New European Health Data Space Requirements Will Transform Healthcare Data Management

The European Health Data Space (EHDS) regulation, expected to be approved in early 2025, mandates healthcare providers, medical device manufacturers, and digital health companies to ensure secure cross-border health data exchange and secondary use within the EU. Organizations must implement robust data protection, access controls, and interoperability standards to comply with the new law.

Kiteworks supports EHDS compliance, ensuring protected health information (PHI) remains confidential. The Kiteworks Private Content Network, built on a hardened virtual appliance, empowers healthcare professionals to securely send, store, and share PHI externally. Role-based access controls, end-to-end encryption, and comprehensive audit logging capabilities enable compliance while facilitating both primary and secondary use of health data.

How to Protect PHI and Comply With HIPAA While Meeting Employee Vaccine Mandates

Watch Now

The Challenge of Secure Cross-border Health Data Exchange

Healthcare organizations face significant hurdles implementing EHDS requirements for cross-border health data sharing, including establishing secure processing environments, maintaining data sovereignty, ensuring interoperability across systems, and managing complex access controls while protecting personally identifiable and protected health information (PII/PHI).

New Standards for Patient Data Control and Cross-border Access

Data systems must be transformed to grant patients free access to their health records while enabling controlled sharing across EU borders. The dual requirements of unrestricted patient data access and restricted healthcare professional access create complex technical challenges. Organizations need to implement sophisticated identification management systems, establish secondary data use protocols, and build infrastructure that supports both historical and new electronic records—all while maintaining patient control over their data sharing preferences.

Complex Data Management Requirements

Data management systems must be restructured by healthcare providers to handle six distinct categories of health records and prepare fifteen types of data for secondary use. Organizations need to adapt their infrastructure to process everything from patient summaries to laboratory results, while simultaneously managing pathogen genomic and administrative data. This expansion of data scope requires new systems capable of organizing, storing, and sharing diverse healthcare information for both direct patient care and research purposes.

Build Secure Cross-border Data Access Infrastructure

Healthcare organizations must establish secure processing environments that track and manage complex data access requests across EU borders. They need to integrate with HealthData@EU while maintaining equivalent access conditions for all EU users. This requires implementing new security protocols, developing cross-border cooperation frameworks, and creating systems to monitor data request traceability—all while ensuring consistent data accessibility through a standardized infrastructure.

Essential Steps to Achieve EHDS Compliance

Comprehensive Solutions for EHDS Data Access Management

Kiteworks solves healthcare organizations’ EHDS compliance challenges with comprehensive authentication and access controls. The Kiteworks platform delivers unified security, combining multiple authentication methods (credential-based, MFA, SAML 2.0 SSO) with granular role-based permissions to enable secure patient and professional access. The single-tenant private cloud architecture with comprehensive audit logging ensures secure cross-border data exchange, meeting both primary and secondary use requirements.

Unified Platform for Complex Health Data Management

Kiteworks supports all required health data types with comprehensive tracking capabilities. The platform’s audit logging system captures detailed metadata and activity logs without performance throttling, even during high-volume periods. SafeVIEW DRM provides secure document viewing with watermarking protection, while role-based access controls manage permissions for both primary and secondary data use. This unified approach enables secure handling of diverse healthcare information across patient care and research contexts.

Secure Cross-border Health Data Infrastructure

Kiteworks addresses EHDS cross-border requirements through its hardened virtual appliance architecture, which integrates multiple security layers including network firewall, WAF, and encryption. Available as a single-tenant private cloud deployment, Kiteworks enables secure data exchange while maintaining consistent access controls across borders. Comprehensive audit logging tracks all access requests and permissions, while SafeVIEW DRM provides secure document viewing capabilities. This multi-layered security approach ensures standardized, secure data accessibility across the EU.

FAQs

The European Health Data Space regulation is expected to be approved in early 2025, requiring healthcare organizations to implement secure cross-border health data exchange and secondary use capabilities within the EU two years after its entry into force.

Healthcare providers, medical device manufacturers, and digital health companies operating within the EU must comply with EHDS requirements for data protection, access controls, and interoperability standards.

EHDS covers six priority categories of protected health information (PHI): patient summaries, e-prescriptions, e-dispensations, medical images/reports, laboratory results, and discharge reports, plus 15 types of data for secondary use including pathogen genomic and administrative data.

EHDS requires organizations to provide patients free access to their health records while allowing them to control sharing permissions. Healthcare professionals must have controlled access across EU borders, subject to patient restrictions.

Organizations must implement secure processing environments, maintain data sovereignty, ensure cross-border interoperability, establish comprehensive access controls, and integrate with HealthData@EU while maintaining consistent security protocols.