Regulatory Fit-for-Purpose Considerations for Patient-Generated Health Data

Executive Summary

Patient-generated health data (PGHD) are health-related data created, recorded, or gathered by or from patients, or their family members/other caregivers, to help address a health concern. PGHD complements information captured in other health care data sources and has the potential to alleviate challenges existing in pharmacoepidemiology data collection, such as misclassification, representativeness, and missing information. PGHD remains of interest to regulators, as insights gleaned from real-world evidence (RWE) generated using PGHD can help fill important gaps in clinical trial data and observational studies. This white paper summarizes key indicators of relevance, reliability, and quality to determine if PGHD is fit-for-purpose and offers practical considerations to support the initial development of medical products using PGHD collected in real-world settings, as well as subsequent development and surveillance of medical products using PGHD derived from regulatory-approved medical devices. Currently, the utility of PGHD to support drug and/or treatment applications remains unclear. Duke-Margolis proposes that regulators build a common framework based on present and evolving notions of fit-for-purpose PGHD.

Read the full paper here.