The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring

• DOI: 10.2196/49208
• Publication Date: 2024-01-29T03:58:17Z
• Authors: Meelim Kim; Kevin Patrick; Camille Nebeker; Job Godino; Spencer Stein; Predrag Klasnja; Olga Perski; Clare Viglione; Aaron Coleman; Eric Hekler
• Keywords: Milestone; Digital Health

Digital therapeutics (DTx) are a promising way to provide safe, effective, accessible, sustainable, scalable, and equitable approaches advance individual population health. However, developing deploying DTx is inherently complex in that includes multiple interacting components, such as tools support activities like medication adherence, health behavior goal-setting or self-monitoring, algorithms adapt the provision of these according needs may change over time. While myriad frameworks exist for different phases development, no single framework exists guide evidence production across its full life cycle, from initial development long-term use. To fill this gap, we propose real-world (RWE) pragmatic, iterative, milestone-driven approach DTx. The RWE derived 4-phase model used behavioral interventions, but it key adaptations specific unique characteristics ensure highest level fidelity users, also incorporates data (RWD) entire cycle intended any group interested contexts, including those industry, care, public health, academia. Moreover, entities fund research supports agencies regulate might find useful they endeavor improve how DTxcan