Introduction
Patient-generated health data (PGHD) refers to health-related data that are created, recorded, or gathered by patients or their family members/caregivers to address health concerns. This data serves as a complement to other sources of health information and can help overcome challenges in collecting pharmacoepidemiology data, such as misclassification and missing information. Regulators are interested in PGHD because insights from real-world evidence (RWE) generated using this data can fill gaps in clinical trial data and observational studies. This white paper outlines key indicators for determining the relevance, reliability, and quality of PGHD to assess its suitability for use. It also provides practical considerations for using PGHD in developing medical products and monitoring them using data from regulatory-approved devices. The potential of PGHD to support drug applications is still uncertain, and Duke-Margolis recommends developing a common framework based on evolving concepts of fit-for-purpose PGHD.
Body Paragraph 1: Background Information
Patient-generated health data (PGHD) is becoming increasingly important in healthcare due to its ability to provide valuable insights into patient experiences and outcomes. This type of data is created by patients or their family members/caregivers as they track their own health concerns or seek treatment from healthcare providers. While PGHD may be useful for certain purposes, it can also be challenging to collect, record, or gather accurately due to issues such as misclassification and missing information. Regulators are interested in PGHD because it can help fill gaps in clinical trial data and observational studies by providing real-world evidence (RWE).
Body Paragraph 2: Key Indicators for Determining the Relevance, Reliability, and Quality of PGHD
To assess the suitability of patient-generated health data for use in developing medical products or monitoring them using regulatory-approved devices, several key indicators should be considered. These include: relevance – does the data provide useful information that addresses specific health concerns; reliability – is the data accurate and reliable; quality – is the data complete and consistent with other sources of information? By evaluating these factors, regulators can determine whether PGHD is suitable for use in various contexts.
Body Paragraph 3: Practical Considerations for Using PGHD in Medical Product Development and Monitoring
While there are many benefits to using patient-generated health data in medical product development and monitoring, there are also several practical considerations that must be taken into account. These include ensuring that the technology used to collect the data is reliable and secure; establishing clear protocols for recording and analyzing the data; involving patients themselves in the process of collecting and analyzing their own health information; and ensuring that any conclusions drawn from the analysis are communicated clearly to stakeholders involved in product development or monitoring efforts. By addressing these practical considerations upfront, healthcare organizations can maximize the benefits of using patient-generated health
