Data sovereignty requirements for patient-oriented AI-driven clinical research in Germany

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.

Using the method of a narrative literature review combined with a design thinking approach, this paper aims to contribute to the literature by answering the following research question: What are the practical requirements for the thorough implementation of data sovereignty and informed consent in healthcare?

We show that privacy-preserving technologies, human-centered usability and interaction design, explainable and trustworthy AI, user acceptance and trust, patient involvement, and effective legislation are key requirements for data sovereignty and self-determination in clinical research. We outline the implications for the development of IT solutions in the German healthcare system.