Digital health is the application of software or hardware, often using mobile smartphone or sensor technologies to improve patient or population health and health care delivery.1 In contrast to drugs and traditional medical devices, which have strict regulatory guidelines on safety and efficacy, the clinical evidence generation for digital health tools may be motivated by other factors, including adoption, utilization, and value, that may influence study design and quality. The landscape of clinical evidence underlying digital health interventions has not been well characterized.2,3 We sought to evaluate the characteristics of digital health studies registered in ClinicalTrials.gov.
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Chen CE, Harrington RA, Desai SA, Mahaffey KW, Turakhia MP. Characteristics of Digital Health Studies Registered in ClinicalTrials.gov. JAMA Intern Med. Published online February 25, 2019179(6):838–840. doi:10.1001/jamainternmed.2018.7235
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