FDA officials discuss new AI tool HALO, other applications of AI

Officials from the US Food and Drug Administration (FDA) discussed the launch of a new artificial intelligence (AI) system to consolidate 40 different application data sources across all centers at the Food and Drug Law Institute’s (FDLI) Annual Meeting on Thursday.

The system—HALO (Harmonized AI and Lifecycle Operation)—was announced Wednesday, alongside the version 4.0 of the agency’s Elsa tool. FDA said that is integrating HALO and Elsa, enabling staff to query data and create workflows without the need to manually upload documents for each chat. This consolidation of HALO is expected to enhance the implementation of AI capabilities within the agency's operations.

Panel discussion

During the panel discussion, FDA officials discussed HALO and how they use AI tools in other areas of their work, such as processing Freedom of Information Act (FOIA) requests.

The session was moderated by Tala Fakhouri, VP of consulting at Parexel and former associate director for data science and AI policy at FDA.

Sridhar Mantha, acting chief information officer for the Office of Digital Transformation at FDA, said that HALO is a new unified data platform designed to consolidate more than 40 distinct applications, submission data sources, systems, and portals across all FDA centers.

 “This is a single data platform that has the highest level of security. The data is compartmentalized and segmented by center,” Mantha said. He added that the platform “aggregates the data across all the centers.”

“This is pretty amazing. I don’t think a lot of companies are even there yet that have an integrated data platform,” Fakhouri said.

Tiffany Branch, director of the Office of Management and Enterprise Services within the Office of the Commissioner, discussed how the agency is using AI to process FOIA requests. Using AI tools, the agency has been able to process FOIA requests 85% more efficiently than it did using manual processes.

“We get 12,000 FOIA requests a year, and that is only increasing 20 percent annually. This is where we can get AI to be more effective,” Branch said.

Fakhouri asked Steven Musser, FDA’s associate commissioner for human foods, whether AI is utilized in inspections.

Musser said that “I would parse that a little bit. I don’t really see at this point how we would use it in an inspection because it would be difficult for an inspector to integrate this information during an inspection.” He added that what AI is good for is for detecting “anomalous patterns with imports and economically motivated adulteration.”

Musser added that AI tools are also good at distilling information and “drawing conclusions that we as humans cannot see.”