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The government's health research agency is funding a bold new program to build AI agents that can autonomously manage heart failure patients. ARPA-H's ADVOCATE program will award $62.7M to six teams—including Kaiser Permanente, Duke, Stanford, and three health tech companies—to develop FDA-authorized clinical AI. If successful, the initiative could generate $28B in yearly cost savings and help address critical cardiology care gaps across the U.S.
ARPA-H just launched its ADVOCATE program—a four-year, $62.7 million initiative to build autonomous AI agents capable of managing heart failure patients between clinical visits. Think of it as a 24/7 digital care team member: monitoring patients, adjusting medications, and escalating concerns to human clinicians only when necessary. Six teams, including Kaiser Permanente, Duke University, Stanford University, and health tech companies Atman Health, Tempus AI, and UpDoc, have been selected to build and validate the system.
A major piece of this puzzle is regulatory. No agentic (generative) AI has ever received FDA authorization for clinical use—only predictive AI tools have cleared that bar so far. ARPA-H is working hand-in-hand with the FDA to create a brand-new regulatory framework, with participating teams expected to submit an FDA authorization package within two years.
By the Numbers:
Why it matters: Heart disease is the leading cause of death in the U.S., yet access to cardiologists—especially in rural areas—remains a critical gap. ADVOCATE isn't just a tech experiment; it's an attempt to rewrite the rules for how AI can be deployed in high-stakes clinical settings, potentially opening the door for a new generation of FDA-authorized autonomous healthcare tools.