ARPA-H launches the world’s first bid to build an FDA-authorized clinical AI for cardiovascular care 

Selected teams will build patient-facing AI, a supervisory agentic AI, and a scalable deployment plan to bring around-the-clock heart care to every American — including the nearly half of U.S. counties without a single cardiologist.

The Advanced Research Projects Agency for Health (ARPA-H) today announced the teams receiving contract awards from its Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) program. The goal of the program is to create the world’s first, reliable, FDA-authorized clinical agentic AI system that serves 24/7 as a new, digital member of the clinical care team. ARPA-H’s commitment is up to $33.7 million in the first year of the four-year, $62.7 million program. If successful, ADVOCATE will save lives, reduce preventable hospitalizations, and generate an estimated $28 billion in annual cost savings across the heart failure population alone. 

“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,” said ADVOCATE Program Manager Haider Warraich, M.D., a practicing cardiologist. “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. This work will change how we practice medicine — and it would not happen without ARPA-H driving the vision for the future.” 

The U.S. spends nearly half a trillion dollars on heart disease annually and still experiences far worse cardiovascular outcomes than peer nations. More than 200,000 Americans die each year from preventable impacts of cardiovascular disease (CVD), which is the leading cause of death in the country, and nearly half of U.S. counties have no cardiologist at all. The root cause is a care model that depends on scarce in-person specialist visits to manage a chronic condition. The result is avoidable hospitalizations, delayed medication titration, poor medicine adherence, and workforce burnout that hits hardest in rural and underserved communities. ADVOCATE is designed to end that era of intermittent, geography-limited cardiovascular specialty care by pairing clinical teams with a trustworthy, always-available digital teammate. 

Ensuring a successful system to scale beyond the program, ADVOCATE will engage the U.S. Food and Drug Administration (FDA) throughout the program lifecycle to develop the regulatory framework for this new class of patient-facing clinical AI. Selected performers will also work with ARPA-H to establish shared evaluation standards, interoperability requirements, and reimbursement pathways. 

“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," said Rick Abramson, M.D., Director, FDA Digital Health Center of Excellence. 

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. 

Selected Performer Teams 

TA1: Patient-Facing Clinical AI Agent 

These teams will develop a patient-facing clinical AI agentic system capable of autonomously supporting patients with heart failure between healthcare visits and escalating to the human care team as a new autonomous member of the clinical team. 

• Atman Health: The team will develop a clinical AI agentic system built on evidence-based clinical decision engine. Large language models (LLMs) with a voice-first interface that patients talk to, and the system adjusts on the fly to ask each patient the diagnostic questions most likely to be useful. 
• Tempus AI: The team will develop a clinical AI agentic system extending their existing Olivia patient health app, adding continuous monitoring with deeper clinical analysis when it detects meaningful changes in a patient’s health. 
• Updoc: The team will develop a clinical AI agentic system whose conversational intelligence is separated from clinical authority by a clinician-built rules system that validates every proposed action against approved protocols before execution. 

TA2: Supervisory AI Agent 

This team will design and build the disease-agnostic supervisory AI system that continuously monitors the TA1 clinical agents after successful deployment. This includes detecting unsafe recommendations, and out-of-distribution behavior in real time — providing an ongoing assurance layer that the FDA, health systems, patients, and clinicians can trust. 

• Stanford University: The team will develop a supervisory system using a three-stage, compute-escalating pipeline — outlier filtering, rule-based screening, and a deep-research auditing agent — that produces inspectable per-claim rationales. 

ADVOCATE's TA1 must submit a first-of-its-kind FDA-authorization package for this product within 24-months of contract award. Performers across both areas will work closely together to develop technical interfaces, safety benchmarks, and evaluation protocols throughout the program. 

TA3: Scalable Implementation in Health Systems 

These teams, anchored in prominent health systems, will design and execute the real-world implementation strategy that brings ADVOCATE technology to patients and clinicians across diverse care settings, with a particular focus on rural and underserved communities where cardiology access is most constrained. 

• Duke University: The team will provide a multi-site validation platform testing ADVOCATE agents across five health systems and rural sites on both Epic and Cerner/Oracle electronic health records (EHRs), amplified by the American Heart Association’s national reach. 
• Kaiser Permanente: The team will provide an enterprise-scale deployment across 21 medical centers and 260+ clinics, embedding ADVOCATE agents into Epic (EHR) software workflows for heart failure patients and generating reusable deployment blueprints via shadow-mode deployments and pragmatic randomized clinical trials. 

If ADVOCATE succeeds, preventable cardiovascular deaths will decrease, hospitalizations will drop, medication adherence will improve, and clinicians will be freed to focus on the patients and decisions that need them most. Crucially, ADVOCATE develops a pathway for agentic AI to emerge as a new autonomous member of the clinical team, for every patient with every condition. Patients in the communities most cut off from specialty care today will gain a trusted, always-available member of their care team. 

For more on ADVOCATE, visit the program page.