A real-world data challenge: guidance for aligning data privacy compliance and fit-for-purpose usability

The growing use of real-world data (RWD), particularly from electronic health records (EHRs), has heightened the need for careful attention to data privacy, utility, and transparency. We examine the complex processes involved in curating privacy-compliant EHR-derived RWD, highlighting key de-identification considerations and techniques. We emphasize the importance of aligning curation practices with privacy laws and regulations, with a particular focus on the comprehensive documentation of de-identification techniques. Such documentation should reflect intended data use, accessibility, availability, accuracy, and granularity. For researchers, greater transparency in these practices can improve compliance and lead to more robust and reliable real-world evidence. For policymakers, it provides a foundation to develop more specific and actionable guidelines and oversight mechanisms. Ultimately, highly transparent curation process enhances the reliability of RWD and supports rigorous, nuanced, and informed decision-making across the health care ecosystem.