AEGIS: An Operational Infrastructure for Post-Market Governance of Adaptive Medical AI Under US and EU Regulations
AEGIS:一种用于美国和欧盟法规下适应性医疗AI市场后治理的操作基础设施
机构 * Department of Clinical Science, Intervention and Technology, Karolinska Institutet(临床科学、干预与技术部门,Karolinska研究院) ; Department of Medical Radiation Physics, Stockholm University(医学辐射物理学部门,斯德哥尔摩大学) ; Department of Oncology-Pathology, Karolinska Institutet(肿瘤学-病理学部门,Karolinska研究院) ; Department of Clinical Physiology, Karolinska University Hospital(临床生理学部门,Karolinska大学医院) ; Department of Textile Technology, University of Bor s(纺织技术部门,Bor s大学) ; Department of Medical Technologies, Karolinska University Hospital(医学技术部门,Karolinska大学医院) ; Department of Biomedical Engineering and Health System, KTH Royal Institute of Technology(生物医学工程与健康系统部门,KTH皇家理工学院)
专题命中 医学数据与评测 :medical AI(title,abstract);healthcare AI(abstract);分类 cs.LG
AI总结 本文提出AEGIS框架,通过数据集整合、模型监控和条件决策模块,实现FDA PCCP和EU AI Act条款的执行,支持医疗AI的持续学习与安全更新。