This paper is in the following e-collection/theme issue:

Viewpoints and Perspectives (619) Theoretical Frameworks and Concepts (338) Digital Therapeutics (19) Viewpoints on and Experiences with Digital Technologies in Health (99)

Published on in Vol 26 (2024)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/49208, first published .
The Digital Therapeutics Real-World Evidence Framework: An Approach for Guiding Evidence-Based Digital Therapeutics Design, Development, Testing, and Monitoring

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

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

Authors of this article:

Meelim Kim1, 2, 3, 4 Author Orcid Image ;   Kevin Patrick1, 3 Author Orcid Image ;   Camille Nebeker1, 3, 4 Author Orcid Image ;   Job Godino1, 3, 5 Author Orcid Image ;   Spencer Stein6 Author Orcid Image ;   Predrag Klasnja7 Author Orcid Image ;   Olga Perski1, 8 Author Orcid Image ;   Clare Viglione1 Author Orcid Image ;   Aaron Coleman9 Author Orcid Image ;   Eric Hekler1, 3, 4 Author Orcid Image
Article Authors Cited by (13) Tweetations (11) Metrics

Journals

  1. Lee H, Choi E, Shin J, Kim T, Oh J, Shin B, Sim J, Shin J, Kim M. The Impact of Intervention Design on User Engagement in Digital Therapeutics Research: Factorial Experiment With a Mixed Methods Study. JMIR Formative Research 2024;8:e51225 View
  2. Eccleston C, Fisher E, Keefe F, Palermo T, Toelle T. Digital therapeutics and behavioral chronic pain management: closing the gap between innovation and effective use. Pain 2025;166(3):475 View
  3. Wu Y, Zhang J, Ge P, Duan T, Zhou J, Wu Y, Zhang Y, Liu S, Liu X, Wan E, Sun X. Application of Chatbots to Help Patients Self-Manage Diabetes: Systematic Review and Meta-Analysis. Journal of Medical Internet Research 2024;26:e60380 View
  4. Lakhan S. Sentiment and Thematic Analysis of User Reviews for FDA-Cleared Prescription Digital Therapeutics: A Mixed-Methods Real-World Evidence Study. Cureus 2025 View
  5. Shomali M, Kumbara A, MacLeod J, Iyer A. Personalized cardiometabolic care powered by artificial intelligence. Frontiers in Endocrinology 2025;16 View
  6. Green M, Chakravarthy K. Artificial intelligence–enhanced pain management: the NXTSTIM EcoAI platform. Pain Management 2025;15(8):467 View
  7. Jung G, Lim H, Han K, Kim H, Lee U. Designing a Visual Analytics Tool to Support Data Analysis Tasks of Digital Mental Health Interventions: Case Study. JMIR Human Factors 2025;12:e64967 View
  8. Brill E, Vinay R, Nißen M, Joshi P, Klöppel S, Kowatsch T. Toward a Smartphone-Based and Conversational Agent–Delivered Just-in-Time Adaptive Holistic Lifestyle Intervention for Older Adults Affected by Cognitive Decline: Two-Week Proof-of-Concept Study. JMIR Formative Research 2025;9:e66885 View
  9. Peerbolte T, van Diggelen R, van den Haak P, Geurts K, Evers L, Bloem B, de Vries N, van den Berg S. Conversational Agents Supporting Self-Management in People With a Chronic Disease: Systematic Review. Journal of Medical Internet Research 2025;27:e72309 View
  10. Sapanel Y, Cloutier L, Morton A, Lin S, Seres G, Ho D. Understanding Economic Decision-Making in Digital Therapeutics Development: Qualitative Approach. Journal of Medical Internet Research 2025;27:e79746 View
  11. Lee H, Hwang J, Yon D, Rhee S. Multimodal and Multidimensional Artificial Intelligence Technology in Obesity. Journal of Obesity & Metabolic Syndrome 2025;34(4):394 View

Books/Policy Documents

  1. Vyas S, Gupta S, Tyagi A. Meta-Health. View

Conference Proceedings

  1. Koul S, Mishra V, Taylor I. 2024 First International Conference on Pioneering Developments in Computer Science & Digital Technologies (IC2SDT). System Dynamics Modeling for Understanding the Adoption of Digital Therapeutics View