The Advanced Research Projects Agency for Health has awarded contracts to six teams to build the first FDA-authorized agentic AI system for cardiovascular care. ARPA-H announced the selections Sept. 9 under its Agentic AI-EnableD CardioVascular CAre TransfOrmation, or ADVOCATE, program.
The four-year, $62.7 million program will fund up to $33.7 million in its first year. The goal is a clinical AI agent that operates 24/7 as a digital member of the care team, autonomously supporting heart failure patients between visits and escalating to clinicians when needed.
“What we are trying to achieve with ADVOCATE is a technology that can serve as a clinician-extender: an autonomous agent smart enough to understand a patient’s treatment needs, capable of providing certain care autonomously, and equally capable of engaging the clinical team when needed,” said Haider Warraich, MD, ADVOCATE program manager and a practicing cardiologist, in a news release.
Three companies — Atman Health, Tempus AI and Updoc — will build the patient-facing clinical AI agents. Stanford (Calif.) University will develop the supervisory AI system that monitors those agents for unsafe recommendations. Durham, N.C.- based Duke University and Oakland, Calif.-based Kaiser Permanente will lead real-world implementation, with Duke testing across five health systems and rural sites on Epic and Oracle Health EHRs, and Kaiser Permanente deploying across 21 medical centers and more than 260 clinics on Epic.
ARPA-H will work with the FDA throughout the program to build a regulatory framework for this class of patient-facing AI, and has contracted with Johns Hopkins University Applied Physics Laboratory in Laurel, Md., as an independent evaluator. The lead patient-facing developer must submit an FDA authorization package within 24 months.
Nearly half of U.S. counties have no practicing cardiologist, and cardiovascular disease kills more than 200,000 Americans annually, according to ARPA-H. The agency projects the program could generate $28 billion in annual cost savings across the heart failure population if successful.
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