Abstract
Prescription Digital Therapeutics (PDTs) are emerging as promising tools for treating and managing mental and brain health conditions within the context of daily life. This commentary distinguishes PDTs from other Software as Medical Devices (SaMD) and explores their integration into mental and brain health treatments. We focus on research programs and support from the National Institutes of Health (NIH), discussing PDT research supported by the NIH's National Institute on Child Health and Development (NICHD), National Institute of Mental Health (NIMH), and National Institute on Aging (NIA). We present a hierarchical natural language processing topic analysis of NIH-funded digital therapeutics research projects. We delineate the PDT landscape across different mental and brain health disorders while highlighting opportunities and challenges. Additionally, we discuss the research foundation for PDTs, the unique therapeutic approaches they employ, and potential strategies to improve their validity, reliability, safety, and effectiveness. Finally, we address the research and collaborations necessary to propel the field forward, ultimately enhancing patient care through innovative digital health solutions.