Digital Therapeutics: Software as Medicine

Medicine is no longer delivered only through pills and procedures—sometimes, it runs on code. Digital Therapeutics: Software as Medicine explores how clinically validated software becomes an active treatment, not just a support tool.
This book takes a regulatory-and-clinical lens. It explains how digital therapeutics are designed, tested, prescribed, and measured like medicine, with outcomes, evidence, and accountability at the center. Readers learn why behavior-change software, cognitive therapies, and algorithm-driven interventions require the same rigor as drugs—because they directly affect health.
Rather than celebrating apps, the book focuses on credibility: clinical trials, FDA pathways, adherence, and real-world effectiveness. It examines where digital therapeutics succeed, where they fail, and why evidence—not engagement—defines legitimacy.
This book challenges assumptions:
• When does software become treatment?
• How is efficacy proven without chemistry?
• Why regulation protects patients and builders alike?
This book is for clinicians, founders, regulators, and health innovators who believe software can heal—but only if it earns the right to be called medicine.