FDA
Automated Generation of Custom MedDRA Queries Using SafeTerm Medical Map
Vandenhende, Francois, Georgiou, Anna, Georgiou, Michalis, Psaras, Theodoros, Karekla, Ellie, Hadjicosta, Elena
In pre-market drug safety review, grouping related adverse event terms into standardised MedDRA queries or the FDA Office of New Drugs Custom Medical Queries (OCMQs) is critical for signal detection. We present a novel quantitative artificial intelligence system that understands and processes medical terminology and automatically retrieves relevant MedDRA Preferred Terms (PTs) for a given input query, ranking them by a relevance score using multi-criteria statistical methods. The system (SafeTerm) embeds medical query terms and MedDRA PTs in a multidimensional vector space, then applies cosine similarity and extreme-value clustering to generate a ranked list of PTs. Validation was conducted against the FDA OCMQ v3.0 (104 queries), restricted to valid MedDRA PTs. Precision, recall and F1 were computed across similarity-thresholds. High recall (>95%) is achieved at moderate thresholds. Higher thresholds improve precision (up to 86%). The optimal threshold (~0.70 - 0.75) yielded recall ~50% and precision ~33%. Narrow-term PT subsets performed similarly but required slightly higher similarity thresholds. The SafeTerm AI-driven system provides a viable supplementary method for automated MedDRA query generation. A similarity threshold of ~0.60 is recommended initially, with increased thresholds for refined term selection.
Empathy by Design: Aligning Large Language Models for Healthcare Dialogue
Umucu, Emre, Solis, Guillermina, Garza, Leon, Rivas, Emilia, Lee, Beatrice, Kotal, Anantaa, Piplai, Aritran
Abstract--General-purpose large language models (LLMs) have demonstrated remarkable generative and reasoning capabilities but remain limited in healthcare and caregiving applications due to two key deficiencies: factual unreliability and a lack of empathetic communication. These shortcomings pose significant risks in sensitive contexts where users, particularly nonprofessionals and caregivers, seek medically relevant guidance or emotional reassurance. T o address these challenges, we introduce a Direct Preference Optimization (DPO)-based alignment framework designed to improve factual correctness, semantic coherence, and human-centric qualities such as empathy, politeness, and simplicity in caregiver-patient dialogues. Our approach fine-tunes domain-adapted Large Language Models (LLMs) using pairwise preference data, where preferred responses reflect supportive and accessible communication styles while rejected ones represent prescriptive or overly technical tones. Empirical evaluations across multiple open and proprietary LLMs show that our DPO-tuned models achieve higher semantic alignment, improved factual accuracy, and stronger human-centric evaluation scores compared to baseline and commercial alternatives such as Google's medical dialogue systems. These improvements demonstrate that preference-based alignment offers a scalable and transparent pathway toward developing trustworthy, empathetic, and clinically informed AI assistants for caregiver and healthcare communication. Caring for individuals with chronic or neuro-degenerative conditions such as Alzheimer's disease and dementia requires not only clinical coordination but also constant emotional resilience. Family caregivers and care partners often become the primary interpreters of medical information, navigating complex treatment decisions, behavioral changes, and communication challenges on a daily basis. LLMs have rapidly become integrated into everyday life. They can explain complex ideas in plain language, adjust to a user's tone, and offer a sense of understanding that static websites cannot. For caregivers seeking clear, kind, and quick answers, these systems can feel like an always-available companion in moments of doubt or stress.
MCP-AI: Protocol-Driven Intelligence Framework for Autonomous Reasoning in Healthcare
ElSayed, Zag, Erickson, Craig, Pedapati, Ernest
Healthcare AI systems have historically faced challenges in merging contextual reasoning, long-term state management, and human-verifiable workflows into a cohesive framework. This paper introduces a completely innovative architecture and concept: combining the Model Context Protocol (MCP) with a specific clinical application, known as MCP-AI. This integration allows intelligent agents to reason over extended periods, collaborate securely, and adhere to authentic clinical logic, representing a significant shift away from traditional Clinical Decision Support Systems (CDSS) and prompt-based Large Language Models (LLMs). As healthcare systems become more complex, the need for autonomous, context-aware clinical reasoning frameworks has become urgent. We present MCP-AI, a novel architecture for explainable medical decision-making built upon the Model Context Protocol (MCP) a modular, executable specification for orchestrating generative and descriptive AI agents in real-time workflows. Each MCP file captures clinical objectives, patient context, reasoning state, and task logic, forming a reusable and auditable memory object. Unlike conventional CDSS or stateless prompt-based AI systems, MCP-AI supports adaptive, longitudinal, and collaborative reasoning across care settings. MCP-AI is validated through two use cases: (1) diagnostic modeling of Fragile X Syndrome with comorbid depression, and (2) remote coordination for Type 2 Diabetes and hypertension. In either scenario, the protocol facilitates physician-in-the-loop validation, streamlines clinical processes, and guarantees secure transitions of AI responsibilities between healthcare providers. The system connects with HL7/FHIR interfaces and adheres to regulatory standards, such as HIPAA and FDA SaMD guidelines. MCP-AI provides a scalable basis for interpretable, composable, and safety-oriented AI within upcoming clinical environments.
