For Covered Entities, Business Associates & Digital Health Platforms

HIPAA compliance built for the way healthcare works today.

Auditerra helps healthcare providers, business associates, and digital health platforms manage protected health information across HIPAA, HITRUST, and 21 CFR Part 11 obligations.

HIPAA 2024HITRUST CSF v11SOC 221 CFR Part 11TEFCANIST CSF
No long-term commitment48-hour deliveryCredits toward any tierExpert-reviewed output

What makes Healthcare & Life Sciences complex

Compliance in this industry is documentation-heavy, evidence-driven, and unforgiving of gaps. Below are the operational realities that turn vertical compliance into a full-time program rather than an annual checkbox.

Auditerra helps teams move from scattered spreadsheets to a structured compliance program — with shared evidence, clear ownership, and audit-ready documentation.

2024 HIPAA Modernization

HHS finalized sweeping Security Rule changes making MFA, encryption, and network segmentation mandatory. Most covered entities are still operating under 2013 guidance.

Business Associate Agreement Sprawl

Health systems work with hundreds of BAs. Managing BAA inventories, annual security assessments, and HIPAA flowdown is a full-time operational burden.

HITRUST Certification Complexity

HITRUST r2 requires 219+ controls across 19 domains. Without automation, organizations spend 6–12 months on evidence collection alone.

Every framework your organization is accountable to

Auditerra maps controls across every framework simultaneously — one evidence artifact satisfies multiple requirements.

HIPAA Security RuleHHS Office for Civil RightsUp to $2M per violation category
HIPAA Privacy RuleHHS Office for Civil RightsOCR settlements averaging $1.2M
HITRUST CSF v11HITRUST AllianceLoss of major health-system contracts
21 CFR Part 11FDAWarning letters + product holds
SOC 2 Type IIAICPA / Customer auditorsEnterprise contract loss
TEFCAONC / Sequoia ProjectRemoval from QHIN network

Auditerra maps controls across all applicable frameworks simultaneously — one evidence artifact satisfies multiple requirements.

The cost of non-compliance is not theoretical

HIPAA Security Rule Violation
HHS Office for Civil Rights
Penalty Exposure
Up to $2M per violation category per year + criminal penalties up to 10 years
HIPAA Breach Notification Failure
HHS OCR + State AGs
Penalty Exposure
$100–$50,000 per violation. Average OCR settlement: $1.2M
HITRUST Non-Certification Loss
Health System Procurement
Penalty Exposure
Contract loss with major health systems requiring certified BAs

Built for the way Healthcare & Life Sciences teams actually work

Six purpose-built workflows that turn compliance obligations into structured programs.

HIPAA Risk Analysis Automation

Maps PHI flows, identifies threats and vulnerabilities, assigns likelihood and impact scores, produces OCR-compliant risk analysis documentation.

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BAA Management & Monitoring

Centralized Business Associate Agreement registry with expiry tracking and annual re-assessment reminders.

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HITRUST CSF Inheritance Mapping

Automatically map HITRUST controls to HIPAA, NIST 800-53, and PCI requirements. Maximize control inheritance to minimize duplicate remediation.

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Breach Notification Workflow

60-day OCR notification timelines, affected individual notification templates, and state AG reporting workflows pre-built.

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21 CFR Part 11 Validation Readiness

Evidence collection and audit trail documentation for FDA-regulated electronic records systems.

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EHR & Cloud Integration Evidence

Native connectors for AWS HealthLake, Azure Health Data Services, and major health IT vendors.

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Our HITRUST r2 journey was 14 months of spreadsheet chaos before Auditerra. They inherited our HIPAA controls, mapped the gaps, and got us certified in 7 months.

VP, Information Security
Regional Health System · 4,200 employees
HITRUST r2 Certified★ ★ ★ ★ ★

Start with a HIPAA Security Rule gap analysis — before OCR does it for you.

The 2024 HIPAA modernization rules are in effect. Our $990 readiness check identifies every gap and delivers a remediation roadmap in 48 hours.

No long-term commitment48-hour deliveryCredits toward any tierExpert-reviewed output