TY - JOUR
T1 - Navigating the EU AI Act
T2 - Implications for Regulated Digital Medical Products
AU - Aboy, Mateo
AU - Minssen, Timo
AU - Vayena, Effy
PY - 2024
Y1 - 2024
N2 - 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 medical device innovation.
AB - 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 medical device innovation.
U2 - 10.1038/s41746-024-01232-3
DO - 10.1038/s41746-024-01232-3
M3 - Journal article
C2 - 39242831
VL - 7
JO - Nature PJ Digital Medicine
JF - Nature PJ Digital Medicine
SN - 2398-6352
M1 - 237
ER -