ReviewTherapeutic innovation & regulatory science2026
Diving into the Regulatory Landscape of Digital Therapeutics.
Review in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Digital therapeutics (DTx) are emerging as a transformative approach in healthcare, offering software-driven, evidence-based interventions for the prevention, management, and treatment of medical conditions such as chronic diseases, mental health disorders, and substance use disorders. Unlike general wellness applications or traditional digital health tools, DTx products are subject to rigorous clinical validation and regulatory scrutiny, ensuring their safety, efficacy, and integration into clinical practice. This manuscript explores the defining characteristics of digital therapeutics, differentiating them from other digital health technologies, and examines their role in patient-centric care. It further investigates global regulatory frameworks, including those in the United States, Europe, and Korea, highlighting the need for harmonized guidelines and structured approval pathways. The paper also discusses the importance of robust clinical trial design, validation methods, and post-market surveillance to support the adoption and reimbursement of DTx. Real-world examples such as EndeavorRx
Indexed as
Identifiers
41787224What 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.