Getting Ready for the EU AI Act in Healthcare. A call for Sustainable AI Development and Deployment

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.