ADVOCATE Frequently Asked Questions (FAQs)

Per Section 1 c of Appendix C of the ADVOCATE ISO, offerors are required to complete and submit Appendix C: Volume I, II, & III as well as Attachment 3 and Attachment 3a/b. It has come to our attention that the nomenclature used for upload slots in the ARPA-H proposal portal does not directly align with the attachment names in the ADVOCATE ISO. The portal has been updated to include additional upload slots; however, the names of these slots cannot be changed. To help offerors align the ISO-required attachments with the slot names displayed in the portal, we have provided the following mapping that indicates where each ISO-required attachment should be uploaded:

• APPENDIX C Volume I: Technical and Management Proposal – Upload under portal slot labeled "Tech and Management Proposal"
• APPENDIX C Volume II and ATTACHMENT 3: Cost Proposal and Cost Proposal Narrative – Upload under slot labeled “Cost Proposal or Basis of Estimate” as a consolidated ZIP file
• APPENDIX D Volume III: Administrative & National Policy Requirements Submission – Upload under portal slot labeled "Admin and National Policy Supporting Documentation"
• ATTACHMENT 3a/b: Cost Proposal Spreadsheet – Upload under portal slot labeled "Cost Proposal Spreadsheet"

Please note as the portal only allows for the upload of one file per slot, we are requesting Proposers combine APPENDIX C Volume II (Cost Proposal) and ATTACHMENT 3 (Cost Proposal Narrative) into a single ZIP file for upload.

Finally, Proposers are not required to resubmit their project solution summary as a part of their full proposal.

• Please combine all required cost proposal documents, including the main cost proposal spreadsheet, supplemental spreadsheets for each team member or sub-performer, and the cost narrative, into a single ZIP file.
• Clearly label each file within the ZIP to indicate the submitting organization or team member. 
• Upload this ZIP file in the portal slot labeled “Cost Proposal Spreadsheet.

As outlined in Appendix C - Full Proposal Format and Instruction of the ADVOCATE ISO, each proposer is required to submit a conforming full proposal, which must include three distinct volumes, in addition to the relevant Cost Spreadsheet attachment as described below:

• Appendix C: Volume I, Technical and Management Proposal,
• Appendix C: Volume II, Cost Proposal, and
• Appendix D: Volume III, Administrative and Policy Requirements Submission
• Attachment 3: Cost Proposal Narrative
• Attachment 3a/b: Cost Spreadsheet

For multi-party proposals, the lead organization must submit a consolidated cost proposal and cost narrative covering all team members, along with separate cost spreadsheets and narratives for each team member.

The lead organization must submit a consolidated cost proposal and cost narrative covering all team members, along with separate cost spreadsheets and narratives for each team member.

An entity, under a single Unique Entity Identifier (UEI), can submit a single proposal as the prime proposer for TA1 or TA2 or TA3. Entities wishing to submit to both TA1 and TA2, must submit separate, technically independent proposals. Those interested in TA3 cannot submit a proposal for TA1 or TA2. Entities may propose within multiple teams as sub-proposers or other appropriate teaming arrangements.

Teaming profiles can be found on the ADVOCATE teaming page.

Refer to Section 2.1.3 of the ADVOCATE ISO regarding non-US entities.

No. This solicitation is open to all eligible proposers, and there is no consortia membership associated with this ISO.

To access the technical expertise drop down, a program needs to be selected first.

Having sub-proposers or being part of a multi-party team is not a requirement. Teams should create the strongest submission possible.Proposer team structure is not prescribed in the ISO. Consistent with Section 2.3 of the ISO, Proposer Team Structure, offerors should identify the teaming arrangement most suitable to their specific combination of expertise, capabilities, and execution plan.

Email advocate@arpa-h.gov. Include “Teaming Profile Update” in the subject.

Proposers are responsible for outlining their own milestone and deliverable timeline as part of their proposal submission. This gives them the flexibility to tailor the schedule to their project’s needs and vision. Once proposals are selected, the Government may further refine these timelines during the negotiation phase to better align with ADVOCATE program objectives and expectations.

• Proposers must submit a single, integrated solution summary. 
• Teams wishing to submit to both TA1 and TA2, must submit separate, technically independent solution summaries. 
• Proposers can submit two separate solution summaries: one for the work described in TA1 and another for TA2.
• Proposers interested in submitting a solution summary for TA3 cannot submit a solution summary for TA1 and TA2 in any capacity (e.g. prime, sub-performer, or multi-party team).

No, a Principal Investigator can only submit one Solution Summary per TA.

• Under a prime/sub teaming arrangement, the prime’s authorized official/authorized organization representative is responsible for submitting the proposal on behalf of the entity.
• Multi-party teaming arrangements, the selected lead team member is responsible for submitting the proposal on behalf of the multi-party team.

See Section 3, Submission Information, and Appendix B, Solution Summary Format Instructions, of the ISO.

See ISO Section 5.1, “Proposers interested in submitting a proposal for TA3 cannot submit a proposal for TA1 and TA2 in any capacity (e.g. prime, subperformer, or multi-party team). TA3 proposers can only submit one proposal for the TA3 work outlined in this solicitation.”

Large Language Models (LLM) may be used to extract data elements, summarize text, and generate text to assist reviewers. LLMs will not substitute for human judgement. There will be human review of the original document.

LLMs may be used to extract data elements, summarize text, and generate text to assist reviewers. LLMs will not substitute for human judgement in evaluating full proposals. There will still be human review of the original document.

When LLMs are used (to extract data elements, summarize text, and generate text), all data will be transmitted exclusively through secure API calls, with external tool calls such as web searches disabled. Vendor contracts and technical controls enforce strict security measures: data sent for inference is never used to train public models, and all access, retention, and logging are tightly restricted and fully auditable.

