Pediatric Applications of Digital Therapeutics: Clinical Evidence and Implementation Landscape

Digital therapeutics (DTx) are evidence-based software interventions designed to prevent, manage, or treat medical conditions through validated therapeutic mechanisms of action. They are emerging as a transformative paradigm in pediatric healthcare, where accessibility, engagement, and personalization are particularly critical. This review examines the landscape of prescription digital therapeutics for children and adolescents, focusing on current applications, regulatory considerations, implementation challenges, and future innovations. Although only a limited number of prescription digital therapeutics have been formally authorized for pediatric use, early examples demonstrate feasibility and therapeutic benefit for conditions such as attention-deficit/hyperactivity disorder (ADHD) and amblyopia. Beyond these, research is rapidly expanding into a broader set of conditions, including autism spectrum disorders, anxiety, substance use prevention, and management of chronic illnesses, highlighting the potential of digital therapeutics to complement traditional treatment approaches in specific contexts. Despite this promise, several barriers to implementation remain, with access constrained by the digital divide, socioeconomic disparities, and variability in insurance reimbursement. Additional challenges include ensuring developmental appropriateness, addressing privacy and safety concerns specific to children, and creating sustainable clinical integration pathways. Looking ahead, emerging technologies such as artificial intelligence-driven personalization, immersive virtual and augmented reality environments, and integration with wearable devices offer opportunities to overcome current limitations. Pediatric digital therapeutics hold promise as tools that may advance precision medicine, though current evidence is limited mainly to a few conditions, such as ADHD and amblyopia. With the potential to deliver scalable, cost-effective, and engaging interventions that expand access to high-quality care for children worldwide.