EHDS Readiness Guide
With the first compliance deadline approaching, now is the time to ensure your institution meets EHDS standards for secure health data access and sharing.
The Countdown to EHDS Readiness has begun
The EHDS readiness timeline is moving quickly, with foundational requirements due soon. Acting now allows your institution to stay ahead of the curve, reduce the risk of non-compliance penalties, and avoid last-minute challenges. Early preparation also enables smoother implementation, minimizes disruptions, and strengthens patient trust through secure, compliant data management.
Follow along
EHDS Readiness timeline
Ensure your institution is prepared for EHDS with clear compliance guidelines and a timeline of essential milestones. From meeting regulatory standards to optimizing data interoperability, EHDS readiness is crucial for a smooth transition and sustained data security.
2024
EHDS initiative launch
The European Health Data Space (EHDS), establishing the foundation for a unified health data framework across Europe, has been approved 2024 and will come in force early 2025. With the aim of enabling secure, interoperable data exchange, EHDS sets in motion a new era in healthcare collaboration and data-driven insights for both clinical and research purposes
2025-
Transition phase
All healthcare institutions within the EU are expected to complete the transition phase for EHDS by the end of 2028, achieving foundational compliance for secure and interoperable health data exchange. This milestone marks the point at which institutions should have updated their systems to meet EHDS standards, ensuring data compatibility and readiness for further phases
2028
Compliance for Primary Use (MyHealth@EU)
In 2028, healthcare institutions must achieve full EHDS compliance for primary data use, enabling seamless access to electronic health records (EHRs) across the EU to support real-time patient care.
2028
Compliance for Secondary Use (HealthData@EU)
Healthcare institutions must meet EHDS standards for secondary data use during 2028, enabling secure, anonymized data sharing for research and public health initiatives.
2030
Sharing of Genomics
and -omics Data
Healthcare institutions must achieve readiness to share genomics, -omics and some additional data types.
2034
Access to Countries outside EU
Data access can be granted for researchers outside EU at the end of 2034.
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EHDS Readiness Essentials
EHDS readiness encompasses key requirements for data transparency, secure access, and interoperability across Member States. Meeting these standards builds a trusted healthcare data ecosystem that enables safe data sharing for better patient care and research.
Obligations for Data Holders
Data holders are required to align their data practices with EHDS standards. This includes cataloging datasets, accurately reporting data availability, and securely managing data access upon request.
All data holders will be expected to:
- Describe and catalog available datasets.
- Report the existence of data sets in alignment with EHDS.
- Ensure secure, authorized data access upon request.
EHR System Standards
To comply with EHDS, healthcare providers must update EHR systems to ensure compatibility with EU standards for data interoperability, security, and accessibility. These upgrades are essential for creating a seamless cross-border healthcare data ecosystem
EHR systems must meet the following:
- Ensure EHR compatibility with European data-sharing infrastructures.
- Enable secure, interoperable data sharing across borders.
- Prevent unauthorized data access through advanced security measures.
Reporting Expectations
EHDS requires healthcare providers to report and update data availability accurately. Regular reporting allows health data access points to maintain a complete and current view of available datasets, supporting compliance and efficient data use for healthcare and research
All data holders will be expected to:
- Regularly update data availability records.
- Ensure data reporting aligns with national health data access bodies’ guidelines.
- Maintain transparency in data updates and access status.
Risks and Barriers to EHDS Readiness
Implementing EHDS may present challenges, including technical integration, data privacy concerns, and resource limitations. Recognizing these risks allows institutions to develop proactive strategies for maintaining compliance and minimizing disruptions
Risks to consider:
- Data integration and compatibility with existing systems.
- Ensuring consistent data quality across all systems.
- Addressing citizen concerns over privacy for secondary health data use.
- Resource and funding limitations for required upgrades.
EHDS Readiness Frequently Asked Questions
EHDS requires healthcare providers to ensure that their data systems are compatible with EHDS standards and that data can be shared securely. Institutions need to prepare for a unified trustworthy EU data environment where electronic personal health data is accessible across borders with proper GDPR compliance.
Institutions must ensure that their Electronic Health Record (EHR) systems are compatible with the EHDS data standards (e.g., OMOP CDM, FHIR). They also need to implement secure data-sharing protocols and ensure that data availability is well-managed.
EHDS will ensure that diverse data from hospitals, clinics, and research institutions is harmonized into a standardized format. This is crucial for secondary health data use in research and innovation.
Through data harmonization, federated analytics, and secure sharing, EHDS2 allows researchers and policymakers to access large, anonymized datasets across borders for faster clinical trials, disease prevention, and public health studies.
EHDS will ensure that diverse data from hospitals, clinics, and research institutions is harmonized into a standardized format. This is crucial for secondary health data use in research and innovation.
The EU Commission has earmarked €810 million to support the EHDS transition, alongside national budgets and additional funding through Recovery and Resilience Plans, which include €14 billion for digitalization projects.
Institutions can apply for funding to help with the transition to EHDS through available EU channels. Details on application processes and eligibility are expected to be released in upcoming guidelines.
The key barriers include data privacy concerns, lack of standardized data formats, and technical limitations in some countries. Education and communication will be crucial to overcoming these barriers and gaining the trust of EU citizens.
We’re here to help with your EHDS journey
Send us a message, and our team will get back to you with answers and support tailored to your needs.