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Med."],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Dozens of frameworks have been proposed to assess evidence for digital health interventions (DHIs), but existing frameworks may not facilitate DHI evidence reviews that meet the needs of stakeholder organizations including payers, health systems, trade organizations, and others. These organizations may benefit from a DHI assessment framework that is both rigorous and rapid. Here we propose a framework to assess Evidence in <jats:underline>D<\/jats:underline>igital health for <jats:underline>EF<\/jats:underline>fectiveness of <jats:underline>IN<\/jats:underline>terventions with <jats:underline>E<\/jats:underline>valuative <jats:underline>D<\/jats:underline>epth (Evidence DEFINED). Designed for real-world use, the Evidence DEFINED Quick Start Guide may help streamline DHI assessment. A checklist is provided summarizing high-priority evidence considerations in digital health. Evidence-to-recommendation guidelines are proposed, specifying degrees of adoption that may be appropriate for a range of evidence quality levels. Evidence DEFINED differs from prior frameworks in its inclusion of unique elements designed for rigor and speed. Rigor is increased by addressing three gaps in prior frameworks. First, prior frameworks are not adapted adequately to address evidence considerations that are unique to digital health. Second, prior frameworks do not specify evidence quality criteria requiring increased vigilance for DHIs in the current regulatory context. Third, extant frameworks rarely leverage established, robust methodologies that were developed for non-digital interventions. Speed is achieved in the Evidence DEFINED Framework through screening optimization and deprioritization of steps that may have limited value. 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Silberman and Sarlati and Ms. Kaur are employed by Elevance Health (formerly Anthem, Inc.). Dr. Silberman has previously been employed by Vida Health, Inc., Johnson & Johnson Health and Wellness Solutions, and EdLogics, LLC. Dr. Willey is employed by HealthCore, Inc., a wholly-owned subsidiary of Elevance Health. Dr. Wicks is an associate editor at the Journal of Medical Internet Research and is on the editorial advisory boards of BMJ, BMC Medicine, The Patient, and Digital Biomarkers. Dr. Wicks is employed by Wicks Digital Health Ltd, which has received funding from Ada Health, AstraZeneca, Baillie Gifford, Biogen, Bold Health, Camoni, Compass Pathways, Coronna, EIT, Endava, Happify, HealthUnlocked, Inbeeo, Kheiron Medical, Lindus Health, MedRhythms, PatientsLikeMe, Sano Genetics, Self Care Catalysts, The Learning Corp, The Wellcome Trust, THREAD Research, VeraSci, and Woebot. Dr. Vimal Mishra serves as Vice President, Digital Care at UC Davis Health and previously held roles at Virginia Commonwealth University (VCU). He holds invention disclosures in digital health products and is funded by several federal and state agencies. Dr. Campellone is employed by Click Therapeutics, Inc and has been previously employed by Pear Therapeutics, Inc. Dr. Rodriguez-Chavez is employed by ICON plc; he is a regulatory content editor for the DIA Global Forum. Dr. Vandendriessche is employed by Byteflies. Dr. Sucala is employed by AstraZeneca. Dr. Sucala has previously been employed by Johnson & Johnson Health and Wellness Solutions. Dr. Owusu is employed by Lyra Health, Inc. and has been previously employed by Mahana Therapeutics, Inc. Dr. Park is employed by Geisinger system services. Dr. Carl is employed by Big Health Inc. Dr. Korolev is employed by UConn Health and was previously employed by Merck & Co., Inc. and F. Hoffmann-La Roche AG. All other authors declare no competing interests.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"101"}}