{"title":"驾驭欧盟人工智能法案：对受监管数字医疗产品的影响","authors":"Mateo Aboy, Timo Minssen, Effy Vayena","doi":"10.1038/s41746-024-01232-3","DOIUrl":null,"url":null,"abstract":"The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.","PeriodicalId":19349,"journal":{"name":"NPJ Digital Medicine","volume":null,"pages":null},"PeriodicalIF":12.4000,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.nature.com/articles/s41746-024-01232-3.pdf","citationCount":"0","resultStr":"{\"title\":\"Navigating the EU AI Act: implications for regulated digital medical products\",\"authors\":\"Mateo Aboy, Timo Minssen, Effy Vayena\",\"doi\":\"10.1038/s41746-024-01232-3\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.\",\"PeriodicalId\":19349,\"journal\":{\"name\":\"NPJ Digital Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":12.4000,\"publicationDate\":\"2024-09-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.nature.com/articles/s41746-024-01232-3.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"NPJ Digital Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.nature.com/articles/s41746-024-01232-3\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"NPJ Digital Medicine","FirstCategoryId":"3","ListUrlMain":"https://www.nature.com/articles/s41746-024-01232-3","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
Navigating the EU AI Act: implications for regulated digital medical products
The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.
期刊介绍：
npj Digital Medicine is an online open-access journal that focuses on publishing peer-reviewed research in the field of digital medicine. The journal covers various aspects of digital medicine, including the application and implementation of digital and mobile technologies in clinical settings, virtual healthcare, and the use of artificial intelligence and informatics.
The primary goal of the journal is to support innovation and the advancement of healthcare through the integration of new digital and mobile technologies. When determining if a manuscript is suitable for publication, the journal considers four important criteria: novelty, clinical relevance, scientific rigor, and digital innovation.
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