ARPA-H Launches ADVOCATE to Transform Cardiovascular Care with Agentic AI
The Advanced Research Projects Agency for Health (ARPA-H) has released a new Innovative Solutions Opening (ISO), Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE), aimed at fundamentally modernizing how chronic cardiovascular disease (CVD) is managed in the United States. Announced by ARPA-H’s Scalable Solutions Office (SSO), this solicitation responds to the growing burden of cardiovascular disease, which remains the leading cause of death in the United States, and to persistent gaps in access to specialty care. ADVOCATE seeks to leverage advances in artificial intelligence (AI) to deliver scalable, continuous, and patient-centered cardiovascular care while establishing new pathways for regulatory approval, reimbursement, and clinical deployment.
Solicitation Overview and Program Objectives
ADVOCATE is designed to overcome both technical and structural barriers that currently limit the safe and scalable use of agentic AI in healthcare. Rather than focusing on isolated decision-support tools, ARPA-H envisions an integrated ecosystem of autonomous and semi-autonomous clinical agents capable of providing specialist-level cardiovascular care outside of traditional clinic settings. The program emphasizes interoperability with electronic health records (EHRs), wearable devices, and existing clinical workflows, while maintaining rigorous standards for patient safety, data security, and regulatory compliance.
The program is organized around three interdependent Technical Areas (TAs). Technical Area 1 (TA1) focuses on the development of a patient-facing cardiovascular disease agent capable of clinical reasoning, care navigation, and, where appropriate, autonomous medical actions such as medication adjustments. Technical Area 2 (TA2) centers on a disease-agnostic supervisory agent that provides real-time monitoring, auditability, and control of clinical artificial intelligence systems, enabling scalable oversight without overburdening clinicians. Technical Area 3 (TA3) supports large-scale implementation within healthcare organizations, including integration with electronic health record systems and execution of real-world scalability studies comparing agent-enabled care to usual care.
Program Structure and Phases
ADVOCATE is structured as a 39-month, two-phase program with competitive down-selections at multiple transition points. Phase 1 is divided into Phase 1A, which lasts 12 months, and Phase 1B, which also lasts 12 months. During these periods, performers will develop, integrate, and validate prototype agentic systems through independent verification and validation studies. Phase 2 lasts 15 months and focuses on large-scale scalability studies conducted by healthcare organizations to evaluate clinical outcomes, safety, cost-efficiency, and reimbursement implications in real-world settings. Throughout the program, ARPA-H expects close collaboration across Technical Areas and early, frequent engagement with the U.S. Food and Drug Administration (FDA) to support medical device authorization and qualification pathways.
Key Dates and Submission Milestones
Proposers should pay close attention to the following dates outlined in the ISO:
- January 13, 2026: Solicitation posted
- January 23, 2026: Proposers’ Day, 8:30 AM to 5:00 PM Eastern Standard Time
- January 21, 2026: Proposers’ Day registration deadline for in-person and virtual attendance
- February 27, 2026: Solution Summary due by 5:00 PM Eastern Standard Time
- April 1, 2026: Full Proposal due by 5:00 PM Eastern Standard Time
Funding Approach and Expected Awards
ARPA-H anticipates making multiple awards under this ISO using Other Transaction (OT) agreements. While award size will vary by Technical Area and scope, performers should plan for a multi-year period of performance aligned with the 39-month program structure. Resource sharing is not required but is strongly encouraged, and proposals will be evaluated on both technical merit and the appropriateness of proposed costs relative to risk, complexity, and anticipated impact.
Why ADVOCATE Matters for Human Health
If successful, ADVOCATE has the potential to significantly improve outcomes for millions of patients living with cardiovascular disease by expanding access to continuous, high-quality care, particularly in regions with limited access to cardiologists. By pairing patient-facing clinical agents with independent supervisory oversight, the program aims to establish a trusted, scalable model for artificial intelligence-enabled chronic disease management that can extend beyond cardiovascular conditions to other high-burden diseases. The result could be fewer hospitalizations, improved treatment adherence, lower costs, and more equitable access to specialty care nationwide.
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