ArticleJournal of medical Internet research2023
Learning From Experience and Finding the Right Balance in the Governance of Artificial Intelligence and Digital Health Technologies.
Article in Journal of medical Internet research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 3 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
36 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- AI demonstrates comparable diagnostic performance to radiologists in MRI detection of anterior cruciate ligament tears: a systematic review and meta-analysis.European radiology · 2026Pooled it
- Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review.Journal of medical Internet research · 2026Pooled it
- Opportunities and challenges of artificial intelligence in public health: a systematic review on technological efficacy, ethical dilemmas, and governance pathways.Frontiers in public health · 2025Pooled it
- New Therapeutic Modalities and Collingridge's Dilemma.Pharmaceutical medicine · 2026Article
- Challenges and Recommendations in Regulating AI Medical Devices in the European Union: A Scoping Review.Healthcare (Basel, Switzerland) · 2026Review
- European Union innovation needs regulatory science excellence centres.Nature biomedical engineering · 2026Article
- The Regional Implementation of an Electronic Health Record-Integrated Ambient Scribe in Primary and Secondary Care in England: Real-Time Qualitative Evaluation.JMIR medical informatics · 2026Article
- Expert perspectives on recent US digital medicine regulation policy changes and the TEMPO pilot.NPJ digital medicine · 2026Article
- A scoping review on using real-world data to evaluate the effectiveness of mHealth applications.NPJ digital medicine · 2026Article
- Regulating complexity in AI-enabled omics and multi-omics technologies for precision medicine.NPJ digital medicine · 2026Article
- 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
- Integrating Artificial Intelligence (AI) in Primary Health Care (PHC) Systems: A Framework-Guided Comparative Qualitative Study.Healthcare (Basel, Switzerland) · 2026Article
- 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 (AI) and Emergency Medicine: Balancing Opportunities and Challenges.JMIR medical informatics · 2025Review
- A scoping review of the governance of federated learning in healthcare.NPJ digital medicine · 2025Article
- A roadmap for safe, regulation-compliant Living Labs for AI and digital health development.Science advances · 2025Review
- Digital twins, synthetic patient data, and in-silico trials: can they empower paediatric clinical trials?The Lancet. Digital health · 2025Review
- Could transparent model cards with layered accessible information drive trust and safety in health AI?NPJ digital medicine · 2025Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Artificial intelligence (AI) and machine learning medical tools have the potential to be transformative in care delivery; however, this change will only be realized if accompanied by effective governance that ensures patient safety and public trust. Recent digital health initiatives have called for tighter governance of digital health. A correct balance must be found between ensuring product safety and performance while also enabling the innovation needed to deliver better approaches for patients and affordable efficient health care for society. This requires innovative, fit-for-purpose approaches to regulation. Digital health technologies, particularly AI-based tools, pose specific challenges to the development and implementation of functional regulation. The approaches of regulatory science and "better regulation" have a critical role in developing and evaluating solutions to these problems and ensuring effective implementation. We describe the divergent approaches of the European Union and the United States in the implementation of new regulatory approaches in digital health, and we consider the United Kingdom as a third example, which is in a unique position of developing a new post-Brexit regulatory framework.
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.