Opportunities and Challenges
for Using Digital Health
Applications in Oncology
PROCEEDINGS OF A WORKSHOP
Erin Balogh, Anne Frances Johnson, and Sharyl Nass, Rapporteurs
National Cancer Policy Forum
Board on Health Care Services
Health and Medicine Division
and
Forum on Cyber Resilience
Division on Engineering and Physical Sciences
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
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This activity was supported by Contract No. 200-2011-38807 (Task Order No. 75D30120F00089) and Contract No. HHSN263201800029I (Task Order No. HHSN26300008) with the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health, respectively, and by the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society of Clinical Oncology, Association of American Cancer Institutes, Association of Community Cancer Centers, Bristol-Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, Flatiron Health, Merck, National Comprehensive Cancer Network, National Patient Advocate Foundation, Novartis Oncology, Oncology Nursing Society, Pfizer Inc., Sanofi, and Society for Immunotherapy of Cancer. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-08922-7
International Standard Book Number-10: 0-309-08922-0
Digital Object Identifier: https://doi.org/10.17226/26286
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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2021. Opportunities and challenges for using digital health applications in oncology: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/26286.
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WORKSHOP PLANNING COMMITTEE1
LAWRENCE N. SHULMAN (Chair), Professor of Medicine, Deputy Director for Clinical Services, and Director, Center for Global Cancer Medicine, Abramson Cancer Center, University of Pennsylvania
KAREN BASEN-ENGQUIST, Annie Laurie Howard Research Distinguished Professor, Professor of Behavioral Science; and Director, Center for Energy Balance in Cancer Prevention and Survivorship, The University of Texas MD Anderson Cancer Center
CATHY J. BRADLEY, David F. and Margaret Turley Grohne Chair for Cancer Prevention and Control Research; Professor and Associate Dean for Research, Colorado School of Public Health; and Deputy Director, University of Colorado Cancer Center
DEBORAH ESTRIN, Associate Dean for Impact and Robert V. Tishman ’37 Professor, Computer Science Department, Cornell Tech
LISA KENNEDY SHELDON, Clinical and Scientific Affairs Liaison, Oncology Nursing Society; and Oncology Nurse Practitioner, St. Joseph Hospital
MIA LEVY, Sheba Foundation Director, Rush University Cancer Center; Associate Professor of Medicine, Division of Hematology and Oncology; and System Vice President, Cancer Services, Rush System for Health
J. LEONARD LICHTENFELD, Deputy Chief Medical Officer, American Cancer Society
BRADLEY MALIN, Vice Chair and Professor of Biomedical Informatics, and Professor of Biostatistics and Computer Science, Vanderbilt University Medical Center
DEVEN McGRAW, Chief Regulatory Officer, Ciitizen
NEAL J. MEROPOL, Vice President and Head of Medical and Scientific Affairs, Flatiron Health; and Adjunct Professor, Case Comprehensive Cancer Center
RANDALL A. OYER, Medical Director, Oncology, Ann B. Barshinger Cancer Institute; Medical Director, Cancer Risk Evaluation Program, Penn Medicine Lancaster General Health; and President, Association of Community Cancer Centers
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
Project Staff
ADEGBOYEGA AKINSIKU, Christine Mirzayan Science & Technology Policy Fellow (from January–April 2020)
RACHEL AUSTIN, Senior Program Associate
LORI BENJAMIN BRENIG, Research Associate
ANNALEE GONZALES, Administrative Assistant
LYNETTE MILLETT, Director, Forum on Cyber Resilience
ERIN BALOGH, Co-Director, National Cancer Policy Forum
SHARYL NASS, Co-Director, National Cancer Policy Forum, and Senior Director, Board on Health Care Services
NATIONAL CANCER POLICY FORUM1
EDWARD J. BENZ, JR. (Chair), President and Chief Executive Officer Emeritus, Dana-Farber Cancer Institute; and Richard and Susan Smith Distinguished Professor of Medicine, Genetics and Pediatrics, Harvard Medical School
PETER C. ADAMSON, Global Head, Oncology Development and Pediatric Innovation, Sanofi
GARNET L. ANDERSON, Senior Vice President and Director, Public Health Sciences Division, Fred Hutchinson Cancer Research Center; and Affiliate Professor, Department of Biostatistics, University of Washington
KAREN BASEN-ENGQUIST, Annie Laurie Howard Research Distinguished Professor, Professor of Behavioral Science; and Director, Center for Energy Balance in Cancer Prevention and Survivorship, The University of Texas MD Anderson Cancer Center
SMITA BHATIA, Professor and Vice Chair of Outcomes for Pediatrics; Gay and Bew White Endowed Chair in Pediatric Oncology; Director, Institute for Cancer Outcomes and Survivorship; and Associate Director for Outcomes Research, Comprehensive Cancer Center, The University of Alabama at Birmingham
CHRIS BOSHOFF, Chief Development Officer, Oncology, Global Product Development, Pfizer Inc.
