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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Harnessing Mobile Devices for Nervous System Disorders: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25274.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Harnessing Mobile Devices for Nervous System Disorders PROCEEDINGS OF A WORKSHOP Lisa Bain, Daniel Flynn, and Clare Stroud, Rapporteurs Forum on Neuroscience and Nervous System Disorders Board on Health Sciences Policy Health and Medicine Division PREPUBLICATION COPY: UNCORRECTED PROOFS

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 This activity was supported by contracts between the National Academy of Sciences and the Alzheimer’s Association; Cohen Veterans Bioscience; Department of Health and Human Services’ Food and Drug Administration (5R13FD005362-02) and National Institutes of Health (NIH) (HHSN26300089 [Under Master Base #DHHS-10002880]) through the National Center for Complementary and Integrative Health, National Eye Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute on Drug Abuse, and NIH Blueprint for Neuroscience Research; Department of Veterans Affairs (VA240-14-C-0057); Eli Lilly and Company; Foundation for the National Institutes of Health; Gatsby Charitable Foundation; George and Anne Ryan Institute for Neuroscience at The University of Rhode Island; Janssen Research & Development, LLC; Lundbeck Research USA; Merck Research Laboratories; The Michael J. Fox Foundation for Parkinson’s Research; National Multiple Sclerosis Society; National Science Foundation (BCS- 1064270); One Mind; Sanofi; Society for Neuroscience; Takeda Pharmaceuticals International, Inc.; and Wellcome Trust. 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: International Standard Book Number-10: Digital Object Identifier: https://doi.org/10.17266/25274 Additional copies of this publication 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. Copyright 2018 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. 2018. Harnessing mobile devices for nervous system disorders: Proceedings of a workshop. Washington, DC: The National Academies Press. Doi https://doi.org/ 10.17266/25274 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 technology. 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. C. D. Mote, Jr., 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 statements 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

PLANNING COMMITTEE ON HARNESSING MOBILE TECHNOLOGY TO PREDICT, DIAGNOSE, MONITOR, AND DEVELOP TREATMENTS FOR NERVOUS SYSTEM DISORDERS 1 HUSSEINI MANJI (Co-Chair), Janssen Research & Development LLC JP ONNELA (Co-Chair), Harvard School of Public Health LINDA BRADY, National Institute of Mental Health E. RAY DORSEY, University of Rochester DEBORAH ESTRIN, Cornell University MAGALI HAAS, Cohen Veterans Bioscience DANIEL KARLIN, CEAi, Inc. STORY LANDIS, Director Emeritus, National Institute of Neurological Disorders and Stroke ROBERT McBURNEY, Accelerated Cures Project for Multiple Sclerosis VAIBHAV NARAYAN, Janssen Research & Development, LLC LOUIS PASQUALE, Harvard Medical School NORA VOLKOW, National Institute on Drug Abuse Health and Medicine Division Staff CLARE STROUD, Director, Forum on Neuroscience and Nervous System Disorders SHEENA M. POSEY NORRIS, Program Officer NOAM I. KEREN, Associate Program Officer (until July 2018) DANIEL FLYNN, Research Associate ANDREW M. POPE, Senior Director, Board on Health Sciences Policy 1The 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. v PREPUBLICATION COPY: UNCORRECTED PROOFS

FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS 1 JOHN KRYSTAL (Co-Chair), Yale University STORY LANDIS (Co-Chair), Director Emeritus, National Institute of Neurological Disorders and Stroke SUSAN AMARA, Society for Neuroscience RITA BALICE-GORDON, Sanofi KATJA BROSE, Chan Zuckerberg Initiative EMERY BROWN, Harvard Medical School and Massachusetts Institute of Technology DANIEL BURCH, Pharmaceutical Product Development, LLC JOSEPH BUXBAUM, Icahn School of Medicine at Mount Sinai SARAH CADDICK, Gatsby Charitable Foundation ROSA CANET-AVILES, Foundation for the National Institutes of Health MARIA CARRILLO, Alzheimer’s Association E. ANTONIO CHIOCCA, Harvard Medical School TIMOTHY COETZEE, National Multiple Sclerosis Society JONATHAN COHEN, Princeton University FAY LOMAX COOK, National Science Foundation (until August 2018) JAMES DESHLER, National Science Foundation BILLY DUNN, Food and Drug Administration MICHAEL EGAN, Merck Research Laboratories JOSHUA GORDON, National Institute of Mental Health HENRY T. GREELY, Stanford University RAQUEL GUR, University of Pennsylvania MAGALI HAAS, Cohen Veterans Bioscience RAMONA HICKS, One Mind RICHARD HODES, National Institute on Aging STUART HOFFMAN, Department of Veterans Affairs STEVEN HYMAN, Broad Institute of Massachusetts Institute of Technology and Harvard University MICHAEL IRIZARRY, Eli Lilly and Company FRANCES JENSEN, University of Pennsylvania 1The National Academies of Sciences, Engineering, and Medicine’s forums and round- tables 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

