Agentic AI-EnableD CardioVascular CAre TransfOrmation (ADVOCATE) Innovative Solutions Opening (ISO)

Amendment / Modification

This document is Amendment 02 to the ADVOCATE solicitation (ARPA-H-SOL-26-142). It was posted on February 23, 2026.

This amendment modifies the original solicitation. Specific changes are not detailed in the provided text, but it is an update to the solicitation.

This amendment may impact proposal deadlines, requirements, or evaluation factors. Bidders should review the full amendment for details.

Amendment / Modification

This document is Amendment 01 to the ADVOCATE Innovative Solutions Opening (ISO) solicitation ARPA-H-SOL-26-142. The amendment was posted on February 5, 2026.

This amendment modifies the original solicitation. Specific changes are detailed within the document.

Potential bidders should review this amendment for any changes to requirements, deadlines, or submission instructions before preparing their proposals.

Forms / Attachments / Pricing Sheets

This document is an Excel spreadsheet template designed for bidders to submit cost proposals for opportunities utilizing a Resource Sharing agreement under an Other Transaction (OT).

• Structure: The spreadsheet is organized into multiple sheets for different cost categories, including:
  • Labor Rates
  • Indirect Rates (Fringe, Overhead, G&A, F&A, Profit/Fee)
  • Phase Costs (broken down by fiscal year and task)
  • Other Direct Costs (ODCs), including Materials/Supplies, Equipment, and Travel
  • Subproposer and Consultant cost details
  • Monthly expenditure breakdowns
• Instructions: Detailed instructions are provided on various tabs to guide bidders through the cost proposal preparation process, including data entry, formula usage, and submission requirements.
• Customization: Bidders can add rows for additional personnel, cost categories, or tasks as needed, but must ensure formulas are carried forward correctly.

This template is critical for bidders to accurately and comprehensively detail their proposed costs. It outlines the required format for financial proposals, including labor categories, indirect rates, and phase-specific expenditures. Adherence to the template's structure and instructions is essential for a compliant and evaluable cost proposal.

Solicitation / RFP / RFQ

This solicitation, "Agentic AI-Enabled Cardiovascular Care Transformation (ADVOCATE)," issued by the Advanced Research Projects Agency for Health (ARPA-H) Scalable Solutions Office, seeks innovative solutions to modernize Cardiovascular Disease (CVD) care management. The program aims to develop and implement a patient-facing autonomous agentic AI system for 24/7, scalable, safe, and effective cardiovascular care, addressing technical and structural barriers and supporting regulatory, reimbursement, and clinical deployment blueprints. The initiative focuses on three technical areas (TAs): 1) a "CVD Agent" for patient care, 2) a "Supervisory Agent" for oversight, and 3) "Scaled Implementation" in healthcare organizations.

• TA1 (CVD Agent): Develop a clinically validated, regulatory-compliant, patient-facing AI agent for care management, interacting with EHRs and wearables, capable of diagnostic reasoning, treatment recommendations, and performing FDA-defined medical device functions (e.g., prescription management).

• TA2 (Supervisory Agent): Develop 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, providing EHR data access, performing Scalability Studies to compare agentic care with usual care, and evaluating cost-efficiency and safety.

• Program Structure: A two-phase, 39-month program with specific goals and down-selection points at 12 and 24 months.

• Collaboration: Emphasis on collaboration between TA teams and with an IV&V partner.

• Anticipated Awards: Multiple Other Transaction (OT) Agreements.

• Period of Performance: 39 months, divided into Phase 1A (12 months), Phase 1B (12 months), and Phase 2 (15 months).

• Submission: Requires a solution summary followed by a full proposal, submitted via the ARPA-H Solution Submission Portal.

• Evaluation Criteria: Proposals will be evaluated based on four criteria in descending order of importance: 1) Overall Scientific and Technical Merit, 2) Proposer's Capabilities and/or Related Experience, 3) Potential Contribution to Relevance to the ARPA-H Mission and User Experience, and 4) Assessment of Proposed Cost/Price.

• Key Deadlines:

  • Posting Date: January 13, 2026
  • Proposers' Day: January 23, 2026
  • Solution Summary Due Date: February 27, 2026
  • Proposal Due Date: April 1, 2026

• Eligible Proposers: Responsible sources including universities, non-profit organizations, small businesses, other than small businesses, and non-federal research centers.

• Prohibitions: FFRDCs and government entities are prohibited from responding as prime or sub-performers. Individuals currently providing contracted support services to ARPA-H are ineligible due to OCI.

• Resource Sharing: Highly encouraged, with cash contributions preferred over in-kind.

• Data Management: Proposers must share deidentified/aggregated data and provide detailed plans for data handling.

• Intellectual Property: Encourages alignment with open-source regimes; non-commercial software and technical data are desired deliverables.

• Attachments: Includes appendices for Cybersecurity Requirements, Solution Summary Format, Full Proposal Format, Administrative & National Policy Requirements, Commercialization Roadmap, and an OT Agreement Sample.

