Security & compliance, in the open
Every control, mapped across the frameworks a healthcare security team audits — with the real enforcing code path behind each one. A control is marked Implemented only when it is genuinely enforced and links to a signed, tamper-evident audit record.
PHI never leaves the boundary
No external foundation-model provider processes PHI. All inference runs on an in-boundary served model; PHI never leaves the boundary.
Tamper-evident records of every consequential decision, agent or human.
Deny-by-default, tenant-isolated, attribute-based access to PHI.
PHI stays in-boundary; minimum-necessary, consent, and egress enforcement.
The AI system is mapped, measured, and managed under a governed lifecycle.
The agent fleet is bounded: human gates, kill-switch, prompt/egress controls.
Circuit breakers, cost & rate caps, blast-radius limits, incident response.
Model lineage, signed provenance, and dependency integrity.
Standards-based exchange and the CMS prior-authorization mandate.
1 · In-boundary architecture
No external foundation-model provider processes PHI. All inference runs on an in-boundary served model; PHI never leaves the boundary.
2 · Control register (enforced in code)
Audit & Accountability
| Control | Status | Enforced by (real code path) | Framework crosswalk |
|---|---|---|---|
| HN-AUDIT-INTEGRITY Tamper-evident audit trail (WORM, hash-chained, signed) | Implemented · live proof | @healthnext/audit-evidence — WormAuditLog / chain.ts:sealRecord+verifyChain apps/console — src/server/harness/audit.ts:getWormAuditLog + recentAuditRecords apps/console — src/server/agent/data.ts:appendAudit | nist-800-53: AU-9, AU-10, AU-2, AU-3 nist-csf: PR.PS-04, DE.AE-03 soc2: CC7.2, CC7.3 iso27001: A.8.15, A.5.28 hipaa: 164.312(b), 164.312(c)(1) hitech: 13402 (audit trail) hitrust-ai: 09.aa, 12.c |
| HN-AUDIT-EXPORT Independently-verifiable evidence export | Implemented · live proof | @healthnext/audit-evidence — evidence.ts:buildEvidenceBundle / verifyEvidenceBundle | nist-800-53: AU-7, AU-9(2) soc2: CC7.3 iso27001: A.8.15 hitrust-ai: 09.ab |
Access Control
| Control | Status | Enforced by (real code path) | Framework crosswalk |
|---|---|---|---|
| HN-ACCESS-ENFORCEMENT Deny-by-default access enforcement (ABAC + RLS) | Implemented · live proof | @healthnext/tenancy-abac — AbacPolicyEngine + rls/index.ts:generateTableRls | nist-800-53: AC-3, AC-2, AC-6 nist-csf: PR.AA-05 soc2: CC6.1, CC6.3 iso27001: A.5.15, A.8.3 hipaa: 164.312(a)(1), 164.308(a)(4) hitrust-ai: 01.c, 01.v |
| HN-TENANT-ISOLATION Multi-tenant isolation | Implemented | @healthnext/tenancy-abac — tenant-isolation.ts:assertSameTenant + rls TENANT_GUC | nist-800-53: SC-4, AC-4, SC-2 soc2: CC6.1 iso27001: A.8.22 hitrust-ai: 09.m |
| HN-AUTHN Authentication & session management | Partial | apps/console — surface.ts host-gated console + login gate | nist-800-53: IA-2, IA-2(1), AC-12 soc2: CC6.1 hipaa: 164.312(d) hitrust-ai: 01.b |
Data Protection & Privacy
| Control | Status | Enforced by (real code path) | Framework crosswalk |
|---|---|---|---|
| HN-PHI-EGRESS PHI egress boundary (fail-closed) | Implemented · live proof | @healthnext/phi-gate — gate.ts:BlockingPhiGate.enforceEgress apps/console — src/server/agent/modelops.ts:buildPhiGate | nist-800-53: SC-7, AC-4, SC-7(10) nist-csf: PR.DS-02 soc2: CC6.7, C1.1 iso27001: A.8.12, A.5.14 hipaa: 164.312(e)(1), 164.502(b) owasp-llm: LLM02: Sensitive Information Disclosure owasp-agentic: Excessive Agency / Tool Misuse hitrust-ai: 09.s, 13.j |
