Abstract

DIGITAL THERAPEUTICS: BRIDGING THE GAP BETWEEN EVIDENCE-BASED SOFTWARE INTERVENTIONS AND CLINICAL PRACTICE—CURRENT APPLICATIONS, REGULATORY LANDSCAPE AND EMERGING TECHNOLOGIES

Varshini K.*, Ruba Sree N.

Abstract

Digital therapeutics (DTx) are a paradigm shift in the way that healthcare is delivered today, with evidence-based software therapy that delivers a clear therapeutic mechanism of action in measurable disease prevention, management and treatment. This in-depth review pulls together existing evidence regarding digital therapeutics applications in children and adults and reviews their effectiveness in the field of neurodevelopmental disorders, psychiatric disorders, and management of chronic diseases. We systematically reviewed and analyzed RCTs and clinical evidence to show that prescription digital therapeutics have a good safety profile and similar effect sizes as conventional interventions. Both EndeavorRx and Luminopia have created regulatory history as the first FDA-cleared digital therapeutics for attention-deficit/hyperactivity disorder and amblyopia, respectively, with over 60% response rates in the pediatric patient populations. New applications such as AI- based personalization, virtual reality integration and wearable biosensor systems offer revolutionary prospects for scalable, accessible therapeutic delivery. There are still substantial implementation challenges such as complex reimbursement environments, low provider comfort with digital solutions and health equity gaps that exist among socioeconomic groups. In this review the need for the integrated implementation methods, strong and active post-market surveillance systems and patient-centred design approaches is emphasized, with the aim of getting the transformative potential of digital therapeutics in precision medicine and personalized healthcare delivery.

Keywords: Digital Therapeutics; Evidence-Based Software; FDA-Approved DTx; AI Personalization; Pediatric neurodevelopment.