ReviewScience advances2025
A roadmap for safe, regulation-compliant Living Labs for AI and digital health development.
Review in Science advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed.
- EU's fragmented early-stage medical device study requirements need reform.Nature biomedical engineering · 2026Article
- Introducing Adjunct Medical Products and Artificial Intelligence Governance Gaps.Mayo Clinic proceedings. Digital health · 2026Review
- Reply to: Surgical scene understanding and the emerging challenge of independent validation in an industry-led AI ecosystem.NPJ digital medicine · 2026Article
- Agentic AI for interdisciplinary clinical decision support in high-stakes care.JHEP reports : innovation in hepatology · 2026Article
- Exploring attitudes and acceptance of artificial intelligence in multiple sclerosis from the patient perspective.PLOS digital health · 2026Article
- Blocking the Reflection: Milestones and Hurdles for Digital Twins in Mental Health.Pharmacopsychiatry · 2026Review
- AI-enabled Living Labs: Accelerating innovation in multiple sclerosis care and research.Multiple sclerosis (Houndmills, Basingstoke, England) · 2026Review
- Revolutionizing Multimorbidity Care: A Narrative Review on Artificial Intelligence Applications.Health science reports · 2026Article
- The regulation of artificial intelligence in intensive care units: from narrow tools to generalist systems.NPJ digital medicine · 2026Review
- Digital medicine's international race for regulatory sandboxes and voluntary alternative pathways picks up tempo.NPJ digital medicine · 2026Article
- Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values.Journal of medical Internet research · 2026Article
- MSPEECH (multiple sclerosis monitoring through speech interaction in clinic and at home): a Living Lab study protocol for co-created, speech-based digital biomarkers in multiple sclerosis.Frontiers in digital health · 2026Article
- Interoperability as a Catalyst for Digital Health and Therapeutics: A Scoping Review of Emerging Technologies and Standards (2015-2025).International journal of environmental research and public health · 2025Article
- Overcoming regulatory barriers to the implementation of AI agents in healthcare.Nature medicine · 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
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Safe and agile experimentation spaces are essential for developing AI-enabled medical devices and digital health innovations. "Living Labs" offer a collaborative environment for testing technologies in near-real-world settings, capturing user perspectives and outcomes, often missed in traditional testing. However, the flexibility of Living Labs often clashes with the European Union's rigid regulatory frameworks for medical devices that were not designed for digital technologies. We examine this intersection, showing how flexibility in evaluation and patient interaction can coexist with safety guardrails. Our approach integrates technology readiness, preemptive planning, and iterative modifications to bridge innovation and regulation, fostering adaptive health care technology development.
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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.