Security is a default, not a feature.

All data in transit is encrypted with TLS 1.3. Internal service-to-service communication uses mutual TLS within our virtual private cloud. All data at rest — including the audit log, the inquiry store, and any cached chart context — is encrypted with AES-256 using customer-managed keys where the customer has supplied them, and platform-managed keys otherwise. Keys rotate on a documented schedule and on demand at customer request.

The services that handle PHI are inside a virtual private cloud with no public ingress. Connectivity to a customer’s environment is established over a dedicated private channel — typically AWS PrivateLink or a customer-initiated VPN tunnel — never over the open internet. Public-internet endpoints exist only for the marketing site, the contact form, and the documentation.

Role-based access control with the principle of least privilege. Multi-factor authentication is mandatory for every employee account, every contractor account, and every cloud-console session. Production access is gated behind a Just-in-Time elevation workflow, with the elevation request, the duration, and the action set all written to the audit log. We do not maintain standing production access for any individual.

Every criteria-check output PrefillX produces ships with a reasoning trace logged to an immutable audit store before any outbound action takes place. A missing trace blocks the outbound message — there is no untraced path from model output to pharmacist review. Logs are retained per the terms of the customer’s business associate agreement and exportable to the customer’s SIEM on demand.

Static analysis (SAST) and dependency scanning (SCA) gate every pull request in CI; high-severity findings block merge. Production releases are built from a signed git ref, deployed via an immutable container image, and verified at the orchestration layer before traffic shifts. We will provide a Software Bill of Materials (SBOM) to customers under the BAA on request.

We run continuous vulnerability scans against our infrastructure and our container images. Critical findings are triaged within one business day and remediated under documented service-level objectives. We will commission third-party penetration testing on the schedule required by our SOC 2 audit once that engagement begins. Until then, we run continuous automated vulnerability scanning and triage findings against documented SLOs.

• HIPAA — aligned. IgniteHealth implements the technical, administrative, and physical safeguards required of a business associate under the HIPAA Privacy and Security Rules (45 CFR §164 Subparts C and E). We sign a Business Associate Agreement with every covered entity before any PHI exchange. HIPAA does not have a certification body; any vendor claiming to be “HIPAA-certified” is making an inaccurate claim. We use the accurate term: HIPAA-aligned.
• SOC 2 Type II — in progress. SOC 2 Type II is on our 2026 roadmap. We are mapping controls to the Trust Services Criteria internally; we will engage an independent auditor and enter the observation window once internal control mapping is complete. We will not display a SOC 2 badge until the report is signed.
• HITRUST CSF — roadmap. HITRUST is on our 2027 roadmap. We will not claim certification until we hold the letter.
• NIST AI Risk Management Framework — adopted. We follow the GOVERN, MAP, MEASURE, MANAGE lifecycle for model governance. Model release notes summarise each stage’s outcome and are made available to customers under the BAA.
• FDA Clinical Decision Support — enforcement-discretion non-device. PrefillX is structured to qualify as non-device CDS under the FDA’s 21st Century Cures Act §3060 framework. The pharmacist remains the decision-maker of record on every Flagged refill. PrefillX is not a 510(k) device, and we will not claim it is.

• We never train foundation models on customer PHI.
• We never sell PHI, and we never share it outside the scope of the BAA.
• We never claim certifications we do not hold. If you see a vendor claim “HIPAA-certified” or “FDA-approved” for a CDS tool, that is a flag worth investigating.
• We never use a model output as the legal action of record. The pharmacist’s signature on the chart is the legal locus.

We welcome reports from independent researchers. Send disclosures to admin@ignitehealth.ai. We acknowledge within one business day. We do not pursue legal action against researchers who follow a reasonable disclosure timeline and who do not access PHI beyond what is required to demonstrate the issue.