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ARPA-H's ADVOCATE (Agentic AI-EnableD CardioVascular CAre TransfOrmation) program seeks to develop the first FDA-authorized agentic AI technology providing 24/7 specialty cardiovascular care.
The program funds three components: a patient-facing clinical AI agent that serves autonomously as a digital member of the care team, a supervisory AI overseer that monitors deployed agents for safety and efficacy, and a clinical workflow integration plan for scalable deployment. ARPA-H will select teams of innovators within six months, with team selections anticipated in June 2026.
The program aims to create AI agents capable of continuous patient monitoring, real-time clinical decision support, and autonomous intervention recommendations for cardiovascular disease management.
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Agentic AI-Enabled Cardiovascular Care Transformation What if an FDA-authorized clinical agentic AI could provide safe and effective cardiovascular care to every American?
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 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.
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.
What ARPA-H needs to solve this problem ADVOCATE seeks leaders in the tech sector, academia, non-profit organizations, and small businesses to overcome the technical, regulatory, and market barriers holding back innovation in clinical agentic AI.
The program has three technical areas: development of a patient-facing clinical AI agent, a supervisory agent that ensures clinical AI agents’ consistent safety and effectiveness, and a scalable plan for integration into clinical workflows in healthcare organizations. Notice ID: ARPA-H-SOL-26-142 ARPA-H invites interested parties to review the solicitation, which is posted and maintained on SAM.
gov. The solicitation outlines the opportunity and its requirements, key dates and deadlines, submission documents and templates, evaluation criteria for submissions, and information on how to apply. Solution Summary Due: February 27, 2026 A summary is required to submit a full proposal.
Full Proposal Due: April 1, 2026 at 5:00PM ET After submission of a solution summary, proposers will either be encouraged or discouraged from submission of a full proposal. It is strongly recommended that only proposers who are encouraged to submit a full proposal do so. Reminder: Dates are estimates and subject to change.
Please reference the solicitation for the most up-to-date information as late submissions will not be reviewed. Review Solicitation Details Ready to apply? To submit a Solution Summary, sign-in to the ARPA-H Solutions site .
Please note: Because of significant interest in the ADVOCATE program—a signal of both the urgency of cardiovascular disease and the promise of clinical agentic AI—ADVOCATE is piloting secure large language model (LLM) tools to assist with the initial review of Solution Summaries. Read the full statement to learn more .
Frequently Asked Questions Review responses to common questions about this funding opportunity asked by others in the proposer community. You can also ask a question. Review FAQs and Ask A Question This is an optional event for the proposer community to learn more about this opportunity, ask questions, and make connections.
This event is not intended for patients, patient advocates, the media, or general interest audiences. View the Proposers' Day recording View the Lightning Talk presentations This optional webinar for the proposer community was an additional chance to ask questions and get clarification on the ADVOCATE ISO. See the Special Notice ( ARPA-H-SN-26-148 ) for additional details.
ARPA-H anticipates that teaming will be necessary to achieve the goals of ADVOCATE. Prospective proposers are encouraged to form teams with varied technical expertise to submit a research proposal. To facilitate this process, we have created a teaming page where prospective proposers can share their profiles and learn more about other interested parties.
"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 certain care autonomously as well as engage the clinical team as needed." ARPA-H to revolutionize cardiovascular disease management with clinical agentic AI
Based on current listing details, eligibility includes: Technology sector leaders, academic institutions, non-profit organizations, and small businesses. Teams must submit a Solution Summary before full proposal submission. Solicitation notice ARPA-H-SOL-26-142 posted on SAM.gov. Applicants should confirm final requirements in the official notice before submission.
Current published award information indicates Total program budget not disclosed. Multiple awards anticipated for development of FDA-authorized clinical agentic AI systems for 24/7 cardiovascular care. Always verify allowable costs, matching requirements, and funding caps directly in the sponsor documentation.
The current target date is April 1, 2026. Build your timeline backwards from this date to cover registrations, approvals, attachments, and final submission checks.
Federal grant success rates typically range from 10-30%, varying by agency and program. Build a strong proposal with clear objectives, measurable outcomes, and a well-justified budget to improve your chances.
Requirements vary by sponsor, but typically include a project narrative, budget justification, organizational capability statement, and key personnel CVs. Check the official notice for the complete list of required attachments.
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