Vaikora for Healthcare

When an AI clinical scribe transcribes a patient encounter, who controls what gets written to the EHR? When a prior-authorization agent reads PHI from a clearinghouse, what prevents it from passing that PHI to a downstream tool not covered by your BAA? When a member-services agent answers a covered member’s question, what proves to your HIPAA auditor that the agent never disclosed PHI to an unauthorized party?

Vaikora is the deterministic runtime control layer for AI agents that handle PHI. Every agent action gets evaluated against HIPAA-aligned policy rules before it executes, and every decision lands in a HITRUST-compatible audit log.

The healthcare AI agent problem

Healthcare has the strictest data-protection regime of any industry plus the largest scope creep in AI use over the last 18 months. Clinical scribes, prior-auth automation, medication-reconciliation agents, member-services chatbots, and lab-result interpreters are all live in production at major health systems by 2026.

The standard risks scale poorly under HIPAA:

• PHI exposure through agent tool calls to systems outside the BAA chain
• Cross-patient context bleeding in shared agent memory
• 42 CFR Part 2 substance-use records leaking into general care notes
• AI-generated content treated as part of the legal medical record without provenance

Compliance frameworks Vaikora addresses

• HIPAA Privacy and Security Rules: per-action audit log, minimum-necessary enforcement at the tool-call layer, encryption-at-rest for log storage
• 42 CFR Part 2 (substance use): stricter access controls on the subset of records that fall under Part 2
• HITRUST CSF: alignment to v11+ controls
• State privacy laws (CCPA, NY SHIELD, TX-MRT): per-state rule sets

Sample policy rules

- name: phi_stays_inside_baa_chain
  match: { tool: ["api.post", "webhook.post"], payload.contains_phi: true, target.in_baa: false }
  decision: deny

- name: substance_use_records_require_explicit_consent
  match: { tool: chart.read, arg.record_type: "42_cfr_part_2", context.consent.scope: "!includes:42_cfr_part_2" }
  decision: deny

- name: minimum_necessary_on_member_query
  match: { tool: eligibility.lookup, arg.fields: "*", caller.role: "member_services_agent" }
  decision: filter_to: ["member_id", "plan", "effective_date", "copay"]

- name: clinical_scribe_does_not_finalize_orders
  match: { tool: ehr.order.create, caller.agent_type: "clinical_scribe" }
  decision: require_approval

Resources

• Vaikora flagship product page
• OWASP LLM Top 10 mapping
• Book a demo

FAQs for Healthcare

• Does Vaikora cover both Privacy Rule and Security Rule obligations? The policy enforcement layer addresses Security Rule technical safeguards (access control, audit logs, integrity). Privacy Rule obligations (minimum necessary, accounting of disclosures) are partly addressed by enforcement rules and partly by upstream processes Vaikora supports.
• Can Vaikora exclude specific record types from agent access? Yes. Rules can match on record classifications including 42 CFR Part 2, behavioral health, genetic testing, and any custom classification scheme you maintain.
• Does the audit log meet HITRUST v11 requirements? The export format includes the data elements HITRUST v11 audit controls require. Customers in regulated environments typically pass HITRUST audits with Vaikora logs as primary evidence.
• Is Vaikora a Business Associate? Yes. Data443 executes BAAs with healthcare customers as part of the standard contract.