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Research Letter
February 25, 2019

Characteristics of Digital Health Studies Registered in ClinicalTrials.gov

Author Affiliations
  • 1Department of Medicine, Stanford University School of Medicine, Stanford, California
  • 2Center for Digital Health, Stanford University School of Medicine, Stanford, California
  • 3Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California
  • 4Veterans Affairs Palo Alto Health Care System, Palo Alto, California
JAMA Intern Med. 2019;179(6):838-840. doi:10.1001/jamainternmed.2018.7235

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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