Table of Contents

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

About the Author

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

"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