Synthetic data in AI-powered medical devices – the EU regulatory implications

The growing use of synthetic data in AI technologies is one of the major technological trends particularly relevant in the healthcare sector. AI - powered medical devices may be trained and evaluated with the support of synthetic data. As synthetic data applications increase, specific legal, ethical, and regulatory challenges arise. The EU regulatory framework for synthetic data relies on existing provisions of the Medical Devices Regulation, the General Data Protection Regulation, and the AI Act. None of these acts defines the notion of synthetic data and provides specifically tailored provisions relating to it. The legal and ethical approaches will differ depending on the type of synthetic data at stake, its generation methods, and final use. The potential beneficial applications of synthetic data in healthcare regulatory processes should be carefully evaluated not only from the point of view of their legality but also from the point of view of their compliance with ethical principles of fairness, accuracy, and trustworthiness. This article contributes to a broader scholarly discussion about the ethical implications of legal gaps identified in the debate of the matter.