Chabria: Is RFK Jr. better on women's health than Newsom? We're about to find out
Things to Do in L.A. Tap to enable a layout that focuses on the article. Is RFK Jr. better on women's health than Newsom? We're about to find out Halle Berry speaks Wednesday during the New York Times DealBook Summit, where she criticized Gov. Gavin Newsom for vetoing a bill that would guarantee access to menopause treatment for California women. This is read by an automated voice. Please report any issues or inconsistencies here .
Goodbye, finger pricks? Diabetes patients could monitor glucose with lightwaves.
Diabetes patients could monitor glucose with lightwaves. Future versions of the noninvasive prototype may be as small as a watch. Breakthroughs, discoveries, and DIY tips sent every weekday. A new, noninvasive blood-glucose monitoring system may allow people with diabetes to finally ditch their painful finger pricks and under the skin sensors. Although the current iteration is comparatively bulky, MIT scientists writing in the journal say they are well on their way to scaling down their invention.
Keeping Medical AI Healthy and Trustworthy: A Review of Detection and Correction Methods for System Degradation
Guan, Hao, Bates, David, Zhou, Li
Artificial intelligence (AI) is increasingly integrated into modern healthcare, offering powerful support for clinical decision-making. However, in real-world settings, AI systems may experience performance degradation over time, due to factors such as shifting data distributions, changes in patient characteristics, evolving clinical protocols, and variations in data quality. These factors can compromise model reliability, posing safety concerns and increasing the likelihood of inaccurate predictions or adverse outcomes. This review presents a forward-looking perspective on monitoring and maintaining the "health" of AI systems in healthcare. We highlight the urgent need for continuous performance monitoring, early degradation detection, and effective self-correction mechanisms. The paper begins by reviewing common causes of performance degradation at both data and model levels. We then summarize key techniques for detecting data and model drift, followed by an in-depth look at root cause analysis. Correction strategies are further reviewed, ranging from model retraining to test-time adaptation. Our survey spans both traditional machine learning models and state-of-the-art large language models (LLMs), offering insights into their strengths and limitations. Finally, we discuss ongoing technical challenges and propose future research directions. This work aims to guide the development of reliable, robust medical AI systems capable of sustaining safe, long-term deployment in dynamic clinical settings.
Black Friday Protein Powder Deals and Supplement Steals (2025)
From protein supplements and electrolytes to greens powders and energy drinks, these are the discounted picks worth snagging. The wellness industry is a wild marketplace. You can't trust the marketing alone, and FDA regulation on protein powder deals is quite limited. It pays to be cautious. So for this year's Black Friday, we sifted through the markdowns, cross-checked claims, verified third-party tests, and sampled the supplements so you don't have to.
Black Friday Protein Powder Deals and Supplement Steals (2025)
From protein supplements and electrolytes to greens powders and energy drinks, these are the discounted picks worth snagging. The wellness industry is a wild marketplace. You can't trust the marketing alone, and FDA regulation is quite limited. It pays to be cautious. So for this year's Black Friday, we sifted through the markdowns, cross-checked claims, verified third-party tests, and sampled the supplements so you don't have to.
Diffusion Models at the Drug Discovery Frontier: A Review on Generating Small Molecules versus Therapeutic Peptides
Wang, Yiquan, Ma, Yahui, Chang, Yuhan, Yan, Jiayao, Zhang, Jialin, Cai, Minnuo, Wei, Kai
Diffusion models have emerged as a leading framework in generative modeling, poised to transform the traditionally slow and costly process of drug discovery. This review provides a systematic comparison of their application in designing two principal therapeutic modalities: small molecules and therapeutic peptides. We dissect how the unified framework of iterative denoising is adapted to the distinct molecular representations, chemical spaces, and design objectives of each modality. For small molecules, these models excel at structure-based design, generating novel, pocket-fitting ligands with desired physicochemical properties, yet face the critical hurdle of ensuring chemical synthesizability. Conversely, for therapeutic peptides, the focus shifts to generating functional sequences and designing de novo structures, where the primary challenges are achieving biological stability against proteolysis, ensuring proper folding, and minimizing immunogenicity. Despite these distinct challenges, both domains face shared hurdles: the scarcity of high-quality experimental data, the reliance on inaccurate scoring functions for validation, and the crucial need for experimental validation. We conclude that the full potential of diffusion models will be unlocked by bridging these modality-specific gaps and integrating them into automated, closed-loop Design-Build-Test-Learn (DBTL) platforms, thereby shifting the paradigm from mere chemical exploration to the on-demand engineering of novel~therapeutics.