Breaking down European health data borders: this new provisional agreement will improve health data access 

The European Health Data Space (EHDS) has taken a crucial step towards high-quality healthcare without borders and the solidarity of data 

On March 14th, final negotiations were held, and the European Council and Parliament reached a provisional agreement about a common framework for sharing health data beyond EU national boundaries while respecting individual rights.  

Belgian Minister of Health, Frank Vandenbroucke, led the negotiations since Belgium is holding the presidency of the Council of the European Union. Frank Vandenbroucke emphasized the importance of sharing health data for the quality of care and the development of healthcare policies. 

The EHDS will make it easier for healthcare professionals to share, access and use health data across borders within the European Union. A single market for digital health services and products will improve the quality and continuity of research, insights, and ultimately healthcare for patients across the EU. Under the new regulations, all electronic health record (EHR) systems must thus comply with the European exchange format, making them interoperable and eventually easy to share at the EU level. The end result is that for example a Belgian tourist to collect his prescription in an Italian pharmacy or to consult an Italian doctor who will have access to his health information. 

The EHDS enables patients to not only have access to their health data wherever they are in the EU, but they will also have more control over it. In this regard, members states have the legal right to opt-out for primary and secondary use. Firstly, for primary use, patients may opt-out on the use of their health data by a healthcare professional. As a result, healthcare professionals will only be able to access restricted health data in situations of vital interest. In Belgium, the opt-out option is already in force. Secondly, members states shall allow patients to withhold consent for the secondary use of their health data by opting out. There are exceptions to this right to opt out when it comes to secondary data use for public interest, public health, statistics, scientific research requested by public body in public interest. Lastly, Member states can decide for patients to have the possibility to opt-in for secondary use of their data in the case of certain categories of data such as genomic data, biobank and from wellness applications. Finally, member states can also specify stricter measures for governing the access to highly sensitive data, like genetic data. 

In addition, member states may establish trusted data holders to securely process health data access requests, reducing the administrative burden. If researchers detect clinically significant findings on the health of a patient whose data was used in their research, they must inform the relevant treating health professional or patient through this trusted data holder. The agreement will be submitted to the Council and Parliament for approval before formal adoption.  

The EHDS is considered a key pillar of the European Health Union and the first of nine European sector- and domain-specific data spaces set out by the Commission in its 2020 communication, "A European strategy for data." 

If you want to learn more about the European Health Data Space (EHDS), you can watch our EHDS Basic Introduction short course. 

References: 

European Health Data Space: Council and parliament strike deal. European Council / Council of the European Union. (2024, March 15). https://www.consilium.europa.eu/en/press/press-releases/2024/03/15/european-health-data-space-council-and-parliament-strike-provisional-deal 

Europese Ruimte voor Gezondheidsgegevens (EHDS) zet een cruciale stap naar hoogstaande en      solidaire gezondheidszorg Zonder Grenzen. Frank Vandenbroucke.Belgium. (2024, March 15). https://vandenbroucke.belgium.be/nl/europese-ruimte-voor-gezondheidsgegevens-ehds-zet-een-cruciale-stap-naar-hoogstaande-en-solidaire#:~:text=De%20EHDS%20is%20een%20cruciaal,onderzoek%20in%20het%20algemeen%20belang