The HITRUST CSF is a certifiable security and privacy framework that harmonizes requirements from multiple sources (including HIPAA-related safeguards) into a single control set.

How do e1, i1, and r2 assessments differ?

They represent increasing levels of rigor. e1 focuses on essential controls, i1 adds broader control coverage, and r2 is the most rigorous validated assessment—often chosen for higher risk or contractual requirements.

Who typically needs HITRUST certification?

Organizations handling healthcare data or working with payers, providers, and life sciences firms—especially when customers or partners require a HITRUST-validated assessment.

How long does a HITRUST assessment take?

Duration depends on scope, readiness, and assessment type. e1 is typically faster; i1 and r2 require more extensive evidence and validation activities.

How does HITRUST relate to HIPAA?

HIPAA sets regulatory requirements; HITRUST CSF provides a certifiable control framework that maps to HIPAA safeguards and other standards to demonstrate a consistent, validated security posture.

Where does Audora fit for HITRUST work?

Auditors and assessment teams use Audora as a system of record for planning, evidence collection, sampling, testing, review notes, and reporting—streamlining validated assessments and exports.

Frameworks Explained

HiTRUST CSF

HITRUST CSF is a certifiable, risk-based framework that harmonizes controls across HIPAA, NIST, ISO, PCI, and more. Its goal is to provide a single, high-assurance certification (e.g., i1 or r2) accepted widely across healthcare ecosystems and third-party risk programs.

What is HiTRUST CSF’s target audience & industries?

Healthcare & life sciences (payers, providers, pharma), health tech, and vendors handling PHI/PII who face demanding enterprise assurance requirements.

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Does it apply to my organization?

Likely relevant if you:

Handle customer or regulated data and sell B2B globally
Need a market-recognized certification for enterprise/partner access
Want a risk-based security management framework

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What are the benefits and risks of conducting a HiTRUST CSF Audit?

One certification mapped to many frameworks
Speeds healthcare vendor reviews and contracts
Strong, prescriptive testing and QA rigor
Consolidates overlapping audits
Market access & trust with a recognized certificate
Risk-based security aligned to your business
Avoid lost deals and procurement delays

What are the core HiTRUST CSF requirements?

Scoping via HITRUST factors: Systems, regulatory drivers, data volumes/sensitivity (PHI/PII), hosting, and organizational complexity.
Assessment type selection: i1 (foundational, moderate assurance) or r2 (comprehensive, high assurance).
Requirement statements & tailoring: MyCSF-driven control selection, inheritance where applicable, maturity targets across Policy, Process, Implemented, Measured, Managed.
Policies, standards, procedures: Prescriptive documentation mapped to requirement statements with ownership and review cycles.
Implementation evidence: Screenshots with timestamps, system-of-record exports, configuration baselines, logs, tickets—traceable to requirement IDs.
Measurement & management: Defined metrics, monitoring, trend analysis, and corrective action workflows.
Validated assessment: Authorized External Assessor testing; sampling strategy; issue tracking.
HITRUST QA review: Respond to QA comments, clarifications, and evidence requests; finalize scoring.
Certification/letter issuance: i1 or r2 certification; maintenance windows and interim monitoring.
Ongoing program: Control operation, exceptions management, periodic reassessment per HITRUST cadence.

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What are the general guidelines for executing a HiTRUST CSF audit ?

Select assessment type: i1 (foundational) vs r2 (high assurance) based on risk and customer requirements.
Scope with HITRUST factors: Systems, data types (PHI/PII), regulatory drivers, org complexity, hosting model.
Control selection & tailoring: Use MyCSF to determine requirement statements and maturity targets.
Policy/procedure & implementation: Write required policies; implement controls with roles, workflows, and tool evidence.
Evidence rigor: Ensure traceable artifacts, screenshots with timestamps, exports showing population completeness, and test logs.
Readiness assessment: Identify PRISMA gaps across Policy, Process, Implemented, Measured, Managed.
Validated assessment: Engage an Authorized External Assessor to test and submit to HITRUST QA.
QA & remediation: Respond quickly to QA comments; provide clarifications or additional evidence.
Certification & maintenance: Track corrective actions, operate controls continuously, and plan reassessments per HITRUST cadence.
Leverage mappings: Reuse HITRUST evidence for HIPAA, SOC 2, ISO 27001 where mapped.

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What are estimated timelines to complete a SOC 1 audit?

Startup: i1: 3–5 months - r2: 9–12 months
Small: i1: 3–6 months - r2: 9–12 months
Medium: i1: 6–9 months - r2: 10–14 months
Large: i1: 9–12 months - r2: 12–18 months

What are the typical costs?

Costs vary by size, scope, and readiness by organizations: (i1 / r2)

Startups: 1 - 25 employees, single product, 1 prod environment, 1 region, few to no vendors - 18k–$50k / $40k–$85k
Small Companies: <100, 1–2 products, 1–2 environments, low vendor count - $80k–$160k / $250k–$450k
Medium Companies: 100 - 1,000 employees, multi-product, multi-region, moderate vendor count - $160k–$300k / $350k–$600k
Large Companies: >1,000 employees, complex/regulatory environment, high vendor count - $300k–$600k+ / $600k–$900k+
HITRUST QA rigor and evidence depth are substantial; consolidation benefits are strongest in complex healthcare pipelines.
(Ranges include typical readiness + audit/assessment (and operating period where applicable). Costs are USD and combine internal enablement/consulting + external auditor/assessor/cert body where relevant).

Where to Learn More

HIMSS: Cloud Security Toolkit — https://www.himss.org/resources
KPMG: HITRUST Assurance Overview — https://kpmg.com (search “HITRUST assurance programme”)
PwC: HITRUST & Assurance Insights — https://www.pwc.com (search “HITRUST”)