GEORGE KOOB, National Institute on Alcohol Abuse and Alcoholism WALTER KOROSHETZ, National Institute of Neurological Disorders and Stroke ALAN LESHNER, American Association for the Advancement of Science (Emeritus) HUSSEINI MANJI, Janssen Research & Development, LLC ATUL PANDE, Tal Medical STEVEN PAUL, Voyager Therapeutics, Inc. EMILIANGELO RATTI, Takeda Pharmaceuticals International, Inc. DOUGLAS SHEELEY, National Institute of Dental and Craniofacial Research TODD SHERER, The Michael J. Fox Foundation for Parkinson’s Research DAVID SHURTLEFF, National Center for Complementary and Integrative Health PAUL SIEVING, National Eye Institute NORA VOLKOW, National Institute on Drug Abuse ANDREW WELCHMAN, Wellcome Trust DOUG WILLIAMSON, Lundbeck STEVIN ZORN, MindImmune Therapeutics, Inc. Health and Medicine Division Staff CLARE STROUD, Forum Director SHEENA M. POSEY NORRIS, Program Officer NOAM I. KEREN, Associate Program Officer (until July 2018) DANIEL FLYNN, Research Assistant BARDIA MASSOUDKHAN, Financial Associate ANDREW M. POPE, Senior Director, Board on Health Sciences Policy

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: DROR BEN-ZEEV, University of Washington School of Medicine JESSE CEDARBAUM, Biogen IVAN LEE, University of Massachusetts Amherst JOHN TOROUS, Harvard Medical School 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 LESLIE Z. BENET, University of California, San Francisco. 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. ix PREPUBLICATION COPY: UNCORRECTED PROOFS

Contents 1 INTRODUCTION AND BACKGROUND 1 Workshop Objectives, 2 Organization of the Proceedings, 3 2 EXPLORING OPPORTUNITIES AFFORDED BY MOBILE TECHNOLOGY 5 Technical, Methodological, and Ethical Challenges, 8 3 TRANSFORMING DIGITAL DATA INTO INSIGHT: COLLECTION, ANALYSIS, STANDARDIZATION, AND VALIDATION 9 Collecting the Data, 12 Validating Digital Data, 15 Organizing, Managing, and Interpreting Digital Data, 17 Activating the Data, 18 4 REGULATORY CONSIDERATIONS AND PATHWAYS 21 Regulatory Pathways for Medical Devices, 22 Regulatory Use of Digital Data in Clinical Trials, 24 Navigating the Regulatory Web, 27 5 INTEGRATING MOBILE TECHNOLOGY INTO CLINICAL PRACTICE 29 Clinician Use of Mobile Health Technologies, 32 Health Care Systems’ Integration of Mobile Technology, 33 xi PREPUBLICATION COPY: UNCORRECTED PROOFS

xii CONTENTS 6 DESIGNING MOBILE TECHNOLOGIES FOR RESEARCH AND CLINICAL PRACTICE THAT REFLECT PATIENT ATTITUDES AND PREFERENCES 37 Surveying Consumer Attitudes About Mobile Technology, 39 Assessing Function in Real-Life Settings, 40 Integrating Digital Technologies into Clinical Trials: Benefits to Patients, 42 Informed Consent, 43 Digital Technologies as Interventions, 43 7 MOVING FORWARD BY BUILDING PARTNERSHIPS 45 An Ecosystem of Partnerships, 46 Enabling Partnerships Through Data Sharing, 51 Final Remarks, 54 APPENDIXES A References 55 B Workshop Agenda 59 C Registered Attendees 67 PREPUBLICATION COPY: UNCORRECTED PROOFS

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The critical importance of using mobile technology is clear to anyone in the health professions, particularly those who treat people with central nervous system (CNS) disorders. To explore current developments and opportunities for using mobile technology to advance research and treatment of CNS disorders, the National Academies’ Forum on Neuroscience and Nervous System Disorders hosted a workshop in June 5–6, 2018. This publication summarizes the presentations and discussions at the workshop.

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