Form / Attachment / Pricing Sheet

This document is an Excel spreadsheet (Attachment 3a) designed for bidders to submit their cost proposals for ARPA-H opportunities that do not involve a Resource Sharing agreement. It provides a structured template for detailing all anticipated costs.

• Version Control: The 'Change Notes' sheet tracks revisions to the spreadsheet, detailing modifications to formulas, categories, and instructions.
• Cost Breakdown: Includes sheets for 'Constants' (defining labor categories, indirect rates, business types), 'Labor Rates' (detailing individual personnel rates and escalations), 'Phase Costs' (breaking down costs by phase and fiscal year), and 'Task Costs' (allocating costs to specific tasks within each phase).
• Summary Tables: 'Summary Cost Table' and 'Total Amount' sheets aggregate costs for an overall view.
• Supporting Schedules: Dedicated sheets for 'Subproposer', 'Consultants', 'Travel', 'Materials-Supplies', 'Equipment', and 'Other Direct Costs (ODC)' allow for detailed cost itemization.
• Instructions: The 'Instructions' sheet provides guidance on how to complete the workbook, emphasizing not to delete tabs or rows and to ensure data consistency across sheets.

This spreadsheet is critical for bidders to accurately and comprehensively detail their proposed costs. It outlines the required format for direct labor, indirect costs, subcontracts, consultants, travel, materials, equipment, and other direct costs, broken down by phase and task. Adherence to the template and instructions is necessary for a compliant cost proposal.

Form / Attachment / Pricing Sheet

This document outlines the required format and content for a bidder's cost proposal narrative. It supplements the Cost Proposal Workbook for Other Transactions, requiring proposers to provide detailed justifications for cost drivers and assumptions.

• Formatting: 8-1/2 by 11 inch paper, 1-inch margins, non-serif font, minimum 11 point size. No page limit specified.
• Required Information:
  1. Solicitation #
  2. Full Proposal Title
  3. Technical Approach (TA) Selection
  4. Prime Awardee/entity submitting the proposal
  5. Unique Entity Identifier (UEI) of prime proposer/awardee
  6. Type of Organization and website URL (select all that apply: Large Business, Small Disadvantaged Business, Other Small Business, HBCUs, MI, Other Educational, Other Non-Profit)
  7. Technical Point of Contact (POC)
  8. Administrative POC
  9. Other Team Members (Sub-performers) and their organization types
  10. Total proposed cost (separated by base and option(s))
  11. Cognizant auditor information (if applicable)
  12. Date proposal submitted
  13. Proposal validity period (minimum 120 days)
• Cost Details:
  • Level of Effort and Labor Costs (using burdened labor rates)
  • Materials (itemized, with justification for items > $10,000)
  • Equipment Purchases (itemized, with justification for items > $10,000)
  • Travel (purpose, # trips, # days, # people, destinations, cost)
  • Other Direct Costs (ODCs)
  • Consultant Costs (fully burdened rates, hours, travel)
  • Sub-awardee Costs (detailed as per sections 1-7)
  • Resource Sharing (source, nature, amount)
  • Potential Cost Reductions (Optional)

This document is critical for bidders to understand the specific financial and organizational information required for their proposal submission. It details the structure, content, and justification needed for all cost elements, including labor, materials, equipment, travel, and sub-awardees. Adherence to these requirements is necessary for a compliant and competitive proposal.

Form / Attachment / Pricing Sheet

This document is a sample "Other Transaction Agreement" (OT Agreement) template used by ARPA-H. It outlines the standard terms and conditions that would govern an agreement between ARPA-H and a performer for research and development projects. It serves as a foundational document for potential bidders to understand the contractual framework.

• Agreement Structure: Details the articles and attachments that form the agreement, including Scope, Term, Management, Obligation & Payment, Disputes, Intellectual Property Rights, and more.
• Definitions: Provides clear definitions for key terms used throughout the agreement (e.g., Agreement Officer, Performer, Government Purpose Rights, Subject Invention).
• Attachments: References critical attachments such as the Task Description Document (TDD), Report Requirements, Schedule of Milestones and Payments, and Background Intellectual Property Assertions.
• Key Clauses: Includes specific clauses on Intellectual Property Rights (patent and data rights), Foreign Access to IP, Property Disposition, Public Release of Information, Security Requirements, and prohibitions on certain telecommunications equipment.
• Administrative Details: Outlines points of contact for both the Government and the Performer, payment procedures, and dispute resolution processes.

This template provides potential bidders with a comprehensive understanding of ARPA-H's standard contractual terms for Other Transaction Agreements. It highlights critical areas such as intellectual property ownership, data rights, reporting requirements, and payment schedules, which are essential for evaluating the feasibility and terms of participation in an ARPA-H opportunity. Bidders should pay close attention to Articles VII (Intellectual Property Rights) and X (Public Release or Dissemination of Information) as these significantly impact the ownership and use of developed technologies and research findings.