Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) Innovative Solutions Opening (ISO)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Advanced Research Projects Agency for Health (ARPA-H), under the National Institutes of Health, has released an Innovative Solutions Opening (ISO) for the Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE) program. This initiative seeks to develop an Agentic AI system to deliver autonomous and semi-autonomous clinical care directly to patients with cardiovascular disease (CVD). The program aims to modernize CVD care management by addressing technical and structural barriers, and supporting regulatory, reimbursement, and clinical deployment blueprints. This opportunity will result in multiple Other Transaction (OT) Agreements.
Scope of Work
The ADVOCATE program focuses on three key Technical Areas (TAs):
- TA1 (CVD Agent): Develop a clinically validated, regulatory-compliant, patient-facing AI agent for CVD care management. This agent will interact with EHRs and wearables, perform diagnostic reasoning, offer treatment recommendations, and manage prescriptions as an FDA-defined medical device function.
- TA2 (Supervisory Agent): Create a disease-agnostic agent for continuous monitoring, auditability, and regulatory compliance of clinical agents, assessing risk, acuity, and accuracy.
- TA3 (Scaled Implementation): Integrate CVD and Supervisory agents into healthcare settings, ensuring EHR data access. This TA includes performing Scalability Studies to compare agentic care with usual care and evaluating cost-efficiency and safety. Collaboration between TA teams and an independent Verification & Validation (IV&V) partner is emphasized.
Contract & Timeline
- Opportunity Type: Innovative Solutions Opening (ISO) leading to Other Transaction (OT) Agreements.
- Period of Performance: A two-phase, 39-month program, with down-selection points at 12 and 24 months.
- Set-Aside: None specified.
- Eligible Proposers: Universities, non-profit organizations, small businesses, other than small businesses, and non-federal research centers. FFRDCs, government entities, and individuals with Organizational Conflict of Interest (OCI) are prohibited.
- Proposers' Day: January 23, 2026.
- Solution Summary Due: February 27, 2026.
- Full Proposal Due: April 1, 2026.
Submission & Evaluation
Proposers must submit a solution summary followed by a full proposal via the ARPA-H Solution Submission Portal. Proposals will be evaluated based on:
- Overall Scientific and Technical Merit
- Proposer's Capabilities and/or Related Experience
- Potential Contribution to Relevance to the ARPA-H Mission and User Experience
- Assessment of Proposed Cost/Price Resource sharing is highly encouraged, with cash contributions preferred. Proposers must provide detailed plans for sharing deidentified/aggregated data. ARPA-H encourages alignment with open-source regimes for intellectual property, desiring non-commercial software and technical data deliverables.
Key Attachments
- ARPA-H-SOL-26-142_ADVOCATE ISO.pdf: The main solicitation document.
- Attachment 2 - ARPA-H - OT Agreement Sample.docx: Sample Other Transaction Agreement.
- Attachment 3 - ARPA-H Cost Proposal Narrative.docx: Guidelines for the cost proposal narrative.
- Attachment 3a/3b - ARPA-H Cost Proposal Spreadsheet - OTs.xlsx: Cost proposal templates (with/without Resource Sharing).