CLASSICA D8.3 Liability Landscape

Sara Gerke; Mindy Duffourc; David Simon

doi:10.5281/zenodo.17639241

CLASSICA D8.3 Liability Landscape

Sara Gerke
, Mindy Duffourc
, David Simon

Research output: Book/Report › Report › Academic

Abstract

Liability in Artificial Intelligence in healthcare, especially in AI-assisted surgery, is an emerging issue with significant implications for patients, surgeons, clinical adoption, and regulatory oversight. We conducted normative legal, interdisciplinary, and empirical research (focus groups with surgeons from the EU and the US) to understand better the legal frameworks that may govern liability for patient injuries related particularly to the use of AI-driven technologies in surgery, the risks and regulation of AI development more generally, and to assess surgeons’ views concerning liability for using AI-driven technology in surgery.

Original language	English
Place of Publication	Brussels
Publisher	CLASSICA project
Commissioning body	European Union
Number of pages	34
DOIs	https://doi.org/10.5281/zenodo.17639241
Publication status	Published - 19 Oct 2025

Keywords

Horizon Europe
liability
AI liability in healthcare
Medical Devices Regulation (MDR)
US Food and Drug Administration (FDA)

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10.5281/zenodo.17639241Licence: CC BY

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KW - US Food and Drug Administration (FDA)

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CLASSICA D8.3 Liability Landscape

Abstract

Keywords

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