Prescription Software: Digital Therapeutics
Dr. Jonathan Kessler
LeMay Publishing
HEALTHCARE
Prescription Software: Digital Therapeutics
Digital Health14,865 words77 chapters
Published by LeMay Publishing. 14,865 words across 77 chapters.
About This Publication
A regulatory and clinical guide to prescription digital therapeutics, distinguishing therapeutic software from general digital health and mapping the pathway from FDA clearance to clinical deployment.
Published by LeMay Publishing, a division of LeMay. Massachusetts.
ISBN: 979-8-0000-7010-9
Chapters
1PRESCRIPTION SOFTWARE: DIGITAL THERAPEUTICS
2A Regulatory and Clinical Guide to Prescription Digital Therapeutics
3ABOUT THE AUTHOR
4TABLE OF CONTENTS
5FOREWORD
6CHAPTER 1: THE EMERGENCE OF SOFTWARE AS MEDICINE
71.1 Historical Context and Definitional Foundations
81.2 Distinguishing Digital Therapeutics from Digital Health
91.3 The Therapeutic Software Paradigm
101.4 Scope and Organization of This Volume
11CHAPTER 2: REGULATORY FRAMEWORKS AND AUTHORIZATION PATHWAYS
122.1 The FDA's Evolving Approach to Software as a Medical Device
132.2 De Novo Classification and the 510(k) Pathway
142.3 The Prescription Digital Therapeutic (PDT) Designation
152.4 International Regulatory Perspectives
162.5 The Digital Health Center of Excellence
172.6 Post-Market Surveillance and Software Lifecycle Management
18CHAPTER 3: CLINICAL EVIDENCE STANDARDS AND TRIAL DESIGN
193.1 Evidentiary Requirements for Regulatory Clearance
203.2 Randomized Controlled Trials in Digital Therapeutics
213.3 Comparator Selection and Blinding Challenges
223.4 Outcome Measures and Clinically Meaningful Endpoints
233.5 Real-World Evidence and Post-Authorization Studies
243.6 Meta-Analytic Synthesis and Systematic Review
25CHAPTER 4: MECHANISMS OF ACTION IN DIGITAL THERAPEUTICS
264.1 Cognitive Behavioral Therapy–Based Architectures
274.2 Contingency Management and Motivational Frameworks
284.3 Neurocognitive Training and Attention Modification
294.4 Biofeedback and Physiological Regulation
304.5 Pharmacological Augmentation Through Digital Means
314.6 Toward a Taxonomy of Digital Therapeutic Mechanisms
32CHAPTER 5: THERAPEUTIC AREAS AND APPROVED PRODUCTS
335.1 Substance Use Disorders
345.2 Chronic Insomnia
355.3 Attention Deficit Hyperactivity Disorder
365.4 Irritable Bowel Syndrome
375.5 Chronic Pain and Musculoskeletal Conditions
385.6 Type 2 Diabetes and Cardiometabolic Disease
395.7 Major Depressive Disorder and Anxiety Disorders
405.8 Emerging Indications and Pipeline Products
41CHAPTER 6: PRESCRIBING, DISPENSING, AND CLINICAL INTEGRATION
426.1 The Prescribing Workflow for Digital Therapeutics
436.2 Electronic Health Record Integration
446.3 Pharmacy and Distribution Models
456.4 Patient Onboarding and Adherence
466.5 Monitoring and Clinical Decision Support
476.6 Multidisciplinary Care Team Considerations
48CHAPTER 7: HEALTH ECONOMICS, REIMBURSEMENT, AND MARKET ACCESS
497.1 Pricing Models and Value-Based Contracting
507.2 Payer Coverage Decisions and Formulary Placement
517.3 Health Technology Assessment for Digital Therapeutics
527.4 Cost-Effectiveness Analysis and Budget Impact Modeling
537.5 Medicare, Medicaid, and Public Payer Considerations
547.6 Global Market Access and Reimbursement Landscapes
55CHAPTER 8: DATA GOVERNANCE, PRIVACY, AND CYBERSECURITY
568.1 HIPAA Compliance in Therapeutic Software
578.2 Data Minimization and Purpose Limitation
588.3 Cybersecurity Frameworks for Medical-Grade Software
598.4 Patient Consent and Data Ownership
608.5 International Data Protection Regulations
618.6 Ethical Considerations in Behavioral Data Collection
62CHAPTER 9: IMPLEMENTATION SCIENCE AND ORGANIZATIONAL ADOPTION
639.1 Frameworks for Institutional Implementation
649.2 Clinician Training and Change Management
659.3 Health System Governance and Formulary Committees
669.4 Quality Metrics and Outcome Tracking
679.5 Scaling and Sustainability
689.6 Lessons from Early Adopter Institutions
69CHAPTER 10: FUTURE DIRECTIONS AND EMERGING PARADIGMS
7010.1 Artificial Intelligence and Adaptive Therapeutics
7110.2 Combination Products: Software Plus Drug
7210.3 Decentralized Trials and Digital Endpoints
7310.4 Platform-Based Therapeutic Ecosystems
7410.5 Regulatory Harmonization and Global Standards
7510.6 The Next Decade of Prescription Software
76BIBLIOGRAPHY
77INDEX