{"title":"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","authors":"Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen","doi":"10.1109/mc.2024.3414368","DOIUrl":null,"url":null,"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.","PeriodicalId":10623,"journal":{"name":"Computer","volume":"62 1","pages":""},"PeriodicalIF":2.0000,"publicationDate":"2024-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives\",\"authors\":\"Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen\",\"doi\":\"10.1109/mc.2024.3414368\",\"DOIUrl\":null,\"url\":null,\"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.\",\"PeriodicalId\":10623,\"journal\":{\"name\":\"Computer\",\"volume\":\"62 1\",\"pages\":\"\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-08-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Computer\",\"FirstCategoryId\":\"94\",\"ListUrlMain\":\"https://doi.org/10.1109/mc.2024.3414368\",\"RegionNum\":4,\"RegionCategory\":\"计算机科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"COMPUTER SCIENCE, HARDWARE & ARCHITECTURE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Computer","FirstCategoryId":"94","ListUrlMain":"https://doi.org/10.1109/mc.2024.3414368","RegionNum":4,"RegionCategory":"计算机科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"COMPUTER SCIENCE, HARDWARE & ARCHITECTURE","Score":null,"Total":0}
Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives
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.
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.