Frequently Asked Questions

Objective: Common questions for stakeholders.

Clinical / CMIO

Q: Does this replace our existing EHR?

No. Regain Medical is a supervisory console designed to run alongside your EHR (Epic, Cerner, etc.). It pulls data via FHIR, visualizes AI reasoning, and pushes documentation back (phase-gated, optional). It is an "additive" layer, not a replacement.

Q: Can we customize the clinical protocols?

Yes. The "Governance Playbook" allows your clinical leadership to define specific thresholds, medication formularies, and escalation rules that the AI must follow.

IT / Security

Q: Where does the data live?

We support Data Residency requirements. Data can be hosted in a segregated, single-tenant environment within a US Cloud Region (AWS/Azure) controlled by your keys, or potentially on-premise if required.

Q: Who has access to PHI?

Only authorized personnel. We offer a US-only personnel access model for support and maintenance. All access is time-bound ("break-glass"), justified by a ticket, and fully logged.

Research / IRB

Q: Is this FDA approved?

No. The platform is designed to align with FDA SaMD and MDDT pathways. The goal of the ADVOCATE partnership is to generate the clinical evidence required for future authorization.

Q: How do you handle "Hallucinations"?

We use a Multi-Agent Debate architecture (Generator-Verifier) and a deterministic Safety DSL. If the system cannot ground a claim in evidence, it is programmed to say "I don't know" or flag it for human review, rather than guessing.

Last Updated: 2026-01-20