Medical artificial intelligence: the European legal perspective
Abstract
Although the European Commission proposed new legislation for the use of "high-risk artificial intelligence" earlier this year, the existing European fundamental rights framework already provides some clear guidance on the use of medical AI.
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European fundamental rights also provide legal and ethical guidelines for the adoption, development and application of medical AI.
“European fundamental rights also provide legal and ethical guidelines for the adoption, development and application of medical AI [140].”
From Connecting the dots in trustworthy Artificial Intelligence: From AI principles, ethics, and key requirements to responsible AI systems and regulation (2023) · cites this paper as [140]
Cites
O'Sullivan, S., Nevejans, N., Allen, C., Blyth, A., Leonard, S., Pagallo, U., Holzinger, K., Holzinger, A., Sajid, M. I., & Ashrafian, H. (2019) · The International Journal of Medical Robotics and Computer Assisted Surgery · doi:10.1002/rcs.1968 · Cited by 437 · see citing works
Self-citationThe Ten Commandments of Ethical Medical AI
Muller, H., Mayrhofer, M. T., Van Veen, E.-B., & Holzinger, A. (2021) · Computer · doi:10.1109/mc.2021.3074263 · Cited by 102 · see citing works
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Ali, S., Abuhmed, T., El-Sappagh, S., Muhammad, K., Alonso-Moral, J. M., Confalonieri, R., Guidotti, R., Del Ser, J., Díaz-Rodríguez, N., & Herrera, F. (2023) · Information Fusion · doi:10.1016/j.inffus.2023.101805 · Cited by 1,762 · see citing works
Díaz-Rodríguez, N., Del Ser, J., Coeckelbergh, M., López de Prado, M., Herrera-Viedma, E., & Herrera, F. (2023) · Information Fusion · doi:10.1016/j.inffus.2023.101896 · Cited by 800 · see citing works
Albahri, A. S., Duhaim, A. M., Fadhel, M. A., Alnoor, A., Baqer, N. S., Alzubaidi, L., Albahri, O. S., Alamoodi, A. H., Bai, J., Salhi, A., et al. (2023) · Information Fusion · doi:10.1016/j.inffus.2023.03.008 · Cited by 716 · see citing works
Kiseleva, A., Kotzinos, D., & De Hert, P. (2022) · Frontiers in Artificial Intelligence · doi:10.3389/frai.2022.879603 · Cited by 278 · see citing works
Fairness and Explanation in AI-Informed Decision Making
Angerschmid, A., Zhou, J., Theuermann, K., Chen, F., & Holzinger, A. (2022) · Machine Learning and Knowledge Extraction · doi:10.3390/make4020026 · Cited by 161 · see citing works
Self-citationLarge Language Models lack essential metacognition for reliable medical reasoning
Griot, M., Hemptinne, C., Vanderdonckt, J., & Yuksel, D. (2025) · Nature Communications · doi:10.1038/s41467-024-55628-6 · Cited by 113 · see citing works
Patient perspectives on informed consent for medical AI: A web-based experiment
Park, H. J. (2024) · DIGITAL HEALTH · doi:10.1177/20552076241247938 · Cited by 95 · see citing works
Patnaik, P., & Bakkar, M. (2024) · Technology in Society · doi:10.1016/j.techsoc.2024.102750 · Cited by 100 · see citing works
GNN-SubNet: disease subnetwork detection with explainable graph neural networks
Pfeifer, B., Saranti, A., & Holzinger, A. (2022) · Bioinformatics · doi:10.1093/bioinformatics/btac478 · Cited by 69 · see citing works
Self-citationSáez, C., Ferri, P., & García-Gómez, J. M. (2024) · Journal of Medical Internet Research · doi:10.2196/50295 · Cited by 36 · see citing works
- Authors
- Stöger, K., Schneeberger, D., & Holzinger, A.
- Affiliations
- University of Vienna (AT)
- University of Alberta (CA)
- Venue
- Communications of the ACM
- Published
- 2021-10-25
- Volume
- 64
- Issue
- 11
- Pages
- 34-36
- ISSN
- 0001-0782 (ISSN-L)
- 1557-7317
- OpenAlex
- W3211108032
- Cited by
- 101
- References
- 2
- Citations by year
- 2026: 5 · 2025: 15 · 2024: 43 · 2023: 15 · 2022: 22 · 2021: 1
- FWCI
- 131.96
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Communications of the ACM (publishedVersion)
- Topics
- Social Sciences › Law › Digitalization, Law, and Regulation
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Social Sciences › Safety Research › Ethics and Social Impacts of AI
- Keywords
- artificial intelligence in healthcare, EU AI Act, fundamental rights, AI regulation, health data protection
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