User Modeling Meets Research Integrity: Challenges in Translating AI-powered Rehabilitation Systems into Regulated Clinical Practice

Abstract

Artificial intelligence (AI) is increasingly embedded in rehabilitation technologies designed for children with developmental disorders, offering new opportunities for personalised, adaptive care. However, the translation of these systems from lab to clinic is often decisively shaped by regulatory frameworks such as the EU General Data Protection Regulation (GDPR), the Medical Device Regulation (MDR), and the forthcoming AI Act. This position paper explores how these three regulatory pillars influence the ethical deployment of AI and the design and innovation process behind pediatric rehabilitation tools. Drawing from recent literature and ongoing policy developments, we argue that GDPR, MDR, and the AI Act should not be viewed merely as compliance hurdles but as co-design forces that enable trustworthy, interpretable, and clinically viable AI. We propose a forward-looking framework to align innovation with regulation to facilitate the safe and effective implementation of AI-powered rehabilitation in child-centred healthcare.

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