The European Health Data Space (EHDS): A Game Changer for Clinical Research and Pharma?
The European Health Data Space (EHDS) is an initiative introduced by the European Commission to enhance the sharing and use of health data across the EU. It aims to facilitate primary and secondary use of electronic health data while ensuring patient rights and data privacy.
- Primary use (for patients and healthcare providers) focuses on improving patient care by allowing seamless, cross-border access to electronic health records (EHRs).
- Secondary use (for research, innovation, policy-making) enables authorized entities, such as CROs and biopharma companies, to access health data for clinical research and healthcare advancements.
The EHDS is part of a broader European strategy to establish a federated infrastructure for health data exchange, ensuring interoperability between health systems while maintaining strict regulatory oversight. In this article, we’ll explore how the EHDS framework empowers the secondary use of health data, unlocking new opportunities for clinical research, digital health, and innovation across Europe.
Timeline: When Does EHDS Go Live?
The EHDS Regulation was published in March 2025 and will be implemented in phases:
- By 2027: Digital Health Authorities must be established in each EU country to oversee implementation.
- By 2029: Primary use regulations will take effect, allowing cross-border access to EHRs for key data categories (e.g., patient summaries, prescriptions).
- By 2031: Secondary use of health data (for research, clinical trials, and AI training) will be fully operational.
- By 2034: Third-country entities may apply to access EHDS data, provided they meet EU data reciprocity requirements.
What Data is Covered?
EHDS takes a broad and flexible approach to defining health data, covering:
- Electronic Health Records (EHRs) – patient histories, lab results, imaging, prescriptions
- Genomic Data – unlocking breakthroughs in precision medicine
- Clinical Trial Data – providing access to real-world evidence
- Wellness App & Wearable Data – linking lifestyle factors with clinical outcomes
- Social and Environmental Determinants – enhancing AI models with non-traditional health indicators
EHDS strictly prohibits the use of health data for marketing, insurance risk profiling, and any activity harmful to public health.
Key Benefits for CROs and Biopharma
The EHDS presents substantial opportunities for CROs and biopharma companies, particularly in drug development, epidemiological studies, and clinical trial design. Key benefits include:
- Access to Large-Scale, High-Quality Data
- EHDS enables access to anonymized and pseudonymized health records, allowing researchers to analyze disease patterns, treatment effectiveness, and patient outcomes across Europe.
- Clinical trial sponsors can access aggregated patient data to optimize trial site selection and enhance patient recruitment strategies.
- Streamlining Real-World Evidence (RWE) Generation
- The EHDS supports secondary use of health data, providing a structured framework for RWE studies that inform regulatory decisions.
- Biopharma firms can use EHDS data to monitor long-term drug safety and efficacy post-market approval.
- Accelerating AI and Digital Health Innovations
- AI-driven drug discovery and diagnostics will benefit from access to structured, interoperable health data under EHDS.
- Companies developing digital health applications can integrate EHDS data into clinical decision-support tools and personalized medicine strategies.
- Enhancing Cross-Border Clinical Trials
- Standardized health data exchange across EU Member States will reduce administrative burdens for multinational clinical trials.
- EHDS will enable faster patient recruitment and monitoring, helping CROs streamline trial execution and regulatory compliance.
- Interoperability mandates ensure EHR systems are compatible across all EU member states, eliminating cross-border research barriers.
How EHDS Works
- Data Registration & Discovery
- Hospitals, pharma companies, research institutions, and digital health firms must register datasets in national databases.
- Access via Health Data Access Bodies (HDABs)
- Companies must apply for access through HDABs, with approvals granted within three months—a major improvement over traditional multi-year approval processes.
- Secure Processing & Data Use
- Approved users access data in a highly secure, EU-regulated environment—data cannot be downloaded or used outside approved frameworks.
- Mandatory Transparency & Results Sharing
- Entities using EHDS data must publish research outcomes within 18 months, ensuring public benefit.
Challenges and Considerations for Industry Stakeholders
While the EHDS presents unprecedented opportunities, companies must navigate regulatory and technical challenges:
- Strict Data Governance: Companies must comply with GDPR-aligned safeguards and obtain approvals from Health Data Access Bodies before using EHDS data.
- Data Processing Requirements: Accessing EHDS data will require adherence to secure processing environments, ensuring data protection and confidentiality.
- Interoperability Standards: Biopharma companies and CROs will need to align with EU-mandated EHR formats and interoperability frameworks.
Conclusion: The Future of Clinical Research in Europe
The EHDS is poised to revolutionize healthcare data accessibility and clinical research in Europe. For CROs and biopharma companies, it offers a unique opportunity to access structured health data, enhancing drug development, patient recruitment, and real-world evidence generation.
By proactively engaging with EU regulators, Digital Health Authorities, and HDABs, industry stakeholders can position themselves early to leverage EHDS capabilities, accelerate clinical trials, and drive innovation in personalized medicine. The future of clinical research and digital health in Europe is data-driven—EHDS will be at the heart of this transformation.
