July 6th 2023

Published in Frontiers in Medicine: The application of data altruism in clinical research through empirical and legal analysis lenses

Published in Frontiers in Medicine: The application of data altruism in clinical research through empirical and legal analysis lenses

The CARE partner KU Leuven has worked with clinical research stakeholders to understand their views and gain insights into the legal ramifications of the recently introduced concept of data altruism. This novel mechanism was introduced by the recently adopted Data Governance Act (DGA), which, along with the proposal for a European Health Data Space (EHDS) promise to solve the existing challenges with respect to access to and (re)use of personal data for research. However, the new regulation with this novel mechanism might make things more complex. The DGA was adopted on 30 May 2022, and the law will enter into force on 23 September 2023.

Data altruism is understood as the voluntary sharing of personal and/or non-personal data by individuals or legal entities, without seeking a reward, for objectives of general interest, such as clinical research. New data altruism organizations will be acting as hubs for data, in a way similar to biobanks: on the one hand, they will be collecting data from individuals and companies, and on the other, they will be making the data available to other stakeholders.

Based on interviews with experts (including legal) throughout Europe, KU Leuven colleagues Teodora Lalova-Spinks, Janos Meszaros, and Prof. Isabelle Huys studied the novel mechanism. Their analysis indicates that while there is positive intent to make data sharing easier, there will likely be difficulties in the application of the act in the clinical research setting, given the interplay of the new rules with the GDPR. Further clarity from the legislator will be expected in this regard.

To learn more, click here: The application of data altruism in clinical research through empirical and legal analysis lenses