ReviewPharmacy (Basel, Switzerland)2025
Therapeutic Evaluation and Utilization Analysis of Mental Health Prescription Digital Therapeutics Within the Current Regulatory Landscape.
Review in Pharmacy (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Decoding FDA Labeling of Prescription Digital Therapeutics: A Cross-Sectional Regulatory Study.Cureus · 2025Article
- Assessing rural populations' barriers to mental healthcare and perceptions towards prescription digital therapeutics: a cross-sectional survey.Frontiers in digital health · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Prescription digital therapeutics (PDTs) are emerging as a pivotal component of digital healthcare, providing software-based therapies for various diseases. This review aims to analyze the regulatory landscape in the U.S., safety, efficacy, and current challenges of PDTs, focusing on mental health conditions. Relevant articles were searched on PubMed, Google Scholar, ClinicalTrials.gov, and FDA Guidance Documents databases, supplemented by manual searches of reference lists from included studies. Inclusion criteria covered English-language studies on the development and application, therapeutic efficacy, and regulatory guidelines of PDTs in mental health. Data extraction and synthesis were conducted to summarize key findings and trends in the literature. FDA regulatory frameworks for PDTs are evolving through pathways of de novo and 510(k) applications, with patient-centric guidance. Clinical trials and real-world data support PDTs' safety and efficacy, while highlighting regulatory needs. Challenges include payer coverage, patient accessibility, and data privacy concerns. Mixed patient feedback reveals areas for improvement. Limited healthcare provider engagement and payer coverage contributed to financial challenges for PDT manufacturers. Future trends suggest that PDTs will expand beyond mental health. The evolving landscape underscores the need for continued research, regulatory refinement, and collaborative efforts across stakeholders to ensure the successful integration of PDTs into healthcare.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.