Prepare for phased EHDS implementation
EHDS implementation is moving from regulation to reality. Use this guide to understand the governance, data, technology, and operational capabilities your organization will need to support secure health data access and secondary-use research.
Now is the time to assess EHDS readiness
EHDS entered into force on March 26, 2025, beginning a phased transition from regulation to application. Healthcare organizations should use this period to assess readiness, close capability gaps, and prepare for practical requirements around secure access, interoperability, data governance, and secondary use.
Key areas to assess for EHDS readiness
EHDS readiness depends on more than understanding the regulation. Organizations need clear ownership, trusted data access processes, interoperable infrastructure, and secure workflows for approved secondary use.
- Governance and ownership: Define who owns EHDS readiness, how decisions will be made, and how approved data requests will be reviewed and documented.
- Data access and interoperability: Understand where relevant data sits today, how it can be made available, and what changes are needed to support EHDS-aligned access and exchange.
- Secure secondary-use workflows: Prepare secure environments and repeatable processes that allow approved users to analyze health data without creating unnecessary burden for governance, IT, and research teams.
Follow along
EHDS implementation 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.
2025
Regulation enters into force
EHDS entered into force on March 26, 2025, beginning the phased transition from regulation to practical implementation.
2026
Readiness planning and operating model design
Healthcare organizations should clarify ownership, assess current data access processes, identify interoperability and governance gaps, and define how EHDS-related responsibilities will be managed.
2027
Capability build-out and implementation preparation
Organizations should begin putting the required workflows, secure environments, governance processes, and operational capacity in place so they are prepared as implementing acts, guidance, and technical specifications become more concrete.
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.
Ready to see where your organization stands?
Complete a short EHDS readiness questionnaire to share where your organization stands across governance, interoperability, secure data access, secondary-use workflows, and operational capacity. Your responses will help us prepare a complimentary EHDS readiness workshop focused on your priorities, potential gaps, and next steps — helping you move from awareness to practical readiness for EHDS implementation.
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.
See all FAQs here
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