| HN-MIN-NECESSARY Minimum-necessary data projection | Implemented · live proof | @healthnext/semantic-layer — compile.ts:projectable() (+ tenancy-abac computeMinimumNecessary) | hipaa: 164.502(b), 164.514(d) nist-800-53: AC-6, SI-12 soc2: C1.1, P4.1 iso27001: A.8.10, A.8.11 hitrust-ai: 06.d, 13.k |
| HN-CONSENT Member consent & special-protection records (42 CFR Part 2) | Implemented · live proof | @healthnext/consent — resolution.ts + semantic-layer compile.ts consent predicate | part2: 2.12, 2.13, 2.31 hipaa: 164.508, 164.522 nist-800-53: AC-21, PT-2, PT-3 soc2: P3.1, P3.2 hitrust-ai: 06.c, 13.c |
| HN-ENCRYPTION Encryption in transit & at rest | Partial | @healthnext/audit-evidence — crypto.ts KeyProvider (KMS/HSM-pluggable) | nist-800-53: SC-13, SC-28, SC-8 soc2: CC6.7 iso27001: A.8.24 hipaa: 164.312(a)(2)(iv), 164.312(e)(2)(ii) hitrust-ai: 06.d |
| HN-ACCESS-LOGGING Access logging (every read of a member record is an audit entry) | Implemented · live proof | @healthnext/agent-harness — governed-tool.ts defineGovernedTool (audits every invocation) apps/console — src/server/agent/model-tools.server.ts → data.ts:appendAudit | hipaa: 164.312(b), 164.308(a)(1)(ii)(D) nist-800-53: AU-2, AC-6(9) hitrust-ai: 09.aa |
| HN-PCI-CARDHOLDER Cardholder data protection (PCI DSS) — scoped | N/A | HealthNext does not process or store cardholder data in the core product; premium-billing card handling is delegated to a PCI-compliant payment processor. This control becomes IN-SCOPE only when a deployment brings card data into the estate ("when in PCI estate"), at which point the segmentation + encryption controls above apply to that boundary. | pci-dss: Req 3, Req 4, Req 7, Req 8 nist-800-53: SC-28, AC-3 |
AI Governance
| Control | Status | Enforced by (real code path) | Framework crosswalk |
|---|---|---|---|
| HN-AI-INBOUNDARY In-boundary model routing (no PHI to external models) | Implemented · live proof | @healthnext/modelops — modelops.ts:getModelOps (in-boundary default, PHI gate inside) apps/console — src/server/agent/modelops.ts:getModelOps + modelStatus | nist-ai-rmf: MANAGE 2.2, MAP 5.1 iso42001: 8.3, A.10.2 owasp-llm: LLM02: Sensitive Information Disclosure hitrust-ai: AI.04 |
| HN-AI-LIFECYCLE Governed AI lifecycle (map / measure / manage) | Partial | @healthnext/tenant-model — fork client + published eval snapshot | iso42001: 6.1, 8.2, 9.1 nist-ai-rmf: GOVERN 1.1, MEASURE 2.3, MAP 1.1 hitrust-ai: AI.01, AI.02 |
Agent & LLM Safety
| Control | Status | Enforced by (real code path) | Framework crosswalk |
|---|---|---|---|
| HN-HUMAN-GATE Human-in-the-loop approval gates (AI never holds the decision) | Implemented · live proof | @healthnext/agent-harness — orchestrator.ts approval-gate dispatch (propose + hold) apps/console — src/server/agent/model-tools.server.ts:executeGovernedToolCall (isGated) | nist-ai-rmf: MANAGE 1.1, GOVERN 3.2 iso42001: A.9.2 owasp-llm: LLM06: Excessive Agency owasp-agentic: Excessive Agency, Insufficient Oversight nist-800-53: AC-3, CM-5 hitrust-ai: AI.06 |
| HN-AGENT-TOOL-SCOPING Least-privilege tool scoping (an agent calls only declared tools) | Implemented | @healthnext/agent-harness — registry.ts agentCanUse + orchestrator dispatch check apps/console — src/server/agent/model-tools.server.ts:buildGovernedModelTools + executeGovernedToolCall | owasp-agentic: Tool Misuse, Excessive Agency owasp-llm: LLM06: Excessive Agency nist-800-53: AC-6, CM-7 nist-ai-rmf: MANAGE 2.2 hitrust-ai: AI.06 |
| HN-PROMPT-INJECTION Prompt-injection & untrusted-content defenses | Partial | @healthnext/agent-harness — governed-tool typed I/O + phi-gate egress | owasp-llm: LLM01: Prompt Injection, LLM05: Improper Output Handling owasp-agentic: Memory Poisoning, Tool Misuse nist-ai-rmf: MEASURE 2.7, MANAGE 2.2 hitrust-ai: AI.03 |
