September 30, 2013
8 PDT/9 MDT/10 CDT/11 EDT
Attendees: David Blake, Ross McKinney, Co-Chairs; Betty Harvey and Valerie Smothers, staff; Teresa Anderson, Elizabeth Boyd, Mike Champa, Michaeline Daboul, Luke Diorio, Julie Gottlieb, Norman Kahn, Kirke Lawton, Nancy Lowitt, Monika Markowitz, Raj Mehrotra, Pamela Miller, Heather Pierce, Tim Robinson, Bill Sacks, Cory Schmidt, Steve Singer, Rebecca Spence, John Sweeney, Raju Vestemean, and Gary Wimsett.
Each member of the group introduced themselves. Steve Singer is Director of Education and Outreach and John Sweeney is the Manager of the PARS data base at the ACCME. Norman Kahn is the Executive Vice President at the Council of Medical Specialty Societies. Ross McKinney, co-chair of the group, is a pediatric infection disease specialist and co-chair of the Institute of Medicine committee that examined harmonized reporting on conflict of interest. David Blake is Vice President of Corporate Integrity at Cedars Sinai and also serves as co-chair of this group. Bill Sacks is Vice President of HCCS and spearheaded their Conflict of Interest Smart Tool. Raj Mehrotra also from HCCS and is the Director of data base services. Michaeline Daboul is Co-founder and President of MMIS, which makes Medispend. Betty Harvey is an XML consultant who has worked in many standards organization; she will serve as technical staff for this group. Gary Wimsett is the Director of Conflict of Interest at the University of Florida College of Medicine. Tim Robinson is the co-founder of MMIS. Monika Markowitz is the Director of the Office of Research Integrity and Ethics at the Virginia Commonwealth University. Pam Miller works on special projects at the New England Journal of Medicine editorial office. Heather Pierce is the Senior Director Science Policy Regulation at the AAMC. Luke Diorio is Director of Business Strategy and Business Development, and Kirke Lawton is the Senior Director of Enterprise Information at the AAMC. Mike Champa is from Huron Consulting and works with their research administration software system. Nancy Lowitt is the Associate Dean for Faculty Affairs and Professional Development and Chief Conflict of Interest Officer at the University of Maryland School of Medicine. Cory Schmidt is the Director of Conflict of Interest Compliance at the Cleveland Clinic. Radu Vestemean is founder and President of Knowledge4You. Elizabeth Boyd is Vice Chancellor of Research Compliance at the University of California Riverside School of Medicine and is a member of the AAMC Forum on Conflict of Interest (FOCI) Steering Committee meeting. Teresa Anderson directs the Conflict of Interest Office at Wake Forest University and is a member of the AAMC FOCI Steering Committee as well.
Dr. McKinney explained that clinicians and researchers often complete Conflict of Interest (COI) forms frequently and on a repetitive basis. The Institute of Medicine put together a panel to discuss the possibility of creating a common COI reporting process in an electronic form. It was ultimately judged feasible. A paper was published in JAMA, and an IOM discussion paper was published. He noted that data security adds to the credibility of the system and the data it houses. It was determined this large data base should be housed in an existing organization, and the AAMC stepped forward. The AAMC contacted MedBiquitous as part of their development process.
Heather thanked everyone for agreeing to participate in the group. The IOM made recommendations related to conflict of interest in 2009, and in 2011 the IOM convened a group to look at whether the system described would be possible. Now we are at the point of building the enabling technical standards and the system. The AAMC is honored to take on this work. The governance structure will be a separate initiative.
Dr. Blake added that the IOM paper’s suggestions and recommendations will serve as a starting point to move forward. Valerie stated the intent of this group was to build on that foundation.
Valerie stated the goal of our work: to develop an initial technical specification that will enable multi-institution and multi-system interoperability around financial interest and disclosure data for the health professions.
4 Development process
Valerie explained that it is the work of this group to build the plumbing to move data from one system to another system to enable the IOM report goals. Subject matter experts are essential to drive the process. Betty Harvey will be doing the heavy lifting on developing the XML schema. Slide 7 shows an overview of our ANSI-accredited development process. For the next 6 months this group will work to develop a draft standard to present to the Standards Committee, which is the consensus body of MedBiquitous. The draft will be reviewed and balloted by the Standards Committee. The Standards Committee will work with this working group to resolve any substantive issues that arise. The project plan details what will happen over the next 6 months. The first few tasks are complete. The next step is developing explicit use cases about what we are trying to accomplish with the technical specifications. The technical specification will be designed to support the AAMC system, but we do not want to be exclusive. The standard should be applicable to other uses or contexts as well. After the use case development we will do a data analysis to determine the requirements for each use case. Then the technical specification will be developed. This is a highly iterative process. Once we have a solid specification, we will ask people to do a technical review. AAMC is funding this project in an accelerated fashion. The resulting standard will be made available under very open terms at no cost.
Valerie provided an overview of the MedBiquitous wiki. There is a space for confidential documents as well as a glossary of common terms. Sometimes we come upon areas where best practices are helpful; there is a page for documenting those. There is a page for specifications and schemas and another for use cases and scenario section. There is page listing working group members and their email address. We also have a mailing list; each member should have received a note with call information.
6 Project Plan and timeline
Dr. Blake asked about the timeline. Valerie commented that use case development should be complete shortly after the AAMC annual meeting. Bill commented that related work to define functionality of the system would impact the use cases and cross pollination would be important. Heather replied that there would be a great deal of cross pollination. She offered to assist with making sure related efforts feed into the products developed by MedBiquitous. The next meeting will be Oct 7th at 12:00.