ARPA-H to invest $62 million to develop AI agent for heart failure treatment

The Advanced Research Projects Agency for Health (ARPA-H) is investing $62.7 million through its ADVOCATE program to develop FDA-authorized, autonomous AI agents for heart failure treatment. The initiative aims to address severe cardiologist shortages in rural America, where nearly half of U.S. counties lack specialists. Six initial teams, including Kaiser Permanente, Duke, Stanford, Atman Health, Updoc, and Tempus AI, will compete to build, monitor, and deploy these clinical-grade conversational tools directly into electronic health records.

ARPA-H Advocate program funding

• ▪The Advanced Research Projects Agency for Health announced on September 9, 2026, that it plans to commit $62.7 million to develop artificial intelligence bots to direct heart failure treatment
• ▪The Advanced Research Projects Agency for Health awarded $33.7 million for the first year of its four-year ADVOCATE program to six initial teams
• ▪The initial contract recipients for the ADVOCATE program include Atman Health, UpDoc, Tempus AI, Stanford University, Duke University, and the Kaiser Permanente health system

Autonomous AI agent capabilities

• ▪The ADVOCATE program aims to produce partially autonomous, FDA-authorized AI devices capable of assessing symptom severity, prescribing drugs, and ordering lab tests for heart failure patients
• ▪Updoc was awarded $9 million to develop a conversational AI assistant, while Tempus AI was awarded $9.5 million to add continuous monitoring features to its patient health app
• ▪Atman Health plans to use up to $7.7 million in ADVOCATE funding to advance its large language models with a voice-based interface for heart failure patients

Heart failure care gaps

• ▪An estimated 6.7 million Americans live with heart failure, which is the leading cause of death in the United States
• ▪Nearly half of all United States counties do not have a practicing cardiologist, leading to higher rates of cardiovascular disease and treatment gaps in rural areas

FDA regulatory pathway development

• ▪The ADVOCATE program leaders plan to work alongside the Food and Drug Administration to establish a regulatory framework for clinical-grade, agentic artificial intelligence tools
• ▪The Food and Drug Administration has not yet approved any agentic artificial intelligence tool for clinical care

Competitive program structure

• ▪The Johns Hopkins University Applied Physics Laboratory has been contracted to serve as an independent evaluator of the developed AI technologies
• ▪The ADVOCATE program is structured competitively, meaning total award amounts depend on meeting aggressive research milestones, and underperforming teams can be removed
• ▪Stanford University researchers will build a supervisory system under the ADVOCATE program to identify unsafe recommendations produced by the patient-facing AI tools

Health system deployment strategy

• ▪Kaiser Permanente was awarded $16.3 million to deploy the AI agents into Epic electronic health records workflows across 21 medical centers and over 260 clinics
• ▪Duke University was awarded $15.5 million to create a platform to test the AI agents across five health systems on Epic and Oracle electronic health records systems

Debatable claims

• ▪The FDA should authorize autonomous AI agents to prescribe medications
• ▪ARPA-H should not fund clinical AI tools that bypass human oversight
• ▪Autonomous AI creates a lower standard of care in rural communities