CATHY J. BRADLEY, David F. and Margaret Turley Grohne Chair for Cancer Prevention and Control Research; Professor and Associate Dean for Research, Colorado School of Public Health; and Deputy Director, University of Colorado Cancer Center
OTIS W. BRAWLEY, Bloomberg Distinguished Professor, Department of Epidemiology, Bloomberg School of Public Health, Department of Oncology, School of Medicine, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
CYNTHIA BROGDON, Head, U.S. Oncology Portfolio Strategy, Bristol-Myers Squibb
WILLIAM G. CANCE, Chief Medical and Scientific Officer, American Cancer Society
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
ROBERT W. CARLSON, Chief Executive Officer, National Comprehensive Cancer Network
CHRISTINA CHAPMAN, Assistant Professor of Radiation Oncology, University of Michigan
GWEN DARIEN, Executive Vice President, Patient Advocacy and Engagement, National Patient Advocate Foundation
NANCY E. DAVIDSON, President and Executive Director, Seattle Cancer Care Alliance; Raisebeck Endowed Chair for Collaborative Research, Senior Vice President, Director, and Professor, Clinical Research Division, Fred Hutchinson Cancer Research Center, and Head, Department of Medicine, Division of Medical Oncology, University of Washington
JAMES H. DOROSHOW, Director, Division of Cancer Treatment and Diagnosis; Deputy Director for Clinical and Translational Research; and Head, Oxidative Signaling and Molecular Therapeutics Group, National Cancer Institute
NICOLE F. DOWLING, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention
SCOT W. EBBINGHAUS, Vice President and Therapeutic Area Head, Oncology Clinical Research, Merck Research Laboratories
KOJO S. J. ELENITOBA-JOHNSON, Professor, Perelman School of Medicine; and Director, Center for Personalized Diagnostics and Division of Precision and Computational Diagnostics, University of Pennsylvania
STANTON L. GERSON, Director, Case Comprehensive Cancer Center; Interim Dean and Senior Vice President, Medical Affairs, School of Medicine; Professor, Department of Medicine and Department of Environmental Health Sciences; Director, National Center for Regenerative Medicine, Case Western Reserve University
JULIE R. GRALOW, Executive Vice President and Chief Medical Officer, American Society of Clinical Oncology
ROY S. HERBST, Ensign Professor of Medicine and Professor of Pharmacology; Director, Center for Thoracic Cancers; Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital; Associate Cancer Center Director, Translational Science, Yale School of Medicine
HEDVIG HRICAK, Chair, Department of Radiology, Memorial Sloan Kettering Cancer Center
CHANITA HUGHES-HALBERT, Vice Chair for Research and Professor, Department of Preventive Medicine, Associate Director for Cancer Equity, Norris Comprehensive Cancer Center, University of Southern California
MIMI HUIZINGA, Vice President and Head, U.S. Oncology Medical, Novartis Oncology
ROY A. JENSEN, Director, The University of Kansas Cancer Center; William R. Jewell, M.D. Distinguished Masonic Professor, Kansas Masonic Cancer Research Institute; and Immediate Past President, Association of American Cancer Institutes
RANDY A. JONES, Professor of Nursing, Robert Wood Johnson Foundation Nurse Faculty Scholar Alumnus, University of Virginia School of Nursing
BETH Y. KARLAN, Vice Chair, Women’s Health Research Professor, Department of Obstetrics and Gynecology, David Geffen School of Medicine; and Director, Cancer Population Genetics, Jonsson Comprehensive Cancer Center, University of California, Los Angeles
SAMIR N. KHLEIF, Director, Jeannie and Tony Loop ImmunoOncology Lab; and Biomedical Scholar and Professor of Oncology, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center
MIA LEVY, Sheba Foundation Director, Rush University Cancer Center; Associate Professor of Medicine, Division of Hematology and Oncology; and System Vice President, Cancer Services, Rush System for Health
SCOTT M. LIPPMAN, Director, Moores Cancer Center; Distinguished Professor of Medicine, Senior Associate Dean, and Associate Vice Chancellor for Cancer Research and Care, and Chugai Pharmaceutical Chair in Cancer, University of California, San Diego
NEAL J. MEROPOL, Vice President and Head of Medical and Scientific Affairs, Flatiron Health; and Adjunct Professor, Case Comprehensive Cancer Center
LARISSA NEKHLYUDOV, Professor of Medicine, Harvard Medical School; Internist, Brigham and Women’s Hospital; and Clinical Director, Internal Medicine for Cancer Survivors, Dana-Farber Cancer Institute
RANDALL A. OYER, Medical Director, Oncology, Ann B. Barshinger Cancer Institute; Medical Director, Cancer Risk Evaluation Program, Penn Medicine Lancaster General Health; and President, Association of Community Cancer Centers
