CDISC Blog

I was appointed to the U.S. Health Information Technology (HIT) Standards Committee, with ratification of this appointment in May of this year. This was just in time to observe “Summer Camp” activities and review the progress that committee had made since the time it was created (along with the HIT Policy Committee) in 2009. These achievements were particularly impressive when summarized at this 28 September meeting; they were acknowledged at a reception at the White House later that afternoon. Aneesh Chopra began the praise at this reception and continued to bring in a number of senior White House staff to reinforce their satisfaction with the productivity, civility and commitment of these two FACAs….”unprecedented” was the consistent underlying theme.

I had mixed feelings, having been too new to serve on the committees that had been formed prior to my appointment. I felt guilty to have been in the midst of those who truly deserved the praise. On the other hand, I felt pleasure that at least a couple of us from CDISC (Bron Kisler and myself) had given prior testimony to Task Forces of the HIT Standards Committee. I also felt fear and concern, hoping that the ‘train that has left the station’ has not already gone too far ahead for us to cleanly bring in the clinical research standards work that we have been doing for the past 14 years. Most of all, I felt opportunity…. that there is now an acknowledgement of the importance of global clinical research in this critical effort to encourage the adoption of EHRs across the U.S. and beyond. Many of the members of the HIT Standards Committee are well aware of the efforts of CDISC and of our willingness to collaborate, including two key players who have served on the CDISC Board of Directors.

Here are a few notes and quotes from the meeting that preceded the reception --- the culmination of “Summer Camp”--- during which friendship bracelets and whistles were distributed!

The meeting took place 28 September 2011, two days short of the one-year anniversary of Meaningful Use Stage One. There have been proposals that Stage One of Meaningful Use (during which EHR users receive monetary incentives to meet a base set of requirements for using EHRs meaningfully) should be extended before entering the requirements for Stage Two. The sentiment for the HIT Standards Committee, however, was expressed in the opening remarks by one of the two Chairs, Jonathan Perlin of HCA, who spoke of the work to date being a ‘beginning – a trajectory’, a set of building blocks upon which we can do more; these do NOT define the limits. We need to balance innovation vs. specification; don’t ‘constrain’ but rather define what can be supported. And, we must learn from others who have pushed the envelope.

The other chair, Dr. John Halamka of Beth Israel Deaconsess, spoke of concerns from representatives of countries outside of the U.S. They have expressed their frustration in that they feel, in their countries, they cannot articulate a standard until it is perfect; since it is never perfect, it is never articulated. One way of thinking of a definition for standards is that they are ‘implementable’ and that their success is measured by adoption vs. volumes of documentation. He stated: “We have not constrained possibilities for the future; we have identified what is ‘good enough’ for today.

” Dr. Farzad Mostashari, head of the Office of the National Coordinator (ONC), commented that Stage Two of Meaningful Use will be more rigorous in terms of exchange and interoperability. It is an escalator. He asked if we are ready, and how big of a step should we take next? Some have actually pointed out the “under-recognition” of the progress that has been made by EHRs. The foundation is very important and we need to acknowledge what is missing – that there is really an unfortunate lack of transport standards to support nationwide exchange (not just regional or local exchanges). Yes, a CCD (CDA) can be created, but the transport standards are not available to move the information where we want. The Policy Committee recommended waiting to go to Meaningful Use Stage Two, but he feels we cannot wait. One CEO of an EHR company stated….we need something/’anything’ for a transport standard. “Yes, it will be imperfect, but we need to move ahead”, commented Dr. Mostashari. He also emphasized the need to think about moving data nationally and beyond, not just within regions or entities.

 “Standards aren’t created; they are adopted” was a salient quote from Dr. Halamka later in the day.

Many of you reading this will be able to relate all of these comments to the goals of CDISC, especially those we will have for 2012. These HIT Standards efforts are directly relevant for the CDISC Healthcare Link initiative (see the blogs below on the Interoperability Showcase, where the use of EHRs for research and device safety were demonstrated at DIA2011 in June in Chicago). The concerns about releasing an ‘imperfect standard’ are specifically relevant with respect to launching SHARE (a metadata repository for clinical research standards) and the development of new standards for therapeutic areas for numerous different diseases. CDISC just received a NIH-FDA grant to look at a more streamlined approach to standards development for this purpose. Among the challenges (opportunities) facing us are: a) managing a robust, quality process that is far more streamlined than the one we used for developing our core standards; b) thinking outside of the box in order to develop such a process and accompanying tools such as SHARE; c) linking our work with healthcare and genomics standards; d) re-engaging our CDISC volunteers and engaging new volunteers from around the globe; e) not expecting a perfect standard before it is made available for comment, testing, iteration, improvement and gradually broader adoption.

There is no “perfect” standard --- standards are based upon consensus around what will be used/adopted and, therefore, upon simplicity and ease of use. Improvement will continue as we learn more based upon this use.

Rebecca D. Kush, PhD, President and CEO, CDISC