Prescription Digital Therapeutics Research Across Clinical, Engagement, Regulatory, and Implementation Domains: A Bibliometric and Thematic Study.

Abstract

Prescription digital therapeutics (PDTs) are Food and Drug Administration (FDA)-authorized software-based treatments designed to treat a range of conditions on the smartphone. Their development and deployment rely on four foundational scientific domains: clinical, engagement, regulatory, and implementation. However, the relative representation of these domains in the PDT literature has not been systematically characterized. We conducted a bibliometric and thematic analysis of PubMed-indexed articles published between 2020 and 2025 containing the term "prescription digital therapeutic(s)." Metadata and abstracts were extracted, cleaned, and analyzed using natural language processing for this review. Topic modeling was performed to identify key thematic areas, and each abstract was classified into one or more of the four foundational domains using a structured keyword heuristic framework. Trends in publication volume, authorship, domain co-occurrence, and thematic focus were visualized. Sixty-one unique articles met the inclusion criteria. Publication activity increased over time, peaking in 2022 and 2024. Most first authors were based in the United States, with industry-affiliated authorships predominating. The most frequently publishing journals were Frontiers in Psychiatry and Health Affairs (Millwood). Clinical science was referenced in 45 (74%) papers, followed by engagement science in 35 (58%), regulatory science in 28 (46%), and implementation science in 18 (29%). Only seven (12%) articles addressed all four domains. Topic modeling identified five major themes: substance use and cost modeling, regulatory frameworks, insomnia treatment, engagement strategies, and gamified pediatric interventions. Co-occurrence analysis revealed strong overlap between clinical and engagement domains, while regulatory and implementation science appeared less frequently in combination. The literature on PDTs remains concentrated in clinical and engagement domains, with limited attention to regulatory strategy and real-world implementation. Greater integration across all four scientific domains is needed to ensure that PDTs are not only effective but also scalable, fundable, and embedded into routine care.