ReviewNPJ digital medicine2022
Regulatory considerations to keep pace with innovation in digital health products.
Review in NPJ digital medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers, 2 of them syntheses 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
49 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Smartphone Apps for Cardiovascular and Mental Health Care: Digital Cross-Sectional Analysis.JMIR mHealth and uHealth · 2025Pooled it
- Characterisation of digital therapeutic clinical trials: a systematic review with natural language processing.The Lancet. Digital health · 2024Pooled it
- Evaluating the First CE-Marked LLM-Based Chatbot for Evidence-Based Neurology.European journal of neurology · 2026Article
- Digital Mental Health: A Narrative Review of FDA-Authorized Products for Psychiatric Treatment and Diagnostic Support.Brain sciences · 2026Review
- Article
- Multisite, External Validation of an AI-Enabled ECG Algorithm for Detection of Low Ejection Fraction.JACC. Advances · 2026Article
- Early viability assessment of a Business-to-Consumer (B2C) model for digital diabetes screening in Switzerland.BMC health services research · 2026Article
- Digitalisation of medicine in LMICs (sub-Saharan Africa): enablers, barriers, and funding strategies for sustainable health systems.Frontiers in public health · 2026Review
- FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges.Npj mental health research · 2025Article
- Development of an evidence-based evaluation framework for digital health software products.Scientific reports · 2025Article
- Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study.Journal of medical Internet research · 2025Article
- Artificial intelligence in pediatric healthcare: current applications, potential, and implementation considerations.Clinical and experimental pediatrics · 2025Article
- Use and Acceptance of Innovative Digital Health Solutions Among Patients and Professionals: Survey Study.JMIR human factors · 2025Article
- Developing a standardized framework for evaluating health apps using natural language processing.Scientific reports · 2025Article
- Unmasking the Complex Interplay of Obesity Hypoventilation Syndrome, Heart Failure, and Sleep Dysfunction: A Physiological and Psychological Perspective in a Digital Health World.Behavioral sciences (Basel, Switzerland) · 2025Review
- Toward a New Conceptual Framework for Digital Mental Health Technologies: Scoping Review.JMIR mental health · 2025Article
- Unpacking Performance Factors of Innovation Systems and Studying Germany's Attempt to Foster the Role of the Patient Through a Market Access Pathway for Digital Health Applications (DiGAs): Exploratory Mixed Methods Study.Journal of medical Internet research · 2025Article
- Download to heal: navigating the pixelated path of digital therapeutics in psychiatric care.Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999) · 2025Review
- Building robust, proportionate, and timely approaches to regulation and evaluation of digital mental health technologies.The Lancet. Digital health · 2025Review
- Advances in the application of human-machine collaboration in healthcare: insights from China.Frontiers in public health · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Rapid innovation and proliferation of software as a medical device have accelerated the clinical use of digital technologies across a wide array of medical conditions. Current regulatory pathways were developed for traditional (hardware) medical devices and offer a useful structure, but the evolution of digital devices requires concomitant innovation in regulatory approaches to maximize the potential benefits of these emerging technologies. A number of specific adaptations could strengthen current regulatory oversight while promoting ongoing innovation.
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.