What if an FDA-authorized clinical agentic AI could provide safe and effective cardiovascular care to every American?

The Problem

• Over 200,000 Americans die each year from preventable impacts of cardiovascular disease (CVD), the leading cause of death in the U.S. Despite spending almost half a trillion dollars on heart disease alone, the US experiences much worse outcomes than many other similar nations.
• Treatments for managing heart health with diet, exercise, and affordable medications are simple, inexpensive, and effective. Yet nearly half of American counties lack a cardiologist, meaning that many patients across the country are missing out on life-saving care and interventions.
• Clinical artificial intelligence (AI) agents could help fill this gap, but we don’t currently have a clear way to ensure they consistently operate safely and effectively at scale in real-world settings.

The Solution

• The Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) program aims to transform advanced cardiovascular disease management with an agentic AI system that can provide 24/7 holistic clinical care.  
• ADVOCATE will support the development of clinical AI agents that can be trusted to autonomously adjust changes in appointments, medications, diet, and exercise. In parallel, ADVOCATE will support the development of a supervisory AI "overseer” to monitor clinical AI agents after they have been deployed in clinical practice to ensure their continued safety and efficacy.
• ADVOCATE's transformative goal is to create a first-of-its-kind, reliable, FDA-authorized clinical agentic AI system that serves around the clock as a new, digital member of the clinical care team.  
• Together, these efforts will enable an integrated, holistic cardiovascular care platform to provide real-time guidance that patients and care teams can act on. The program will partner with health systems to successfully deploy the technology across diverse care environments—from major health systems to rural clinics and community settings. 

Only ARPA-H can...

• Harness the power of American innovation to quickly develop agentic AI that is safe, transparent, and effective in healthcare settings.
• Unleash the best technical experts across sectors to tackle a leading cause of death in the U.S. and accelerate pathways for regulatory and reimbursement approvals.
• Build trust with patients, doctors, and other stakeholders around patient-facing AI agents through rigorous testing and demonstrating measurable improvements in safety, outcomes, and equity.
• Pave the way for AI technology to serve as a clinician-extender, first for advanced CVD and eventually for all chronic conditions.