FDA Launches Elsa 4.0 and Expands HALO Data Integration
The U.S. FDA announces the launch of its internal AI tool, Elsa 4.0, and the integration of over 40 disparate data sources, systems, and portals related to applications and submissions into the HALO platform. The FDA states that the integration of HALO and Elsa will enable employees to query data and build workflows without the need to manually upload files during every interaction.
Key Highlights
- On May 6, the FDA announced the launch of its internal AI tool, Elsa 4.0.
- The FDA has integrated over 40 data sources, systems, and portals related to applications and submissions into the HALO platform.
- HALO stands for “Harmonized AI & Lifecycle Operations for Data.”
- Elsa 4.0 introduces new features such as custom agents, document generation, data analysis and visualization, secure web search, speech-to-text conversion, and OCR.
- The FDA notes that Elsa is deployed within a Google Cloud Platform environment certified at the FedRAMP High security level and does not use input data or submission data from regulated industries for training purposes.
FDA Advances AI Modernization Efforts
May 7, 2026. According to the official website of the U.S. Food and Drug Administration (FDA). The agency has announced further advancements in its modernization initiatives, including the launch of its internal AI tool. Elsa 4.0, and the completion of the integration of multiple data sources, systems, and portals.
The FDA stated that Elsa 4.0 represents a significant upgrade to the agency’s internal AI toolkit. It is accessible to all FDA employees, including scientific reviewers and investigators.
FDA Integrates Over 40 Data Sources into HALO
The FDA has also integrated over 40 disparate data sources, systems, and portals spanning across all its centers and related to applications and submissions into a new platform named HALO.
HALO stands for “Harmonized AI & Lifecycle Operations for Data.”
The FDA indicated that it has begun integrating HALO with Elsa, thereby enabling FDA employees to query data and construct workflows without the need to manually upload files during every chat session.
The FDA noted that the HALO integration is expected to facilitate the deeper deployment of AI capabilities throughout the agency’s operations.
FDA Commissioner Highlights Benefits of AI Tools
FDA Commissioner Marty Makary stated that the new capabilities of Elsa once again position the FDA at the forefront of deploying AI tools to empower its workforce.
He added that reducing burdensome tasks allows employees to focus more intently on scientific work, while simultaneously enhancing workflow efficiency and improving the overall employee experience.
Jeremy Walsh, the FDA’s Chief AI Officer, stated that as applications, data sources, systems, and submission portals are integrated into HALO and as Elsa’s capabilities are enhanced, Elsa will soon become the primary gateway for accessing FDA systems and data.
He noted that while in the past, FDA employees brought data to Elsa, Elsa now sits atop the data.
Elsa 4.0 Adds New AI Features
The FDA stated that since the launch of Elsa 1.0 in June 2025. Which was delivered ahead of schedule and under budget. The agency’s Office of Digital Transformation has continuously rolled out improved features and explored new use cases in collaboration with agency reviewers to help streamline agency operations.
According to the FDA, the new features introduced in Elsa 4.0 include:
- Custom agents, document generation, and quantitative data analysis and visualization, including chart creation;
- Web search capabilities via secure web access;
- Speech-to-text dictation;
- OCR (Optical Character Recognition) to convert scanned documents and images into searchable text;
- Enhanced chat flexibility; and
- Optimized search capabilities for locating key information within large document repositories.
FDA Emphasizes Data Security and Human Oversight
The FDA stated that Elsa is built within a Google Cloud Platform environment certified at the FedRAMP High security level. It does not use input data or any data submitted by regulated industries for training purposes, thereby safeguarding the sensitive research and data handled by FDA employees.
The FDA noted that while Elsa’s enhanced search functionality allows it to access up-to-date, secure web-based data in its responses. The system itself is not connected to the public internet.
The FDA further emphasized that agency employees are involved in every stage of the AI workflows within Elsa, with human subject matter experts validating all inputs, analytical processes, and implemented outputs.
