Jeremy Walsh will lead the Food and Drug Administration’s artificial intelligence efforts as chief AI officer, the agency confirmed Thursday.
The appointment comes as the FDA launches the rollout of a generative AI platform across its centers, according to the statement.
Walsh, who announced his appointment to head IT and AI at the agency last week on LinkedIn, previously was chief technologist at consulting firm Booz Allen Hamilton, where he worked for 14 years and focused on healthcare AI.
At the FDA, Walsh will work with engineers, scientists and analysts to find ways to improve healthcare services using AI and cloud computing, according to his LinkedIn post.
The White House’s Office of Management and Budget last month directed agencies to name a chief AI officer and to develop and retain AI talent. In one of his first executive orders this year, President Donald Trump revoked a Biden administration plan for regulating AI in healthcare.
Confusion about how the Trump administration will approach AI technologies in healthcare poses risks for medical device developers, AdvaMed Digital Health Tech board members said during a panel discussion in April. FDA staff cuts have added to the uncertainty. But panel members said companies were still moving forward with AI projects while they wait for guidance on policy direction.
Launch of AI system
FDA Commissioner Martin Makary, in the statement, said the agency would debut a common AI system across its centers to speed scientific reviews. The plan follows the completion of a generative AI pilot and is expected to free up FDA scientists and subject matter experts to spend less time on repetitive tasks that slow reviews.
“I was blown away by the success of our first AI-assisted scientific review pilot,” Makary said. “We need to value our scientists’ time and reduce the amount of non-productive busywork that has historically consumed much of the review process.”
“The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” he added.
Markary directed all FDA centers to integrate the generative AI system with the agency’s internal data platforms by June 30.
The rollout will be coordinated by Walsh and Sridhar Mantha, who recently led the Office of Business Informatics in the FDA’s Center for Drug Evaluation and Research, according to the statement. The FDA said more details on the initiative would be released in June.
