Protection of Personal Medical Data in the Era of Digitalization: Legal Guarantees and Prospects

Abstract

This article explores the protection of personal medical data in an era defined by digital technologies, global connectivity, and new healthcare paradigms. Given the heightened sensitivity of health information, we analyze existing international frameworks—namely the EU General Data Protection Regulation (GDPR), the Council of Europe’s Convention 108, and U.S. regulations such as HIPAA—and discuss how they apply in an environment increasingly shaped by cloud computing, big data analytics, and artificial intelligence. Drawing on leading case law from the Court of Justice of the EU, the European Court of Human Rights, and U.S. courts, we highlight ongoing challenges, including informed consent, data re-identification, cross-border transfers, and cyberattacks targeting healthcare systems. By juxtaposing stringent European data protection models with the more fragmented American healthcare privacy landscape, we identify practical and conceptual gaps that require urgent regulatory attention. Finally, the article suggests possible avenues for greater harmonization and stronger enforcement—ranging from sector-specific standards for AI-driven health analytics to clearer frameworks for data ownership and accountability—aimed at safeguarding individual privacy while facilitating innovation in digital healthcare.