ArticleJournal of the American Medical Informatics Association : JAMIA2024
Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety.
Article in Journal of the American Medical Informatics Association : JAMIA, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 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
7 citing papers in PubMed.
- A Futures Framework for Clinical AI Governance: Anticipating Emerging Risks, Shifting Roles, and Regulatory Challenges.Journal of medical Internet research · 2026Article
- Recent Advances in AI and GenAI for Health Informatics.Healthcare (Basel, Switzerland) · 2026Review
- Artificial Intelligence in Orthopaedic Research: A Technical Report on Opportunities and Pitfalls.Cureus · 2026Article
- Robustness of steroidomics-based machine learning for diagnosis of primary aldosteronism: a laboratory medicine perspective.Clinical chemistry and laboratory medicine · 2025Article
- Rethinking clinical trials for medical AI with dynamic deployments of adaptive systems.NPJ digital medicine · 2025Review
- Regulation of artificial intelligence in healthcare: Clinical Laboratory Improvement Amendments (CLIA) as a model.Journal of the American Medical Informatics Association : JAMIA · 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
11 authors.
Funding
Abstract
objectivesSurface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software. MATERIALS AND
methodsWe use sepsis as a case study to highlight the patient safety and regulatory compliance tradeoffs that 6129 hospitals in the United States must navigate.
resultsSepsis CDS remains in broad, routine use. There is no commercially available sepsis CDS system that is FDA cleared as a medical device. There is no public disclosure of an HDO turning off sepsis CDS due to regulatory compliance concerns. And there is no public disclosure of FDA enforcement action against an HDO for using sepsis CDS that is not cleared as a medical device. DISCUSSION AND
conclusionWe present multiple policy interventions that would relieve the current tension to enable HDOs to utilize artificial intelligence to improve patient care while also addressing FDA concerns about product safety, efficacy, and equity.
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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.