LAS VEGAS — The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration’s promises to deregulate artificial intelligence and promote its widespread use.

FDA Commissioner Marty Makary indicated that one of the agency’s priorities is fostering an environment that’s good for investors, and that FDA regulation needs to move “at Silicon Valley speed.” He announced the changes during an address to conference attendees at the Consumer Electronics Show.

The agency will soften its approach to the regulation of clinical decision support software, which include AI-enabled products that help doctors navigate diagnoses and treatment options. The agency previously considered products that delivered a single recommendation as FDA-regulated medical devices. Now, those products can enter the market without FDA review as long as they fulfill the agency’s other criteria for escaping regulation. 

Continue to STAT+ to read the full story…

© ANDREW CABALLERO-REYNOLDS/AFP via Getty Images

arXiv:2601.01321v1 Announce Type: new Abstract: Digital twins, as precise digital representations of physical systems, have evolved from passive simulation tools into intelligent and autonomous entities through the integration of artificial intelligence technologies. This paper presents a unified four-stage framework that systematically characterizes AI integration across the digital twin lifecycle, spanning modeling, mirroring, intervention, and autonomous management. By synthesizing existing technologies and practices, we distill a unified four-stage framework that systematically characterizes how AI methodologies are embedded across the digital twin lifecycle: (1) modeling the physical twin through physics-based and physics-informed AI approaches, (2) mirroring the physical system into a digital twin with real-time synchronization, (3) intervening in the physical twin through predictive modeling, anomaly detection, and optimization strategies, and (4) achieving autonomous management through large language models, foundation models, and intelligent agents. We analyze the synergy between physics-based modeling and data-driven learning, highlighting the shift from traditional numerical solvers to physics-informed and foundation models for physical systems. Furthermore, we examine how generative AI technologies, including large language models and generative world models, transform digital twins into proactive and self-improving cognitive systems capable of reasoning, communication, and creative scenario generation. Through a cross-domain review spanning eleven application domains, including healthcare, aerospace, smart manufacturing, robotics, and smart cities, we identify common challenges related to scalability, explainability, and trustworthiness, and outline directions for responsible AI-driven digital twin systems.

arXiv:2601.01718v1 Announce Type: new Abstract: We introduce Yuan3.0 Flash, an open-source Mixture-of-Experts (MoE) MultiModal Large Language Model featuring 3.7B activated parameters and 40B total parameters, specifically designed to enhance performance on enterprise-oriented tasks while maintaining competitive capabilities on general-purpose tasks. To address the overthinking phenomenon commonly observed in Large Reasoning Models (LRMs), we propose Reflection-aware Adaptive Policy Optimization (RAPO), a novel RL training algorithm that effectively regulates overthinking behaviors. In enterprise-oriented tasks such as retrieval-augmented generation (RAG), complex table understanding, and summarization, Yuan3.0 Flash consistently achieves superior performance. Moreover, it also demonstrates strong reasoning capabilities in domains such as mathematics, science, etc., attaining accuracy comparable to frontier model while requiring only approximately 1/4 to 1/2 of the average tokens. Yuan3.0 Flash has been fully open-sourced to facilitate further research and real-world deployment: https://github.com/Yuan-lab-LLM/Yuan3.0.

arXiv:2601.00926v1 Announce Type: cross Abstract: Modern enterprise retrieval systems must handle short, underspecified queries such as ``foreign transaction fee refund'' and ``recent check status''. In these cases, semantic nuance and metadata matter but per-query large language model (LLM) re-ranking and manual labeling are costly. We present Metadata-Aware Cross-Model Alignment (MACA), which distills a calibrated metadata aware LLM re-ranker into a compact student retriever, avoiding online LLM calls. A metadata-aware prompt verifies the teacher's trustworthiness by checking consistency under permutations and robustness to paraphrases, then supplies listwise scores, hard negatives, and calibrated relevance margins. The student trains with MACA's MetaFusion objective, which combines a metadata conditioned ranking loss with a cross model margin loss so it learns to push the correct answer above semantically similar candidates with mismatched topic, sub-topic, or entity. On a proprietary consumer banking FAQ corpus and BankFAQs, the MACA teacher surpasses a MAFA baseline at Accuracy@1 by five points on the proprietary set and three points on BankFAQs. MACA students substantially outperform pretrained encoders; e.g., on the proprietary corpus MiniLM Accuracy@1 improves from 0.23 to 0.48, while keeping inference free of LLM calls and supporting retrieval-augmented generation.

