Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Apr 8:323:66-70.
doi: 10.3233/SHTI250050.

Data Governance in Healthcare AI: Navigating the EU AI Act's Requirements

Affiliations

Data Governance in Healthcare AI: Navigating the EU AI Act's Requirements

Konstantinos Kalodanis et al. Stud Health Technol Inform. .

Abstract

The integration of Artificial Intelligence (AI) into healthcare has the potential to revolutionize patient care, diagnostics, and treatment planning. However, this integration also introduces significant challenges related to data governance, privacy, and compliance with emerging regulations. The European Union's (EU) AI Act proposes a comprehensive regulatory framework aimed at ensuring that AI systems are trustworthy and respect fundamental rights. This paper provides an in-depth analysis of the data governance requirements stipulated by the EU AI Act specifically within the context of healthcare AI. Furthermore, it explores strategies for compliance, examines the interplay with existing regulations such as the General Data Protection Regulation (GDPR), and addresses the ethical considerations inherent in deploying AI in healthcare settings.

Keywords: EU AI Act; artificial intelligence; data governance; healthcare.

PubMed Disclaimer

References

MeSH terms

LinkOut - more resources