Data Governance for Real-World Data Management: A Proposal for a Checklist to Support Decision Making

Area of Science:

• Health Informatics
• Data Governance
• Real-World Evidence

Background:

• Real-world data (RWD) and real-world evidence (RWE) are crucial for healthcare decision-making.
• A lack of consensus exists regarding appropriate data governance (DG) for RWD/RWE.
• Data sharing and evolving data protection regulations pose significant concerns.

Purpose of the Study:

• To propose recommendations for international standards in evaluating RWD/RWE governance practices.
• To develop a framework for assessing the acceptability of RWD governance.

Main Methods:

• Literature review to identify key RWD/RWE DG topics.
• A 3-round Delphi panel with European policymakers, HTA experts, and hospital managers.
• Development and refinement of a checklist based on expert consensus.

Main Results:

• Key DG topics identified: privacy, security, management, linkage, access, and RWE generation/use.
• 24 statements were evaluated by 21 experts.
• Progressive consensus was achieved, leading to a refined checklist by removing less critical statements.

Conclusions:

• This study provides a method for qualitative evaluation of RWD/RWE DG.
• Proposed checklists can aid RWD/RWE users in ensuring governance quality and integrity.
• The checklists complement existing data protection laws.