Things to consider in 2025 - Europe's Health Data Space Act
The Future of Health Data: What the European Health Data Space (EHDS) Act Means for You
The European Health Data Space (EHDS) Act is on the horizon, poised to revolutionize how health data is accessed, shared, and utilized across the European Economic Area (EEA). This ambitious legislation aims to enhance healthcare innovation, improve patient outcomes, and streamline data governance. But what does it mean for healthcare professionals, medical technology companies, and patients?
What is the EHDS Act?
The EHDS Act is a legislative initiative designed to create a unified framework for health data in the EU. Its goal? To make health data more accessible for patient care, medical research, and innovation—all while safeguarding privacy and data security.
The EHDS Act consists of three major parts:
Primary Use of Health Data:Focuses on the processing of electronic health data for direct patient care, such as diagnosis, treatment, and healthcare delivery.Enables patients and healthcare professionals to access health data across EU borders through platforms like MyHealth@EU.Aims to improve continuity of care and empower patients with better control over their health data.
Secondary Use of Health Data:Involves processing health data for purposes beyond direct patient care, including scientific research, healthcare innovation, policymaking, public health monitoring, and education.Establishes Health Data Access Bodies (HDABs) in each EU Member State to manage data requests and ensure secure data sharing.Facilitates easier access to anonymized or pseudonymized datasets, promoting AI development, clinical research, and post-market surveillance.
Electronic Health Records (EHRs) and Wellness Applications:Covers the technological infrastructure that supports the storage, management, and exchange of electronic health data.Sets interoperability standards for EHR systems and ensures that wellness applications can securely connect with health data systems.Aims to create a seamless digital health ecosystem across the EU, enhancing both patient and healthcare provider experiences.
These components work together to promote secure, cross-border health data sharing, drive medical innovation, and improve healthcare outcomes while maintaining strict data privacy and security standards.
Key Features of the EHDS Act
Improved Data Access & Sharing The Act supports both primary use (direct patient care) and secondary use (research, innovation, and policy development). It fosters cross-border data sharing, making healthcare more cohesive across the EU.
Integration with Existing Laws The EHDS Act complements existing regulations like the General Data Protection Regulation (GDPR), Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and the Artificial Intelligence Act (AI Act). It doesn’t override these laws but ensures data governance is streamlined and consistent.
Broad Scope of Data From electronic health records (EHRs) to genetic data, and even information generated from medical devices and wellness apps, the EHDS Act covers both personal and non-personal health data.
Why It Matters: Opportunities & Benefits
Accelerated Medical Innovation: Easier access to diverse datasets will speed up research and the development of new treatments and technologies.
Enhanced Post-Market Surveillance: Simplifies data collection for medical devices, supporting compliance with EU regulations.
Cross-Border Healthcare: Imagine seamless medical care when traveling across the EU, with healthcare professionals accessing your health data securely and efficiently.
Potential Risks & Challenges
Data Privacy Concerns: Managing health data alongside GDPR requirements will be complex, especially concerning sensitive information like genetic data.
Regulatory Overlap: Companies must navigate a web of EU and national laws, potentially complicating compliance efforts.
Commercial Risks: The Act may expose proprietary data to competitors, raising concerns around intellectual property and trade secrets.
When Will It Take Effect?
The EHDS Act will become legally binding 20 days after its publication in the Official Journal of the European Union. Its provisions will be implemented in phases:
General Applicability: Begins 2 years after the publication.
Secondary and Primary Data Use: Phased in over 4 to 6 years, depending on the data category.
EHR System Requirements: Fully applicable 6 years after the Act enters into force.
This phased approach allows organizations time to adapt and comply with the new regulations.
What Should Companies Do Now?
Review Data Governance Strategies: Ensure your data handling practices align with the EHDS Act’s requirements.
Identify At-Risk Data: Understand which datasets fall under the Act and assess any potential commercial risks.
Leverage New Opportunities: The Act opens doors for data-driven research and cross-border collaborations. Prepare to capitalize on these.
The Bottom Line
The EHDS Act is more than just another regulation—it’s a transformative shift in how health data is managed across Europe. While it offers vast opportunities for innovation, it also presents new compliance challenges. Staying ahead means adapting early, ensuring robust data strategies, and being ready to thrive in a data-driven healthcare landscape.
