Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation
In: European Journal of Health LawSearch for other papers by Sofia Palmieri in
Current site
Google Scholar
Search for other papers by Paulien Walraet in
Current site
Google Scholar
Search for other papers by Tom Goffin in
Current site
Google Scholar
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.
Purchase
Buy instant access (PDF download and unlimited online access):
Institutional Login
Log in with Open Athens, Shibboleth, or your institutional credentials
Personal login
Log in with your brill.com account
| All Time | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 3287 | 560 | 63 |
| Full Text Views | 240 | 76 | 4 |
| PDF Views & Downloads | 546 | 158 | 14 |
Inevitable Influences: AI-Based Medical Devices at the Intersection of Medical Devices Regulation and the Proposal for AI Regulation
In: European Journal of Health LawSearch for other papers by Sofia Palmieri in
Current site
Google Scholar
PubMed
Search for other papers by Paulien Walraet in
Current site
Google Scholar
PubMed
Search for other papers by Tom Goffin in
Current site
Google Scholar
PubMed
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.
| All Time | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 3287 | 560 | 63 |
| Full Text Views | 240 | 76 | 4 |
| PDF Views & Downloads | 546 | 158 | 14 |