5 citations · 9 across the 10 of their papers we have counts for
10 papers
Large language models in medical time series analysis
Yu Han, Cigdem Beyan, Xiang Zhang +6
Medical time series (MedTS), including electrocardiograms (ECG), electroencephalograms (EEG), photoplethysmography (PPG), and vital-sign recordings, are central to clinical diagnos…
Measuring Cross-Jurisdictional Transfer of Medical Device Risk Concepts with Explainable AI
Yu Han, Aaron Ceross
Medical device regulators in the United States(FDA), China (NMPA), and Europe (EU MDR) all use the language of risk, but classify devices through structurally different mechanisms.…
Standard Applicability Judgment and Cross-jurisdictional Reasoning: A RAG-based Framework for Medical Device Compliance
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
Identifying the appropriate regulatory standard applicability remains a critical yet understudied challenge in medical device compliance, frequently necessitating expert interpreta…
AI for Regulatory Affairs: Balancing Accuracy, Interpretability, and Computational Cost in Medical Device Classification
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
Regulatory affairs, which sits at the intersection of medicine and law, can benefit significantly from AI-enabled automation. Classification task is the initial step in which manuf…
Toward Automated Regulatory Decision-Making: Trustworthy Medical Device Risk Classification with Multimodal Transformers and Self-Training
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
Accurate classification of medical device risk levels is essential for regulatory oversight and clinical safety. We present a Transformer-based multimodal framework that integrates…
Transforming Medical Regulations into Numbers: Vectorizing a Decade of Medical Device Regulatory Shifts in the USA, EU, and China
Yu Han, Jeroen Bergmann
Navigating the regulatory frameworks that ensure the safety and efficacy of medical devices can be challenging, especially across different regions. These frameworks often require…
The Use of Readability Metrics in Legal Text: A Systematic Literature Review
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
Understanding the text in legal documents can be challenging due to their complex structure and the inclusion of domain-specific jargon. Laws and regulations are often crafted in s…
Regulator-Manufacturer AI Agents Modeling: Mathematical Feedback-Driven Multi-Agent LLM Framework
Yu Han, Zekun Guo
The increasing complexity of regulatory updates from global authorities presents significant challenges for medical device manufacturers, necessitating agile strategies to sustain…
Revolutionizing Pharma: Unveiling the AI and LLM Trends in the Pharmaceutical Industry
Yu Han, Jingwen Tao
This document offers a critical overview of the emerging trends and significant advancements in artificial intelligence (AI) within the pharmaceutical industry. Detailing its appli…
Uncovering Regulatory Affairs Complexity in Medical Products: A Qualitative Assessment Utilizing Open Coding and Natural Language Processing (NLP)
Yu Han, Aaron Ceross, Jeroen H. M. Bergmann
This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care. Through qualitative resea…