Frequently Asked Questions

The European Health Data Space (EHDS) is the first common European Union (EU) data space for the European Health Union, an exciting new initiative that aims to advance digital health for all Member States. EHDS was officially launched in the spring of 2024 following approval by the European Parliament and the European Council. 
The EHDS encompasses a legal framework of rules, common standards and practices and infrastructures for healthcare data governance in the EU. It covers electronic health records (EHR), health data from apps and medical devices, and health data in registries. 
The EHDS was created in response to the lack of effective data collection at EU level. It is unique to the health sector, providing enhanced protection for sensitive health data and builds on the high data protection standards of the EU’s General Data Protection Regulation (GDPR). Furthermore, it streamlines access while positioning Europe to take advantage of AI in healthcare globally. 

The EHDS will enable a genuine single market for digital health products and services. 
The two primary objectives of EHDS are: 
Primary use (MyHealth@EU): Granting EU citizens full control over their healthcare data with the goal of achieving better healthcare across the EU. 
Secondary use (HealthData@EU): Creating a trustworthy environment, in which health data can be shared beyond the original patient care pathway and used in data generation for research, innovation and public health purposes. 
Citizens will have immediate and simple access to their  electronic personal health data anywhere in the EU, with clear opt-out options for both primary and secondary use. By default, data will be exchanged unless a patient actively chooses to prohibit it. The EHDS also establishes a legal framework to securely access and process a wide range of sensitive health data for research, innovation and policymaking.  

Healthcare data can vary greatly from one organization to another. The EHDS represents a fundamental shift in how we handle health data, reinforcing health data governance and overriding Member State national legislation. It aims to harmonize healthcare data accessibility and standards in line with the Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) adopted across the EU.  
Data harmonization to a common format takes unstructured data and creates structured data that is analysis-ready. Users can then generate evidence based on a wide variety of data sources. OMOP is additionally compatible with disparate health-related data sources like the Fast Healthcare Interoperability Resources (FHIR) data model.

Overall, unlocking data for research through the EHDS will accelerate the development of life-saving treatments and personalized medicines. The timeline for data analysis will be reduced from months and years to days and weeks. In terms of benefits to specific stakeholder groups:  
Healthcare professionals and institutions  
– Faster access to patient records  
– Expanding the evidence base for decisions  
– Reduced administrative burden  
– A direct financial impact as high as 15% of hospital expenditure  
– A potential revenue stream by providing access to healthcare data  
Researchers  
– Substantial amounts of high-quality health data will be accessible  
– The specifics, location and quality of the data will be available  
– Access to health data will be cheaper and effective  
– Privacy of patients will be protected (anonymized or pseudonymized format)  
Regulators and policymakers  
– There will be greater data transparency for more effective healthcare systems and policymaking   
– Enhanced access will reduce costs and increase efficiency  
Industry  
– Health data standardization and specifications will allow easier entry into new EU markets for EHR systems  
– More health data to facilitate applied research and innovation  
– Unlock the development of devices integrating artificial intelligence technology  
– Small and mid-sized enterprises will gain access to high-quality health data sets for research and innovation purposes  

The implementation of EHDS is expected to generate €5.5 billion in savings over ten years through better access and exchange of health data in healthcare. The framework will also The implementation of EHDS is expected to generate €5.5 billion in savings over ten years through better access and exchange of health data in healthcare. The framework will also inform policymaking to better reflect the real public health needs of different countries. It is also expected to contribute to a 20-30% additional growth in the digital health market.  
More efficient use of health data is estimated to provide €4.5 billion in savings for research, innovation and policymaking. Greater integration will enable fast identification of individuals for prevention and screening measures together with more effective patient monitoring leading to earlier diagnoses.  
In addition to these points, the EHDS will make real-world evidence readily accessible to researchers, enabling more robust evidence for designing and conducting confirmatory trials and answering questions that may not be addressed otherwise. For example, opportunities could emerge to find treatments for rare diseases, particularly where small datasets and fragmentation currently prevent advances in treatments. A powerful opportunity also exists to supplement randomized controlled clinical trials through the use of external control arms that can be assembled through harnessing the EHDS.  

