Negotiators from the European Parliament and Council reached a provisional agreement on 15 March 2024 on the EHDS legislative text which reflects many of the society’s key asks. ESMO welcomes the provisional agreement as it holds enormous potential to empower patients and boost medical research whilst addressing the needs of healthcare professionals.
The EHDS is a European Union (EU) initiative that will establish rules, common standards and practices, infrastructures and a governance framework for both the primary and secondary use of electronic health data across the EU. The EHDS will enable the (re)use of existing health data for secondary purposes, such as research and innovation - including research conducted in the oncology space. Moreover, the EHDS will provide a framework enabling patients with cancer to easier access their electronic health data and exercise more control over how their data is being used.
ESMO believes that the EHDS can be a key enabler of scientific research, and we have advocated for the inclusion of provisions specifically aimed at creating a better environment for cancer research, whilst enabling medical oncologists to work effectively and deliver high-quality care under the new legislative framework.
We in that regard particularly welcome that the co-legislators - in line with some of ESMO’s recommendations - have agreed to:
- Provide citizens with the right to opt-out from the processing of health data for secondary use purposes, rather than adopting an opt-in approach, whilst providing citizens with the option to reverse their decision to op-out at any time;
- Enable the development of and access to training programs for health professionals allowing them to exercise their role as regards the primary use of and access to electronic health data;
- Promote cooperation with health professionals on the implementation of the EHDS Regulation through the establishment of a Stakeholder Forum.
In view of the upcoming 2024 European Elections, ESMO hopes for a swift formal adoption of the legislative text by the Parliament and Council and stands ready to collaborate with all stakeholders on implementing a EHDS that advances cancer research.
For further information, please contact: publicpolicy@esmo.org