arXiv:2608. 12360v1 Announce Type: cross Abstract: Background: AI/ML-enabled medical devices are increasingly deployed in healthcare under evolving regulatory frameworks.
arXiv:2607. 15992v1 Announce Type: new Abstract: Over the past decade, responsible AI (RAI) has produced a substantial body of practice for identifying and mitigating the risks AI poses in high-stakes settings.
Over the past decade, responsible AI (RAI) has produced a substantial body of practice for identifying and mitigating the risks AI poses in high-stakes settings. Yet this work has not produced a market that rewards trustworthiness.
arXiv:2407. 11823v4 Announce Type: replace Abstract: The United States Food and Drug Administration's (FDA's) 510(k) pathway allows manufacturers to gain medical device approval by demonstrating substantial equivalence to a legally marketed device.
arXiv:2608. 15424v1 Announce Type: cross Abstract: The rapid adoption of large language models has enabled the development of clinical multi-agent systems (MAS) capable of integrating multimodal patient data and supporting increasingly complex clinical decision-making.
arXiv:2606. 19899v1 Announce Type: cross Abstract: This paper addresses a rapidly emerging policy challenge: how to generate and interpret credible evidence about the biological capabilities and risks of AI scientists, or agentic AI systems capable of autonomously or collaboratively performing multi-step scientific tasks.
arXiv:2606. 14149v1 Announce Type: new Abstract: Large Language Models (LLMs) are increasingly deployed in healthcare settings, yet their tendency to hallucinate poses risks when clinical decisions are involved.
arXiv:2608. 07796v1 Announce Type: new Abstract: Large language models perform strongly on medical knowledge benchmarks, but reliable clinical deployment requires agents to conduct defensible investigations over heterogeneous, longitudinal records: determining what evidence is needed, retrieving and reconciling structured and free-text data, grounding conclusions in verifiable evidence, and deferring cases that cannot be resolved reliably.
arXiv:2605. 12895v2 Announce Type: replace-cross Abstract: Clinical decision-support systems are expert systems whose recommendations clinicians act on directly, yet they are usually cleared on one aggregate accuracy number from a held-out test set.
arXiv:2605. 02050v2 Announce Type: replace-cross Abstract: This work establishes a framework for standardizing AI evaluation RCTs (sometimes called human uplift studies).
arXiv:2608. 02238v1 Announce Type: cross Abstract: Ensuring trust in AI systems is essential for the safe and ethical integration of machine learning systems into high-stakes domains such as digital health.
arXiv:2606. 11830v1 Announce Type: new Abstract: Background.
arXiv:2607. 08038v1 Announce Type: new Abstract: Diagnostic error is a major threat to patient safety, yet current large language model (LLM) systems often treat diagnosis as a one-shot prediction task, lacking safeguards against missed high-risk alternatives or rigorous verification of their reasoning.