Proposers interested in submitting a proposal for TA3 cannot submit a proposal for TA1 and TA2 in any capacity (e.g. prime, subperformer, or multi-party team). TA3 proposers can only submit one proposal for the TA3 work outlined in this solicitation.

If their health systems are proposing for TA3, clinicians can still be part of TA1/TA2 teams as independent consultants. Because conflict of interest mitigation between all proposers will be a key aspect of the program, conflicts of interest must be identified and disclosed in accordance with section 6.2 of the ADVOCATE ISO which may also require submission of a mitigation plan.

• Proposers must submit a single, integrated solution summary. 
• Teams wishing to submit to both TA1 and TA2, must submit separate, technically independent solution summaries. 
• Proposers can submit two separate solution summaries: one for the work described in TA1 and another for TA2.
• Proposers interested in submitting a solution summary for TA3 cannot submit a solution summary for TA1 and TA2 in any capacity (e.g. prime, sub-performer, or multi-party team).

The target population will be individuals who have heart failure with reduced and preserved ejection fraction.

Proposers should propose costs that align with their proposed solution.

Yes, the ADVOCATE Proposers’ Day was recorded and is available on the ADVOCATE webpage under the heading Proposers' Day

ISO Section 1.2.2’s overview states that “TA1 and TA2 performers are encouraged to propose the use of industry standards for interoperability and orchestration.” Propose your recommended solution for interoperability and orchestration (data models, APIs, agent orchestration tools, etc.) that would enable a TA1 and TA2 solution to successfully work together.

ISO Section 1.2.2 states that “the target population will be individuals who are post-myocardial infarction or have heart failure.” A patient experiencing hypertension would need that managed, but looking at full chronic care management for HF and PMI patients.

ISO Section 1.2 states “Ensuring safety is paramount. ADVOCATE must address unmitigated risks associated with the use of agentic AI systems in healthcare.” Safety is critical for this project. The ISO does not require a specific formal method; propose the safety cases and formal methods that you think will best address safety.

Yes, please describe your team’s commercialization experience and regulatory strategy within the Capabilities section of the Full Proposal.

No, the APA agreement is executed once a proposer has been selected for negotiation of a potential award.  After selection, the Performer will begin development of their own agreement with their associated performers, the language should NOT be extracted from the OT Agreement as this language is simply outlining what an APA is and its purpose. The performer is responsible for creating this document and obtaining all necessary signatures.

Yes, as the Prime Organization, please capture sub-performer costs in Attachment 3a and submit budget sheets with accompanying letters of support from the Sub-performers.

As part of the full proposal, proposed in-kind cost share can be assigned a ($) value. See Section 4.3 Resource Sharing of the ISO.

Travel that is required for the ADVOCATE program includes one in-person kickoff meeting and one annual program meeting. For budgeting purposes, please include costs assuming these meetings will take place in Washington, DC. For additional travel to collaborate with TA3 Performers, please budget assuming travel will require cross-country transit (ex. If in CA, please budget assuming you will be required to travel to a major city on the east coast.)

Senior/Key Personnel includes individuals who contribute to the scientific development or execution of a project in a substantive, measurable way. These include individuals (performer, sub-performer, and team members) whose absence from the project would significantly impact the approved scope of the project; in other words, were the individual to leave the program, the change would be so substantial that ARPA-H would need to be notified.

The biographical sketch and current and pending (other) support forms are only needed for Senior or Key Personnel. The link can be found in Section 3. Organizational Conflict of Interest (OCI) Affirmations and Disclosure in Appendix D of the ISO. 

Under the following link: https://www.nsf.gov/policies/nspm-33, Performers must complete the forms listed under the Common disclosure forms section.

Yes, please certify in Section 4 of Appendix D and have Senior and Key Personnel sign the attached document.

Only TA3 Proposers will be responsible for conducting Human Subject Research (and therefore responsible for acknowledging in Section 7 of Appendix D) the HSR to be completed in the Phase II Scalability Study.

Section 1.2.2 (TA3 description) states that TA3 performers will “have facilitated TA1 and TA2 agent integration and access to patient data from EHR and wearable /Remote Patient Monitoring (RPM) platforms.” 

Sharing as complete EHR data and wearable/RPM data as possible for the target population of patients with heart failure and/or post-myocardial infarction will help TA1 and TA2 performers be successful. 

However, TA2 is disease agnostic and therefore will benefit from a wider range of data. 

Section 1.2.1 (TA3 description) states that TA3 performers will “provide access to their EHR data and pre-production environments….” to the selected TA1 and TA2 performers. 

TA3’s goal in Phase 1B is to facilitate successful execution of TA1 and TA2 in their clinical and informatics environment. They could do so by providing access to their EHR pre-production environments to TA1 and TA2 performers in Phase 1Bsolutions and/or should explain how they will make that access and successful deployment possible and describe via their technical approaches (e.g., de-identification techniques, isolated “sandbox” environments, etc.).

Revenue sharing is not expected by the ADVOCATE program. T3 organizations are being paid to meet milestones that include sharing data, providing expertise, and collaborating with TA1 and TA2 performers for program success. Organizations may make their own agreements beyond the program.

TA2 proposals should have some clinical expertise in their team and a plan for clinical validation. TA2 performers will have multiple TA3 performers to provide data and clinical expertise.

For TA1 and TA2, more automation is preferred.

Attachment 2 is a sample OT Agreement. There are no binding terms and conditions at this time, however, proposers are encouraged to provide their proposed redlines to the sample OT Agreement with their full proposal submission so that if chosen to proceed to negotiation of a potential award we have the proposed redlines from which to begin. Proposers must include comments providing rationale for any suggested edits of a non-administrative nature. Proposed redlines are not evaluated or considered as part of selections.