Data sovereignty requirements for patient-oriented AI-driven clinical research in Germany; [Anforderungen an die Datensouveränität in der patientenorientierten und KI-gestützten klinischen Forschung in Deutschland]

The rapidly growing quantity of health data presents researchers with ample opportunity for innovation. At the same time, exploitation of the value of Big Data poses various ethical challenges that must be addressed in order to fulfil the requirements of responsible research and innovation (Gerke et al. 2020; Howe III and Elenberg 2020). Data sovereignty and its principles of self-determination and informed consent are central goals in this endeavor. However, their consistent implementation has enormous consequences for the collection and processing of data in practice, especially given the complexity and growth of data in healthcare, which implies that artificial intelligence (AI) will increasingly be applied in the field due to its potential to unlock relevant, but previously hidden, information from the growing number of data (Jiang et al. 2017). Consequently, there is a need for ethically sound guidelines to help determine how data sovereignty and informed consent can be implemented in clinical research.