NIH issues RFI on Real-World Data, including EHR, for NIH-supported biomedical and behavioral research

The NIH Office of Data Science Strategy has released an RFI to solicit public comments on the use of Real-World Data (RWD), including Electronic Health Records, for Biomedical and Behavioral Research.

Researchers are increasingly using data collected in real-world settings to augment traditional research studies as well as develop more effective treatments and interventions for patients. These "real-world data (RWD)", defined by the U.S. Food and Drug Administration, are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.

Examples of RWD include data derived from electronic health records, medical claims data, data from product or disease registries, and data gathered from other sources (such as digital health technologies) that can inform on health status. While these data hold tremendous promise for biomedical and behavioral research, they can be collected from a variety of sources through multiple mechanisms, creating challenges for researchers and questions for those whose data are being shared.

Importantly, NIH is committed to ensuring participant privacy and autonomy are protected in all NIH supported research. As NIH establishes health-related research data platforms that include access to RWD, NIH continues to prioritize maximizing data access while upholding participant preferences regarding the collection and use of their data.

Most recently, through a NIH Director Advisory Committee, NIH met with stakeholders to understand their perspectives on benefits and risks of combining and using human datasets, particularly from disparate sources (e.g., research and non-research settings) and how their data should be used in biomedical research. NIH will continue working to incorporate these perspectives in its research studies to build trust and honor participant preferences.

Input requested on this RFI will be used to inform NIH's continuing development of guidance on the use of RWD for research and assist in the planning for appropriate mechanisms and programs for research with RWD.

Responses must be received no later than December 14, 2023 11:59:59 p.m. (ET).

Visit datascience.nih.gov/rfi-rwd to learn more and submit your response.