Operational Resilience
| Control | Status | Enforced by (real code path) | Framework crosswalk |
|---|---|---|---|
| HN-KILL-SWITCH Fleet kill-switch (halt the agent fleet) | Implemented · live proof | @healthnext/agent-harness — fleet-control.ts:InMemoryFleetControlPlane.setKillSwitch + orchestrator gate | nist-800-53: IR-4, SI-4, CP-2 nist-csf: RS.MI-01, RS.MA-01 nist-ai-rmf: MANAGE 4.1, MANAGE 2.4 iso42001: A.9.2, A.10.4 owasp-agentic: Cascading Failures, Insufficient Oversight hitrust-ai: AI.08 |
| HN-CIRCUIT-BREAKER Per-agent circuit breakers | Implemented · live proof | @healthnext/agent-harness — fleet-control.ts circuit breaker (open/half-open/closed) | nist-800-53: SI-4, CP-10, IR-4 nist-csf: RS.MI-01, RC.RP-01 owasp-agentic: Cascading Failures, Resource Exhaustion hitrust-ai: AI.08 |
| HN-COST-RATE-CAPS Per-tenant cost & rate caps | Implemented | @healthnext/agent-harness — fleet-control.ts rate cap + cost cap (rolling window) | nist-800-53: SC-5, SC-6, AU-12 nist-ai-rmf: MANAGE 2.4 owasp-llm: LLM10: Unbounded Consumption owasp-agentic: Resource Exhaustion hitrust-ai: AI.08 |
| HN-BLAST-RADIUS Blast-radius limits (bounded concurrent high-risk actions) | Implemented · live proof | @healthnext/agent-harness — fleet-control.ts blast-radius slot accounting | nist-800-53: SC-5, CM-7, CP-2 nist-ai-rmf: MANAGE 2.4, MANAGE 4.1 owasp-agentic: Cascading Failures, Excessive Agency hitrust-ai: AI.08 |
| HN-INCIDENT-RESPONSE Incident detection & response runbook | Partial | apps/console — Operations Wall (NOC) + Observe gate/egress incident stream | nist-800-53: IR-1, IR-4, IR-6, IR-8 nist-csf: RS.MA-01, RS.AN-01, RS.CO-02 hipaa: 164.308(a)(6) hitech: 13402 (breach notification) soc2: CC7.4, CC7.5 hitrust-ai: 11.a, 11.c |
| HN-BCDR Backup & disaster recovery | Inherited | The durable run store + audit chain persist to managed Postgres with provider-level backups/PITR; RPO/RTO and a tested DR runbook are inherited from the deployment's managed data plane and documented per-deployment. | nist-800-53: CP-9, CP-10 nist-csf: RC.RP-01 soc2: A1.2, A1.3 iso27001: A.8.13, A.5.30 hipaa: 164.308(a)(7) hitrust-ai: 12.b |
Supply Chain & Provenance
| Control | Status | Enforced by (real code path) | Framework crosswalk |
|---|---|---|---|
| HN-AI-PROVENANCE Model & data provenance (no PHI in weights) | Implemented | @healthnext/tenant-model — real-fork-client.ts partitionSources + discipline attestation | nist-ai-rmf: MAP 4.1, MANAGE 3.1 iso42001: A.7.2, A.7.3 nist-800-53: SR-3, SR-4, SA-8 owasp-llm: LLM03: Supply Chain, LLM04: Data and Model Poisoning hitrust-ai: AI.05 |
| HN-AI-SIGNING-IDENTITY Human vs agent signing-identity separation | Planned | Today every record is per-tenant-signed and the actor (agent vs human) is in the signed metadata. A distinct signing identity per actor-class (so the key itself proves agent-vs-human) is on the roadmap (tracked as P3). | nist-800-53: IA-9, AU-10 nist-ai-rmf: MANAGE 4.1 owasp-agentic: Identity & Impersonation hitrust-ai: AI.07 |
Interoperability & Patient Access
| Control | Status | Enforced by (real code path) | Framework crosswalk |
|---|---|---|---|
| HN-CMS-PRIOR-AUTH Electronic prior authorization (CMS-0057-F) | Partial · live proof | @healthnext/agent-harness — fleet/prior-authorization.ts (criteria → determination → human gate) | cms-0057-f: Prior Authorization API, Provider Access API, Payer-to-Payer API nist-ai-rmf: MANAGE 1.1 hitrust-ai: AI.06 |