CLEO A. SAMUEL-RYALS, Associate Professor of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
RICHARD L. SCHILSKY, Principal Investigator, American Society of Clinical Oncology Targeted Agent and Profiling Utilization Registry (TAPURTM) Study; and Professor Emeritus, University of Chicago
JULIE SCHNEIDER, Associate Director, Research Strategy and Partnership, Oncology Center of Excellence, Food and Drug Administration
SUSAN M. SCHNEIDER, Associate Professor, Emerita, Duke University School of Nursing
LAWRENCE N. SHULMAN, Professor of Medicine, Deputy Director for Clinical Services, and Director, Center for Global Cancer Medicine, Abramson Cancer Center, University of Pennsylvania
LARA STRAWBRIDGE, Director, Division of Ambulatory Payment Models, Patient Care Models Group, Center for Medicare & Medicaid Innovation, Centers for Medicare & Medicaid Services
GEORGE J. WEINER, C.E. Block Chair of Cancer Research, Professor of Internal Medicine and Pharmaceutical Science, and Director, Holden Comprehensive Cancer Center, The University of Iowa
ROBERT A. WINN, Director, Massey Cancer Center; Senior Associate Dean for Cancer Innovation; Professor, Pulmonary Disease and Critical Care Medicine; and Lipman Chair in Oncology, School of Medicine, Virginia Commonwealth University
PHYLICIA L. WOODS, Executive Director, Cancer Policy Institute, Cancer Support Community
National Cancer Policy Forum Staff
FRANCIS AMANKWAH, Program Officer
RACHEL AUSTIN, Senior Program Assistant
LORI BENJAMIN BRENIG, Research Associate
ANNALEE GONZALES, Administrative Assistant
MICAH WINOGRAD, Senior Finance Business Partner
ERIN BALOGH, Co-Director, National Cancer Policy Forum
SHARYL J. NASS, Co-Director, National Cancer Policy Forum, and Senior Director, Board on Health Care Services
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Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
CHRISTOPHER R. COGLE, University of Florida
PAUL KLUETZ, Food and Drug Administration
SUSAN K. PETERSON, The University of Texas MD Anderson Cancer Center
KRISTEN B. ROSATI, Coppersmith Brockelman PLC
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by DANIEL MASYS, University of Washington. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
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Acknowledgments
Support from the many annual sponsors of the National Academies of Sciences, Engineering, and Medicine’s National Cancer Policy Forum is crucial to the work of the forum. Federal sponsors include the Centers for Disease Control and Prevention and the National Cancer Institute/National Institutes of Health. Nonfederal sponsors include the American Association for Cancer Research, American Cancer Society, American College of Radiology, American Society of Clinical Oncology, Association of American Cancer Institutes, Association of Community Cancer Centers, Bristol-Myers Squibb, Cancer Support Community, CEO Roundtable on Cancer, Flatiron Health, Merck, National Comprehensive Cancer Network, National Patient Advocate Foundation, Novartis Oncology, Oncology Nursing Society, Pfizer Inc., Sanofi, and Society for Immunotherapy of Cancer.
The forum wishes to express its gratitude to the expert speakers whose presentations helped further the dialogue on opportunities to advance progress in the effective and safe development, implementation, and use of digital health in oncology research and care. The forum also wishes to thank the members of the planning committee for their work in developing an excellent workshop agenda.
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Acronyms and Abbreviations
| AI | artificial intelligence |
| BRCA | BReast CAncer gene |
| CDRH | Center for Devices and Radiological Health |
| CMS | Centers for Medicare & Medicaid Services |
| CodeX | Common Oncology Data Elements eXtensions |
| EHR | electronic health record |
| ENE | extranodal extension |
| ePRO | electronic patient-reported outcome |
| FDA | Food and Drug Administration |
| FHIR | Fast Healthcare Interoperability Resources |
| GA4GH | Global Alliance for Genomics and Health |
| GDO | Genetic Discrimination Observatory |
| HIPAA | Health Insurance Portability and Accountability Act |
| HITECH Act | Health Information Technology for Economic and Clinical Health Act |
| mCODE | Minimal Common Oncology Data Elements |
| ML | machine learning |
| MSK | Memorial Sloan Kettering |
| MSKCC | Memorial Sloan Kettering Cancer Center |
| PRO | patient-reported outcome |
| PRO-CTCAETM | PRO-Common Terminology Criteria for Adverse Events |
| PROVE | Patient-Reported Outcomes, Value & Experience |
| SEER | Surveillance, Epidemiology, and End Results program |
