ARPA-H SSO: “AGENTIC AI-ENABLED CARDIOVASCULAR CARE TRANSFORMATION” (ADVOCATE)
Below is a brief summary. Please check the full solicitation before applying (link in resources section).
Executive Summary:
ARPA-H is now accepting proposals for ADVOCATE: Agentic AI-Enabled Cardiovascular Care Transformation, a major new Innovative Solutions Opening (ISO) focused on deploying autonomous, FDA-regulated clinical AI agents for cardiovascular disease (CVD) care at national scale.
This program is designed to fund teams that can build, validate, and deploy patient-facing AI agents, paired with independent supervisory AI, and integrate them directly into real healthcare systems. Selected performers will work closely with FDA, large health systems, and ARPA-H leadership to establish a blueprint for scalable, reimbursable agentic AI in healthcare. A Solution Summary is mandatory and is due February 27, 2026, at 5:00 PM EST. Full proposals are by invitation only and are due April 1, 2026, at 5:00 PM EST.
How much funding would I receive?
Total award size: Not specified in the solicitation
Number of awards: Multiple awards anticipated
Funding mechanism: Other Transaction (OT) Agreements
Program length: Up to 39 months
Phase 1A: 12 months
Phase 1B: 12 months (option)
Phase 2: 15 months (option)
What could I use the funding for?
Funding must support development, validation, and deployment of agentic AI systems for cardiovascular care, aligned to one or more of the following Technical Areas (TAs):
TA1 — CVD Agent (Patient-Facing Clinical AI)
Autonomous or semi-autonomous AI agents that:
Provide diagnostic and treatment assistance
Adjust prescriptions for CV conditions (FDA medical device)
Integrate real-time EHR and wearable data
Deliver 24/7 outpatient care management
Clinical reasoning using multimodal inputs (text, voice, image, video)
FDA regulatory engagement and authorization
Deployment into real health systems for scalability studies
TA2 — Supervisory Agent (AI Oversight & Control)
Disease-agnostic AI that:
Monitors safety, accuracy, uncertainty, and risk of clinical AI
Enables real-time control and auditability
Supports FDA Medical Device Development Tool (MDDT) qualification
Continuous post-market monitoring functionality
Strong preference for open-source solutions
TA3 — Scaled Implementation (Health Systems Only)
Integration of TA1 and TA2 agents into live clinical workflows
Access to EHR production and pre-production environments
Execution of large-scale Scalability Studies
Clinical outcome, cost, and reimbursement evidence generation
Are there any additional benefits I would receive?
Selected teams receive:
Direct engagement with FDA throughout development
Access to real EHR data, clinicians, and patients (via TA3 performers)
Participation in large, ARPA-H-funded scalability studies
Validation by an independent IV&V partner
Visibility with payers and CMS-relevant evidence generation
Potential facilitation of investor engagement by ARPA-H
What is the timeline to apply and when would I receive funding?
Key dates (firm):
Posting date: January 13, 2026
Proposers’ Day: January 23, 2026 (8:30 AM – 5:00 PM EST)
Proposers’ Day registration deadline:
In-person: January 21, 2026, at 5:00 PM EST
Virtual: January 21, 2026, at 5:00 PM EST
Solution Summary due: February 27, 2026, at 5:00 PM EST
Full proposal due (if invited): April 1, 2026, at 5:00 PM EST
Funding timing after submission is not specified and is contingent on negotiations and down-selection decisions.
Where does this funding come from?
Agency: Advanced Research Projects Agency for Health (ARPA-H)
Office: Scalable Solutions Office (SSO)
Authority: Other Transaction (OT)
Who is eligible to apply?
Eligible applicants include:
U.S. startups and growth-stage companies
Universities and academic teams
Non-profit organizations
Non-federal research organizations
Not eligible:
Federally Funded Research and Development Centers (FFRDCs)
Federal government entities or employees (as performers)
Entities from covered foreign countries or foreign entities of concern
Organizations with unmitigable ARPA-H conflicts of interest
TA3 applicants cannot apply to TA1 or TA2.
What companies and projects are likely to win?
ARPA-H is explicitly seeking teams that:
Are building agentic (not rules-based) clinical AI
Can meet FDA medical device or MDDT requirements
Have real experience integrating with EHRs and health systems
Can demonstrate a path to non-inferiority vs cardiologists
Are prepared for open data sharing and multi-party collaboration
Can scale beyond pilots into national deployment
Incremental clinical decision support tools are unlikely to be competitive.
Are there any restrictions I should know about?
Key restrictions include:
Foundation models cannot be developed from scratch
Solutions must be interoperable with other agents
Clinical AI must pursue FDA authorization or qualification
Extensive data-sharing and collaboration are mandatory
Foreign talent, ownership, or funding risks are heavily scrutinized
TA1 and TA2 proposals must remain technically independent
How long will it take me to prepare an application?
Solution Summary: ~2–4 weeks for competitive teams
Full Proposal: ~6–10 weeks if invited
Team formation, regulatory strategy, and data architecture must be addressed early.
How can BW&CO help?
BW&CO helps teams:
Translate ADVOCATE requirements into a clear, fundable narrative
Position technical capabilities against TA-specific metrics
Shape FDA and commercialization strategy language
Design compliant multi-party teaming structures
Avoid common ARPA-H disqualifiers
How much would BW&CO Charge?
Fractional support is $300 per hour.
For startups, we offer a discounted rate of $250 per hour to make top-tier consulting more accessible while maintaining the same level of strategic guidance and proposal quality.
Additional Resources
Review the solicitation here.