The EU AI Act: implications and compliance guidance for healthcare facilities
Fabio Dennstädt, Janna Hastings, Paul Windisch, Aleksa Jovanovic, Tijana Žunić Marić, Sarah Brüningk, Daniel M. Aebersold, Antje Knopf, Nikola Cihoric · 2026
Read The EU AI Act: implications and compliance guidance for healthcare facilities by Fabio Dennstädt, Janna Hastings, Paul Windisch, Aleksa Jovanovic, Tijana Žunić Marić, Sarah Brüningk, Daniel M. Aebersold, Antje Knopf, Nikola Cihoric (2026) in the Tower of Babel, a free online library of public-domain works preserved in clean, searchable text. No sign-up. The full text is served as a plain-text file at a predictable URL, where text is present: https://antarctic-labs.com/tower-of-babel/PMC13292296.txt.
Description
Fabio Dennstädt and co-authors write a 2026 compliance guide translating the EU AI Act into steps hospitals can actually follow. The Act, Regulation (EU) 2024/1689, is the first broad legal framework for artificial intelligence, and most clinical AI tools count as high-risk under it. The team analyzed deployer duties in Articles 26, 27, and 50 against clinical governance standards.
Their result is a ten-step roadmap folded into four phases, from governance foundations through ongoing compliance. Duties include fundamental rights impact assessments, site-specific validation of each system, and structured human oversight to counter automation bias. A worked example uses a fictional high-risk breast cancer AI. The authors urge facilities to prepare before the August 2026 enforcement deadline.
Catalog record
| CREATOR | Fabio Dennstädt, Janna Hastings, Paul Windisch, Aleksa Jovanovic, Tijana Žunić Marić, Sarah Brüningk, Daniel M. Aebersold, Antje Knopf, Nikola Cihoric |
|---|---|
| YEAR | 2026 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 87961 |
| LICENSE | https://creativecommons.org/licenses/by/4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |