ARPA-H to revolutionize cardiovascular disease management with clinical agentic AI  

Agency to work toward first FDA authorized autonomous agentic system that can provide high-quality specialty care directly to patients

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new research and development funding opportunity through its Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) program. This program aims to develop the first FDA-authorized, agentic artificial intelligence (AI) technology that can provide 24/7 specialty care for the deadliest chronic disease in the United States. This technology could serve as a clinician extender that patients engage with at all times, keeps a close eye on their heart health, and provides access to personalized information and actions, all of which can help them live long and well with advanced heart disease.   

Cardiovascular disease (CVD) can be successfully managed with diet, exercise, and affordable medications. Yet CVD remains the most common cause of death and disability in the country, leading to hundreds of thousands of preventable deaths and tens of billions of dollars in avoidable healthcare costs every year. Half of U.S. counties do not have a single practicing cardiologist, creating significant access and treatment hurdles. ADVOCATE will support a transformative advance by integrating wearable health monitors, digital health records, and agentic AI. Agentic AI refers to systems that can act independently to achieve pre-determined goals with minimal human oversight. Together, these tools will be brought together to provide real-time guidance that patients and care teams can act on.  

“One of the most serious – and preventable – consequences of chronic disease is heart failure,” said HHS Deputy Secretary Jim O’Neill. “ARPA-H's frontier approach will accelerate AI adoption with a new model of care that can be applied across diseases, improving health and saving lives.” 

“Agentic AI, which can autonomously plan and execute specific tasks, represents a massive opportunity for democratizing healthcare access,” said ARPA-H Director Alicia Jackson, Ph.D. “ADVOCATE will allow patients to ask questions about their heart health and get reliable support and clinical interventions,  helping make this AI-powered future real for CVD and other chronic diseases and paving the way for FDA-authorized agentic tools for many other conditions.”  

The ADVOCATE program seeks to develop agentic AI technology that connects to patient records, assists in scheduling appointments, provides diet and physical therapy recommendations, writes and modifies prescriptions, supports diagnoses, and recommends when a human healthcare provider should step in. The program is focused on patients with heart failure and those who have had heart attacks. ADVOCATE will also develop a ‘supervisory agent’ that will ensure that all clinical AI agents being used in clinical practice provide safe and effective clinical recommendations to patients. The goal of ADVOCATE is for these technologies to be FDA-authorized, and ARPA-H will work closely with HHS partners to overcome blockers to innovation. If successful, ADVOCATE could pave the way for authorizing clinical agentic AI for more conditions.  

“While there has been progress in developing AI technologies that can serve as chat bots for patients, these technologies have limited capabilities to help patients in a meaningful way,” said ADVOCATE Program Manager Haider Warraich, M.D. “What we are trying to achieve with ADVOCATE is a technology that can essentially serve as a clinician-extender: an autonomous agent smart enough to understand patients’ treatment needs, which can both provide health care directly to the patient as well as engage the clinical team as needed.”  

The ADVOCATE program directly advances America’s AI Action Plan by accelerating AI adoption in healthcare, one of the sectors identified as most in need of innovation. By building an FDA-ready, agentic AI ‘clinician-extender’ for cardiovascular disease, ADVOCATE embodies the Action Plan’s call for domain-specific AI testbeds, world-class scientific datasets, and AI that complements, not replaces, clinicians. It also strengthens U.S. leadership in safe, high-impact AI applications that can be shared with partners around the world. If successful, ADVOCATE will reduce chronic CVD, saving $55 billion annually in healthcare costs.    

Through an Innovative Solutions Opening (ISO), ADVOCATE invites proposals across three technical areas, including 1) developing a patient-facing AI agent, 2) developing a supervisory component to ensure continued agent accuracy and patient safety, and 3) recruiting health systems that will engage in and provide resources for the design and development of the technologies and deploy these technologies in their clinical settings.    

ARPA-H anticipates that teaming will be necessary to achieve the goals of ADVOCATE. Prospective proposers are encouraged to form teams representing varied technical and operational expertise from private and public entities to submit a research proposal. Other Transactions Agreements (not procurement contracts, grants, or cooperative agreements) under this ISO are anticipated. Investments will depend on the quality of the proposals received.  

Learn more about ADVOCATE on its program page, including information about the ISO and Proposers’ Day registration.