Monday, March 15, 2010

In ONC I Trust

It's my nature to question authority.

Whether it's religion, politics, or even my local administrative leadership, authority figures must earn my trust.

Earning that trust is not easy. As folks who work closest with me know, I believe that much of Dilbert is based on true case studies.

Over the past year, I've worked very closely with many people at ONC - David Blumenthal, John Glaser, Judy Sparrow, Farzad Mostashari, Chuck Friedman, Carol Bean, Doug Fridsma, Chris Brancato, Jonathan Ishee, Arien Malec (on loan to ONC for 8 months), and Jodi Daniel. I've worked with HHS CTO Todd Park. I've worked with US CTO Aneesh Chopra.

They've earned my trust.

The ONC folks work long hours, nights, and weekends. They do not have a dogmatic philosophical, industry, or architectural bias. They are simply trying to move the ball forward to improve healthcare quality and efficiency using IT tools.

Meaningful Use is a brilliant construct. If it were not for meaningful use, the stimulus would simply be a hardware and software purchasing program. Clinicians would waste government dollars buying technology and never use it (or use it in limited ways such as revenue cycle automation). I've seen numerous technology programs fail because clinicians just give the technology to their kids or sell it on eBay. Meaningful use requires metrics of adoption of the measure of success. Clinicians only receive stimulus dollars AFTER they have fully adopted the technology.

NHIN Direct is a powerful idea. My blog is filled with entries suggesting that we need a reference implementation for simple transport of data packages (X12, NCPDP, HL7 v2, CDA, CCR) among payers, providers and patients. NHIN Direct will assemble energetic, well intentioned people to create open source software that solves real world transport problems. I'm serving on the NHIN Direct Implementation Group. We'll have running code, implementation guidance, and data use agreements by October.

I've enjoyed my 5 years harmonizing standards as part of HITSP. The tireless volunteers really made a difference. But there were issues. The AHIC Use Cases were overly complex. The Interoperability Specifications, which were designed to support the AHIC Use Cases, tightly coupled transport and content standards. It was challenging to use a portion of a use case to solve a limited real world problem. In HITSP's final contract year, the Tiger Teams did remarkable work creating highly reusable content, vocabulary, transport and security modules called capabilities and service collaborations that were much more aligned with ARRA and easier for implementers to understand.

The new Standards Harmonization framework being proposed by ONC using the National Information Exchange Model (NIEM) is something to be embraced, not feared. I've been misquoted saying something like "we'll extend the Department of Justine infrastructure to include healthcare." That's not at all what I said. My actual comments reflected on the wisdom of the NIEM methodology which follows the HITSP Tiger Team approach - define the business needs and find the parsimonious data content, vocabulary and transport standards to meet that need. NIEM methodology is consistent with CDA, CCR, and simple transport. It does not replace the decades of work that have already been done. Instead it provides a methodology for defining needs, selecting and developing standards, and implementing those standards in a testable, sustainable way. Over the next few weeks, I'll write about the several recent RFPs that embrace NIEM methodologies issued including

*Office of the National Coordinator (ONC) CIO-SP2i Solicitation Number 10-233-SOL-00070 entitled "Standards and Interoperability Framework – Use Case Development and Functional Requirements for Interoperability

*Office of the National Coordinator (ONC) CIO-SP2i Solicitation Number 10-233-SOL-00072 entitled "Harmonization of Standards and Interoperability Specifications."

*Office of the National Coordinator (ONC) CIO-SP2i Solicitation Number 10-233-SOL-00080 entitled "Standards and Interoperability Framework Standards Development."

I've written letters of support for responses to all these RFPs.

I was recently asked about the Certification NPRM and if the temporary process and permanent process might create market confusion by changing certification criteria after 2 years and requiring that clinicians replace the systems acquired under the temporary process. My answer was simple - ONC leaders would not let that happen. The people there understand that this is a journey and will ensure that change is managed as evolutionary phases, not revolutionary quantum leaps.

Finally, I trust the HIT Policy Committee and HIT Standards Committees. These folks are good people, with diverse backgrounds, and different points of view. You will not see hegemony of any single person or organization. All their calls and work are done in open public forums. They have included the best people with the greatest good of patients as their driving motivation.

