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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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Suggested Citation:"Front Matter." 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. doi: 10.17226/26286.
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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 PREPUBLICATION COPY—Uncorrected Proofs

THE NATIONAL ACADEMIES PRESS  500 Fifth Street, NW  Washington, DC 20001 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 A ­ merican Asso- ciation 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 Compre- hensive 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-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/26286 Additional copies of this publication are available 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. Copyright 2021 by the National Academy of Sciences. All rights reserved. Printed in the United States of America 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. PREPUBLICATION COPY—Uncorrected Proofs

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technol- ogy. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of ­Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPY—Uncorrected Proofs

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The state- ments and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National ­Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPY—Uncorrected Proofs

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 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 s­ peakers. The responsibility for the published Proceedings of a Workshop rests with the workshop ­rapporteurs and the institution. v PREPUBLICATION COPY—Uncorrected Proofs

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 vi PREPUBLICATION COPY—Uncorrected Proofs

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. vii PREPUBLICATION COPY—Uncorrected Proofs

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 viii PREPUBLICATION COPY—Uncorrected Proofs

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 Immuno- Oncology Lab; and Biomedical Scholar and Professor of Oncology, Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center MIA LEVY, The Sheba Foundation Director, Rush University Cancer Center; Associate Professor, Department of Internal Medicine, Division of Hematology, Oncology, and Cell Therapy, Rush University; 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, Medical Director, Brigham & Women’s Primary Care Associates at Longwood; Professor of General Internal Medicine and Primary Care, Harvard Medical School; and Clinical Director, Internal Medicine for Cancer Survivors, Dana-Farber Cancer Institute ix PREPUBLICATION COPY—Uncorrected Proofs

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 x PREPUBLICATION COPY—Uncorrected Proofs

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 xi PREPUBLICATION COPY—Uncorrected Proofs

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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 mak- ing each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsive­ ness to the charge. The review comments and draft manuscript remain confi- dential 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 proceed- ings was overseen by DANIEL MASYS, University of ­Washington. He was responsible for making certain that an independent examination of this proceed- ings 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. xiii PREPUBLICATION COPY—Uncorrected Proofs

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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, Asso- ciation 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 prog- ress 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. xv PREPUBLICATION COPY—Uncorrected Proofs

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Contents ACRONYMS AND ABBREVIATIONS xxi PROCEEDINGS OF A WORKSHOP 1 WORKSHOP OVERVIEW 1 OVERVIEW OF DIGITAL HEALTH APPLICATIONS IN ONCOLOGY 6 DIGITAL HEALTH TECHNOLOGIES FOR PATIENTS AND CLINICIANS 13 Patient-Oriented Technologies, 14 Clinician-Oriented Technologies, 21 HEALTH DATA ACCESS AND USE 25 Leveraging Electronic Health Records and Artificial Intelligence to Improve Cancer Care, 25 Using Artificial Intelligence to Improve Care Delivery, 27 Making Data Usable, 28 POLICY CONSIDERATIONS 32 Regulatory Considerations, 32 Legal Considerations, 34 Payment Models, 37 Ethical Considerations, 39 REFLECTIONS AND SUGGESTIONS 42 REFERENCES 44 xvii PREPUBLICATION COPY—Uncorrected Proofs

xviii CONTENTS APPENDIX A: STATEMENT OF TASK 49 APPENDIX B: WORKSHOP AGENDA 51 PREPUBLICATION COPY—Uncorrected Proofs

Boxes, Figures, and Table BOXES 1 Suggestions from Individual Workshop Participants to Advance the Appropriate Use of Digital Health Applications in Oncology, 3 2 Examples of the Impact of the COVID-19 Pandemic Discussed by Workshop Participants: Rapid Changes in Cancer Research and Care, 7 FIGURES 1 Outpatient visits at the Rush University Cancer Center at the start of the COVID-19 pandemic, 11 2 Number of clinical trials started annually that include a connected digital product, 15 3 Conventional physician-led symptom monitoring leads to underreporting compared to patient-reported outcomes among patients with cancer, 17 4 A workflow model for implementing electronic patient-reported outcomes in oncology clinical practice, 18 TABLE 1 Availability of Different Types of Data in Electronic Health Records, 31 xix PREPUBLICATION COPY—Uncorrected Proofs

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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 Genome 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 xxi PREPUBLICATION COPY—Uncorrected Proofs

xxii ACRONYMS AND ABBREVIATIONS MSK Memorial Sloan Kettering MSKCC Memorial Sloan Kettering Cancer Center PRO patient-reported outcome PRO-CTCAETM PRO-common terminology criteria for adverse events SEER Surveillance, Epidemiology, and End Results program PREPUBLICATION COPY—Uncorrected Proofs

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Digital health encompasses a broad array of tools and strategies with the goals of advancing research, increasing health care access and quality, and making care more personalized. It encompasses health content, digital health interventions, and digital applications, such as communication tools connecting patients and clinicians (e.g., secure email in the patient portal, text, chat, video visit), remote monitoring tools, clinical decision support tools, and systems for exchanging health information. Patient-facing tools, tools for clinicians, and systems to facilitate research and care improvement are all part of this diverse landscape, and each raises unique opportunities and potential challenges.

To examine key policy issues for the effective and safe development, implementation, and use of digital health technologies in oncology research and care, the National Cancer Policy Forum of the National Academies of Sciences, Engineering, and Medicine held a virtual workshop in collaboration with the Forum on Cyber Resilience. The workshop, Opportunities and Challenges for Using Digital Health Applications in Oncology, held on July 13-14, 2020, convened a broad group of experts, including clinicians and researchers; patient advocates; and representatives of federal agencies, health professional societies, health care organizations, insurers, and the pharmaceutical and health technology industries. Many workshop speakers found the opportunities presented by digital health tools to be particularly compelling for oncology; however, capitalizing on these opportunities necessitates careful attention to the design, implementation, and use of digital health technologies. This publication summarizes the presentations and discussions from the workshop.

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