| HN-FHIR-EXCHANGE Standards-based health data exchange (FHIR / X12) | Partial | @healthnext/connector-fhir + connector-x12 + connector-davinci — integration-fabric governed connectors | cms-0057-f: Patient Access API, FHIR US Core nist-800-53: SC-8, SI-10 hitrust-ai: 09.s |
3 · Framework coverage (mappings, not certifications)
| Framework | Authority · version | Applicable | Coverage |
|---|---|---|---|
| SOC 2 Type II | AICPA · 2017 TSC (rev. 2022) | 11 | 82% |
| ISO/IEC 27001 | ISO/IEC · 2022 | 8 | 88% |
| ISO/IEC 42001 | ISO/IEC · 2023 | 5 | 90% |
| NIST SP 800-53 Rev. 5 | NIST · Rev. 5 | 21 | 83% |
| NIST CSF 2.0 | NIST · 2.0 | 7 | 86% |
| NIST AI RMF (AI 600-1) | NIST · 1.0 + Generative AI Profile (AI 600-1) | 11 | 77% |
| OWASP LLM Top 10 | OWASP · 2025 | 7 | 93% |
| OWASP Agentic Top 10 (ASI) | OWASP · Agentic Security Initiative | 9 | 83% |
| HITRUST AI Security Certification | HITRUST · AI Security Assessment | 25 | 80% |
| HIPAA Security & Privacy Rules | HHS / OCR · 45 CFR Parts 160 & 164 | 10 | 80% |
| HITECH Act | HHS · 2009 (as amended) | 2 | 75% |
| 42 CFR Part 2 | SAMHSA / HHS · 2024 final rule | 1 | 100% |
| CMS Interoperability and Prior Authorization Final Rule (CMS-0057-F) | CMS · 2024 (effective 2026–2027) | 2 | 50% |
| PCI DSS v4.0 (conditional) | PCI SSC · 4.0 | 0 | 0% |
4 · Policy register
POL-PHI-BOUNDARY — PHI Boundary & In-Boundary AI (v1.2)
Protected health information never leaves the tenant boundary. All model inference runs on an in-boundary served model; egress to any unmanaged destination is blocked, not redacted.
Owner: Chief Information Security Officer · Review: quarterly · Last 2026-04-15 · Next 2026-07-15
Enforced by: @healthnext/phi-gate (BlockingPhiGate.enforceEgress); @healthnext/modelops (getModelOps (in-boundary default))
POL-MIN-NECESSARY — Minimum Necessary (v1.1)
Any access to PHI is limited to the minimum data necessary for the stated purpose-of-use. PHI and quasi-identifier fields are dropped unless the purpose justifies them.
Owner: Privacy Officer · Review: semi-annual · Last 2026-03-01 · Next 2026-09-01
Enforced by: @healthnext/semantic-layer (compile.ts:projectable()); @healthnext/tenancy-abac (computeMinimumNecessary)
POL-CONSENT — Consent & Special-Protection Records (v1.0)
Member consent is honored as a denial control. Substance-use-disorder records (42 CFR Part 2) and other special-protection classes receive heightened restriction and never egress to unauthorized destinations.
Owner: Privacy Officer · Review: semi-annual · Last 2026-02-01 · Next 2026-08-01
Enforced by: @healthnext/consent (resolution.ts + semantic-layer consent predicate)
POL-LEAST-PRIVILEGE — Least Privilege & Access Control (v1.3)
Access is deny-by-default and scoped by tenant, role, and purpose. Agents may invoke only the tools they declare. Database row-level security is the last line of defense.
Owner: Chief Information Security Officer · Review: quarterly · Last 2026-04-15 · Next 2026-07-15
Enforced by: @healthnext/tenancy-abac (AbacPolicyEngine + generateTableRls); @healthnext/agent-harness (registry.ts:agentCanUse)
POL-HUMAN-OVERSIGHT — Human Oversight of AI Decisions (v1.1)
AI never holds a final decision that changes clinical, financial, or member-facing state. Such actions are proposed by an agent and held for human sign-off.
Owner: Chief Medical Officer · Review: quarterly · Last 2026-04-15 · Next 2026-07-15
Enforced by: @healthnext/agent-harness (orchestrator.ts approval gates)
POL-AUDIT-RETENTION — Audit Logging & Retention (v1.2)
Every consequential action is recorded to a tamper-evident, append-only audit trail and retained for the regulatory retention period. The trail is independently verifiable.
