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Institute of Medicine Digital Learning Collaborative of the IOM Roundtable on Value & Science-Driven Health Care May 30, 2014 National Academy of Sciences Building Room 120 2101 Constitution Avenue, NW Washington, DC Roundtable on Value & Science-Driven Health Care Digital Learning Collaborative May 30, 2014 Table of Contents SECTION 1: DAY OF MATERIALS • Agenda • Participant list SECTION 2: BACKGROUND MATERIALS • Panel I: EHR-enabled research as part of a learning health system - Kush, R. D. 2011. Transforming Medical Research with Electronic Health Records. iHealth Connections 1(1):16-20. • Panel II: Standards available to facilitate EHR-enabled research - Gallego-Haag, E., F. Darbouze. 2014. Structured Data Capture (SDC) Initiative. • Panel III: EHR-enabled research activities - I-SPY 2 Trial. I-SPY 2 Innovations. http://www.ispy2trial.org/about/i-spy-2-trial. - Petkov, V. I., L. T. Penberthy, B. A. Dahman, A. Poklepovic, C. W. Gillam, J. H. McDermott. 2013. Automated determination of metastases in unstructured radiology reports for eligibility screening in oncology clinical trials. Experimental Biology and Medicine 238(12):1370-1378. • Panel IV: Opportunities for vendors to lead the way - Cole, G. 2014. Implementing Standards-based EHR-enabled Research. - Cusack, C. M., G. Hripcsak, M. Bloomrosen, S. T. Rosenbloom, C. A. Weaver, A. Wright, D. K. Vawdrey, J. Walker, L. Mamykina. 2013. The future of clinical data capture and documentation: a report from AMIA’s 2011 Policy Meeting. Journal of the American Medical Informatics Association 20(1):134-140. - Neri, P. M., L. A. Volk, S. Samaha, S. E. Pollard, D. H. Williams, J. M. Fiskio, E. Burdick, S. T. Edwards, H. Ramelson, G. D. Schiff, D. W. Bates. 2014. Relationship between documentation method and quality of chronic disease visit notes. Applied Clinical Informatics 5(2):480-490. - Rosenbloom, S. T., J. C. Denny, H. Xu, N. Lorenzi, W. W. Stead, K. B. Johnson. 2001. Data from clinical notes: a perspective on the tension between structure and flexible documentation. Journal of the American Medical Informatics Association 18(2):181-186. - Rothmerier, R. 2010. To EDC and Beyond: Ross Rothmeier at Covance evaluates electronic data capture as part of an electronic trial management system: what lies ahead for EDC and what is required for its success. Applied Clinical Trials Magazine. http://www.appliedclinicaltrialsonline.com/. SECTION 3: ORGANIZATIONAL BACKGROUND • IOM Roundtable on Value & Science-Driven Health Care (VSRT) background information • Digital Learning Innovation Collaborative (DLC) background information SECTION 4: PARTICIPANT BIOGRAPHIES AND MEETING LOGISTICS • Participant biographies • Meeting logistics SECTION 1 Day of Materials IOM ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE DIGITAL LEARNING COLLABORATIVE MAY 30, 2014 NATIONAL ACADEMY OF SCIENCES BUILDING ROOM 120 2101 CONSTITUTION AVE NW WASHINGTON DC Meeting goals 1. Learning from EHRs. Together with the Learning Healthcare Community’s Essential Standards to Enable Learning (ESTEL) working group, convene essential stakeholders, including standards groups, federal agencies, academic health systems (AHSs), and electronic health record (EHR) and research technology vendors around the issue of the implementing standards-based EHR-enabled research. 2. Facilitative standards. Describe approaches to EHR-enabled research, including those based on the ONC Structured Data Capture (SDC) Initiative, CDISC Healthcare Link, IHE Quality, Research and Public Health, and FDA eSource Guidance and identify how to realize available opportunities. 3. Vendor opportunities. Identify opportunities for vendors, interested AHSs, and research sponsors to accelerate progress towards more widely implemented EHR- enable research 8:00 am Coffee and light breakfast available 8:30 am Welcome, introductions, and meeting overview Welcome from the IOM Michael McGinnis, Institute of Medicine Opening remarks and meeting overview by Collaborative Chairs Jonathan Perlin, HCA Inc. Reed Tuckson, Tuckson Health Connections, LLC 8:45 am EHR-enabled research as part of a learning health system The learning health system context Doug Fridsma, Office of the National Coordinator for Health IT Essential Standards to Enable Learning (ESTEL) Rebecca Kush, Clinical Data Interchange Standards Consortium Q&A and Open Discussion 9:15 am Standards available to facilitate EHR-enabled research ONC’s Structured Data Capture initiative Evelyn Gallego-Haag and Farrah Darbouze, Office of the National Coordinator for Health IT Enabling interoperability across the continuum of health and health care Charles Jaffe, HL7 eSource: FDA Guidance on using electronic source data