EHDS Overview

AI-enabled diagnostics use advanced algorithms to analyze health data for disease detection and treatment recommendations. EHDS supports the application of AI by providing access to harmonized datasets, accelerating innovation in diagnostics, and improving healthcare outcomes across the EU.

Anonymization is the irreversible process of removing personal identifiers from health data to ensure individual privacy. In EHDS, anonymized data is critical for enabling secondary uses, such as research and innovation, by providing valuable insights while protecting the identities of individuals.

These technologies irreversibly remove identifiable elements from health data, ensuring privacy protection. By enabling the safe secondary use of health data, anonymization tools are a cornerstone of EHDS, supporting research and innovation without compromising individual patient identities or GDPR compliance. 

AI in health leverages machine learning and analytics to process complex health data, supporting diagnostics, treatment planning, and personalized medicine. EHDS enables AI by providing access to harmonized datasets, accelerating innovation while ensuring compliance with privacy and ethical standards.

Chronic disease surveillance monitors the incidence and prevalence of long-term conditions. EHDS enables systematic tracking through harmonized data, helping policymakers and healthcare providers identify trends, allocate resources, and implement preventive measures efficiently across the EU. 

Consent management systems enable individuals to control how their health data is used and shared. In EHDS, such mechanisms ensure transparency and empower citizens to manage permissions, fostering trust in data-sharing practices while enabling compliance with privacy regulations. 

The directive allows EU citizens to access healthcare in other member states and claim reimbursement from their home country. EHDS complements this by enabling the seamless exchange of electronic personal health data, improving patient outcomes and care coordination across borders. 

Cybersecurity in health involves protecting health data from unauthorized access, breaches, and misuse. EHDS prioritizes robust cybersecurity measures, ensuring the confidentiality, integrity, and availability of health data while enabling secure exchanges across Member States. 

DABs are national entities responsible for overseeing secondary use of health data under the EHDS. They manage data requests, ensure compliance with EU regulations, and guarantee privacy protection. Acting as gatekeepers, these bodies facilitate secure and efficient access to datasets for research, innovation, and policy development. 

Data fragmentation refers to the disjointed and inconsistent storage of health information across systems and formats. EHDS addresses this by promoting harmonized data standards, enabling integrated analysis, and ensuring that diverse datasets are interoperable for healthcare, research, and policymaking. 

Data governance encompasses the policies, standards, and practices that ensure health data is managed securely, ethically, and effectively. Within EHDS, governance frameworks guarantee compliance with EU regulations, promote data quality and consistency, and protect individuals’ privacy while enabling robust data use for research and innovation. 

A data intermediary facilitates the secure exchange and processing of health data between entities. Under EHDS, intermediaries ensure compliance with data-sharing regulations, manage data requests, and provide the infrastructure needed for seamless cross-border data access while maintaining robust privacy and security safeguards. 

Data minimization is a principle requiring only the collection and processing of the minimum amount of personal data necessary for specific purposes. Within EHDS, it ensures ethical and compliant handling of health data, reducing risks of misuse while enabling efficient research, policymaking, and innovation.

Data portability allows individuals to request and transfer their personal data in a usable format between systems or providers. Under EHDS, it empowers EU citizens to seamlessly access and share their electronic personal health data, ensuring continuity of care and enhancing interoperability. 

DQA ensures health data accuracy, completeness, and reliability. Within EHDS, robust DQA mechanisms are vital for building trust in data-driven decision-making, whether for research, clinical trials, or public health initiatives across the EU.

A Digital Health Authority is a national body responsible for implementing EHDS regulations, overseeing health data governance, and ensuring data privacy and security. These authorities play a critical role in facilitating interoperability, managing cross-border data exchange, and addressing challenges related to digital healthcare within the EU.

EHDS drives innovation and expansion in the digital health market by creating a single EU-wide market for health data. This fosters competition, simplifies regulatory compliance for businesses, and enhances the adoption of advanced health technologies across member states.

eDispensation allows patients to retrieve electronic prescriptions from pharmacies across EU borders. As part of MyHealth@EU, it ensures interoperability between national systems. This feature simplifies healthcare access for mobile EU citizens, enabling a smooth and consistent experience when filling prescriptions outside their home country.

The eHealth Network is a collaborative platform uniting national authorities responsible for digital health within the EU. It supports the development of cross-border health services like MyHealth@EU. The network ensures that policies, standards, and practices align to foster interoperability and advance EHDS goals effectively.

eIDAS is an EU regulation that provides a framework for secure electronic identification and trust services. It supports EHDS by enabling reliable patient and healthcare provider identification, ensuring trust in digital health interactions across member states.

An EHR is a digital compilation of a patient’s medical history, including diagnoses, treatments, allergies, and test results. Maintained by healthcare providers, it supports accurate, efficient care delivery. Under EHDS, standardized EHRs facilitate cross-border access, enabling citizens to carry their electronic personal health data wherever needed within the EU. 

EMA is the EU agency that evaluates and monitors medicines. It uses health data to ensure drug safety and efficacy. EHDS enhances EMA’s ability to access high-quality, standardized data, supporting regulatory decisions and advancing medical innovation across the EU.

EMA works with EHDS to utilize health data for regulatory science, pharmacovigilance, and drug approval processes. Access to harmonized, high-quality data strengthens EMA’s ability to ensure safe and effective medicines for European citizens.

ERNs are networks of healthcare providers across the EU that focus on rare and complex diseases. They facilitate collaborative care and research by sharing knowledge and health data, supported by EHDS, to improve diagnosis, treatment, and patient outcomes for challenging conditions.

ECAs use real-world health data to create synthetic control groups in clinical trials. By replacing or supplementing traditional control arms, they reduce costs and ethical concerns. EHDS facilitates the use of ECAs by providing access to high-quality, harmonized health data for robust trial designs. 

