Health data protection and patient safety in Germany, Bulgaria, North Macedonia and China

Abstract

This review compares personal health information protection in Germany, Bulgaria, North Macedonia, and mainland China, emphasizing patient safety, biomedical research, and digital health services. Comparative legal analysis and a narrative review examined legislation, judgments, regulatory guidance, and five scholarly publications retrieved by September 24, 2026. Analytical categories included lawful processing, confidentiality, patient access, research, supervision, international transfers, and product requirements. Germany and Bulgaria share the General Data Protection Regulation but differ in sectoral implementation. North Macedonia illustrates European legal approximation, including distinctive prior-approval requirements and transfer concerns. China combines sensitive information safeguards with network data governance and additional controls on human genetic resources. Similar terminology does not imply equivalent institutions or transfer permissions. The European Health Data Space adds phased obligations, requiring separation of current compliance from future preparedness. Clinical literature supports attention to record accuracy, understandable patient access, and trustworthy research, without establishing comparative national health outcomes. Recommended practices include purpose specific governance, traceable access, appropriate impact assessments, accessible correction procedures, and separate review of research and cross border requirements. Public benefit depends on whether confidentiality, accuracy, and lawful availability jointly support safe care, equitable participation, and accountable knowledge generation.