Accessibility and equity considerations in the clinical validation of prescription digital therapeutics: a scoping review

Background: Prescription digital therapeutics (DTx) are software-based medical interventions regulated by the Food and Drug Administration (FDA). Ensuring accessibility and equity is crucial, as effectiveness depends on patient engagement. This scoping review examines whether clinical validation studies adequately assess health equity, cultural competence, and digital accessibility. This study aimed to evaluate the extent to which FDA-mandated clinical trials of DTx products report diverse participant characteristics, cultural adaptations, and digital literacy considerations. Methods: A systematic search of PubMed, Google Scholar, and ClinicalTrials.gov identified clinical validation studies of FDA-approved DTx products. Studies were assessed for health equity factors using the PROGRESS-Plus framework and categorized based on reporting of cultural competence, linguistic accessibility, and digital literacy. Results: Thirty-two studies covering six FDA-approved DTx products were included. Over 60% reported participant demographics (gender, race/ethnicity, education level), but fewer than 15% addressed other health equity factors. Fifteen studies excluded participants who were not fluent in English. No studies incorporated cultural adaptation frameworks or linguistic translations. Two studies found digital literacy significantly affected intervention effectiveness. Conclusions: Clinical validation studies of DTx lack sufficient assessment of health equity, cultural competence, and digital accessibility. Addressing these gaps is essential to ensure equitable access and effectiveness for diverse populations.