FDA Introduces AI Tool ‘Elsa’ to Enhance Clinical Reviews

The U.S. Food and Drug Administration (FDA) has launched an artificial intelligence (AI) tool named Elsa, aimed at assisting its employees with various tasks ranging from clinical reviews to investigations. In an era characterized by widespread disinformation and challenges to scientific integrity, the FDA is embracing AI technology to streamline its processes.

Overview of Elsa

Elsa, intriguingly named after the snow queen from the animated film Frozen, has successfully completed a pilot program involving the FDA’s scientific reviewers. According to the agency, this AI tool is capable of reading, writing, and summarizing a wide array of information, including adverse events and assessments. Additionally, Elsa can perform label comparisons and generate code, significantly expediting the review of clinical protocols and identifying scientific evaluations”>high-priority inspection targets.

Security and Data Handling

The FDA asserts that Elsa is designed to be a secure platform. However, details regarding the training process for the AI remain somewhat unclear. The agency has stated that Elsa was not trained using data submitted by the regulated industry. The information utilized for training is contained within Amazon Web Services’ GovCloud”>internal resources, which are intended to maintain confidentiality and security.

Significance of Elsa’s Launch

The introduction of Elsa marks a pivotal moment in the FDA’s journey into the realm of artificial intelligence. “Today marks the dawn of the AI era at the FDA. With the release of Elsa, AI is no longer a distant promise but a dynamic force enhancing and optimizing the performance and potential of every employee,” stated Jeremy Walsh, the FDA’s Chief AI Officer. He further emphasized that as the agency learns how employees utilize the tool, the development team will be able to enhance its capabilities to better meet the evolving needs of both employees and the agency.

Conclusion

The FDA’s deployment of Elsa represents a significant advancement in the agency’s operational efficiency and its commitment to leveraging technology in the pursuit of public health. As the agency continues to explore the potential of AI, it remains focused on ensuring that these innovations are implemented securely and effectively.

This article originally appeared on Engadget at Engadget.

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