Legal, ethical, and policy challenges of artificial intelligence translation tools in healthcare.

Artificial intelligence (AI) translation tools, such as Google Translate and ChatGPT, are increasingly used in healthcare for medical communication to overcome language barriers between patients and providers. While these tools offer accessible and efficient translation, their use raises significant legal, ethical, and policy concerns. Key patients' rights, including the rights to privacy, informed consent, and equitable access to care, may be compromised. Current European regulations, including the EU AI Act, General Data Protection Regulation, and Medical Devices Regulation, offer only partial protection, leaving important regulatory gaps. This study employs a mixed-methods approach combining legal doctrinal analysis of EU regulatory frameworks with manual content analysis of platform terms of service. It integrates interdisciplinary perspectives from bioethics, digital health, and health communication to evaluate the implications of AI-mediated translation in clinical care. Findings reveal persistent and overlapping risks: violations of data privacy, inaccuracies in translation, bias and discrimination, and unclear liability when errors occur. To mitigate these risks, we propose targeted policy interventions, including developing guidelines for AI translation use in healthcare settings. This article contributes to digital health policy debates by identifying legal pathways to regulate AI translation tools in healthcare, ensuring their use supports patients' rights and promotes health equity.