The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research

The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research

This paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and res...

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Bibliographic Details
Main Authors: Massimo Bottini, Seung-Jun Ryu, Adrian Elmi Terander, Stefanos Voglis, Nicolai Maldaner, David Bellut, Luca Regli, Carlo Serra, Victor E. Staartjes
Format: Article
Language:English
Published: Korean Spinal Neurosurgery Society 2025-03-01
Series:Neurospine
Subjects:
artificial intelligence
machine learning
medical devices
spine surgery
regulatory framework
Online Access:http://e-neurospine.org/upload/pdf/ns-2449186-593.pdf
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