TEMPO: Experimenting with AI Sandboxes in the United States

AbstractThe U.S. Food and Drug Administration (FDA) has launched a pilot program to use "sandboxes" to promote innovation related to selected digital devices, including those involving health AI. Sandboxes allow manufacturers to use new technologies in real-world applications before they are required to seek the usual premarket review. The pilot, called TEMPO (Technology-Enabled Meaningful Patient Outcomes), will support another Trump administration demonstration called ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) aimed at improving the management of chronic disease. The AI and other digital tools used in TEMPO must focus on controlling the chronic conditions targeted by ACCESS. The FDA pilot has several appealing features, but important questions regarding TEMPO's implementation and longer-term implications remain.