ARPA-H Launches $62.7M ADVOCATE Program to Build FDA-Authorized AI for Heart Care

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services, officially announced contract awards for its new Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) program. The four-year, $62.7 million initiative seeks to develop the world's first reliable, FDA-authorized clinical agentic AI system designed to function 24/7 as an autonomous, digital member of clinical care teams, with initial year commitments reaching up to $33.7 million. Targeting heart failure—a chronic condition impacting nearly 8 million Americans—the ADVOCATE program funds multidisciplinary teams including Tempus AI, UpDoc, Atman Health, Stanford University, Duke University, and Kaiser Permanente. Participating organizations are tasked with engineering dual AI systems: a patient-facing agent capable of continuously monitoring patient health, adjusting medication regimens, and engaging human clinicians when necessary, alongside a supervisory "overseer" AI that continuously audits safety and efficacy. By working directly with the U.S. Food and Drug Administration (FDA) to pioneer a regulatory pathway for patient-facing autonomous AI, the agency aims to bridge critical geographic care gaps, as nearly half of U.S. counties lack a practicing cardiologist. ARPA-H projects that widespread deployment could save thousands of lives and yield up to $28 billion in annual healthcare savings.