TY - JOUR
T1 - Navigating the European Union Artificial Intelligence Act for Healthcare
AU - Busch, Felix
AU - Kather, Jakob Nikolas
AU - Johner, Christian
AU - Moser, Marina
AU - Truhn, Daniel
AU - Adams, Lisa C.
AU - Bressem, Keno K.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/12
Y1 - 2024/12
N2 - The European Union’s recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically on AI. This is particularly important for the healthcare domain, as other existing harmonisation legislation, such as the Medical Device Regulation, do not explicitly cover medical AI applications. Given the far-reaching impact of this regulation on the medical AI sector, this commentary provides an overview of the key elements of the AI Act, with easy-to-follow references to the relevant chapters.
AB - The European Union’s recently adopted Artificial Intelligence (AI) Act is the first comprehensive legal framework specifically on AI. This is particularly important for the healthcare domain, as other existing harmonisation legislation, such as the Medical Device Regulation, do not explicitly cover medical AI applications. Given the far-reaching impact of this regulation on the medical AI sector, this commentary provides an overview of the key elements of the AI Act, with easy-to-follow references to the relevant chapters.
UR - http://www.scopus.com/inward/record.url?scp=85201301230&partnerID=8YFLogxK
U2 - 10.1038/s41746-024-01213-6
DO - 10.1038/s41746-024-01213-6
M3 - Comment/debate
AN - SCOPUS:85201301230
SN - 2398-6352
VL - 7
JO - npj Digital Medicine
JF - npj Digital Medicine
IS - 1
M1 - 210
ER -