ReviewDigital health
Considerations for regulation and evaluation of digital mental health technologies.
Review in Digital health. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Reported best practices for effective risk management of medical devices: a scoping review.Frontiers in medical technology · 2026Pooled it
- Adoption of Digital Mental Health Interventions in National Health Service England, Scotland, and Wales: Freedom of Information Questionnaire Study.JMIR mental health · 2026Article
- Strength of Evidence to Support Decision-Making on the Use of Digital Mental Health Technologies in NICE Evaluations: Cross-Sectional Analysis of Studies.JMIR mental health · 2026Article
- [Proposal for Responsible Use of Generative Artificial Intelligence in Medical Practice].Revista de neurologia · 2025Review
- Passive Sensing for Mental Health Monitoring Using Machine Learning With Wearables and Smartphones: Scoping Review.Journal of medical Internet research · 2025Article
- Toward a New Conceptual Framework for Digital Mental Health Technologies: Scoping Review.JMIR mental health · 2025Article
- Article
- Artificial intelligence in digital mental health technology: Considerations for regulation.Digital healthReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
Digital mental health technologies (DMHTs) are becoming well established within mental health services and through direct-to-consumer models. Due to their scalable nature, DMHTs may support services to bridge the gap between demand and the available workforce, particularly where existing pathways have long delays or restricted capacity. Challenges and risks associated with DMHTs also need consideration. Regulatory and health technology assessment (HTA) agencies play a key role in ensuring the potential of DMHTs is achieved and their risks are mitigated. However, the nature of DMHTs and advances in digital technology present challenges for regulation and evaluation. In this paper, we describe eight key considerations across the regulatory and HTA pathway for DMHTs. These relate to 1) intended purpose, 2) qualification and classification, 3) risk management, 4) clinical evidence, 5) resource requirements and economic evidence, 6) post-market surveillance and life cycle assessment, 7) replicability and equity, and 8) wider responsibilities. Ensuring clarity within these considerations and addressing outstanding uncertainties is necessary to ensure that the benefits of DMHTs are unlocked, while also ensuring that people have access to high quality and safe tools.
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.