A new commentary published in the Journal of the Royal Society of Medicine on June 27, 2026, argues that current risk-based regulatory frameworks for medical AI are insufficient to protect patient autonomy. The authors contend that while machine learning can improve clinical accuracy, existing measures, such as the European Union's AI Act passed in 2025, fail to address inherent system opacity, bias, and the potential for over- or undertreatment. The AI Act currently classifies medical AI as 'high risk,' imposing strict controls on developers, but the authors highlight that this system-level focus overlooks critical individual impacts and long-term systemic consequences.

Thomas Ploug (Professor of Data and AI Ethics at Aalborg University) and his co-authors emphasize that regulation must pivot toward patient-centered rights rather than purely technical safety. The commentary proposes specific safeguards for patients interacting with AI-generated diagnoses or treatment plans, including the right to request clear explanations, provide or withdraw consent, obtain second opinions, and refuse screenings based on publicly available data. The authors state that urgent collaboration between clinicians, regulators, and patient advocacy groups is necessary to ensure these rights remain integrated as AI technologies continue to evolve within health systems.

A new commentary published in the Journal of the Royal Society of Medicine on June 27, 2026, argues that current risk-based regulatory frameworks for medical AI are insufficient to protect patient autonomy. The authors contend that while machine learning can improve clinical accuracy, existing measures, such as the European Union's AI Act passed in 2025, fail to address inherent system opacity, bias, and the potential for over- or undertreatment. The AI Act currently classifies medical AI as 'high risk,' imposing strict controls on developers, but the authors highlight that this system-level focus overlooks critical individual impacts and long-term systemic consequences.

Thomas Ploug (Professor of Data and AI Ethics at Aalborg University) and his co-authors emphasize that regulation must pivot toward patient-centered rights rather than purely technical safety. The commentary proposes specific safeguards for patients interacting with AI-generated diagnoses or treatment plans, including the right to request clear explanations, provide or withdraw consent, obtain second opinions, and refuse screenings based on publicly available data. The authors state that urgent collaboration between clinicians, regulators, and patient advocacy groups is necessary to ensure these rights remain integrated as AI technologies continue to evolve within health systems.