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

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

White Paper

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

Published date

May 31, 2024

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.

Duke-Margolis Authors

Nora Emmott Headshot

Nora Emmott, MPH

Senior Policy Analyst

Rachele Hendricks-Sturrup headshot

Rachele Hendricks-Sturrup, DHSc, MSc, MA

Research Director
Senior Team Member

Maryam Nafie Headshot

Maryam Nafie

Policy Research Assistant

Margolis Summer Experience

Neha Shaw

2023 Margolis Intern