DENMARK — A commentary published on June 27, 2026, in the Journal of the Royal Society of Medicine calls for new patient rights in AI-driven healthcare. The authors argue that current risk-based regulatory approaches fail to adequately protect patients.

The commentary, titled "The need for patient rights in AI-driven healthcare - risk-based regulation is not enough," was authored by Dr Thomas Ploug, Rikke Frank Jørgensen, Hanne Marie Motzfeldt, Naomi Ploug, and Søren Holm. Ploug, a Professor of Data and AI Ethics at Aalborg University in Denmark, served as the lead author. The authors state that current regulatory approaches could lead to over- and undertreatment, as well as discrimination against certain patient groups.

While recognizing that AI and machine learning systems can enhance clinical accuracy, the authors identified concerns regarding the inherent inaccuracy, opacity, and potential for bias within AI systems. They assert that current regulatory efforts, including the European Union's AI Act passed in 2025, do not sufficiently address these issues. The AI Act categorizes medical AI as high risk and introduces strict controls on providers and deployers of medical AI.

The authors contend that the risk-based framework overlooks individual patient preferences, the systemic and long-term effects of AI implementation, and the disempowerment of patients in regulatory processes. "Patients have different values when it comes to accuracy, bias, or the role AI plays in their care. Regulation must move beyond system-level safety and account for individual rights and participation," Ploug said.

The commentary proposes the introduction of specific patient rights concerning AI-generated diagnosis or treatment planning. These proposed rights include the ability to request an explanation, give or withdraw consent, seek a second opinion, and refuse diagnosis or screening based on publicly available data without explicit consent.

"AI is transforming healthcare, but it must not do so at the expense of patient autonomy and trust. It is time to define the rights that will protect and empower patients in an AI-driven health system," Ploug said. The authors warn that without urgent engagement from healthcare stakeholders, including clinicians, regulators, and patient groups, these rights may not keep pace with the rapid evolution of AI in healthcare.