ArticlePLOS digital health2022
A distributed approach to the regulation of clinical AI.
Article in PLOS digital health, 2022. 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.
- Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR-Guided Scoping Review of Global Guidance and Evidence (2017-2025).Journal of clinical medicine · 2026Review
- A nursing perspective on human-AI collaboration in personalized breast cancer care pathways.Frontiers in oncology · 2026Article
- Application of AI and digital health tools in public health management of T2DM: from mechanism prediction to personalized treatment.Frontiers in public health · 2026Review
- Framework for bias evaluation in large language models in healthcare settings.NPJ digital medicine · 2025Article
- Validating a novel measure for assessing patient openness and concerns about using artificial intelligence in healthcare.Learning health systems · 2025Article
- Lessons for local oversight of AI in medicine from the regulation of clinical laboratory testing.NPJ digital medicine · 2024Article
- Equity and AI governance at academic medical centers.The American journal of managed care · 2024Article
- Digital Determinants of Health: Health data poverty amplifies existing health disparities-A scoping review.PLOS digital health · 2023Article
- Digital Education for the Deployment of Artificial Intelligence in Health Care.Journal of medical Internet research · 2023Article
- Article
- Artificial Intelligence Algorithms in Health Care: Is the Current Food and Drug Administration Regulation Sufficient?JMIR AI · 2023Article
- Article
- Addressing the "elephant in the room" of AI clinical decision support through organisation-level regulation.PLOS digital health · 2022Article
- Comment on "Artificial intelligence and machine learning in pediatrics and neonatology healthcare".Revista da Associacao Medica Brasileira (1992) · 2022Article
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
Regulation is necessary to ensure the safety, efficacy and equitable impact of clinical artificial intelligence (AI). The number of applications of clinical AI is increasing, which, amplified by the need for adaptations to account for the heterogeneity of local health systems and inevitable data drift, creates a fundamental challenge for regulators. Our opinion is that, at scale, the incumbent model of centralized regulation of clinical AI will not ensure the safety, efficacy, and equity of implemented systems. We propose a hybrid model of regulation, where centralized regulation would only be required for applications of clinical AI where the inference is entirely automated without clinician review, have a high potential to negatively impact the health of patients and for algorithms that are to be applied at national scale by design. This amalgam of centralized and decentralized regulation we refer to as a distributed approach to the regulation of clinical AI and highlight the benefits as well as the pre-requisites and challenges involved.
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.