14 March 2025
Unlike certified medical chatbots, these AI systems are not specifically designed for healthcare but are increasingly used for tasks like summarizing medical records and drafting patient communication. Van Kolfschooten warns that such tools pose risks, including misinformation, privacy breaches, and bias, as they lack the regulatory safeguards of certified medical AI. While the MDR, MedDO, and the EU AI Act impose strict oversight on purpose-built healthcare chatbots, general-purpose AI falls into a regulatory grey area. Van Kolfschooten calls for stricter policies and clinical guidelines to ensure the responsible use of AI in medicine and to safeguard patient safety in an evolving digital healthcare landscape.