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.
"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
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