Evidence map›Paper›PMID 42453683›Full record

ArticleFrontiers in digital health2026

From

Shiyi Xu

Abstract read
In one paragraph

Article in Frontiers in digital health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Shiyi XuCapital Medical University Second Clinical School, Capital Medical University, Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The integration of Large Language Models (LLMs) into clinical workflows has blurred the boundary between passive decision-support tools and systems capable of autonomous diagnostic reasoning. Current regulatory instruments-including the US FDA Clinical Decision Support Software (CDSS) guidance and the EU Artificial Intelligence Act (Regulation EU 2024/1689)-classify these systems primarily as "decision support," yet the non-deterministic outputs and emergent reasoning of generative AI introduce liability complexities these frameworks were not designed to address. This hypothesis and theory article examines the regulatory gap surrounding LLM-associated clinical errors. Drawing on regulatory precedents, case law, and a representative scenario of polypharmacy mismanagement, we analyze the risks of automation bias and the structural inadequacy of the Learned Intermediary Doctrine when applied to generative AI. We advance the autonomy-liability correspondence hypothesis: legal liability should be allocated as a monotonic function of a system's structural autonomy from meaningful human review. From this we derive a "Three-Tiered Liability Escalation Framework" (T-LEF) that allocates accountability among AI developers, healthcare institutions, and clinicians according to measurable degrees of autonomy. Arguing that traditional Explainable AI is technically insufficient for foundation models, we propose Clinical Algorithmic Audit Trails (CAAT)-a cryptographically secured, privacy-preserving traceability infrastructure-as a complement to explainability, uncertainty estimation, human-factors evaluation, and post-market surveillance, alongside a structured Safe Harbor provision to support compliant innovation. Because paediatric patients-from neonates to adolescents-constitute a population in which these failure modes are both more probable and more consequential, we give paediatric care explicit focus: under-representation of paediatric data in training corpora, weight- and development-based dosing across narrow therapeutic windows, and children's inability to detect or contest erroneous recommendations jointly intensify these concerns, and a dedicated section examines how the T-LEF, the Clinically Deceptive Hallucination (CDH) evidentiary test, and CAAT apply to paediatric deployment. We acknowledge that the T-LEF and CAAT remain prospective proposals requiring empirical validation, stakeholder consultation, and refinement before adoption. This framework is offered as a structured contribution to regulatory deliberation, not a finalized implementation blueprint.

Indexed as

artificial intelligence ethicsclinical decision supportgenerative AIhealth policymedical liabilitypaediatric patient safetypaediatrics

Identifiers

PMID42453683
PMCPMC13364840

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.