Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives

IF 2 4区计算机科学 Q3 COMPUTER SCIENCE, HARDWARE & ARCHITECTURE

Computer Pub Date : 2024-08-30 DOI:10.1109/mc.2024.3414368

Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen

引用次数: 0

Abstract

Despite the immense potential of artificial intelligence (AI)-powered medical devices to revolutionize health care, concerns regarding their safety in life-critical applications remain. This article proposes extending the general idea of AI lifecycle with regulatory activities relevant to AI-enabled medical systems.

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为欧盟人工智能医疗设备制定符合法规的生命周期：行业观点

尽管人工智能（AI）驱动的医疗设备在医疗保健领域具有巨大的变革潜力，但其在生命攸关的应用中的安全性问题仍然令人担忧。本文建议将人工智能生命周期的一般概念扩展到与人工智能医疗系统相关的监管活动中。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Computer 工程技术-计算机：软件工程

CiteScore

3.90

自引率

4.50%

发文量

378

审稿时长

12 months

期刊介绍： Computer, the flagship publication of the IEEE Computer Society, publishes peer-reviewed articles written for and by computer researchers and practitioners representing the full spectrum of computing and information technology, from hardware to software and from emerging research to new applications. The aim is to provide more technical substance than trade magazines and more practical ideas than research journals. Computer seeks to deliver useful information for all computing professionals and students, including computer scientists, engineers, and practitioners of all levels.