FDA’s IT strategy will focus on modernization, AI

The US Food and Drug Administration (FDA) has published its Information Technology Strategy for Fiscal Years 2024 to 2027, with a focus on modernization efforts, the integration of ecosystems across the agency, improved data sharing, adoption of new technologies, and investment in talent and leadership.

The IT strategy document follows the recent release of a report from the agency to prioritize IT leadership to help streamline infrastructure and create more efficient systems. FDA also recently published a notice in the Federal Register requesting stakeholder input on how to use the agency’s modernization framework to advance its technology and data capabilities (RELATED: FDA looking externally and internally to develop future IT leaders, Regulatory Focus 16 January 2023; RELATED: FDA seeks input on boosting data and technology capabilities, Regulatory Focus 13 April 2023).

Cybersecurity has been a top concern at FDA, and modernization efforts have helped in part to thwart cyber threats that have sharply increased since the start of the COVID-19 pandemic (RELATED: FDA’s top cybersecurity officials discuss heightened threats, technology modernization, Regulatory Focus 20 March 2023).

Vid Desai, chief information officer (CIO) in FDA’s Office of Digital Transformation (ODT), noted that the new IT strategy meets the agency’s Prescription Drug User Fee Act (PDUFA VII) reauthorization commitments through 2027, as well as obligations under the Food and Drug Omnibus Reform Act of 2022. In a message accompanying the IT strategy, he described the agency’s plan as ambitious, citing the FDA’s need to stay up to date with the latest available technologies while safeguarding “assets, intellectual property, and personal information the public entrusts us with.”

“We must enforce more robust governance, become more agile and think differently to narrow the gap between current IT capabilities and the rapid pace of innovation and technology advancements to continue protecting the American people,” Desai wrote.

FDA outlined six major IT goals in the document, starting with the creation of a “shared OneFDA ecosystem” that would facilitate a more integrated culture at the agency and aid in cross-functional collaboration. Sharing of data across agency offices and centers would become “the norm,” the agency said. The objectives of a shared ecosystem are to enhance collaboration and communication, promote transparency, optimize investments, and strengthen governance, according to the IT strategy document.

Another main goal is to improve the IT infrastructure of the agency through modernization efforts, which include the use of flexible infrastructure, increased cloud adoption, providing stable services, and adopting a “Zero Trust” approach for agency cybersecurity. FDA also aims to improve enterprise services that ensure solutions are stable, resilient, and adaptable.

Additional goals are to enable data sharing on a broad level to increase efficiency and innovation in public health, analyze the potential and risk associated with emerging technologies like artificial intelligence, and build a team of experts, leaders, and talent to aid in these goals and keep the agency at the forefront of change in IT.

As the IT strategy is implemented, it will “underpin governance decisions” related to budget formulation, investments, and resource allocation, according to FDA.

“Culturally, this strategy is a paradigm shift from an ODT-only IT strategy to an enterprise IT strategy designed and driven in collaboration with FDA’s Center and Office partners,” Desai wrote, noting that it is the FDA’s first agency-wide IT strategy.

FDA IT Strategy for FY 2024-2027

FDA’s IT strategy will focus on modernization, AI

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