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High Patient Willingness to Grant Broad Consent for Real-World Data Use in Rheumatology-Implications for Real-World
Jutta G Richter1,2, Antonia Becker1,2, Tim Filla1,2
1Department for Rheumatology, University Hospital Düsseldorf, Medical Faculty of Heinrich-Heine-University, Moorenstrasse 5, Düsseldorf, 40225, Germany.
Journal of Medical Internet Research
|June 8, 2026
Summary
Patients with inflammatory rheumatic diseases showed high willingness to grant broad consent for secondary use of their real-world data (RWD) via the Data Nexus platform (DNP). This supports AI-driven research and advances patient care through secure data sharing.
Area of Science:
- Medical Informatics
- Health Data Governance
- Real-World Data Research
Background:
- Medical real-world data (RWD) is often siloed, hindering clinical research and patient care advancements.
- The pan-European Data Nexus platform (DNP) aims to link RWD for research, including AI applications, to generate real-world evidence.
- Germany has stringent regulations for health data secondary use, requiring informed consent.
Purpose of the Study:
- To evaluate an informed broad consent form for the Data Nexus platform (DNP).
- To assess patient willingness for secondary use of RWD within a German regulatory context.
- To understand implications for future data governance and regulatory use of RWD.
Main Methods:
- A broad consent form for the DNP was developed and distributed to rheumatology outpatients.
- Agreement rates to predefined consent items were analyzed.
- A zero-inflated model predicted response rates for RWD donation.
Main Results:
- 74.9% of patients consented to DNP data donation; 78.4% agreed to all consent items.
- Individual item approval exceeded 86%, indicating strong acceptance of secondary RWD use.
- Patients consented to AI analysis and data sharing with third parties, including industry.
Conclusions:
- This study is the first to assess broad consent willingness in patients with inflammatory rheumatic diseases for RWD platforms.
- High patient willingness indicates acceptance of secondary data use under structured governance.
- The DNP facilitates GDPR-compliant data sharing for real-world and AI-driven research, maintaining patient trust.
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