arXiv:2601.01576v1 Announce Type: cross Abstract: Evaluating novelty is critical yet challenging in peer review, as reviewers must assess submissions against a vast, rapidly evolving literature. This report presents OpenNovelty, an LLM-powered agentic system for transparent, evidence-based novelty analysis. The system operates through four phases: (1) extracting the core task and contribution claims to generate retrieval queries; (2) retrieving relevant prior work based on extracted queries via semantic search engine; (3) constructing a hierarchical taxonomy of core-task-related work and performing contribution-level full-text comparisons against each contribution; and (4) synthesizing all analyses into a structured novelty report with explicit citations and evidence snippets. Unlike naive LLM-based approaches, \textsc{OpenNovelty} grounds all assessments in retrieved real papers, ensuring verifiable judgments. We deploy our system on 500+ ICLR 2026 submissions with all reports publicly available on our website, and preliminary analysis suggests it can identify relevant prior work, including closely related papers that authors may overlook. OpenNovelty aims to empower the research community with a scalable tool that promotes fair, consistent, and evidence-backed peer review.

arXiv:2601.01627v1 Announce Type: cross Abstract: As Large Language Models (LLMs) are increasingly deployed in healthcare field, it becomes essential to carefully evaluate their medical safety before clinical use. However, existing safety benchmarks remain predominantly English-centric, and test with only single-turn prompts despite multi-turn clinical consultations. To address these gaps, we introduce JMedEthicBench, the first multi-turn conversational benchmark for evaluating medical safety of LLMs for Japanese healthcare. Our benchmark is based on 67 guidelines from the Japan Medical Association and contains over 50,000 adversarial conversations generated using seven automatically discovered jailbreak strategies. Using a dual-LLM scoring protocol, we evaluate 27 models and find that commercial models maintain robust safety while medical-specialized models exhibit increased vulnerability. Furthermore, safety scores decline significantly across conversation turns (median: 9.5 to 5.0, $p

arXiv:2601.01668v1 Announce Type: cross Abstract: Clinicians routinely navigate fragmented electronic health record (EHR) interfaces to assemble a coherent picture of a patient's problems, medications, recent encounters, and longitudinal trends. This work describes EHRSummarizer, a privacy-aware, FHIR-native reference architecture that retrieves a targeted set of high-yield FHIR R4 resources, normalizes them into a consistent clinical context package, and produces structured summaries intended to support structured chart review. The system can be configured for data minimization, stateless processing, and flexible deployment, including local inference within an organization's trust boundary. To mitigate the risk of unsupported or unsafe behavior, the summarization stage is constrained to evidence present in the retrieved context package, is intended to indicate missing or unavailable domains where feasible, and avoids diagnostic or treatment recommendations. Prototype demonstrations on synthetic and test FHIR environments illustrate end-to-end behavior and output formats; however, this manuscript does not report clinical outcomes or controlled workflow studies. We outline an evaluation plan centered on faithfulness, omission risk, temporal correctness, usability, and operational monitoring to guide future institutional assessments.

arXiv:2508.17215v2 Announce Type: replace-cross Abstract: Large Vision-Language Models (LVLMs) augmented with Retrieval-Augmented Generation (RAG) are increasingly employed in medical AI to enhance factual grounding through external clinical image-text retrieval. However, this reliance creates a significant attack surface. We propose MedThreatRAG, a novel multimodal poisoning framework that systematically probes vulnerabilities in medical RAG systems by injecting adversarial image-text pairs. A key innovation of our approach is the construction of a simulated semi-open attack environment, mimicking real-world medical systems that permit periodic knowledge base updates via user or pipeline contributions. Within this setting, we introduce and emphasize Cross-Modal Conflict Injection (CMCI), which embeds subtle semantic contradictions between medical images and their paired reports. These mismatches degrade retrieval and generation by disrupting cross-modal alignment while remaining sufficiently plausible to evade conventional filters. While basic textual and visual attacks are included for completeness, CMCI demonstrates the most severe degradation. Evaluations on IU-Xray and MIMIC-CXR QA tasks show that MedThreatRAG reduces answer F1 scores by up to 27.66% and lowers LLaVA-Med-1.5 F1 rates to as low as 51.36%. Our findings expose fundamental security gaps in clinical RAG systems and highlight the urgent need for threat-aware design and robust multimodal consistency checks. Finally, we conclude with a concise set of guidelines to inform the safe development of future multimodal medical RAG systems.

