The U.S. Food and Drug Administration (FDA) has officially launched a new generative AI tool named Elsa, aimed at improving the efficiency of its employees.

Importance of the Tool

According to FDA officials, Elsa is designed to:

• Modernize agency functions and leverage AI capabilities.
• Enhance service delivery to the American public.

This AI technology, powered by a large language model, can:

• Summarize adverse events for safety profile assessments.
• Perform quicker label comparisons.
• Generate code for developing databases for nonclinical applications.

The FDA has already utilized Elsa to streamline clinical protocol reviews, reducing the time required for scientific evaluations and identifying high-priority inspection targets.

Future Plans

Elsa is considered the first step in the FDA’s broader AI strategy. The agency plans to:

• Expand the tool’s use across various operational areas.
• Integrate it with additional applications, such as data processing.

Developed within a secure GovCloud environment, Elsa ensures that FDA employees can access internal documents while keeping sensitive information protected. The models are not trained on data from regulated industries, safeguarding proprietary research.

Context and Trends

The FDA’s focus on AI aligns with recent federal initiatives to enhance AI deployment across government agencies. The White House has emphasized the need for action plans on AI implementation.

The FDA has been actively exploring AI applications in healthcare, including:

• Medical devices
• Clinical decision support
• Imaging technologies

Statements from FDA Officials

FDA Commissioner Dr. Marty Makary stated, “Following a very successful pilot program with FDA’s scientific reviewers, I set an aggressive timeline to scale AI agency-wide by June 30. Today’s rollout of Elsa is ahead of schedule and under budget, thanks to the collaboration of our in-house experts across the centers.”

Jeremy Walsh, the FDA’s Chief AI Officer, added, “Today marks the dawn of the AI era at the FDA. Elsa is no longer a distant promise but a dynamic force enhancing the performance of every employee.”

Mike Miliard is the executive editor of Healthcare IT News. Email the writer: mike.miliard@himssmedia.com

Healthcare IT News is a HIMSS publication.