ARPA-H announced on September 9, 2026 the launch of ADVOCATE (Agentic AI-EnableD CardioVascular CAre TransfOrmation), a competitive awards program aimed at building what the agency calls the world’s first FDA-authorized clinical AI system for cardiovascular care, backed by up to $33.7 million in Year 1 of a four-year, $62.7 million program. ADVOCATE Program Manager Dr. Haider Warraich, a practicing cardiologist, said: “Every day, Americans are dying from cardiovascular disease that we know how to prevent and treat — and too often the barrier isn’t the medicine; it’s access to a clinician who can guide the care. 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.”
Three Teams, Three Jobs
The program splits the work across three technical areas. Under TA1, Atman Health, Tempus AI, and Updoc are each separately developing patient-facing autonomous AI agents to support heart failure patients between clinical visits; the release doesn’t specify whether all three will continue through the full program or how many will ultimately be selected. Under TA2, Stanford University is building a supervisory AI agent designed to monitor those systems for unsafe recommendations and out-of-distribution behavior. Under TA3, Duke University and Kaiser Permanente will handle real-world deployment across diverse health systems. TA1 teams face a firm checkpoint: they must submit FDA-authorization packages within 24 months of their contract award.
To ensure rigorous, independent oversight of the ADVOCATE program, ARPA-H has contracted with the Johns Hopkins University Applied Physics Laboratory (JHU/APL) as its external evaluation partner. JHU/APL’s independent assessment of technical performance and clinical outcomes will provide the objectivity needed to validate results, strengthen regulatory confidence, and optimize the program’s impact.
Where the FDA Fits In
ARPA-H is framing the program around the shortage of cardiology access in rural and underserved communities, and around heart failure and preventable cardiovascular disease specifically; the agency projects the effort could generate $28 billion in annual cost savings for heart failure patients, though the release doesn’t explain how that figure was calculated or what population it’s based on. FDA Digital Health Center of Excellence Director Dr. Rick Abramson tied the program’s success to close coordination with the agency: “Patient-facing agentic AI is one of the most consequential frontiers in digital health. Getting the regulatory framework right requires close, iterative collaboration between developers, clinicians, and the FDA. ARPA-H’s ADVOCATE program is the kind of ambitious effort that will be critical as we think about continuous ongoing monitoring of autonomous clinical AI for both safety and effectiveness.”
About ARPA-H
The Advanced Research Projects Agency for Health (ARPA-H) is a U.S. government agency focused on solving complex and challenging health problems through innovative research. Established in 2022 under the Department of Health and Human Services, it follows a high-risk, high-reward research model inspired by DARPA. ARPA-H supports breakthrough technologies in areas such as cancer, biotechnology, artificial intelligence, diagnostics, and preventive health. It brings together researchers, universities, companies, and other organizations to develop transformative solutions. Its programs aim to accelerate medical discoveries and move promising innovations toward real-world applications. Ultimately, ARPA-H seeks to improve patient care, strengthen public health, and create lasting advances in healthcare.
