European Health Data Space (EHDS): Legal Analysis and Strategic Guidance for Health Data Governance
Executive Summary
The European Health Data Space (EHDS) establishes a unified framework for the sharing and reuse of electronic health data across the EU, balancing innovation with GDPR compliance.
Primary use: Health data used for direct patient care and healthcare delivery.
Secondary use: Health data reused for research, innovation, AI development, and public health purposes, requiring HDAB authorization and secure processing.
Key actors:
Health Data Holders: Hospitals, pharma companies, medical device manufacturers, and biobanks controlling access to health data.
Health Data Users: Researchers, companies, and public bodies granted permits for secondary use.
Governance & enforcement: HDABs monitor compliance, EHDS Board provides guidance, and fines can reach up to €20M or 4% of global turnover.
Timelines: Secondary use obligations start March 26, 2029, with extended periods for clinical trial and genetic data; third-country recognition may take up to 10 years.
EHDS introduces patient opt-out rights, secure data environments, and labeling requirements for wellness applications and interoperable medical devices.
Strategic takeaway: Early preparation in governance, compliance, data cataloging, and secure infrastructure is essential for legal, compliance, and R&D teams to mitigate risk and leverage EHDS-driven innovation opportunities.
Introduction: Understanding the European Health Data Space (EHDS)
The European Health Data Space (EHDS), published in the EU Official Journal on 5 March 2025, establishes a comprehensive framework for the collection, sharing, and use of electronic health data across the EU.
EHDS aims to improve patient care, scientific research, and innovation while ensuring strict compliance with GDPR. Healthcare providers, life sciences companies, digital health innovators, and legal counsel must understand EHDS obligations to ensure operational compliance and leverage strategic opportunities.
This article provides a detailed legal overview, practical guidance, and strategic insights for health data governance under EHDS.
Primary vs. Secondary Use of Health Data
Primary Use
Primary use refers to the use of electronic health data for direct healthcare purposes, including:
Diagnosis and treatment of patients
Delivery of healthcare services
Management and administration of healthcare systems
Primary use is largely exempt from secondary use obligations but remains subject to GDPR compliance.
Secondary Use
Secondary use refers to the reuse of health data for purposes beyond the original collection, including:
Scientific research and innovation
Development and evaluation of medical devices, algorithms, or AI systems
Public health policy formulation
Secondary use is highly regulated under EHDS, requiring:
Authorization by Health Data Access Bodies (HDABs)
Access through secure processing environments
Strict anonymization or pseudonymization of data
Key Definitions under EHDS
Health Data Holder (Art. 2(1)(t) EHDS)
A health data holder is any natural or legal person who:
Personal electronic health data: Has the right or obligation to process health data as a data controller for research and innovation purposes.
Non-personal electronic health data: Has the ability to make data available through control of technical design.
Examples: Hospitals, pharmaceutical companies, medical device manufacturers, biobanks.
Health Data User (Art. 2(2)(u) EHDS)
A health data user is any natural or legal person granted a permit by an HDAB to access health data for secondary use.
Includes EU bodies, universities, research organizations, and private companies
Must comply with EHDS obligations on anonymization, secure processing, and prohibited uses
Third-country users can participate if their jurisdiction meets EHDS equivalence or reciprocity requirements
Obligations of Health Data Holders
Maintain a Data Catalogue: Submit machine-readable descriptions of datasets to HDABs, updated annually.
Provide Data on Request: Deliver requested datasets within three months (extendable by three months).
Anonymization & Pseudonymization: Ensure anonymization occurs as early as possible; pseudonymization allowed if legally justified.
Data Quality Labeling: Required for EU or Member State-funded datasets.
Optional Trusted Health Data Holder Status: Allows direct secure provision of data while still requiring HDAB permit coordination.
Rights and Responsibilities of Health Data Users
Permit Applications: Must specify intended use, personnel, expected benefits, GDPR legal basis, and duration.
Secure Processing: Access data only via HDAB secure processing environment.
Prohibited Actions: Re-identification, marketing, or sharing outside authorized users.
Transparency: Publish anonymized results within 18 months; HDAB maintains publicly searchable records.
Patient Rights and the Opt-Out Mechanism
EU citizens can reversibly opt-out of secondary use of their personal health data.
Member States must provide accessible and understandable mechanisms for opt-out.
Implementation may vary, particularly for legacy or pseudonymized datasets.
Governance and Enforcement
EHDS Board & Stakeholder Forum
EHDS Board: Advisory body coordinating HDAB practices and sharing best practices.
Stakeholder Forum: Includes industry, researchers, patients, and healthcare professionals.
Enforcement Tools
HDABs monitor compliance, revoke permits, and impose fines (up to €20M or 4% global turnover for severe breaches).
Data Protection Authorities enforce opt-out rights and GDPR compliance.
Individuals can seek material and non-material damages, and NGOs can lodge complaints on behalf of individuals.
Timelines for Implementation
26 March 2025: EHDS enters into force
26 March 2029: Secondary use obligations commence
26 March 2031: Clinical trial and genetic data included
26 March 2035: Third-country recognition may be established
Wellness Applications and Medical Devices
Wellness Applications: Must demonstrate EHR interoperability, obtain digital labels, and secure user consent for data integration.
Medical Devices: Conformity assessment under MDR, IVDR, AI Act, and EHDS registration required for devices claiming EHR interoperability.
Strategic Insights: Practical Implications for Health Data Governance
Clarify Roles: Determine whether your organization is a data holder, health data user, or both.
Define Use Cases: Distinguish between primary vs. secondary use to avoid misclassification and potential fines.
Data Governance Framework: Implement cataloguing, anonymization/pseudonymization, and quality labeling procedures.
Secure Infrastructure: Develop or integrate HDAB-approved secure processing environments.
Compliance Policies: Establish internal controls for GDPR legal basis, record-keeping, and reporting obligations.
Patient Rights: Implement opt-out mechanisms and ensure transparency to maintain public trust.
Third-Country Engagement: Monitor EHDS recognition of non-EU jurisdictions before enabling cross-border data access.
Conformity Assessments: For medical devices and wellness applications, coordinate compliance across MDR, IVDR, AI Act, and EHDS to minimize administrative burden.
Expanded Takeaways for Legal and Compliance Teams
Early Preparation is Critical: Begin internal readiness programs for data mapping, cataloging, and consent management.
Cross-Functional Collaboration: Legal, compliance, IT, and R&D teams must work together to meet EHDS obligations.
Training and Awareness: Staff handling health data must understand EHDS requirements, including data sharing, anonymization, and reporting.
Policy Alignment: Align internal policies with HDAB processes, opt-out management, and secure processing requirements.
Monitoring & Audit: Establish mechanisms to monitor compliance, audit data access, and document due diligence.
Strategic Opportunity: Proper EHDS compliance can position organizations as trusted health data holders, providing faster access for approved data users and potential collaboration with research entities.
Conclusion: Preparing for a Transformative Regulatory Environment
The European Health Data Space represents a paradigm shift in EU health data governance, combining patient rights, regulatory oversight, and opportunities for innovation.
For legal and compliance teams, EHDS is not merely a technical requirement—it is a strategic imperative. Early preparation in areas such as role identification, governance, compliance frameworks, secure processing, and patient rights is essential to mitigate risks, reduce administrative burdens, and capitalize on research and innovation opportunities.
Organizations that proactively embrace EHDS principles will not only achieve regulatory compliance but also enhance trust with patients, regulators, and partners, positioning themselves as leaders in the emerging European digital health ecosystem.
