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Person-Generated Health Data (PGHD) is health-related data created, recorded, or gathered by individuals (or by family members or caregivers). The sources of PGHD include wearable devices or phones, electronic surveys, apps, or any other interactions with technology that generate personal data about health. PGHD provides a window into the health and behaviors of individuals in their daily lives, in between episodic encounters with the healthcare system. These data can be captured passively and continuously, thus creating a more accurate and holistic picture of the individual that is not captured by electronic health records (EHRs) or insurance claims data that documents payment for clinical encounters and prescriptions. PGHD can provide valuable insights into:

Disease burden: develop a patient-centered understanding of disease impact on everyday function and quality of life

Patient identification: leverage rich signs and symptoms data to identify populations who might receive the greatest benefit from a given treatment

Real-world effectiveness: uncover the behavioral and physiological determinants of health that impact the effectiveness of treatments

We believe these data are the key to improving health outcomes, care delivery, and patient lives – and should therefore be a part of all evidence generation strategies. The FDA is recognizing the important role of these data by identifying PGHD as one of the main sources of real-world data and suggesting PGHD be leveraged to create real-world evidence for key analyses in randomized trials and observational studies.

As life science organizations and regulatory bodies continue to adopt novel approaches to health measurement, PGHD (enabled by direct connections with individuals) will be critical to unlocking deeper insights for developing new medical products and providing more person-centric care.

This definition was adapted from Duke Margolis Center for Health Policy’s definition, September 2019

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