HealthData@EU Pilot - Deliverable 8.2 Recommendations on quality controlling, assurance & provenance

This deliverable, D8.2, is part of Work Package 8 (WP8) of the HealthData@EU Pilot, a project that concluded on December 31, 2024. The HealthData@EU Pilot tested the implementation of the European Health Data Space (EHDS) infrastructure for the secondary use of health data, supporting research, innovation, policymaking, and regulatory activities. Objective D8.2 provides recommendations on quality controlling, assurance, and provenance based on insights from the five use cases of the pilot. The deliverable assesses the feasibility, challenges, and best practices related to ensuring data quality across different national frameworks. Approach The analysis follows the HealthData@EU Data Life Cycle, as defined in the TEHDAS Joint Action, and includes: Theoretical analysis: Reviewing expected quality control and assurance mechanisms based on existing standards. Practical assessment: Documenting the actual quality measures implemented in the five use cases, including data provenance tracking. Comparative evaluation: Identifying gaps between theoretical models and real-world implementation, with reference to the EHDS Regulation. Key Findings Divergences in national data quality standards, impacting harmonization efforts. Challenges in ensuring data provenance and traceability across multiple jurisdictions. Differences in quality control implementation among participating countries. Lessons learned from real-world implementation, informing recommendations for future EHDS infrastructure development.