Achieving a European Health Data Space that boosts oncology research and strengthens patients’ rights
ESMO is engaging with the European Union (EU institutions) to ensure the implementation of a research-friendly EHDS that can help advance cancer research in Europe, ultimately leading to better cancer treatments and patient care.
The EHDS is an EU legislative initiative - first proposed by the European Commission in May 2022 - that will establish a common ‘data space’ comprised of rules, joint standards and practices, infrastructures and a governance framework for both the primary and secondary use of electronic health data across the Union.
As part of the EHDS, researchers as well as public, private and not-for-profit entities will be able to re-use existing electronic health data - including data from electronic health records, population-based health data registries, clinical trials, research cohorts, and many other sources - for secondary purposes such as research and innovation. The EHDS will also make electronic health data available for cancer research.
Data can only be accessed in anonymised or pseudonymised format with patients having the right to ‘opt-out’ in most cases from having their data entered in the EHDS. Moreover, to gain access to the data, researchers will have to obtain a permit from Health Data Access Bodies, new public entities to be set up under the EHDS Regulation.
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.
Following the proposal by the European Commission in May 2022, the EU institutions reached an inter-institutional agreement on the final EHDS legal text on 15 March 2024. The implementation and establishment of the EHDS will start as from the publication in the Official Journal of the EU - expected for the 2nd half of 2024.
Given the importance and potential of the EHDS for supporting cancer research and improving the care provided to patients with cancer, ESMO advocated extensively for the inclusion of provisions aimed at making the EHDS a robust instrument for accelerating medical research in the oncology field. In line with recommendations issued by ESMO to EU institutions, the final agreement on the EHDS of March 2024 includes provisions to:
- Provide citizens with the right to opt-out from the processing of health data for secondary use purposes, rather than adopting an EU-wide opt-in approach for all data categories, whilst still providing citizens with the option to reverse their decision to op-out at any time;
- Enable the development of and access to training programmes for health professionals allowing them to exercise their role in the primary use of electronic health data;
- Promote cooperation with health professionals on the implementation of the EHDS Regulation through the establishment of a Stakeholder Forum.
EU institutions and Member States will shortly commence with the implementation of the EHDS, which will include, amongst other issues, the preparation of over thirty Implementing and Delegated Acts (part of the EU implementing legislation). To maximise the value of the EHDS for cancer research, ESMO considers it imperative that the following is taken into account in the implementation and establishment of the EHDS:
- 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 the risks of biases in future cancer research as well as potential fragmentation in the availability of data;
- To be able to fulfil their obligations under the legislation in an adequate manner, we recommend providing training 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 to provisions concerning fees for making electronic health data available for secondary use, principles for fee policies and fee structures that the Commission will establish should prevent excessive costs being imposed on academic institutions and non-commercial entities involved in cancer research;
- 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;
- 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.
ESMO stands ready to collaborate with the EU institutions and all involved stakeholders to achieve an EHDS that maximises the potential of electronic health data for the benefit of cancer research.
For further information, please contact: publicpolicy@esmo.org