for clinical investigations Ron Fitzmartin, Food and Drug Administration Role of CDISC and IHE in EHR-enabled research Landen Bain, Clinical Data Interchange Standards Consortium Q&A and Open Discussion 10:15 am Break 10:30 am EHR-enabled research activities The I-SPY Trial Sarah Davis, I-SPY Duke University experience Iain Sanderson, Duke University NYU experience John Speakman, New York University Virginia Commonwealth University experience David Fenstermacher, Virginia Commonwealth University Q&A and Open Discussion 11:45 am Lunch 12:30 pm Opportunities for vendors to lead the way Scott Moss, Epic Ryan Moog, Cerner George Cole, Allscripts Trent Rosenbloom, Vanderbilt University Joseph Dustin, Medidata Solutions Ken Pool, OZ Systems Vijay Pillai, Oracle Q&A and Open Discussion 1:30 pm Accelerating progress Session description: A moderated roundtable discussion about what different stakeholder groups can do in order to accelerate progress including stimulating sharing and measuring success. Q&A and Open Discussion 3:00 pm Summary and next steps Comments from the Chairs Jonathan Perlin, HCA Inc. Reed Tuckson, Tuckson Health Connections, LLC Comments and thanks from the IOM Michael McGinnis, Institute of Medicine 3:30 pm Adjourn ROUNDTABLE ON VALUE & SCIENCE-DRIVEN HEALTH CARE Digital Learning Collaborative May 30, 2014 Meeting Participants Chairs: Edward W. Campion, MD Senior Deputy Editor and Online Editor Jonathan B. Perlin, MD, PhD, MSHA New England Journal of Medicine President, Clinical Services and Chief Medical [email protected] Officer Hospital Corporation of America Michael N. Cantor, MD, MA [email protected] Director, Clinical Research Informatics New York University School of Medicine Reed V. Tuckson, MD, FACP [email protected] Managing Director Tuckson Health Connections Basit Chaudhry, MD, PhD [email protected] Founder & CEO Tuple Health Participants: [email protected] Holt Anderson Timothy Chen Executive Director Director, Quality & Regulatory Affairs North Carolina Healthcare Information & Medidata Solutions Communications Alliance [email protected] [email protected] James J. Cimino, MD Landen Bain Chief, Laboratory for Informatics Development Healthcare Liaison National Institutes of Health Clinical Data Interchange Standards Consortium [email protected] [email protected] George Cole Hunt Blair Principal Scientist, Community Solutions Principal Advisor, HIT-enabled Care Allscripts Transformation [email protected] Office of the National Coordinator for Health IT [email protected] Farrah Darbouze Public Health Analyst John L. Burch Office of the National Coordinator for Health IT JLB Associates [email protected] [email protected] Current as of 9am on 6/3/14 Sarah Davis, MS Mark E. Frisse, MD, MS, MBA Translational Bioinformatics Product Manager Accenture Professor, Biomedical Informatics University of California San Francisco Vanderbilt University [email protected] [email protected] Joseph Dustin Evelyn Gallego-Haag, MBA Senior Solutions Consultant Initiative Coordinator, Standards & Medidata Solutions Interoperability Framework [email protected] Office of the National Coordinator for Health IT [email protected] Christine Dymek, EdD Analyst, Division of Healthcare Quality and Charles E. Geyer, Jr., MD Outcomes Professor, Medicine; Chair, Cancer Research; Office of the Assistant Secretary for Planning Associate Director, Clinical Research and Evaluation Virginia Commonwealth University Massey [email protected] Cancer Center [email protected] Margo Edmunds, PhD Vice President, Evidence Generation and Amer Haider Translation CEO AcademyHealth Doctella [email protected] [email protected] David A. Fenstermacher, PhD Marcelline Harris, PhD Chief Research Information Officer Associate Professor, Nursing Virginia Commonwealth University University of Michigan [email protected] [email protected] Ronald Fitzmartin, PhD, MBA Erin Holve, PhD, MPH, MPP Senior Advisor, Office of Strategic Programs Senior Director Food and Drug Administration AcademyHealth [email protected] [email protected] Scott C. Fogerty Betsy L. Humphreys, MLS Senior Business Development Executive Deputy Director GNS Healthcare National Library of Medicine [email protected] [email protected] Douglas B. Fridsma, MD, PhD Charles Jaffe, MD, PhD Chief Science Officer and Director, Office of CEO Science and Technology Health Level 7 International Office of the National Coordinator for Health IT [email protected] [email protected] Kim Johnson Charles P. Friedman, PhD President Director, Health Informatics Program ResearchTec University of Michigan [email protected] [email protected] Rebecca D. Kush, PhD Ken Pool, MD Founder, President, and CEO Co-Founder, Chief Operating
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