EORTC calls for a balanced and feasible European Health Data Space (EHDS)

Brussels, Belgium – 8 July 2026 – EORTC welcomes the work of the TEHDAS2 initiative to develop guidelines and technical specifications for the European Health Data Space (EHDS), a key step towards facilitating secure and effective health data sharing across Europe.

As a sponsor of independent clinical trials and a holder of extensive clinical research data, EORTC has published a position paper outlining recommendations to ensure that the EHDS supports innovation while safeguarding scientific integrity and remaining operationally feasible for data holders.

“The EHDS represents a major opportunity to advance research and improve patient outcomes across Europe. To succeed, it must strike the right balance between facilitating data access and protecting the scientific value, sustainability and intellectual property that underpin high-quality clinical research,” said Dr Denis Lacombe, CEO of EORTC.

Key EORTC Recommendations

• Ensure that only mature and validated clinical trial data are shared, with a 12-month exclusive access period for data holders to publish study results following study completion.
• Allow data holders to provide scientific input on secondary-use data access requests where methodological concerns exist.
• Establish safeguards to ensure that the volume of data requests remains operationally manageable.
• Clarify and preserve intellectual property rights, including protections for databases.
• Limit the administrative burden associated with populating the EHDS catalogue, particularly for older clinical trials.
• Allow the use of established data standards, such as CDISC, rather than imposing a single harmonisation approach.

Through these recommendations, EORTC aims to support the development of an EHDS that accelerates research, benefits patients, and strengthens Europe’s clinical research ecosystem.

The European Organisation for Research and Treatment of Cancer (EORTC) is a non-governmental, non-profit organisation, which unites clinical cancer research experts, throughout Europe, to define better treatments for cancer patients to prolong survival and improve quality of life. Spanning from translational to large, prospective, multi-centre, phase III clinical trials that evaluate new therapies and treatment strategies as well as patient quality of life, its activities are coordinated from EORTC Headquarters, a unique international clinical research infrastructure, based in Brussels, Belgium.

Caroline Moulins
Head of Communications
caroline.moulins@eortc.org