EAU highlights need for a clear EU legal framework for researchers in the European Health Data Space

15 December 2021 By Mrs. Sarah Collen, EAU Policy Coordinator

Prof. James N’Dow (GB, left photo above), EAU Adjunct Secretary General – Education, and Mrs. Sarah Collen (BE, right photo), EAU Policy Coordinator, co-chair the Health Data Sharing Taskforce of the Biomed Alliance, an initiative of leading European medical societies that together include more than 400,000 researchers and health professionals. On Tuesday 14 December, the Alliance released a statement ahead of the upcoming European Commission legislative proposal on the European Health Data Space (EHDS).

The BioMed Alliance Health Data Sharing Taskforce, in close cooperation with the EAU and the European Organisation for Research and Treatment of Cancer (EORTC), has proposed a set of recommendations for the governance, implementation, and incentivisation of the adoption of the new EHDS. The new EHDS can play a key role in facilitating health data sharing for healthcare provision, health research, and policy making, if certain key aspects are taken into account. The EAU has much relevant experience to offer from leading two international Big Data consortiums funded by the EU Innovation Medicines Initiative (IMI) and from its Research Foundation’s experiences with patient registries and clinical trials.

The statement particularly highlights the need to involve a broad range of stakeholders and to align different legislative approaches with a clear and enabling EU legal framework which will give legal clarity to researchers.

More information can be found here.

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