FDA AI Tool

FDA Launches Generative AI Tool Elsa

Technology

The U.S. Food and Drug Administration (FDA) has launched Elsa, its new generative AI tool, ahead of schedule and under budget. Designed to boost efficiency, Elsa assists employees with various tasks, from scientific reviews to administrative operations. The FDA emphasizes that Elsa's training data did not include any information submitted by the regulated industry, ensuring the protection of sensitive research and data. The system is hosted on Amazon Web Services' GovCloud, a platform specifically designed for handling classified information.

Elsa's Capabilities and Applications

As a language model, Elsa offers capabilities in reading, writing, and summarizing. Its applications within the FDA currently include summarizing adverse events, generating code for nonclinical applications, and accelerating clinical protocol reviews. Early reports suggest dramatic time savings, with tasks that previously took days now completed in minutes. The FDA believes Elsa holds significant promise for streamlining scientific evaluations and identifying high-priority inspection targets.

Concerns and Future Implications

While generative AI offers considerable potential, concerns exist regarding the possibility of "hallucinations"— instances where the AI generates false or misleading information. Although safeguards are in place, the need for human oversight remains crucial to mitigate risks and ensure the reliability of the information generated. The recent FDA layoffs raise questions about the availability of adequate human oversight for this new technology. The FDA plans to expand Elsa's use across the agency as it develops, integrating it into data processing and other generative AI functions.

Source: Gizmodo