National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

GENOMICS-ENABLED
LEARNING HEALTH CARE SYSTEMS

Gathering and Using Genomic Information to
Improve Patient Care and Research

WORKSHOP SUMMARY

Roundtable on Translating Genomic-Based Research
for Health

Board on Health Sciences Policy

Sarah H. Beachy, Steve Olson, and Adam C. Berger, Rapporteurs

INSTITUTE OF MEDICINE
             OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

NOTICE: The workshop that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

This project was supported by contracts between the National Academy of Sciences and the American Academy of Nursing (unnumbered contract); American College of Medical Genetics and Genomics (unnumbered contract); American Heart Association (unnumbered contract); American Medical Association (unnumbered contract); American Society of Human Genetics (unnumbered contract); Association for Molecular Pathology (unnumbered contract); Biogen Idec (unnumbered contract); Blue Cross and Blue Shield Association (unnumbered contract); College of American Pathologists (unnumbered contract); Department of Veterans Affairs (Contract No. VA240-14-C-0037); Eli Lilly and Company (unnumbered contract); Genetic Alliance (unnumbered contract); Health Resources and Services Administration (Contract No. HHSH250200976014I, Order No. HHSH25034021T); International Society for Cardiovascular Translational Research (unnumbered contract); Janssen Research & Development, LLC (unnumbered contract); Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation (Contract No. 20121257); Merck & Co., Inc. (Contract No. CMO-140505-000393); National Cancer Institute (Contract No. HHSN263201200074I, TO#5); National Human Genome Research Institute (Contract No. HHSN263201200074I, TO#5); National Institute of Mental Health (Contract No. HHSN263201200074I, TO#5); National Institute of Nursing Research (Contract No. HHSN263201200074I, TO#5); National Institute on Aging (Contract No. HHSN263201200074I, TO#5); National Society of Genetic Counselors (unnumbered contract); Northrop Grumman Health IT (unnumbered contract); Pfizer Inc. (unnumbered contract); and PhRMA (unnumbered contract). The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.

International Standard Book Number-13: 978-0-309-37112-4
International Standard Book Number-10: 0-309-37112-0

Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2015 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested citation: IOM (Institute of Medicine). 2015. Genomics-enabled learning health care systems: Gathering and using genomic information to improve patient care and research: Workshop summary. Washington, DC: The National Academies Press.

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

Knowing is not enough; we must apply.
Willing is not enough; we must do.
”      

                                                —Goethe

image

INSTITUTE OF MEDICINE
              OF THE NATIONAL ACADEMIES

Advising the Nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. C. D. Mote, Jr., is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Victor J. Dzau is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

PLANNING COMMITTEE1

GEOFFREY GINSBURG (Co-Chair), Director, Center for Applied Genomics and Precision Medicine, Professor of Medicine and of Pathology and Biomedical Engineering, Duke University

SAM SHEKAR (Co-Chair), Chief Medical Officer, Northrop Grumman Health IT

JENNIFER HALL, Director, Program in Translational Genomics, Lillehei Heart Institute, Associate Professor of Medicine, University of Minnesota

ANDREW KASARSKIS, Vice Chair, Department of Genetics and Genomic Sciences, Co-Director, Institute for Genomics and Multiscale Biology, Icahn School of Medicine at Mount Sinai

DEBRA LEONARD, Professor and Chair of Pathology and Laboratory Medicine, The University of Vermont Medical Center

JAMES O’LEARY, Chief Innovation Officer, Genetic Alliance

MICHELLE ANN PENNY, Senior Director, TTx Genetics and Bioinformatics, Eli Lilly and Company

RONALD PRZYGODZKI, Acting Director, Biomedical Laboratory Research and Development, Associate Director for Genomic Medicine, Office of Research and Development, Department of Veterans Affairs

MICHAEL S. WATSON, Executive Director, American College of Medical Genetics and Genomics

CATHERINE A. WICKLUND, Director, Graduate Program in Genetic Counseling, Associate Professor, Department of Obstetrics and Gynecology, Northwestern University

JANET K. WILLIAMS, Professor of Nursing, Chair of the Social Science and Behavioral Research Institutional Review Board, University of Iowa

_________________

1The planning committee’s role was limited to planning the workshop. The workshop summary has been prepared by the rapporteurs as a factual account of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and are not necessarily endorsed or verified by the Institute of Medicine. They should not be construed as reflecting any group consensus.

