Seeking TA3 Clinical Partners
for ADVOCATE AI Trials
Regain provides safety infrastructure for autonomous clinical AI agents. Join us as a TA3 evaluation site for the ARPA-H ADVOCATE program.
Accountability (Who You Work With):
ADVOCATE Partnership Overview (TA3)
Document Version: 2.0
Last Updated: 2026-01-20
1. Safety + Audit Foundation for ADVOCATE Clinical Agents
TA1/TA2 technology prime + read-only first alongside existing EHR + TA3 leads clinical evaluation
- Primary CTA: Schedule TA3 Fit Call
| Trust Indicators | Read-only first integration · TA3-controlled PHI (US) · IRB starter kit · Auditability + governance controls |
Accountability (Who You Work With):
- Executive Sponsor: Anton Kim, Ph.D. (Founder & CEO)
- Integration Lead: EHR connectivity (FHIR/HL7) & pre-prod testing
- Security Lead: Onboarding artifacts & risk assessment support
- TA3 Role: Provides PI + Clinical Champion
2. TA3 Partnership at a Glance
| TA3 Provides | Regain Provides |
|---|---|
| • PI / Clinical Champion | • Supervisory Console (TA2) |
| • IRB Pathway & Research Ops | • Trial Operations Kit (Protocol + Instrumentation) |
| • IT Contact & Pre-prod Access | • Read-only Integration Kit |
| • HF/Post-MI Patient Cohort | • Evidence Capture & Audit System |
3. How We De-Risk Adoption
Step 0: Read-Only First
We start with a minimal FHIR integration surface (read-only) to validate connectivity without risking write-back or order entry.
Step 1: Small Pilot Cohort
Limited rollout to a specific HF/Post-MI cohort under IRB oversight for safety monitoring and workflow validation.
Step 2: Phase-Gated Expansion
Write-back and autonomous actions are enabled only after successful governance review, V&V, and safety milestones are met.
4. How It Works
Technical Note: Standards-based integration via FHIR/HL7 and Model Context Protocol (MCP).
5. Product Suite
Regain Health (Patient App)
A fully ADVOCATE-compatible mobile interface (launching April 2026) for patient engagement, symptom monitoring, and data collection.
Regain Medical (Supervisory Console)
A clinician-facing dashboard that runs alongside Epic/Cerner. It provides "Glass Box" reasoning traces, override controls, and regulatory-grade evidence capture.
6. Trial Operations Kit
We handle the heavy lifting for study execution.
| Deliverable | Description |
|---|---|
| HF/Post-MI Protocol | ADVOCATE-aligned pilot protocol template |
| IRB Starter Kit | Consent forms, AE definitions, operational checklists |
| Data Capture Spec | Evidence pack for regulatory submission |
| Integration Checklist | Step-by-step guide for read-only connectivity |
| Governance Playbook | Phased autonomy definitions and escalation paths |
| Metrics Plan | Safety and efficacy monitoring framework |
7. Security Snapshot
| Area | Commitment |
|---|---|
| Residency | TA3-controlled storage or US-hosted cloud environment |
| Access | Least-privilege RBAC; fully audited |
| Personnel | US-only access option available; time-bound and revocable |
| Compliance | BAA/DUA executed; HIPAA/NIST aligned |
| Response | Documented incident response and rollback procedures |
8. Governance & Autonomy
| Phase | Autonomous Actions | Clinician Confirmation | Forbidden |
|---|---|---|---|
| Phase 1 | Monitoring, reminders | Escalation, care plans | Rx changes, triage |
| Phase 2 | Protocol-bounded titration | Complex cases | Safety deviations |
Mechanisms: Override buttons, Full audit trail, Automated rollback.
9. Timeline & Resourcing
| Period | Goal | Milestones |
|---|---|---|
| Months 0-2 | Alignment | Security review, Contracting, IRB submission |
| Months 3-6 | Integration | Pre-prod access, Validation, Staff training |
| Months 6-12 | Pilot | Small cohort safety evaluation |
> "We move at the speed of your security review."
10. Evidence & Deployments
Execution Proof
Prospective study with N=13 clinician users (2024). Lipid biomarker improvement signal observed. Methods and details available on request.
Operational Maturity
Private Multi-specialty Clinic & Additional production deployment(s) (non-cardiology workflows). Note: Non-US deployments are operational references only. All TA3 PHI is hosted in segregated, TA3-controlled US infrastructure.
11. FAQ
CMIO / Clinical Lead
Q: Does this replace our EHR?
No. Regain Medical is a supervisory console that runs alongside your existing EHR (Epic/Cerner) via read-only FHIR integration.
Q: Who is liable for AI decisions?
You define the autonomy boundaries. Our system enforces them. The clinician remains the "human-in-the-loop" for all high-stakes decisions in Phase 1.
CIO / IT / Security
Q: Who accesses our data?
Data resides in your controlled environment (or US cloud). Personnel access is role-based, audited, and can be restricted to US-only staff.
Q: What is the integration burden?
We start with a minimal, read-only FHIR surface. No write-back is required until after governance and security milestones are met.
12. Next Steps
Ready to explore a TA3 partnership? Use the contact options below to schedule a 30-minute fit call.
Ideal Participants: CMIO, CISO/IT Lead, Clinical Champion (PI)
Regain, Inc. | Privacy Policy | © 2026 Disclaimer: Not FDA-authorized today. TA3-led clinical evaluation. PHI in TA3-controlled US infrastructure.
Ready to explore a TA3 partnership?
Ideal Participants: CMIO, CISO/IT Lead, Clinical Champion (PI)