We live in remarkable times, which I've called the "Greatest Healthcare IT generation" and the "Healthcare IT Good Old Days"

My advice - trust the ONC folks and Federal Advisory Committees. Join the process. Be open about your opinions. Feel free to disagree with any idea or policy. Democracy is messy, but the folks at ONC today have the right people and processes in place to harness our energy and turn it into guidance we can all embrace.


Unknown said...

From my perspective as an active participant on, I agree fully. I've broadened my outlook through participation (and hopefully added a bit to the discussion). However, I would like to see a broader set of opinions and thoughts to help ensure a useful outcome. Your appeal for participation across the board is on the mark, and is, I would argue, an excellent place for folks to add their perspective today. (And I mean "today" quite literally. There is no time like the present!)


Ahier said...

Thanks for providing some good data and sharing your unique perspective with us.

If you want to see some success on transparency see:

For a great analogy on NHIN Direct see:

Unknown said...

I agree. Having attended many of the HIT Standards and Policy Committee meetings, both as a member of the public and as someone who is trying to figure out how to best leverage my skills to help the considerable effort in achieving meaningful use, I share your impression of the quality of work being done. In breadth of experience from both the committee members and in those giving testimonials, in the measured - and sometimes lively - debate, and in the consideration being given to a broad range of stakeholders, including the willingness to learn lessons from other industries, the careful pragmatism of setting baseline standards while minimizing negative impact on innovation. I have been impressed and comforted by the quality of people and thought involved in the process.


David said...

Dear John,

We commend your clarifying the good intentions and strong work ethic of ONC, and applaud ONC’s efforts to increase the transparency of decision making. TRUST is an essential and positive word! The qualifications of the members of the HIT Policy Committee and HIT Standards Committee, likewise, are impressive and contribute toward trust. We strongly agree with you that trust must be earned and also verified through consistent demonstration of transparency and positive outcomes. While we acknowledge that these efforts are under the tight Federal rulemaking constraints and deadlines, it’s our experience that more improvements are needed to advance confidence in the direction that ONC is heading. We have three recommendations:

We believe that a consensus process, open to all stakeholders not just for input but for engagement in decision making, is the best way to reach the goal, although consensus is slower and more difficult to achieve than unilateral decisions. The representatives on the HIT Policy and Standards committees were hand-picked, well-intentioned individuals with informed opinions. As far as we know, there is no structure to ensure that they represent all required constituencies even informally. We recommend a more formal process to ensure that the committees represent all stakeholders including small, medium, and large organizations. We appreciate that inviting the public to listen to workgroup meetings and respond to blogs are steps in the right direction. But unlike true consensus-based processes (HITSP for example), where all can participate, the public’s role in workgroup meetings is limited to a few minutes at the end after decisions have already been made, so it’s unclear whether comments make any difference. Even the best group of 20+ individuals can’t possess the subject matter expertise on all the standards and MU which they recommend. Thus reliance on standards derived from open consensus-based processes remains essential.

Standards-based interoperability is a key goal that requires that people not only buy in to the goal but have confidence that others will too and that the standards will “stick.” They’re more confident when they trust that “following direction” will yield positive results. But there are instances where it appears that a few voices have overridden industry consensus processes built over the past five years, which has led to some “zigzagging” of direction. The US government first endorsed AHIC/HITSP/CCHIT processes and outputs, but now seems to backtrack on much of what has been done. For example, why is it necessary to reinvent user stories for transitions of care under NHIN Direct? Or to revisit HHS-recognized standards for patient summaries or point-to-point document sharing? Why not improve, extend, streamline, and clarify what was already written (e.g., previous AHIC/ONC use cases, HITSP interoperability specs, etc.)?

Zigzags discourage trust: if the many developers who followed (trusted) the previously government-endorsed direction see that the rules change significantly, what’s to say that those rules won’t have major changes again after the 2010 and 2012 elections? Continuity of direction engenders trust: discontinuity engenders uncertainty and doubt and may cause some to think “Why bother? It’s going to change again anyway…”

Certain processes, e.g., commenting on the January IFR and NPRM, were well-communicated and open to all. However, the recent standards harmonization successor RFP process appeared to be much less open, almost invisible, and inaccessible to most. Clear, widespread communications for all HITECH initiatives is very important.

In conclusion, we applaud the goal of Trust, and hope that our recommendations promote increased progress toward this goal.

Respectfully submitted,
David Tao, Hans Buitendijk, and Lawrence McKnight MD
Siemens Healthcare