[Secondary Use of Electronic Medical Record Data from Primary Health Care is Feasible: Report from RADAR Project]

Area of Science:

• Health Services Research
• Data Science
• Medical Informatics

Background:

• Longitudinal "real world" data from ambulatory medical care in Germany is challenging to obtain systematically.
• A vision exists for a large, representative, anonymized, longitudinal, and continuously updated German research data repository.
• This repository aims to link secondary care data and research cohort data (e.g., patient-reported outcomes, biodata) for broader accessibility.

Purpose of the Study:

• To report specific methods and results from the RADAR project.
• To demonstrate the technical and organizational feasibility of establishing a research data repository for ambulatory care in Germany.
• To evaluate privacy protection and IT security concepts for lawful research infrastructure.

Main Methods:

• Surveyed legislation and designed technical/organizational solutions for a research data repository.
• Conducted a feasibility study evaluating functionality, acceptability, and performance for health services research.
• Developed and executed privacy protection and IT security concepts in line with GDPR, focusing on oral anticoagulation data from 7 general practices.

Main Results:

• Implemented privacy-by-design and data minimization concepts, adhering to GDPR Article 25.
• Extracted 40 essential data fields from 100 patients' electronic medical records (EMR) after informed consent.
• Successfully linked 63 quality-of-life questionnaires to pseudonymized EMR data in the repository.

Conclusions:

• The RADAR project proved the technical and organizational feasibility of lawful, pseudonymized data acquisition.
• Linkage of questionnaires to EMR data was successfully demonstrated.
• Secondary use of routine ambulatory care data, even when anonymized, is highly restricted without explicit informed consent under current German law.