AI & Data Companies

AI and data companies face risks that standard control sets often miss: prompt injection, sensitive information disclosure, model and data poisoning, supply-chain vulnerabilities, and excessive agent autonomy.

Our approach: Standard HIPAA Security Rule readiness first. AI and data-specific hardening second. The advisory modules below are optional enhancements on top of mandatory controls.

Standard Controls vs. AI/Data Enhancements

Standard HIPAA Security Rule Readiness

Mandatory controls required for compliance:

  • Logical access and privileged access
  • Change management
  • Incident response
  • Risk management
  • Vendor management
  • Backup and availability
  • Logging and monitoring
  • Confidentiality and privacy (where applicable)

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AI/Data Advisory Enhancements

Optional modules justified by AI-risk frameworks:

  • Data lineage and training data governance
  • Prompt/response telemetry
  • RAG and retrieval governance
  • Model/provider vendor review
  • Agent approval gates
  • AI-assisted SDLC controls
  • Warehouse and analytics governance

Advisory Modules

Each module adds specific controls and documentation practices to address risks unique to AI and data-intensive products.

AI-Assisted SDLC Controls

HIPAA § 164.312(a) access controls and § 164.308(a)(1) risk analysis must extend to AI-assisted development touching ePHI systems.

What This Module Adds

  • ePHI detection scanning in AI-generated code and outputs
  • Secure development standards for health IT applications
  • HIPAA-compliant CI/CD pipelines with ePHI isolation
  • Risk analysis coverage for AI coding tools with ePHI system access

Human Review & Agent Gates

Clinical decision support and AI-assisted diagnostics require human oversight per both HIPAA and FDA guidance on clinical AI systems.

What This Module Adds

  • Clinician review gates for AI-generated health recommendations
  • ePHI access logging for all AI agent interactions
  • Patient safety escalation procedures for AI-flagged anomalies
  • Audit trail requirements for AI-assisted clinical decisions

Model Provider & Vendor Risk

AI model providers accessing ePHI are business associates under HIPAA requiring BAAs per § 164.308(b), with direct Security Rule liability.

What This Module Adds

  • BAA requirements for all AI model providers processing ePHI
  • ePHI training data restrictions and contractual prohibitions
  • De-identification verification before ePHI reaches external models
  • Vendor security posture assessment for AI-specific risks

Prompt & Response Logging

AI interactions involving ePHI must comply with § 164.312(b) audit controls and § 164.530(j) six-year documentation retention requirements.

What This Module Adds

  • ePHI detection and redaction in prompt and response logs
  • Minimum necessary standard applied to AI interaction logging
  • Six-year retention alignment for AI audit trails
  • Access controls on prompt/response log repositories

RAG & Vector Store Controls

Vector stores containing ePHI embeddings must meet § 164.312(a) access controls and § 164.312(e) encryption requirements as ePHI repositories.

What This Module Adds

  • ePHI isolation and segmentation in vector store indexes
  • De-identification verification before embedding health data
  • Access audit trails for vector store queries
  • Encryption at rest and in transit for vector databases containing ePHI

Training & Inference Data Governance

Using ePHI for AI model training requires minimum necessary standard compliance and may require patient authorization under the HIPAA Privacy Rule.

What This Module Adds

  • De-identification per Safe Harbor or Expert Determination methods (§ 164.514)
  • IRB or privacy board review for research use of ePHI in model training
  • Limited data set agreements for permitted training scenarios
  • Data provenance tracking from source ePHI through model artifacts

Warehouse & Analytics Governance

Health data warehouses must implement access controls, audit logging, and minimum necessary standard compliance per HIPAA Security and Privacy Rules.

What This Module Adds

  • Role-based analytics access with minimum necessary ePHI exposure
  • De-identified data sets for reporting and population health analytics
  • Research use governance with IRB oversight and data use agreements
  • Audit logging for all warehouse queries touching ePHI

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