As deep learning (DL) technologies advance, their application in automated visual inspection for Class III medical devices offers significant potential to enhance quality assurance and reduce human error. However, the adoption of such AI-based systems introduces new regulatory complexities-particularly under the EU Artificial Intelligence (AI) Act, which imposes high-risk system obligations that differ in scope and depth from established regulatory frameworks such as the Medical Device Regulation (MDR) and the U.S. FDA Quality System Regulation (QSR). This paper presents a high-level technical assessment of the foreseeable challenges that manufacturers are likely to encounter when qualifying DL-based automated inspections -- specifically static models -- within the existing medical device compliance landscape. It examines divergences in risk management principles, dataset governance, model validation, explainability requirements, and post-deployment monitoring obligations. The discussion also explores potential implementation strategies and highlights areas of uncertainty, including data retention burdens, global compliance implications, and the practical difficulties of achieving statistical significance in validation with limited defect data. Disclaimer: This paper presents a technical perspective and does not constitute legal or regulatory advice.

Modern computer systems often rely on syslog, a simple, universal protocol that records every critical event across heterogeneous infrastructure. However, healthcare's rapidly growing clinical AI stack has no equivalent. As hospitals rush to pilot large language models and other AI-based clinical decision support tools, we still lack a standard way to record how, when, by whom, and for whom these AI models are used. Without that transparency and visibility, it is challenging to measure real-world performance and outcomes, detect adverse events, or correct bias or dataset drift. In the spirit of syslog, we introduce MedLog, a protocol for event-level logging of clinical AI. Any time an AI model is invoked to interact with a human, interface with another algorithm, or act independently, a MedLog record is created. This record consists of nine core fields: header, model, user, target, inputs, artifacts, outputs, outcomes, and feedback, providing a structured and consistent record of model activity. To encourage early adoption, especially in low-resource settings, and minimize the data footprint, MedLog supports risk-based sampling, lifecycle-aware retention policies, and write-behind caching; detailed traces for complex, agentic, or multi-stage workflows can also be captured under MedLog. MedLog can catalyze the development of new databases and software to store and analyze MedLog records. Realizing this vision would enable continuous surveillance, auditing, and iterative improvement of medical AI, laying the foundation for a new form of digital epidemiology.

Abstract--The United States spends more on healthcare than any other nation - nearly 17% of GDP as of the early 2020s - yet struggles with uneven access and outcomes [1] [2]. This paradox of high cost, variable quality, and inequitable access is often described by the "Iron Triangle" of healthcare [3], which posits that improvements in one dimension (access, cost, or quality) often come at the expense of the others. This paper explores how an Intelligent Healthcare Ecosystem (iHE) - an integrated system leveraging advanced technologies and data-driven innovation - can "bend" or even break this iron triangle, enabling simultaneous enhancements in access, cost-efficiency, and quality of care. We review historical and current trends in U.S. healthcare spending, including persistent waste and international comparisons, to underscore the need for transformative change. We then propose a conceptual model and strategic framework for iHE, incorporating emerging technologies such as generative AI and large language models (LLMs), federated learning, interoperability standards (FHIR) and nationwide networks (TEFCA), and digital twins. We introduce an updated healthcare value equation that integrates all three corners of the iron triangle, and we hypothesize that an intelligently coordinated ecosystem can maximize this value by delivering high-quality care to more people at lower cost. Methods include a narrative synthesis of recent literature and policy reports, and Results highlight key components and enabling technologies of an iHE. We discuss how such ecosystems can reduce waste, personalize care, enhance interoperability, and support value-based models, all while addressing challenges like privacy, bias, and stakeholder adoption. The paper is formatted per MDPI guidelines, with APA-style numbered references, illustrative figures (U.S. spending trends, waste breakdown, international spending comparison, conceptual models), equations, and a structured layout. Our findings suggest that embracing an Intelligent Healthcare Ecosystem is pivotal for optimizing the long-standing trade-offs in healthcare's iron triangle, moving towards a system that is more accessible, affordable, and of higher quality for all.