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

IOM Staff

ADAM C. BERGER, Project Director

SARAH H. BEACHY, Associate Program Officer

MEREDITH HACKMANN, Senior Program Assistant

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

ROUNDTABLE ON TRANSLATING
GENOMIC-BASED RESEARCH FOR HEALTH1

GEOFFREY GINSBURG (Co-Chair), Director, Center for Applied Genomics and Precision Medicine, Duke University, Durham, NC

SHARON TERRY (Co-Chair), President and Chief Executive Officer, Genetic Alliance, Washington, DC

NAOMI ARONSON, Executive Director, Technology Evaluation Center, Blue Cross and Blue Shield Association, Chicago, IL

EUAN ANGUS ASHLEY, Representative of the American Heart Association; Director, Center for Inherited Cardiovascular Disease, Stanford University School of Medicine, Palo Alto, CA

PAUL R. BILLINGS, former Chief Medical Officer, Life Technologies, Carlsbad, CA

BRUCE BLUMBERG, Institutional Director of Graduate Medical Education, Northern California Kaiser Permanente, The Permanente Medical Group, Oakland, CA

PAMELA BRADLEY (until October 2014), Staff Fellow, Personalized Medicine Staff, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD

PHILIP J. BROOKS, Health Scientist Administrator, Office of Rare Diseases Research, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD

JOHN CARULLI, Director, Translational Genomics, Biogen Idec, Cambridge, MA

ANN CASHION, Scientific Director, National Institute of Nursing Research, National Institutes of Health, Bethesda, MD

ROBERT B. DARNELL, President and Scientific Director, New York Genome Center; Investigator, Howard Hughes Medical Institute, Heilbrunn Cancer Professor and Senior Physician, Head, Laboratory of Molecular Neuro-Oncology, Rockefeller University, New York, NY

MICHAEL J. DOUGHERTY, Director of Education, American Society of Human Genetics, Bethesda, MD

W. GREGORY FEERO, Contributing Editor, Journal of the American Medical Association, Chicago, IL

_________________

1Institute of Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

ANDREW N. FREEDMAN, Branch Chief, Clinical and Translational Epidemiology Branch, Epidemiology and Genetics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD

JENNIFER L. HALL, Representative of the International Society for Cardiovascular Translational Research; Associate Professor of Medicine, University of Minnesota, Minneapolis

RICHARD J. HODES, Director, National Institute on Aging, Bethesda, MD

MUIN KHOURY, Director, National Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA

GABRIELA LAVEZZARI, Assistant Vice President, Scientific Affairs, PhRMA, Washington, DC

THOMAS LEHNER, Director, Office of Genomics Research Coordination, National Institute of Mental Health, Bethesda, MD

DEBRA LEONARD, Representative of the College of American Pathologists; Professor and Chair of Pathology at the University of Vermont College of Medicine; Physician Leader of Pathology and Laboratory Medicine at Fletcher Allen Health Care, University of Vermont College of Medicine, University of Vermont, Burlington

TERI A. MANOLIO (until March 2015), Director, Division of Genomic Medicine, National Human Genome Research Institute, Rockville, MD

ELIZABETH MANSFIELD, Deputy Office Director for Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD

LAURA K. NISENBAUM, Research Fellow, Tailored Therapeutics, Eli Lilly and Company, Indianapolis, IN

MICHELLE A. PENNY (until February 2015), Senior Director, TTx Genetics and Bioinformatics, Eli Lilly and Company, Indianapolis, IN

ROBERT M. PLENGE, Vice President, Merck Research Labs; Head, Genetics and Pharmacogenomics, Merck Research Laboratories, Boston, MA

AIDAN POWER (until July 2014), Vice President and Head, PharmaTx Precision Medicine, Pfizer Inc., Groton, CT

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

VICTORIA M. PRATT, Representative of the Association for Molecular Pathology; Associate Professor of Clinical Medical and Molecular Genetics and Director, Pharmacogenomics Diagnostic Laboratory, Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis

RONALD PRZYGODZKI, Associate Director for Genomic Medicine and Acting Director of Biomedical Laboratory Research and Development, Department of Veterans Affairs, Washington, DC

MARY V. RELLING, Member and Chair, Department of Pharmaceutical Sciences, St. Jude Children’s Research Hospital, Memphis, TN

NADEEM SARWAR, Vice President and Global Head, Genetics and Human Biology; Chief Clinical Officer, Product Creation Headquarters, Eisai Inc., Cambridge, MA

JOAN A. SCOTT, Chief, Genetic Services Branch, Division of Services for Children with Special Health Needs, Maternal and Child Health Bureau, Rockville, MD

SAM SHEKAR, Chief Medical Officer, Health Information Technology Program, Northrop Grumman Information Systems, McLean, VA

KATHERINE JOHANSEN TABER, Director, Personalized Medicine, American Medical Association, Chicago, IL

DAVID VEENSTRA, Professor, Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle

MICHAEL S. WATSON, Executive Director, American College of Medical Genetics and Genomics, Bethesda, MD

DANIEL WATTENDORF, Deputy Chief, Medical Innovations, Department of the Air Force; Program Manager, Defense Advanced Research Projects Agency/Defense Sciences Office, Arlington, VA

