Getting Ready for the EU AI Act in Healthcare. A call for Sustainable AI Development and Deployment
Journal:
arXiv
Published Date:
May 10, 2025
Abstract
Assessments of trustworthiness have become a cornerstone of responsible AI
development. Especially in high-stakes fields like healthcare, aligning
technical, evidence-based, and ethical practices with forthcoming legal
requirements is increasingly urgent. We argue that developers and deployers of
AI systems for the medical domain should be proactive and take steps to
progressively ensure that such systems, both those currently in use and those
being developed or planned, respect the requirements of the AI Act, which has
come into force in August 2024. This is necessary if full and effective
compliance is to be ensured when the most relevant provisions of the Act become
effective (August 2026). The engagement with the AI Act cannot be viewed as a
formalistic exercise. Compliance with the AI Act needs to be carried out
through the proactive commitment to the ethical principles of trustworthy AI.
These principles provide the background for the Act, which mentions them
several times and connects them to the protection of public interest. They can
be used to interpret and apply the Act's provisions and to identify good
practices, increasing the validity and sustainability of AI systems over time.