had a receiver (and football wasn’t locked out)!

I promise that Part 4 will really conclude this series with my thoughts on Lessons Learned, proudest accomplishments, regrets, and hopes for the future, stemming from my CCHIT experience. Thanks for listening to my sharing from “inside the trenches” of discussions of which the public was not aware.

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