Comprehensive Overview of European Health Data Space: What You Need to Know

The European Union has established guidelines and standards for sharing electronic health data via the European Health Data Space (EHDS). The EHDS aims to establish a unified digital health market across the EU and promotes policymaking, research, and healthcare delivery. It will also enable secure data utilization to enhance public health, diagnosis, and treatment.

This whitepaper provides a comprehensive overview of the EHDS, starting with an introduction and a flow chart illustrating the EHDS framework, definition of key terms, and scope. It specifies which entities the EHDS governs, including its relationship with the GDPR.

It covers the primary use of electronic health data and details the obligations of health professionals, electronic health record (EHR) system manufacturers, importers, distributors, and wellness application manufacturers. It also highlights individuals' rights regarding the use of their health data and addresses governance mechanisms.

The document also addresses the secondary use of health data, the obligations of data holders, and access procedures, including cross-border data access. It concludes with details on European governance, the role of the European Commission, penalties for non-compliance, recommendations for action, and how Securiti helps ensure compliance.