EHDS – European Health Data Space

Overview

The European Health Data Space (EHDS) is the first sectoral EU data space regulation. It enables patients to access their electronic health data across borders and creates a framework for secondary use of health data for research, innovation, and health policy.

Who Is Affected?

The EHDS impacts the entire health ecosystem:

• Healthcare providers (hospitals, doctors’ practices, pharmacies)
• Manufacturers of electronic health record (EHR) systems
• Pharmaceutical companies and medical device manufacturers
• Research institutions and universities
• National health authorities and health data access bodies

Core Obligations

1. Primary use: Patients receive access rights to their electronic health data
2. Interoperability: EHR systems must support the European Electronic Health Record Exchange Format (EHRxF)
3. Secondary use: Framework for health data access through health data access bodies
4. Data quality: Requirements for quality and security of health data
5. MyHealth@EU: Cross-border infrastructure for health data exchange
6. Certification: EHR systems must meet conformity requirements

National Transposition

As an EU regulation, the EHDS applies directly, with phased application:

• Germany: Building on the existing Telematikinfrastruktur and electronic patient record (ePA)
• Austria: Integration with ELGA (Electronic Health Record)
• Switzerland: Not directly affected; own health data ecosystem (EPD)