EHDS Explained: What EU Healthcare Providers, Researchers and Vendors Need to Know Now
By Garry Klooesterman | 2025 Oct 28
5 min
Tags
healthcare
compliance
Summary: The European Health Data Space (EHDS) Regulation is a new EU regulation designed to unify the use and exchange of health data. It will empower patients and enable secure data reuse for research and innovation. In this blog, learn what the EHDS is, its key milestones, and how document technology like that from Apryse can help healthcare organizations prepare for compliance with the regulation.
What is the European Health Data Space (EHDS) Regulation and what is its goal?
The European Health Data Space is the first EU-wide data space dedicated to a specific sector. It's a key component of the European Health Union and is designed to create a single market for digital health services and products. The regulation establishes a common legal and technical framework for electronic health data, focusing on two main areas:
- Primary Use: This empowers patients with the right to access, control, and share their electronic health data across borders.
- Secondary Use: This enables the secure and trustworthy reuse of health data for research, innovation, and public health initiatives under strict authorization and governance.
The EHDS also mandates interoperability of Electronic Health Record (EHR) systems and introduces mandatory CE certification for these systems.
To achieve these goals, two new infrastructures will be created: MyHealth@EU for the primary healthcare data exchange and HealthData@EU for the secondary data use of health data.
Because the regulation directly impacts how healthcare organizations manage, share, and secure electronic health data, technology partners like Apryse can provide solutions to help these organizations achieve compliance.
What are the key dates for EHDS implementation and compliance?
The EHDS was officially published on March 5, 2025, and put into effect on March 26, 2025. However, the obligations will be phased in gradually over the coming years. Here are the key milestones:
- March 2025: The regulation officially implemented, beginning the transition phase.
- By March 2027: The European Commission is expected to adopt key acts that will provide detailed rules for the regulation's operation.
- By March 2029: The first categories of health data, such as patient summaries and ePrescriptions, must be fully exchangeable across all EU Member States. Rules for secondary data use will also begin to apply.
- By March 2031: A second group of data, including medical images, lab results, and hospital discharge reports, will be required to be operational across the EU. Rules on secondary use for the remaining data categories will also start to apply.
How does the EHDS protect patient data and ensure security?
The EHDS is built on existing EU frameworks like GDPR and the Data Governance Act, but it also introduces additional, specific rules for the health sector including:
- Patient Control: Patients have the right to restrict access to their data and even opt out of secondary use, with some exceptions for important public interest purposes.
- Secure Processing: Data processing for secondary use can only occur in secure environments, with strict rules preventing the downloading of personal data.
- Pseudonymization: Researchers and companies can only access pseudonymized data if anonymized data is not sufficient for their purpose and are forbidden to re-identify individuals.
- EHR System Certification: The regulation sets strict security and interoperability criteria for EHR systems. Manufacturers are required to certify their compliance before placing products on the market.
What are the potential benefits of the EHDS for healthcare innovation?
The EHDS is expected to bring significant benefits by enhancing data accessibility and driving digital transformation.
- For Patients: It will provide fast and free access to their health data and enable seamless sharing with health professionals, even across borders, leading to better-informed care.
- For Professionals: It will grant easier access to patient records, reducing administrative burden and improving diagnosis and treatment decisions.
- For Researchers: It will offer a clear and structured system to access large-scale, high-quality health data for scientific advancements and applied innovation.
- For the Industry: It will simplify access to new markets for EHR systems and provide greater availability of anonymized and pseudonymized data to power research.
It’s also worth noting that in a recent survey of 270 EU healthcare leaders, 81% believe EHDS will significantly expand or disrupt the digital health market in Europe over the next three years. (The Financial Analyst)
What capabilities can Apryse provide to help comply with the EHDS?
Complying with the EHDS means healthcare organizations will need to address key pain points such as legacy systems, data silos, and manual workflows. In the same survey we mentioned earlier, 54% of EU healthcare leaders cite technical integration as the biggest challenge to EHDS readiness. (The Financial Analyst)
Apryse SDKs can help address these challenges with solutions that relate specifically to the core requirements of the regulation, offering flexible tools to integrate with legacy systems and accelerate interoperability with minimal disruption, such as:
- Secure Document Handling: Features like encryption, redaction, and audit trails help ensure sensitive data is protected and traceable.
- Interoperability and Data Accessibility: Tools for converting documents between different formats such as DOCX and PDF make it easier to integrate legacy systems. Extracting and tagging structured data enables the secondary use of data such as research and analytics.
- Digital Workflows and Patient Rights: Digital signatures and form-filling can support secure patient consent and intake processes, while remote access capabilities allow for seamless patient interaction with documents on any device.
- Support for Secondary Data Use: Automated document processing can help extract anonymized data for research and feed structured information into AI and machine learning models.
Use Cases in Healthcare
- Hospitals: Digitize patient records, consent forms, and discharge summaries.
- HealthTech vendors: Embed Apryse SDKs into EHR platforms to meet CE certification and interoperability standards.
- Research institutions: Extract structured data from clinical trials and patient records.
Conclusion
The European Health Data Space Regulation is designed to unlock the full potential of digital health data across the EU. As the phased implementation continues over the coming years, it’s essential that healthcare organizations take a proactive approach to complying with the regulation.
Apryse SDKs allow healthcare organizations to focus on key areas like secure document handling, interoperability, and digital workflows to prepare to meet the regulation's requirements and harness the opportunities for innovation it presents.
To learn more, get the eBook. You can also contact us with any questions you may have.
Tags
healthcare
compliance
Garry Klooesterman
Senior Technical Content Creator
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