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.
The paper discusses how autonomous AI systems are moving from advisory to agentic roles in medication prescribing, citing recent U.S. legislation and a Utah pilot program. It argues that three architectural features—calibrated per‑prediction confidence, clear differentiation between epistemic and aleatoric uncertainty, and inferential transparency—are essential for safe autonomous prescribing. A survey of 136 U.S. clinicians shows they require a confidence‑based escalation mechanism, prefer different handling of uncertainty types, and will only accept liability when transparency allows informed decision‑making.
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.
The paper introduces a source‑grounded integrity gate for AI‑assisted personal health records, ensuring that data generated by large language models remains provisional until a deterministic monitor verifies it against the source document. The monitor only accepts candidates that contain a unique supporting quotation, appear within the same laboratory row, and preserve provenance, preventing the model from approving its own output. In Medical DataCloud, the system passed all 22 conformance and mutation tests and, in a replay of nine historical lab reports, admitted 72 of 97 numeric candidates while retaining 25 for human review.
The paper introduces Runtime Assurance Contracts (RAC) as a formal policy framework for high‑risk AI agents, addressing the "assurance‑transition gap" by binding autonomy boundaries, component eligibility, evidence state, transition policy, human‑review capacity, and non‑compensatory gates. RAC allows soft metrics to influence routing while mandating retries, switches, escalations, deferrals, or stops when mandatory gates fail or are unknown, ensuring aggregate performance cannot alone authorize action. The authors define the contract, evidence record, permission rule, and five invariants, and evaluate RAC through deterministic failure‑injection studies, hand‑authored traces, and a prospective synthetic holdout, comparing it to score‑only and restricted protocol baselines.
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.
AI Morbidity and Mortality (AI M&M) is a structured, blameless framework designed to review clinical AI failures. It combines standardized case intake, evidence preservation, investigator reconstruction, tool‑in‑loop attribution, and corrective‑action tracking, classifying each event across four linked dimensions: Trigger, Mechanism, Clinical Pathway, and Corrective Action. The authors demonstrate the framework with five outpatient medication and clinical decision‑support cases, achieving full agreement among reviewers on all classification axes.
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.