arXiv:2509.19088v4 Announce Type: replace-cross Abstract: Scientists and practitioners are aggressively moving to deploy digital twins - LLM-based models of real individuals - across social science and policy research. We conducted 19 pre-registered studies with 164 diverse outcomes (e.g., attitudes towards hiring algorithms, intention to share misinformation) and compared human responses to those of their digital twins (trained on each person's previous answers to over 500 questions). We find that digital twins' answers are only modestly more accurate than those from the homogeneous base LLM and correlate weakly with human responses (average r = 0.20). We document five ways in which digital twins distort human behavior: (i) stereotyping, (ii) insufficient individuation, (iii) representation bias, (iv) ideological biases, and (v) hyper-rationality. Together, our results caution against the premature deployment of digital twins, which may systematically misrepresent human cognition and undermine both scientific understanding and practical applications.

npj Digital Medicine, Published online: 06 January 2026; doi:10.1038/s41746-025-02298-3

Holistic AI in medicine; improved performance and explainability

Nature Medicine, Published online: 06 January 2026; doi:10.1038/s41591-025-04153-0

A large population-based study from Japan reveals both the promise and the limits of genomic profiling in cancer care, and highlights the need for multidimensional data to guide therapy across diverse populations.

Nature Medicine, Published online: 05 January 2026; doi:10.1038/s41591-025-04111-w

Multi-cancer detection tests offer a new paradigm in cancer screening — the use of a single test to simultaneously screen for many cancers — but they raise important ethical questions for their development, evaluation and possible implementation.

Nature Medicine, Published online: 05 January 2026; doi:10.1038/s41591-025-04080-0

This multicenter study demonstrates use of dried and capillary blood as a minimally invasive, scalable approach for Alzheimer’s biomarker testing in research, with potential as a widely scalable population-based research approach, especially in resource-limited settings.

npj Digital Medicine, Published online: 31 December 2025; doi:10.1038/s41746-025-02260-3

A clinically validated 3D deep learning approach for quantifying vascular invasion in pancreatic cancer

Nature Medicine, Published online: 02 January 2026; doi:10.1038/s41591-025-04043-5

Results of the phase 1/2 TACTOPS trial show that autologous T cell therapy targeting PRAME, SSX2, MAGEA4, Survivin and NY-ESO-1 in patients with pancreatic ductal adenocarcinoma is feasible and safe, and leads to encouraging clinical responses and evidence of antigen spreading in responders.

Nature, Published online: 31 December 2025; doi:10.1038/s41586-025-09819-w

An integrated systems engineering framework based on life-cycle inventories is used to quantify the global eco-footprint of wearable healthcare electronics and identify effective mitigation strategies.

npj Digital Medicine, Published online: 30 December 2025; doi:10.1038/s41746-025-02284-9

PIC-SURE: an open-source platform for integrating clinical and genomic data

arXiv:2512.22334v1 Announce Type: new Abstract: We introduce SciEvalKit, a unified benchmarking toolkit designed to evaluate AI models for science across a broad range of scientific disciplines and task capabilities. Unlike general-purpose evaluation platforms, SciEvalKit focuses on the core competencies of scientific intelligence, including Scientific Multimodal Perception, Scientific Multimodal Reasoning, Scientific Multimodal Understanding, Scientific Symbolic Reasoning, Scientific Code Generation, Science Hypothesis Generation and Scientific Knowledge Understanding. It supports six major scientific domains, spanning from physics and chemistry to astronomy and materials science. SciEvalKit builds a foundation of expert-grade scientific benchmarks, curated from real-world, domain-specific datasets, ensuring that tasks reflect authentic scientific challenges. The toolkit features a flexible, extensible evaluation pipeline that enables batch evaluation across models and datasets, supports custom model and dataset integration, and provides transparent, reproducible, and comparable results. By bridging capability-based evaluation and disciplinary diversity, SciEvalKit offers a standardized yet customizable infrastructure to benchmark the next generation of scientific foundation models and intelligent agents. The toolkit is open-sourced and actively maintained to foster community-driven development and progress in AI4Science.