Meta-Consent: Secondary use of health data between data protection and data availability
Leimstädtner, David; Belz, Lea; Zickhardt, Anna-Lena; Schäfer, Ulrike; Buchner, Benedikt; Müller-Birn, Claudia; – 2025
The secondary use of routinely collected patient data presents a key resource for advancing data-driven medicine and related AI-supported applications in the German healthcare system. Realizing this potential requires careful attention to the consent practices that mediate citizens’ data contributions to such research efforts. These consent procedures must be designed to meet ethical and legal standards while also being practical and transparent for citizens. The central safeguard in research involving sensitive data of human participants is the obtaining of explicit, informed consent. This is intended to protect individuals' informational self-determination, promote transparency and trust in research, and uphold the integrity of both the research and its conduct. The open-ended and evolving nature of medical AI applications complicates the prospect of obtaining meaningful informed consent for secondary uses of health data. This presents a central challenge in advancing data-driven medicine: balancing the protection of individuals’ digital self-determination with the promotion of access to high-quality health data sets.