Cross-border access to health data within the EU also creates the opportunity to study differences between healthcare systems and national policies such as vaccination schemes, screening programs and smoking prevention. Public health surveillance will also greatly benefit from a common EU Data Space particularly incidence rates of chronic disorders and rare diseases that are not currently systematically monitored across the EU.  

EHDS will directly and indirectly affect several players across the EU’s health data ecosystem, including: 

Patients 
Patients will have immediate and free access to their personal electronic health data in a user-friendly form, with some exceptions. Patients will also be able to restrict health professionals’ access to their health data—either in whole or in part 

Healthcare professionals 
Health professionals will have access to relevant health data 

Healthcare institutions 
All data holders will be expected to provide a description of their data sets, report their existence, and make them available upon request. (Note that micro-enterprises are excluded from this obligation.) 

Standard approval and release mechanisms are to be put into place that are fair and equitable.  
All queries will be required to be carried out in a secure processing environment, including trusted research and federated environments. 

Researchers (academia and industry) 
Requests for data, and the use of data and associated analyses will be carried out and managed according to via EHDS regulations 

There will be a more standardized process for data requests, data access and analyses. 

Patients will have immediate and free access to their  electronic personal health data in a user-friendly form, with some exceptions  

Patients will also be able to restrict health professionals’ access to their electronic personal health data—either in whole or in part  

Health professionals will have access to relevant health data  

EHDS will enable policymakers and regulators access to relevant health data  
It will make accessing health data easier for researchers and innovators  

The EHDS will facilitate secondary use and enable complex data queries using pseudonymized, anonymized and synthesized data. Furthermore, data request, approval and release mechanisms will be fair and equitable. Importantly, all queries will be done in a secure processing environment, including trusted research and federated environments.  

EHDS regulation will affect approximately 200 university hospitals, 15,000 healthcare institutions, and tens of thousands of researchers. The healthcare data access mechanism has three main players: data holders, health data access points, and data users.  

All data holders will be expected to provide a description of their data sets, report their existence, and make them available upon request. Note that micro-enterprises are excluded from this obligation.

Healthcare providers must ensure that their electronic health record (EHR) systems implement common specifications involving the adjustment or upgrade of existing infrastructure to support the requirements. Furthermore, healthcare providers can choose how to deliver the data. Compliance will be carefully monitored by the national health data access bodies.  
Essential EHR system requirements include sharing personal electronic health data in a commonly used electronic interoperable format compatible with European infrastructures. EHR systems must also enable the safe and secure processing of electronic health data and prevent any unauthorized access to such data.  

The EU Commission has earmarked €810 million to support the EHDS. Different funding instruments will be provided together with national budgets to support the transition into the EHDS. Additional funding through the Recovery and Resilience Plans has earmarked €14 billion for digitalization across sectors that could be made available. More details about how funding will be allocated on an institutional and national level, and more information about the application processes are still to be released. 

Without harmonised implementation across the EU, the EHDS risks further complicating research and economic activity, leading to decreased or delayed innovation. Furthermore, differences between strong central and regional healthcare systems must be navigated and require a degree of flexibility to prevent fragmenting the data landscape. This is hampered by a general lack of a data-sharing culture among health system actors. On the opposite side, there is a risk of centralized data silos that could also pose a data privacy and security risk. For industry, concerns around sufficient safeguards for intellectual property (IP) rights and the protection of trade secrets exist.  

The funding allocated to implementation could be insufficient for the ambitious regulation, and many data holders have limited capacity to integrate their systems. These factors may place a strain on ensuring consistent data quality across the board. In addition to the technical hurdles faced by healthcare providers, educating citizens and allaying fears about the use of sensitive health data for secondary use remains a challenge.  

Gaining the trust of EU citizens will be crucial in making the EHDS a success, and member states will participate in communication efforts. Furthermore, developing fair pricing models for data access, nurturing adequate skills, and ensuring sufficient funding to support pan-European research will need to run in parallel with the new legislation.