Digital Health: Understanding the Benefit-Risk Patient-Provider Framework

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Eric D. Perakslis (Lecturer in Biomedical Informatics, Department of Biomedical Informatics, Lecturer in Biomedical Informatics, Department of Biomedical Informatics, Harvard Medical School) Martin Stanley (Strategic Technology Branch Chief, Strategic Technology Branch Chief, Cybersecurity and Infrastructure Security Agency)

Digital Health

Understanding the Benefit-Risk Patient-Provider Framework

Eric D. Perakslis (Lecturer in Biomedical Informatics, Department of Biomedical Informatics, Lecturer in Biomedical Informatics, Department of Biomedical Informatics, Harvard Medical School), Martin Stanley (Strategic Technology Branch Chief, Strategic Technology Branch Chief, Cybersecurity and Infrastructure Security Agency), Erin Brodwin (Health Tech Reporter and author, Health Tech Reporter and author)

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English

Oxford University Press Inc
20 May 2021

Public health & preventive medicine; Biotechnology; Computer security

"Digital health represents the fastest growing sector of healthcare. From internet-connected wearable sensors to diagnostics tests and disease treatments, it is often touted as the revolution set to solve the imperfections in healthcare delivery worldwide. While the health value of digital health technology includes greater convenience, more personalized treatments, and more accurate data capture of fitness and wellness, these devices also carry the concurrent risks of technological crime and abuses pervasive to cyber space. Even today, the medical world has been slow to respond to these emerging risks, despite the growing permanence of digital health technology within daily medical practice.

With over 30 years of joint experience across the medical and cybersecurity industries, Eric D. Perakslis and Martin Stanley provide in this volume the first reference framework for the benefits and risks of digital health technologies in practice. Drawing on expert interviews, original research, and personal storytelling, they explore the theory, science, and mathematics behind the benefits, risks, and values of emerging digital technologies in healthcare. Moving from an overview of biomedical product regulation and the evolution of digital technologies in healthcare, Perakslis and Stanley propose from their research a set of ten categories of digital side effects, or ""toxicities,"" that must be managed for digital health technology to realize its promise. These ten toxicities consist of adversary-driven threats to privacy such as physical security, cybersecurity, medical misinformation, and charlatanism, and non-adversary-driven threats such as deregulation, cyberchondria, over-diagnosis/over-treatment, user error, and financial toxicity. By arming readers with the knowledge to mitigate digital health harms, Digital Health empowers health practitioners, patients, and technology providers to move beyond fear of the unknown and embrace the full potential of digital health technology, paving the way for more conscientious digital technology use of the future."

By: Eric D. Perakslis (Lecturer in Biomedical Informatics Department of Biomedical Informatics Lecturer in Biomedical Informatics Department of Biomedical Informatics Harvard Medical School), Martin Stanley (Strategic Technology Branch Chief, Strategic Technology Branch Chief, Cybersecurity and Infrastructure Security Agency)
Foreword by: Erin Brodwin (Health Tech Reporter and author Health Tech Reporter and author)
Imprint: Oxford University Press Inc
Country of Publication: United States
Dimensions: Height: 243mm, Width: 160mm, Spine: 19mm
Weight: 520g
ISBN: 9780197503133
ISBN 10: 0197503136
Pages: 264
Publication Date: 20 May 2021
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

"Table of Contents Preface Part 1: Historical Overview and the Evolution of Digital Health Technologies Chapter 1: A Brief History of Biomedical Products Regulation Chapter 2: Medical Benefit-Risk Determination Chapter 3: Medical Ethics Models and Frameworks in Digital Health Chapter 4: The Evolution of Digital Technologies in Healthcare Chapter 5: Pulse Oximetry in Anesthesia -- The ""Perfect"" Medical Technology Use Case Chapter 6: The Technology of Biotechnology and Big Data in Medicines Chapter 7: Electronic Health Records: Promises, Progress, and Problems Part 2: The Ten Toxicities of Digital Health Chapter 8: Introducing the Ten Toxicities Chapter 9: Adversary-Driven Toxicities Chapter 10: Non-Adversary-Driven Toxicities Part 3: Frameworks for Digital Risk and Threat Mitigation Chapter 11: Modeling Cyber Threats as Medical Adverse Events Chapter 12: Current State of Cyber Regulation: Understanding Privacy vs. Security Chapter 13: Cyber Time: The Key Advantage of the Adversary Chapter 14: Quantifying Cyber Threat for Patients, Providers, and Institutions Chapter 15: Case Studies: Notable Healthcare Hacks and Lessons Learned Part 4: Digital Health -- Hope, Hype and Risk Mitigation in Practice Chapter 16: The ""Smart"" Clinic Chapter 17: The Patient as a Mobile Healthcare Consumer Chapter 18: Artificial Intelligence in Healthcare Chapter 19: Virtual Health Assistants Chapter 20: Wearables Part 5: The Future of Digital Health Benefit-Risk Assessment and Management Chapter 21: 5 Mitigations for the 10 Toxicities"

Eric Perakslis is Chief Science Officer at the Duke Clinical Research Insititute, Professor in the Department of Population Sciences at Duke School of Medicine, Lecturer in Biomedical Informatics at Harvard Medical School and on the Board of Directors of the Kidney Cancer Association and Vivli. He has previously served as Chief Information Officer and Chief Scientist (Informatics) at the U.S. Food and Drug Administration, Strategic Advisor on Innovation to Médécins Sans Frontières and internationally as Chief Information Officer of the King Hussein Institute for Biotechnology and Cancer in Amman, Jordan. Martin Stanley leads the Strategic Technology Branch at the Cybersecurity and Infrastructure Security Agency (CISA). He has previously led the Cybersecurity Assurance Program at CISA and the Enterprise Cybersecurity Program at the U.S. Food and Drug Administration, and held executive leadership positions at Vonage and UUNET Technologies. Erin Brodwin, health tech reporter and author.

Reviews for Digital Health: Understanding the Benefit-Risk Patient-Provider Framework

"""The promise of integrating digital technology and health care has inspired hope for transformative change, while raising important concerns around the privacy of our most personal information, and how the management of these data will be secured and governed. In this thoughtful, wise, and exceptionally grounded book, two of the field's most experienced experts provide a rigorous and comprehensive review of the challenges and opportunities, with a pragmatic focus on driving implementable change."" -- David A. Shaywitz, MD, PhD, Astounding HealthTech Advisory Services ""This book is an essential primer for anyone entering the digital health space. As new technologies continue to reshape medicine and health, we are all going to need to step back and assess where we are and where we are likely to be. In this volume, Perakslis and Stanley provide a starting point for getting smart on what is current and what is to come in digital health."" -- Michael Stebbins, PhD, Former Biotechnology lead for the Obama White House and President of Science Advisors, LLC"