The European Parliament today formally adopted in plenary the Regulation for the EHDS, the EU’s flagship initiative for enabling access to electronic health data for healthcare and facilitating the (re)use of such data for research purposes - including cancer research. ESMO welcomes the adopted EHDS legal text as it reflects provisions advocated for by the Society 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 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.
The EHDS - proposed by the European Commission in May 2022 - will create a common EU data space composed of rules, common 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 this, the EHDS will allow researchers as well as public, private and not-for-profit entities to access electronic health data for purposes such as research and innovation, including research conducted in the oncology space.
Given the potential of the EHDS for accelerating research, as well as improving the care provided to patients with cancer in cross-border settings, ESMO advocated relentlessly for an EHDS that boosts cancer research, addresses the needs of medical oncologists, and provides for a more consistent and uniform opt-out approach. We are glad that the EHDS text approved today in plenary - to a significant extent - addresses the points raised by ESMO with EU decision-makers.
As the preparations for the implementation of the EHDS Regulation will shortly commence, including the development of the required Delegated and Implementing Acts, ESMO calls on EU decision-makers to achieve consistency with overlapping regulatory regimes such as the General Data Protection Regulation (GDPR) and Clinical Trials Regulation (CTR), enable robust involvement of medical oncologists in the EHDS roll-out and governance, and avoid fragmented opt-out and consent-related provisions. ESMO will continue to engage with the EU institutions and all stakeholders to ensure the creation of an EHDS that supports medical oncologists and the patients they serve.
For further information, please contact: publicpolicy@esmo.org