The US Food and Drug Administration (FDA) has introduced a generative AI tool following a successful pilot, with the intention of modernising the agency’s functions and leveraging AI to “better serve” US citizens. Marty Makary, FDA commissioner, shares that the agency has now set out an “aggressive timeline” for rollout agency-wide by 30 June.
The tool, named Elsa, is powered by a large language model designed to assist with reading, writing, and summarising, the agency states. Whilst it is already being used for clinical protocol reviews, scientific evaluations and identifying inspection targets; the agency hopes to harness its power in a range of other areas, including in summarising adverse events to support safety profile assessments, performing faster label comparisons, and generating code to help develop databases for non-clinical applications.
Elsa is built within a high-security GovCloud environment, the agency shares, offering secure access for employees to relevant documents. “The models do not train on data submitted by regulated industry, safeguarding the sensitive research and data handled by FDA staff,” it continues.
The successful launch ahead of schedule, comes part of its programme to integrate more AI in areas such as data processing in the future.
FDA chief AI officer, Jeremy Walsh, hailed the launch as “the dawn of the AI era at the FDA”, adding: “As we learn how employees are using the tool, our development team will be able to add capabilities and grow with the needs of employees and the agency.”
Wider trend: Harnessing AI for health and care
Health Innovation Hub Ireland (HIHI) has announced the launch of a new national initiative called HIHI.AI Call 2025, said to support the “development and testing of AI solutions that can make a real impact in Ireland’s healthcare system”. As part of the initiative, HIHI is looking for input from companies, startups, researchers, clinicians and industry leaders who are already focused on developing AI-powered healthcare solutions. Interested suppliers have been asked to take part in an AI in healthcare competition, leading to an opportunity to share and pilot their AI innovations in “real-world clinical settings”, while also having access to HIHI’s national support network.
Guy’s and St Thomas’ NHS Foundation Trust has entered a partnership with Aneira Health to offer AI-enabled healthcare for women working for the NHS, focusing on fitting around busy lives, improving access, and delivering personalised, proactive care. The service is expected to launch this spring, with a small cohort of the trust’s workforce involved in testing the approach.
OpenAI, the AI research and deployment company responsible for ChatGPT, has launched a new benchmark for evaluating the capabilities of health AI systems, built in partnership with 262 physicians practicing across 60 countries. The company shares findings that large language models “have improved significantly over time and already outperform experts in writing responses to examples tested in our benchmark”.
