Navigating the EU AI Act: Implications for Regulated Digital Medical Products (under review)

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Standard

Navigating the EU AI Act: Implications for Regulated Digital Medical Products (under review). / Aboy, Mateo; Minssen, Timo; Vayena, Effy.

I: Nature PJ Digital Medicine, 2024.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Aboy, M, Minssen, T & Vayena, E 2024, 'Navigating the EU AI Act: Implications for Regulated Digital Medical Products (under review)', Nature PJ Digital Medicine.

APA

Aboy, M., Minssen, T., & Vayena, E. (2024). Navigating the EU AI Act: Implications for Regulated Digital Medical Products (under review). Manuskript afsendt til publicering.

Vancouver

Aboy M, Minssen T, Vayena E. Navigating the EU AI Act: Implications for Regulated Digital Medical Products (under review). Nature PJ Digital Medicine. 2024.

Author

Aboy, Mateo ; Minssen, Timo ; Vayena, Effy. / Navigating the EU AI Act: Implications for Regulated Digital Medical Products (under review). I: Nature PJ Digital Medicine. 2024.

Bibtex

@article{5d98320d6bc5460ca63d11a51f8ed43d,
title = "Navigating the EU AI Act: Implications for Regulated Digital Medical Products (under review)",
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{\textquoteright}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 {\textquoteleft}providers{\textquoteright} of these AI systems? After addressing these foundational questions, we discuss the AI Act{\textquoteright}s broader implications for the future of medical device innovation.",
author = "Mateo Aboy and Timo Minssen and Effy Vayena",
year = "2024",
language = "English",
journal = "Nature PJ Digital Medicine",
issn = "2398-6352",
publisher = "Nature Research",

}

RIS

TY - JOUR

T1 - Navigating the EU AI Act: Implications for Regulated Digital Medical Products (under review)

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.

M3 - Journal article

JO - Nature PJ Digital Medicine

JF - Nature PJ Digital Medicine

SN - 2398-6352

ER -

ID: 381798034