The safe use of pharmaceuticals in food-producing animals is vital to protect animal welfare and human food safety. Adverse events (AEs) may signal unexpected pharmacokinetic or toxicokinetic effects, increasing the risk of violative residues in the food chain. This study introduces a predictive framework for classifying outcomes (Death vs. Recovery) using ~1.28 million reports (1987-2025 Q1) from the U.S. FDA's OpenFDA Center for Veterinary Medicine. A preprocessing pipeline merged relational tables and standardized AEs through VeDDRA ontologies. Data were normalized, missing values imputed, and high-cardinality features reduced; physicochemical drug properties were integrated to capture chemical-residue links. We evaluated supervised models, including Random Forest, CatBoost, XGBoost, ExcelFormer, and large language models (Gemma 3-27B, Phi 3-12B). Class imbalance was addressed, such as undersampling and oversampling, with a focus on prioritizing recall for fatal outcomes. Ensemble methods(Voting, Stacking) and CatBoost performed best, achieving precision, recall, and F1-scores of 0.95. Incorporating Average Uncertainty Margin (AUM)-based pseudo-labeling of uncertain cases improved minority-class detection, particularly in ExcelFormer and XGBoost. Interpretability via SHAP identified biologically plausible predictors, including lung, heart, and bronchial disorders, animal demographics, and drug physicochemical properties. These features were strongly linked to fatal outcomes. Overall, the framework shows that combining rigorous data engineering, advanced machine learning, and explainable AI enables accurate, interpretable predictions of veterinary safety outcomes. The approach supports FARAD's mission by enabling early detection of high-risk drug-event profiles, strengthening residue risk assessment, and informing regulatory and clinical decision-making.

The integration of artificial intelligence (AI) in early-stage drug discovery offers unprecedented opportunities for exploring chemical space and accelerating hit-to-lead optimization. However, using docking as a reward function during generative model training is computationally expensive and may yield inaccurate results. Here, we present a novel generative framework that balances pharma-cophore similarity to reference compounds with structural diversity from active molecules. The framework allows users to provide custom reference sets, including FDA-approved drugs or clinical candidates, and guides the de novo generation of potential therapeutics. We demonstrate its applicability through a case study targeting alpha estrogen receptor modulators and antagonists for breast cancer. The generated compounds maintain high pharmacophoric fidelity to known active molecules while introducing substantial structural novelty, suggesting strong potential for functional innovation and patentability. Comprehensive evaluation of the generated molecules against common drug-like properties confirms the robustness and pharmaceutical relevance of the approach.

Large language models readily memorize arbitrary training instances, such as label noise, yet they perform strikingly well on reasoning tasks. In this work, we investigate how language models memorize label noise, and why such memorization in many cases does not heavily affect generalizable reasoning capabilities. Using two controllable synthetic reasoning datasets with noisy labels, four-digit addition (FDA) and two-hop relational reasoning (THR), we discover a reliance of memorization on generalizable reasoning mechanisms: models continue to compute intermediate reasoning outputs even when retrieving memorized noisy labels, and intervening reasoning adversely affects memorization. We further show that memorization operates through distributed encoding, i.e., aggregating various inputs and intermediate results, rather than building a look-up mechanism from inputs to noisy labels. Moreover, our FDA case study reveals memorization occurs via outlier heuristics, where existing neuron activation patterns are slightly shifted to fit noisy labels. Together, our findings suggest that memorization of label noise in language models builds on, rather than overrides, the underlying reasoning mechanisms, shedding lights on the intriguing phenomenon of benign memorization.

Figure A.1 shows the amino acid sequences corresponding to the three SARS-CoV -2 targets. We used a bidirectional Gated Recurrent Unit (GRU) with a linear output layer as an encoder. Figure B.1: The novelty of the scaffold of each generated molecule compared to the most similar scaffold in the training set. Similarity of the fingerprints, is shown next to the scaffold of each generated molecule. We show a representative set of molecules generated for each target in Figure D.1 Figure D.1: Representative molecules generated for (top to bottom): NSP9 Replicase, Receptor-Binding Domain (RBD) of S protein, and Main Protease of SARS-CoV -2 RBD has maximum subgraph similarity to a commercially available drug Telavancin (See Figure E.3).

The generated candidates are novel at both the molecular and chemical scaffold levels when compared to the training data.