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This work addresses challenges in evaluating adaptive artificial intelligence (AI) models for medical devices, where iterative updates to both models and evaluation datasets complicate performance assessment. We introduce a novel approach…

人工智能 · 计算机科学 2026-04-07 Alexis Burgon , Berkman Sahiner , Nicholas A Petrick , Gene Pennello , Ravi K Samala

Although AI systems are increasingly being leveraged to provide value to organizations, individuals, and society, significant attendant risks have been identified and have manifested. These risks have led to proposed regulations,…

人工智能 · 计算机科学 2024-12-06 David Piorkowski , Michael Hind , John Richards

Prognostic and diagnostic AI-based medical devices hold immense promise for advancing healthcare, yet their rapid development has outpaced the establishment of appropriate validation methods. Existing approaches often fall short in…

机器学习 · 计算机科学 2024-09-10 Florian Hellmeier , Kay Brosien , Carsten Eickhoff , Alexander Meyer

Clinical decision-making is a feedback system where risk estimates influence treatment, which in turn changes disease trajectories, and both shape clinicians' measurement practices. Static prediction often fails clinically: models trained…

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…

Artificial intelligence (AI) holds great promise for supporting clinical trials, from patient recruitment and endpoint assessment to treatment response prediction. However, deploying AI without safeguards poses significant risks,…

机器学习 · 计算机科学 2025-10-09 Yao Chen , David Ohlssen , Aimee Readie , Gregory Ligozio , Ruvie Martin , Thibaud Coroller

Quantitative Artificial Intelligence (AI) Benchmarks have emerged as fundamental tools for evaluating the performance, capability, and safety of AI models and systems. Currently, they shape the direction of AI development and are playing an…

Artificial intelligence (AI) systems are increasingly integrated into healthcare and pharmacy workflows, supporting tasks such as medication recommendations, dosage determination, and drug interaction detection. While these systems often…

人工智能 · 计算机科学 2026-05-21 Khalid Adnan Alsayed

Artificial intelligence risks are multidimensional in nature, as the same risk scenarios may have legal, operational, and financial risk dimensions. With the emergence of new AI regulations, the state of the art of artificial intelligence…

计算机与社会 · 计算机科学 2025-09-24 Luis Enriquez Alvarez

Risk-based AI regulation has become the dominant paradigm in AI governance, promising proportional controls aligned with anticipated harms. This paper argues that such frameworks often fail for structural reasons: they implicitly assume…

计算机与社会 · 计算机科学 2025-12-16 Hugo Roger Paz

Artificial Intelligence (AI) systems are now an integral part of multiple industries. In clinical research, AI supports automated adverse event detection in clinical trials, patient eligibility screening for protocol enrollment, and data…

人工智能 · 计算机科学 2025-12-10 Laxmiraju Kandikatla , Branislav Radeljic

Artificial Intelligence and Machine Learning (AI/ML) models used in clinical settings are increasingly deployed to support clinical decision-making. However, when training data become stale due to changes in demographics, environment, or…

人工智能 · 计算机科学 2026-04-28 Ioannis Bilionis , Ricardo C. Berrios , Luis Fernandez-Luque , Carlos Castillo

Artificial Intelligence (AI) models deployed in production frequently face challenges in maintaining their performance in non-stationary environments. This issue is particularly noticeable in medical settings, where temporal dataset shifts…

机器学习 · 计算机科学 2025-05-01 David Fernández Narro , Pablo Ferri , Juan M. García-Gómez , Carlos Sáez

In the future, AI will increasingly find its way into systems that can potentially cause physical harm to humans. For such safety-critical systems, it must be demonstrated that their residual risk does not exceed what is acceptable. This…

人工智能 · 计算机科学 2022-02-14 Michael Kläs , Lisa Jöckel , Rasmus Adler , Jan Reich

Organizations investing in artificial intelligence face a fundamental challenge: traditional return on investment calculations fail to capture the dual nature of AI implementations, which simultaneously reduce certain operational risks…

计算机与社会 · 计算机科学 2025-12-01 Hernan Huwyler

Trust in clinical artificial intelligence (AI) cannot be reduced to model accuracy, fluency of generation, or overall positive user impression. In medicine, trust must be engineered as a measurable system property grounded in evidence,…

计算与语言 · 计算机科学 2026-04-30 Serhii Zabolotnii , Viktoriia Holinko , Olha Antonenko

Artificial Intelligence (AI) technology epitomizes the complex challenges posed by human-made artifacts, particularly those widely integrated into society and exerting significant influence, highlighting potential benefits and their…

人工智能 · 计算机科学 2025-10-06 Michael Papademas , Xenia Ziouvelou , Antonis Troumpoukis , Vangelis Karkaletsis

The integration of artificial intelligence [AI] into clinical trials has revolutionized the process of drug development and personalized medicine. Among these advancements, deep learning and predictive modelling have emerged as…

机器学习 · 计算机科学 2024-12-11 Sydney Anuyah , Mallika K Singh , Hope Nyavor

As AI-based clinical decision support (AI-CDS) is introduced in more and more aspects of healthcare services, HCI research plays an increasingly important role in designing for complementarity between AI and clinicians. However, current…

人机交互 · 计算机科学 2025-04-11 Venkatesh Sivaraman , Katelyn Morrison , Will Epperson , Adam Perer

Although artificial intelligence (AI) shows growing promise for mental health care, current approaches to evaluating AI tools in this domain remain fragmented and poorly aligned with clinical practice, social context, and first-hand user…

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