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Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation

2021·13 Zitationen·European Journal of Health Law
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13

Zitationen

3

Autoren

2021

Jahr

Abstract

In recent years, the use of Artificial Intelligence (AI) in the medical field has attracted increased attention. Due to their impressive advantages, AI systems offer excellent prospects for medical device manufacturers using these systems to upgrade their products. Such AI-based medical devices are already subject to partial regulation within the lines of Medical device regulation 745/2017. However, following the proposal for a regulation on artificial intelligence published by the European Commission, the regulatory landscape for these devices has partially changed. This article aims to clarify the influences that this regulatory intervention by the European Commission brings to the path towards the use and marketing of AI-based medical devices.

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Autoren

Institutionen

Themen

Biomedical Ethics and RegulationArtificial Intelligence in Healthcare and EducationHealth Systems, Economic Evaluations, Quality of Life
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