Emerging Best Practices and Future Directions in Data Privacy and Security

Emerging Best Practices and Future Directions in Data Privacy and Security

Interest in and reliance upon digital data and new technologies to support clinical research continues to increase. With the evolving clinical research landscape, new and enduring data privacy and security risks may arise with uses of sensitive personal information. Stakeholders from within and outside of the clinical research space can shed light on existing approaches and practices for managing data privacy and security challenges as well as how practices could be adapted to support clinical research now and in the near future.

On February 7 and 8, 2023, the Duke-Margolis Center for Health Policy convened an expert workshop to facilitate a shared learning of practices that can address or mitigate risks that may arise from the use of personal health information used in or generated from emergent technologies and methodologies in clinical research. The workshop brought together a range of stakeholders, including industry representatives, clinical researchers, patient voices, and data privacy and security experts, to discuss and assess existing tools and practices that may be applied to new and emerging data privacy and security challenges arising in the clinical research space. Stakeholders also discussed implementation of best practices and explored potential paths forward that could meet data privacy needs while preserving data utility.

Acknowledgement of Federal Support

This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD006807 totaling $2,575,023 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS or the U.S. Government.