Human-in-the-loop reconsidered: Shadow use and reliance management in drug development [0.03%]
以人为中心的药物研发中的辅助使用与依赖管理
Yusuke Inoue
Yusuke Inoue
This article examines the ethical governance of artificial intelligence (AI) use in drug development through joint principles of good AI practice issued by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)....
Beyond consent: Reconstructing ethical justification in medical adaptive machine learning systems [0.03%]
超越知情同意：医学自适应机器学习系统中伦理辩护的重构
Keiichiro Yamamoto,Makoto Udagawa,Eisuke Nakazawa
Keiichiro Yamamoto
Medical Adaptive Machine Learning Systems (MAMLS) that continuously update their models using clinical data blur the conventional boundary between therapy and research, prompting the argument that their use should be classified as research ...
Clinical artificial intelligence (AI) in Japan: Regulatory pathways, domain-specific evidence, and its data infrastructure from an international perspective [0.03%]
从国际视角看日本临床人工智能（AI）的监管路径、特定领域证据及其数据基础设施
Kenji Karako,Wei Tang
Kenji Karako
Artificial intelligence (AI) has advanced rapidly across clinical domains, generating both a growing evidence base and dedicated regulatory frameworks for AI-based software as a medical device (SaMD). This review provides a comprehensive as...
Artificial intelligence (AI)-based pose estimation detects movements linked to unplanned tube removal in ICU patients [0.03%]
基于人工智能（AI）的姿势评估可检测与ICU患者意外拔管相关的动作变化
Aya Umeda,So Mizuno,Fumio Ishizaki et al.
Aya Umeda et al.
Unplanned removal of life-sustaining tubes in intensive care units (ICUs) poses serious risks, yet existing monitoring methods relying on physical restraints have ethical and clinical drawbacks. Here we applied artificial intelligence (AI)-...
Automated radiographic shoulder balance assessment in scoliosis via deep learning [0.03%]
基于深度学习的脊柱侧弯肩部平衡放射图评估方法
Longhao Yang,Fangzheng Xu,Qingzhi Xiang et al.
Longhao Yang et al.
The objective of this study was to develop an automated deep learning-based method for the assessment of shoulder balance in adolescent idiopathic scoliosis (AIS) patients using X-ray images in order to provide a reliable and efficient alte...
Artificial intelligence (AI)-assisted diagnosis of skin diseases: From image classification to dermatology-specific multimodal clinical reasoning [0.03%]
基于人工智能（AI）的皮肤疾病辅助诊断：从图像分类到皮肤病学特定的多模态临床推理
Yuhan Cheng,Chu Zhou,Ping Wang et al.
Yuhan Cheng et al.
Artificial intelligence (AI) in dermatology has moved beyond the early paradigm of single-image classification. Dermatological diagnosis is achieved based on morphology, distribution, symptoms, tactile findings, temporal evolution, patient ...
From companion technologies to social care infrastructure: A multi-level perspective on loneliness-related support in dementia care in an era of artificial intelligence (AI) [0.03%]
从辅助技术到社会关怀基础设施：人工智能时代阿尔茨海默病护理中孤独感支持的多层次视角
Machiko Uenishi,Peipei Song
Machiko Uenishi
Loneliness and social isolation are important psychosocial concerns in dementia care, but they are difficult to address through pharmacological treatment or episodic social activities alone. Companion technologies, including socially assist...
Japanese regulation and approval process for medical artificial intelligence (AI) as software as a medical device (SaMD): Current status and emerging challenges [0.03%]
日本医疗人工智能(AI)作为医疗器械(SaMD)的监管和审批流程:现状与未来挑战
Sara Takahashi,Tomohiko Makino,Reiko Mizutani et al.
Sara Takahashi et al.
The rapid expansion of artificial intelligence (AI) in healthcare has led to increasing adoption of AI-based software as a medical device (SaMD). This paper reviews the current regulatory and approval framework for AI-based SaMD in Japan an...
Proactive adoption of generative artificial intelligence (AI) in the operations of Japan's Pharmaceuticals and Medical Devices Agency (PMDA): Current initiatives, governance, and future perspectives [0.03%]
日本药品和医疗器械机构(PMDA)主动采用生成式人工智能(AI)的现行举措、治理及未来展望
Kohei Amakasu,Junichi Kawana,Osamu Kotera et al.
Kohei Amakasu et al.
The Pharmaceuticals and Medical Devices Agency (PMDA) continues to face increasing operational demands stemming from growing regulatory complexity, expanding data volumes, and evolving scientific and societal expectations. In this context, ...
Artificial intelligence (AI)-assisted full-course case management for primary liver cancer: System design, preliminary implementation, and practical considerations [0.03%]
人工智能（AI）辅助的原发性肝癌全流程病例管理：系统设计、初步实施和实际应用考虑因素
Yanhui Wang,Xian Yue,Ruishuang Zheng et al.
Yanhui Wang et al.
Primary liver cancer presents substantial management challenges across the surgical trajectory, including high recurrence rates, prolonged rehabilitation, and fragmented post-discharge care. This correspondence presents a multidisciplinary ...