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
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
THE NATIONAL ACADEMIES PRESS500 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; The Kavli Foundation, 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: 978-0-309-48510-4
International Standard Book Number-10: 0-309-48510-X
Digital Object Identifier: https://doi.org/10.17226/25274
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/10.17226/25274.
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.
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.
PLANNING COMMITTEE ON HARNESSING MOBILE TECHNOLOGY TO PREDICT, DIAGNOSE, MONITOR, AND DEVELOP TREATMENTS FOR NERVOUS SYSTEM DISORDERS1
HUSSEINI MANJI (Co-Chair), Janssen Research & Development, LLC
JP ONNELA (Co-Chair), Harvard T.H. Chan 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
___________________
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.
This page intentionally left blank.
FORUM ON NEUROSCIENCE AND NERVOUS SYSTEM DISORDERS1
STORY LANDIS (Co-Chair), Director Emeritus, National Institute of Neurological Disorders and Stroke
JOHN KRYSTAL (Co-Chair), Yale University
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
ROBERT CONLEY, Eli Lilly and Company (from October 2018)
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 (until October 2018)
FRANCES JENSEN, University of Pennsylvania
___________________
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.
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
CAROLINE MONTOJO, The Kavli Foundation
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 Associate
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.
This page intentionally left blank.
Contents
Organization of the Proceedings
2 EXPLORING OPPORTUNITIES AFFORDED BY MOBILE TECHNOLOGY
Technical, Methodological, and Ethical Challenges
3 TRANSFORMING DIGITAL DATA INTO INSIGHT: COLLECTION, ANALYSIS, STANDARDIZATION, AND VALIDATION
Organizing, Managing, and Interpreting Digital Data
4 REGULATORY CONSIDERATIONS AND PATHWAYS
Regulatory Pathways for Medical Devices
Regulatory Use of Digital Data in Clinical Trials
5 INTEGRATING MOBILE TECHNOLOGY INTO CLINICAL PRACTICE