Related papers: Regulatory Considerations for Using Artificial Int…
Artificial intelligence (AI) is accelerating progress in modeling T and B cell receptors by enabling predictive and generative frameworks grounded in sequence data and immune context. This chapter surveys recent advances in the use of…
Artificial Intelligence (AI) is poised to transform healthcare delivery through revolutionary advances in clinical decision support and diagnostic capabilities. While human expertise remains foundational to medical practice, AI-powered…
This paper explores the use of Artificial Intelligence (AI) as a tool for diagnosis, assessment, and intervention for individuals with Autism Spectrum Disorder (ASD). It focuses particularly on AI's role in early diagnosis, utilizing…
Clinical decision support systems (CDSS) augmented with artificial intelligence (AI) models are emerging as potentially valuable tools in healthcare. Despite their promise, the development and implementation of these systems typically…
Developing AI models that are useful in clinical practice, requires efficient collaboration between clinicians and AI developers. This poses a practical challenge: clinicians must repeatedly communicate and refine their requirements with AI…
Artificial intelligence (AI) is expected to revolutionize the practice of medicine. Recent advancements in the field of deep learning have demonstrated success in a variety of clinical tasks: detecting diabetic retinopathy from images,…
Evaluating the safety of AI Systems is a pressing concern for organizations deploying them. In addition to the societal damage done by the lack of fairness of those systems, deployers are concerned about the legal repercussions and the…
Recent progress in Large Language Models (LLMs) has drawn attention to their potential for accelerating drug discovery. However, a central problem remains: translating theoretical ideas into robust implementations in the highly specialized…
Recent Artificial Intelligence (AI) models have matched or exceeded human experts in several benchmarks of biomedical task performance, but surgical benchmarks in particular are often missing from prominent medical benchmark suites. Since…
Although general-purpose AI systems offer transformational opportunities in science and industry, they simultaneously raise critical concerns about safety, misuse, and potential loss of control. Despite these risks, methods for assessing…
Present practice of deciding on regulation faces numerous problems that make adopted regulations static, unexplained, unduly influenced by powerful interest groups, and stained with a perception of illegitimacy. These well-known problems…
FDA has been promoting enrollment practices that could enhance the diversity of clinical trial populations, through broadening eligibility criteria. However, how to broaden eligibility remains a significant challenge. We propose an AI…
Artificial intelligence (AI)-driven methods can vastly improve the historically costly drug design process, with various generative models already in widespread use. Generative models for de novo drug design, in particular, focus on the…
Screening patients for clinical trial eligibility remains a manual, time-consuming, and resource-intensive process. We present a secure, scalable proof-of-concept system for Artificial Intelligence (AI)-augmented patient-trial matching that…
Assessing the capabilities and risks of frontier AI systems is a critical area of research, and recent work has shown that repeated sampling from models can dramatically increase both. For instance, repeated sampling has been shown to…
In reaction to growing concerns about the potential harms of artificial intelligence (AI), societies have begun to demand more transparency about how AI models and systems are created and used. To address these concerns, several efforts…
Recent advancements in artificial intelligence (AI), particularly in large language models (LLMs), have unlocked significant potential to enhance the quality and efficiency of medical care. By introducing a novel way to interact with AI and…
This paper introduces a new Phase I design aimed at enhancing the performance of existing methods, including algorithm-based, model-based, and model-assisted designs. The design, developed by integrating the concept of Fisher information,…
The accuracy of coronary artery disease (CAD) diagnosis is dependent on a variety of factors, including demographic, symptom, and medical examination, ECG, and echocardiography data, among others. In this context, artificial intelligence…
The U.S. Food and Drug Administration (FDA) released a landmark draft guidance in January 2026 on the use of Bayesian methodology to support primary inference in clinical trials of drugs and biological products. For sponsors, the central…