FHIR is a globally recognized standard for exchanging healthcare data. It structures health information into “resources,” such as patient data or medications, and defines APIs for seamless interoperability. Its adoption within EHDS ensures consistent data exchange, allowing healthcare systems across the EU to communicate effectively and securely.

A federated data infrastructure allows data to remain stored locally while being accessed and analyzed remotely. This decentralized approach under EHDS ensures data sovereignty, enhances privacy, and facilitates cross-border collaboration, enabling the secure use of distributed datasets for research and healthcare improvements.

Federated learning is an AI technique that trains machine learning models across multiple decentralized data sources without transferring the data itself. In EHDS, this approach safeguards patient privacy while enabling insights from distributed datasets, supporting advancements in personalized medicine and healthcare research.

GDPR is the EU regulation governing personal data processing, ensuring transparency, consent, and privacy. It establishes robust protections for health data, which is sensitive by nature, and serves as the foundation for EHDS compliance, balancing innovation with individual rights and data security.

Genomic and omics data encompass molecular-level information, including DNA sequences, proteomics, and metabolomics. EHDS facilitates the secure use of this health data for personalized medicine, enabling tailored treatments based on genetic profiles while maintaining compliance with privacy and ethical standards. 

This process standardizes diverse health data formats into compatible, analysis-ready structures. EHDS emphasizes harmonization to support cross-border research, policymaking, and clinical advancements, enabling consistent interpretation and integration of health data across the EU.

This framework consists of regulations and guidelines that ensure ethical, secure, and consistent management of health data across the EU. It defines roles, standards, and responsibilities to facilitate interoperability and foster innovation within the EHDS ecosystem.

HealthData@EU is the infrastructure supporting the secure and efficient exchange of health data for secondary purposes, such as research and innovation. By linking national health systems, it enables seamless access to anonymized or pseudonymized data, ensuring compliance with regulations while fostering medical advancements and policy development.

Interoperability refers to the capability of diverse health information systems and applications to communicate, exchange, and utilize data seamlessly. This ensures consistency and usability of health information across organizational, regional, and national boundaries, enabling integrated care, efficient operations, and cross-border healthcare within the EHDS framework.

These standards ensure electronic health record systems can seamlessly exchange and interpret data across different healthcare platforms. EHDS mandates interoperable EHR standards to support cross-border healthcare and secondary health data use, fostering a unified digital health ecosystem.

The NRRP is an EU funding initiative supporting digital health transformation across member states. It provides financial resources to modernize healthcare infrastructures, implement EHDS standards, and digitize health data systems, ensuring readiness for the operationalization of the European Health Data Space.

The OMOP CDM standardizes diverse health data formats into a uniform structure to support large-scale analyses. By harmonizing unstructured or fragmented data, it ensures consistency in research and evidence generation. Its compatibility with FHIR and other models makes it integral to data interoperability under the EHDS framework.

A Patient Summary is a standardized dataset containing essential medical information, such as allergies, medications, and diagnoses. This summary enables healthcare providers across EU countries to quickly access critical patient information, supporting continuity of care and improving outcomes in cross-border healthcare situations.

Personal health data includes information about an individual’s physical or mental health, such as medical history, test results, or genetic data. EHDS emphasizes the secure management and sharing of this sensitive health data to improve care delivery, enable research, and support innovation across the EU. 

Primary use refers to the direct use of health data by individuals and healthcare providers to enhance patient care and improve health outcomes. It enables citizens across the EU to access their electronic health records, prescriptions, and summaries, ensuring seamless healthcare delivery, even when receiving treatment in another EU member state.

Pseudonymization replaces identifiable information in health data with unique identifiers, allowing data to be linked without revealing personal details. It is a key privacy-enhancing technique within EHDS, balancing the need for comprehensive data analysis with the protection of individuals’ identities.

RWD refers to health-related data collected outside clinical trials, such as from electronic health records, registries, and wearables. EHDS supports the secure and standardized use of RWD to generate real-world evidence for research, innovation, and healthcare improvements.

RWE involves insights derived from real-world data, such as patient outcomes or healthcare practices. EHDS facilitates the collection and analysis of RWE, which complements clinical trial data and supports the development of evidence-based healthcare policies and treatments.

Secondary use involves leveraging health data for purposes beyond direct patient care, such as research, public health initiatives, and policymaking. The EHDS ensures this data is shared securely and ethically, enabling valuable insights while maintaining strict privacy standards through anonymization or pseudonymization processes.

An SPE is a digital infrastructure that provides a controlled, secure setting for processing sensitive health data. It prevents unauthorized access and ensures compliance with GDPR. SPEs within EHDS enable researchers and policymakers to query data safely, balancing privacy protection with data accessibility.

This type of data includes information on social and economic factors affecting health outcomes, such as income or education level. EHDS enables analysis of socio-economic data to inform targeted healthcare interventions, public health policies, and equitable resource allocation across diverse populations in the EU.

Telemedicine delivers healthcare services remotely using digital technologies. It relies on secure data exchange for consultations, diagnoses, and treatment planning. EHDS strengthens telemedicine by standardizing data sharing across EU countries, enhancing accessibility, and supporting seamless cross-border care.

A TRE is a secure digital space where sensitive health data can be accessed and analyzed while protecting privacy. Researchers use TREs to conduct studies under stringent compliance protocols. TREs within the EHDS framework ensure secure secondary use of health data for research and innovation, promoting trustworthy practices.

A Finnish initiative, Veturi, focuses on developing EHDS-compliant data platforms. It brings together private and public entities to innovate data-sharing technologies, improve technological capabilities, and foster trust in health data usage. The project exemplifies how partnerships can drive effective implementation of EHDS principles.