CATHERINE A. WICKLUND, Past President, National Society of Genetic Counselors; Director, Graduate Program in Genetic Counseling; Associate Professor, Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL

ROBERT WILDIN, Chief, Genomic Healthcare Branch, National Human Genome Research Institute, Bethesda, MD

JANET K. WILLIAMS, Representative of the American Academy of Nursing; Professor of Nursing, University of Iowa, College of Nursing, Chair of Behavioral and Social Science, Iowa City

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

Fellow

SAMUEL G. JOHNSON (until August 2014), American Association of Colleges of Pharmacy/American College of Clinical Pharmacy Anniversary Fellow

IOM Staff

ADAM C. BERGER, Project Director

SARAH H. BEACHY, Associate Program Officer

MEREDITH HACKMANN, Senior Program Assistant

ANDREW M. POPE, Director, Board on Health Sciences Policy

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report:

STEPHEN LEFFLER, The University of Vermont Medical Center

TRACY A. LIEU, Kaiser Permanente Northern California

SCOTT MOSS, Epic

MARTIN PHILLIP SOLOMON, Brigham and Women’s Primary Care Associates of Brookline

Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by CLYDE J. BEHNEY, Interim Leonard D. Schaeffer Executive Officer of the Institute of Medicine. Appointed by the Institute of Medicine, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the rapporteurs and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
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×

Acknowledgments

The support of the sponsors of the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health was crucial to the planning and conduct of the workshop Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research and for the development of the workshop summary report. Federal sponsors are the Department of Veterans Affairs; Health Resources and Services Administration; National Cancer Institute; National Human Genome Research Institute; National Institute of Mental Health; National Institute of Nursing Research; and National Institute on Aging. Nonfederal sponsorship was provided by the American Academy of Nursing; American College of Medical Genetics and Genomics; American Heart Association; American Medical Association; American Society of Human Genetics; Association for Molecular Pathology; Biogen Idec; Blue Cross and Blue Shield Association; College of American Pathologists; Eli Lilly and Company; Genetic Alliance; International Society for Cardiovascular Translational Research; Janssen Research & Development, LLC; Kaiser Permanente Program Offices Community Benefit II at the East Bay Community Foundation; Merck & Co., Inc.; National Society of Genetic Counselors; Northrop Grumman Health IT; Pfizer Inc.; and PhRMA.

The Roundtable wishes to express its gratitude to the expert speakers who explored how genomic information could be gathered and used for improving patient care and research in the context of a genomics-enabled learning health care system. The Roundtable also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda. The project director would like to thank project staff who worked diligently to develop both the workshop and the resulting summary.

Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
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×
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×
Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×

Abbreviations and Acronyms

AAMC Association of American Medical Colleges
   
CDC Centers for Disease Control and Prevention
CLIA Clinical Laboratory Improvement Amendments
CMS Centers for Medicare and Medicaid Services
   
dbGaP Database of Genotypes and Phenotypes
   
DIGITizE Displaying and Integrating Genetic Information Through the EHR
   
EHR electronic health record
ESPnet EHR Support for Public Health
   
FDA U.S. Food and Drug Administration
   
GeCIP Genomics England Clinical Interpretation Partnership
   
HCC hierarchical condition category
HuGENet Human Genome Epidemiology Network
   
ICD International Classification of Diseases
IOM Institute of Medicine
   
MayoGC Mayo Genome Consortia
   
NIH National Institutes of Health
   
Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
×
PCORI Patient-Centered Outcomes Research Institute
PEER Platform for Engaging Everyone Responsibly
   
ROCC Research on Care Community
RPGEH Research Program on Genes, Environment, and Health
   
SNP single-nucleotide polymorphism
Suggested Citation:"Front Matter." Institute of Medicine. 2015. Genomics-Enabled Learning Health Care Systems: Gathering and Using Genomic Information to Improve Patient Care and Research: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/21707.
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The inclusion of genomic data in a knowledge-generating health care system infrastructure is one promising way to harness the full potential of that information to provide better patient care. In such a system, clinical practice and research influence each other with the goal of improving the efficiency and effectiveness of disease prevention, diagnosis, and treatment. To examine pragmatic approaches to incorporating genomics in learning health care systems, the Institute of Medicine Roundtable on Translating Genomic-Based Research for Health hosted a workshop which convened a variety of stakeholder groups, including commercial developers, health information technology professionals, clinical providers, academic researchers, patient groups, and government and health system representatives, to present their perspectives and participate in discussions on maximizing the value that can be obtained from genomic information. The workshop examined how a variety of systems are capturing and making use of genomic data to generate knowledge for advancing health care in the 21st century. It also sought to evaluate the challenges, opportunities, and best practices for capturing or using genomic information in knowledge-generating health care systems. Genomics-Enabled Learning Health Care Systems summarizes the presentations and discussion of the workshop.

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