Owner: Compliance Officer · Review: annual · Last 2026-01-15 · Next 2027-01-15
Enforced by: @healthnext/audit-evidence (WormAuditLog + verifyChain)
POL-INCIDENT-RESPONSE — Fleet Incident Response (v1.0)
Operators can immediately halt the agent fleet. Repeatedly-failing agents are automatically taken out of rotation. Incidents are detected, contained, and recorded.
Owner: Chief Information Security Officer · Review: quarterly · Last 2026-06-22 · Next 2026-09-22
Enforced by: @healthnext/agent-harness (fleet-control.ts kill-switch + circuit breakers)
POL-CAPACITY — Capacity, Cost & Blast-Radius (v1.0)
Each tenant's run-rate and token cost are capped over a rolling window, and the number of concurrent high-risk agent actions is bounded fleet-wide.
Owner: VP, Platform Engineering · Review: quarterly · Last 2026-06-22 · Next 2026-09-22
Enforced by: @healthnext/agent-harness (fleet-control.ts rate/cost caps + blast-radius)
POL-MODEL-PROVENANCE — Model & Data Provenance (v1.0)
Per-customer models are trained on non-PHI corpora only. PHI and secrets are partitioned out before training and served at runtime via governed RAG. Every training order carries an audit-safe attestation.
Owner: Head of AI / MLOps · Review: semi-annual · Last 2026-03-01 · Next 2026-09-01
Enforced by: @healthnext/tenant-model (real-fork-client.ts:partitionSources)
5 · Sub-processor inventory
| Sub-processor | PHI access | Location | Purpose |
|---|---|---|---|
| Managed Postgres (deployment cloud) | processor | Customer-elected region (US) | Durable storage of the operations graph, run store, and WORM audit chain — inside the tenant boundary. |
| In-boundary served model (LeanLogix-trained fork) | in-boundary-only | In the tenant boundary | Healthcare LLM inference for the agent fleet. |
| Netlify | none | Global edge / US functions | Static hosting + serverless functions for the console + marketing surfaces. |
| Resend | none | US | Transactional email (operational notifications). |
6 · Posture documents (templates — not executed)
Data Processing Addendum (DPA) — DPA · 0.3 (template)
TEMPLATE — not an executed agreement. This is a starting-point draft for a customer's counsel to review and negotiate; it is not legal advice and confers no obligation until both parties sign a final version. Clauses marked with a control reference are enforced in code today; the rest are documentary commitments pending counsel review.
Owner: Chief Information Security Officer · Updated 2026-06-22
Data Retention & Disposal Schedule — Retention · 0.2 (template)
TEMPLATE — not an executed agreement. This is a starting-point draft for a customer's counsel to review and negotiate; it is not legal advice and confers no obligation until both parties sign a final version. Clauses marked with a control reference are enforced in code today; the rest are documentary commitments pending counsel review.
Owner: Compliance Officer · Updated 2026-06-22
Incident Response & Breach Notification Plan — Incident Response · 0.2 (template)
TEMPLATE — not an executed agreement. This is a starting-point draft for a customer's counsel to review and negotiate; it is not legal advice and confers no obligation until both parties sign a final version. Clauses marked with a control reference are enforced in code today; the rest are documentary commitments pending counsel review.
Owner: Chief Information Security Officer · Updated 2026-06-22
Subprocessor Change-Notification Commitment — Subprocessor · 0.2 (template)
TEMPLATE — not an executed agreement. This is a starting-point draft for a customer's counsel to review and negotiate; it is not legal advice and confers no obligation until both parties sign a final version. Clauses marked with a control reference are enforced in code today; the rest are documentary commitments pending counsel review.
Owner: Chief Information Security Officer · Updated 2026-06-22
This document reflects the live system: control status is computed from the actual enforcing code, and Implemented controls link to real Ed25519-signed audit records. Framework mappings are harmonized in the HITRUST AI assessment style. HealthNext holds no SOC 2 / HITRUST / ISO / FedRAMP certification or attestation; the posture is audit-ready by construction. Synthetic demo data is labeled (Sandbox).
This Trust Center reflects the live system: control status is computed from the actual enforcing code, and Implemented controls link to real Ed25519-signed audit records. It is not a marketing snapshot. Frameworks are named exactly; the crosswalk is harmonized in the HITRUST AI assessment style.