AG: Tell me about your main initiatives.
CJ: A crucial one was this October when we restructured the process for developing specifications. HL7 had been a volunteer organization in which any one of the 55 technical committees and workgroups percolate up activities as they saw fit. This process led to confusion on deliverables, conflicts among workgroups and concern around timelines. So one of first things I did was to begin a restructuring in which we formed a technical steering committee (TSC) with representation from logical groupings of the technical committees into steering divisions which added a top-down approach to complement, track and manage the activities of the volunteer organization. This way, all development activities initiate at the TSC level. The steering division members represent typically six-12 technical committees each and were elected by membership. There was a staff-level management component from the CTO whom I appointed, John Quinn. (See HCI’s interview with Quinn)
That was the most crucial first management step — the development of a new process for the program office and management hierarchy. Out of that, I promised development of a roadmap. We are in the process of completing a roadmap that integrates technical, business, policy and organizational timelines so that our stakeholders have a reasonable expectation about what will come in the next one, three and five years. This will also let them know what the policy changes look like so they can implement different specifications, and with whom we will nurture relationships, who we will build resources for, and what new income opportunities we will develop to fund the specific activities.
These have all been laid out in a roadmap and presented to the board in April. After that, we will certainly have a better story to tell our stakeholders, and they will be able to make development decisions based on these deliverables, in terms of content and time. Part of the project management office’s objective will be managing to those business requirements, not least of which is if we commit that we are going to do it that we have resources to meet the timelines. So I think there will be a new look and feel for the organization. I think there have been several initiatives to help support that.
One of those is the development of the joint working group which originally included HL7, ISO and CEN (the European Union’s standards body). Part of the EU directive has been that if you are an EU member you will abide by this standard agreement from CEN. This is important because many of our most cutting-edge affiliate countries, such as the U.K. and the Netherlands, are committed to HL7 standards. So we not only want to harmonize with any CEN requirement, but also deal with gaps which exist between CEN and HL7.
Short of that, we have been looking at other issues, and we continue to have a superb working relationship with HITSP but also just as IHE has joined HL7, we’ve become a founding member of the new IHE corporate structure, and we are working on a memorandum of understanding for implementation guides and joint initiative projects at that level of clinical research where new members have evolved. This is true particularly for pharma, but also like the NIH and CDC, it is a cooperative effort to model the research domain in reference to the information model. This is rather than the painful mapping that has to take place between CDISC – Clinical Data Interchange Standards Consortium Inc. — and the FDA and other relating agencies that are authorized to receive information electronically.
I am the original acronym hater. At Intel, people could tell I had created a particular PowerPoint because there were no acronyms. In any event, NIH funded a good deal of work for the Clinical Data Interchange Standards Consortium so the FDA has guidance on receiving all submissions through the CDISC standard. Recently, they have begun a project for putting all of this CDISC information in an HL7 wrapper, and rest of world has gone along with it. HL7 and CDISC are really the model of how SDOs can achieve common goals. Through the efforts of the National Cancer Institute, we both modeled clinical research within the Reference Information Model so that no mapping is necessary.