5 March 2025 marks the publication of the EHDS Regulation in the Official Journal of the European Union (EU). ESMO welcomes the publication of the, now final, EHDS legislation and calls for the establishment of a robust and harmonious European data space that boosts cancer research in a meaningful way.
“The European Health Data Space, by enabling the (re)use of certain data sources for research purposes, can become an important catalyst for driving therapeutic innovation in oncology. ESMO supports the aims of this EU initiative and hopes that the EHDS will help facilitate cancer research projects in Europe”, commented Prof. Jean-Yves Blay, ESMO Director of Public Policy.
The EHDS is a new initiative by the EU, first proposed by the European Commission in May 2022, comprised of a system that will allow researchers to access certain health data categories - in either anonymised or pseudonymised format - for use in their research projects. A key objective is to enable researchers to ‘tap into’ data sources that are currently not yet fully utilised for research, with the goal to help bring medical innovation to patients.
In addition, the EHDS will also make electronic health data more easily available for primary purposes - i.e. in healthcare settings - enabling healthcare professionals from one EU Member State to electronically access the health records of the patients they treat who come from another Member State - provided that the patient has given his/her consent.
Throughout the political negotiations on the EHDS that took place during 2022-2024, ESMO advocated extensively for a robust data space that can accelerate cancer research and deliver tangible benefits for patients with cancer. The Society welcomes that the final EHDS legislative text reflects the following provisions advocated for by ESMO:
- Citizens are to be provided with the ‘right to opt-out’ from the processing of health data for secondary use purposes (as opposed to the adoption of an EU-wide opt-in approach for all data categories). Citizens will also have the option to reverse their previous decision to op-out at any time;
- The EU Member States are to develop or provide access to training programmes for health professionals enabling them to understand and carry out their role in the primary use of and in the accessing of electronic health data;
- Cooperation with health professionals on the implementation of the EHDS Regulation is to be promoted through the establishment of a new Stakeholder Forum.
Following today’s publication of the final EHDS Regulation, various EU Implementing and Delegated Acts will be developed and adopted in the coming years to facilitate the establishment of the EHDS.
To make the EHDS a robust instrument for driving cancer research, ESMO considers it pertinent that the following is taken into account throughout the establishment of the data space:
- EU-level guidance should be provided aimed at ensuring a harmonious implementation of opt-out mechanisms for the secondary use of data across all EU Member States;
- Patients should be made aware of the negative consequences for research of opting-out from having their data entered into the EHDS, including risks of biases in future cancer research as well as potential fragmentation in the availability of data;
- To be able to fulfill their obligations under the legislation in an adequate manner, training should be provided to healthcare professionals to ensure that they obtain the digital skills and competences required to work well under the EHDS;
- The EHDS should be implemented in a consistent manner with overlapping regulatory regimes, most notably the General Data Protection Regulation (GDPR) and Clinical Trials Regulation (CTR);
- As regards the provisions concerning fees for making electronic health data available for secondary use, the principles for the fee policies and fee structures that the European Commission will establish should prevent that excessive costs are being imposed on academic institutions and non-commercial entities involved in cancer research;
- The templates that the Commission will develop for data access applications, data permits, and data requests should limit bureaucracy for data users to the greatest possible extent. This whilst preventing that applicant institutions will have to present individual authorisations for each of their individual research projects;
- It is important that the Stakeholder Forum is established as a well-resourced body with a strong voice in the governance of the EHDS, with robust involvement of healthcare professionals.
Prof. Blay highlighted that: “To unlock the full potential of the European Health Data Space for innovation in oncology, it is important that cancer researchers are able to access health data in a seamless manner, without facing excessive bureaucracy and costs, and against the backdrop of harmonised opt-out mechanisms for secondary use. ESMO is committed to help achieve this ambition.”
Ahead of the preparation of the EU implementing legislation for the EHDS, ESMO stands ready to work with all stakeholders on addressing critical aspects of the data space initiative, aiming to support cancer research in Europe.