Regulating AI in medicine in the United States and Europe
Open accessAbstract
The regulatory landscape for artificial intelligence (AI) is shaping up on both sides of the Atlantic, urgently awaited by the scientific and industrial community. Commonalities and differences start to crystallize in the approaches to AI in medicine.
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The EU AI Act will require device manufacturers to document their strategy for modifying and subsequently testing and validating AI medical devices.
“Similarly, the EU AI Act will require device manufactures to document their strategy for modifying and subsequently testing and validating AI medical devices (190).”
From Artificial Intelligence in Oncology: Current Landscape, Challenges, and Future Directions (2024) · cites this paper as [190]
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References 11 · Cited by 68
Research works printed but not linked: 8
- [4]Vokinger KN Feuerriegel S Kesselheim AS Lancet Digit Health 2021 3 337 338 33933404
- [5]Oren O Gersh BJ Bhatt DL Lancet Digit Health 2020 2 486 488 33328116
- [7]Lavizzo-Mourey RJ Besser RE Williams DR NEJM 2021 18 1681 1684 33951376
- [8]Canto JG Rogers W Goldberg RJ JAMA 2012 8 813 822 PMC4494682 22357832
- [9]Parikh RB Teeple S Navathe AS JAMA 2019 322 2377 31755905
- [10]Kausha A Altman R Langlotz C JAMA 2020 324 1212 32960230 PMC7509620
- [11]Muehlematter UJ Daniore P Vokinger KN Lancet Digit Health 2021 3 195 203 33478929
- [12]Rajkomar A NPJ Digital Med 2018 1 18 PMC6550213 31304336
- Authors
- Vokinger, K. N., & Gasser, U.
- Affiliations
- Harvard University (US)
- Corresponding author
- Vokinger, Kerstin N.
- Gasser, Urs
- Venue
- Nature Machine Intelligence
- Published
- 2021-09-10
- Volume
- 3
- Issue
- 9
- Pages
- 738-739
- ISSN
- 2522-5839 (ISSN-L)
- PMC
- PMC7611759
- OpenAlex
- W3200737726
- Cited by
- 68
- References
- 11
- Citations by year
- 2026: 9 · 2025: 16 · 2024: 16 · 2023: 18 · 2022: 7 · 2021: 2
- FWCI
- 3.11
- Type
- journal article
- Language
- en
- Open access
- green
- www.zora.uzh.ch
- Licence
- Locations
- Nature Machine Intelligence (publishedVersion)
- PubMed (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (194607)
- Topics
- Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Social Sciences › Law › Digitalization, Law, and Regulation
- Keywords
- AI regulation, artificial intelligence in healthcare, health technology regulation, United States, European Union, comparative regulation
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