Synthetic data in medical imaging within the EHDS: a path forward for ethics, regulation, and standards.

Abstract

The increasing availability of medical imaging data offers unprecedented opportunities for advancing artificial intelligence (AI)-driven healthcare. However, strict data protection regulations in the European Union (EU), especially the General Data Protection Regulation (GDPR), present significant challenges to data sharing and reuse. Synthetic data-artificially generated data that mimic the statistical properties of real data without revealing sensitive information-have emerged as a promising s