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

Meelim Kim   ^{1, 2, 3, 4} , PhD ;   Kevin Patrick   ^{1, 3} , MS, MD ;   Camille Nebeker   ^{1, 3, 4} , PhD ;   Job Godino   ^{1, 3, 5} , PhD ;   Spencer Stein   ⁶ , MPH ;   Predrag Klasnja   ⁷ , PhD ;   Olga Perski   ^{1, 8} , PhD ;   Clare Viglione   ¹ , MPH ;   Aaron Coleman   ⁹ , BA ;   Eric Hekler   ^{1, 3, 4} , PhD

¹ Herbert Wertheim School of Public Health and Human Longevity Science, University of California San Diego, La Jolla, CA, United States

² Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

³ The Qualcomm Institute, University of California San Diego, La Jolla, CA, United States

⁴ The Design Lab, University of California San Diego, La Jolla, CA, United States

⁵ Laura Rodriguez Research Institute, Family Health Centers of San Diego, San Diego, CA, United States

⁶ Spiral Health Inc, San Diego, CA, United States

⁷ School of Information, University of Michigan, Ann Arbor, MI, United States

⁸ Faculty of Social Sciences, Tampere University, Tampere, Finland

⁹ Small Steps Labs LLC dba Fitabase Inc, San Diego, CA, United States