ArticleScientific reports2024
The regulatory status of health apps that employ gamification.
Article in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 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
8 citing papers in PubMed.
- The landscape of artificial intelligence-enabled medical devices in the EU and the US intended for intensive care units.NPJ digital medicine · 2026Article
- The regulation of artificial intelligence in intensive care units: from narrow tools to generalist systems.NPJ digital medicine · 2026Review
- Self-care strategies and interventions to address antimicrobial resistance: evidence review and recommendations for national programs, service providers, caregivers, and self-carers.Frontiers in public health · 2026Review
- If a therapy bot walks like a duck and talks like a duck then it is a medically regulated duck.NPJ digital medicine · 2025Article
- Implementing exergames into healthcare for chronic conditions - insights from stakeholders: a qualitative study.Health research policy and systems · 2025Article
- Is This Chatbot Safe and Evidence-Based? A Call for the Critical Evaluation of Generative AI Mental Health Chatbots.Journal of participatory medicine · 2025Article
- Examining the Effects of the Protection Motivation Theory-Based Online Intervention on Improving the Cognitive Behavioral Outcomes of Caregivers of Children With Atopic Diseases: Quasi-Experimental Study.Journal of medical Internet research · 2025Article
- Consideration of Cybersecurity Risks in the Benefit-Risk Analysis of Medical Devices: Scoping Review.Journal of medical Internet research · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
Smartphone applications are one of the main delivery modalities in digital health. Many of these mHealth apps use gamification to engage users, improve user experience, and achieve better health outcomes. Yet, it remains unclear whether gamified approaches help to deliver effective, safe, and clinically beneficial products to users. This study examines the compliance of 69 gamified mHealth apps with the EU Medical Device Regulation and assesses the specific risks arising from the gamified nature of these apps. Of the identified apps, 32 (46.4%) were considered non-medical devices; seven (10.1%) were already cleared/approved by the regulatory authorities, and 31 (44.9%) apps were assessed as likely non-compliant or potentially non-compliant with regulatory requirements. These applications and one approved application were assessed as on the market without the required regulatory approvals. According to our analysis, a higher proportion of these apps would be classified as medical devices in the US. The level of risk posed by gamification remains ambiguous. While most apps showed only a weak link between the degree of gamification and potential risks, this link was stronger for those apps with a high degree of gamification or an immersive game experience.
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.