The use of patient-generated health data (PGHD) is becoming increasingly important in the healthcare industry. This type of data, which is created, recorded or gathered by patients or their caregivers to address health concerns, can complement information found in other healthcare sources and help overcome challenges in pharmacoepidemiology data collection, such as misclassification and missing information.
In this white paper, Duke-Margolis offers key indicators of relevance, reliability, and quality for determining the usefulness of PGHD. The paper also provides practical considerations to support the initial development of medical products using PGHD collected in real-world settings as well as the subsequent development and monitoring of medical products using PGHD from regulatory-approved devices. While the current utility of PGHD to support drug and treatment applications is uncertain, Duke-Margolis suggests that regulators create a common framework based on present and evolving ideas of fit-for-purpose PGHD.
To learn more about how patient-generated health data can be used effectively in healthcare, read the full paper here.
