Data Management, Cybersecurity Top Priorities for New FDA Office

The US Food and Drug Administration (FDA) announced the formation of the Office of Digital Transformation (ODT), which will report directly to the FDA commissioner. The office is a reorganization of the agency’s data management, IT, and cybersecurity functions.

“The reorganization allows the FDA to bring more effective and efficient data and IT management, built on best practices, to streamline and advance FDA operations by reducing duplicative processes, implementing technological efficiencies using projects that deliver the most customer benefits, and promoting shared services within agency offices and centers to strategically and securely further the agency’s regulatory mission,” the announcement stated.

The reorganization follows the FDA’s Technology Modernization Action Plan, released in 2019, which cemented the agency’s commitment to modernize its approach to technology and support innovation in food safety, medical product applications, and other functions. 

The action plan outlined goals for modernizing the FDA’s technical infrastructure, encouraging communication and collaboration with stakeholders, and enhancing the FDA’s capabilities and resources to develop technology products in support of its regulatory mission.

In March 2020, the FDA released its Data Modernization Action Plan, which was created with the goal of building on the agency’s 2019 work and executing projects to improve data management. 

The Data Modernization Action Plan provided a framework for developing agency-wide data management best practices, creating a strong network of internal and external partnerships, and delivering high-value projects for individual centers across the agency.

In conjunction with the new center, the FDA appointed IT leader Vid Desai as the agency’s new Chief Information Officer. Desai has significant industry experience implementing healthcare IT strategies.

The FDA FY 2022 budget request included funding to bolster the agency’s data and technology modernization efforts.

“Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” Janet Woodcock, MD, FDA’s acting commissioner, explained in the announcement.

“The agency began these efforts because, as a science-based agency that manages massive amounts of data to generate important decisions and information for the public, innovation is at the heart of what we do.”

The Office of Digital Transformation will combine the goals of both the Data Modernization Action Plan and the Technology Modernization Action Plan to advance research and improve digital processes across the agency.

“By prioritizing data and information stewardship throughout all of our operations, the American public is better assured of the safety of the nation’s food, drugs, medical devices and other products that the FDA regulates in this complex world,” Woodcock concluded.

“This reorganization strengthens our commitment to protecting and promoting public health by improving our regulatory processes with a solid data foundation built in at every level.”