In a joint press release issued today, the coalition addresses the importance of achieving consistency with existing regulatory frameworks, as well as a harmonious implementation across the EU and complementary polices to support healthcare professionals - including medical oncologists.
The EHDS is an EU initiative, currently under development, that will aim to boost medical research - including cancer research - by enabling access to existing data sources for secondary purposes. The EHDS will also create rules and infrastructures enabling citizens to better access, control and share their electronic health data in the context of healthcare delivery. The EHDS file is currently in trilogue discussions - with the European Parliament, Commission and Council negotiating on the final legislative text.
ESMO, along with other healthcare stakeholders, has taken note of the ongoing political discussions on establishing opt-out or opt-in systems for secondary use purposes, and calls on EU decision-makers to avoid creating any opt-in system. Should an opt-out system be established - as a political compromise to secure the file’s adoption - then it should only be done as long as it does not lead to inconsistent implementation, increased health data disparities and excessive administrative burdens.
Moreover, the EHDS is expected to profoundly impact the role of healthcare professionals, including medical oncologists. As such, the EHDS should be accompanied by policies promoting digital health skills and tools for health professionals, patients and citizens. The EHDS must also clarify its interaction with other applicable legal frameworks (including the GDPR).
Further information on ESMO’s advocacy on the EHDS can be accessed here.