HITRUST Certified: What “High Trust” Certification Means and How to Get It

Overview of HITRUST Common Security Framework

HITRUST CSF is a certifiable, risk-based control framework that harmonizes requirements from standards and laws such as NIST, ISO, HIPAA, PCI, and GDPR. It lets you manage regulatory risk management through one mapped control set instead of juggling many separate audits.

The framework uses requirement statements and maturity-based scoring to evaluate policy, process, and implementation evidence. When you complete a validated assessment and pass an independent quality assurance review, you earn a recognizable trust mark—often called “High Trust”—that many partners accept in lieu of lengthy bespoke questionnaires.

Because HITRUST CSF is adaptable, you can scope it to the systems, data, and obligations that matter most, making it practical for startups, cloud-first teams, and large enterprises alike.

Stages of HITRUST Certification Process

From readiness to certification

• Scope and readiness: define systems, data types, and assessment level; align to your regulatory drivers.
• Security gap analysis: compare current controls to HITRUST CSF requirements and document deficiencies.
• Remediation planning: prioritize fixes that raise maturity and reduce risk; assign owners and dates.
• Validated assessment: a third-party assessor tests controls, reviews artifacts, and scores results.
• Quality assurance review: the assessor performs internal QA, then HITRUST conducts an independent QA review.
• Certification decision: if scoring and evidence meet thresholds, HITRUST issues the certificate.
• Continuous monitoring: maintain controls, address findings, and complete interim activities when required.

Evidence expectations

Expect to show defined policies, repeatable processes, implemented technical controls, and where applicable, metrics and management review. Assessors validate with interviews, configuration samples, screenshots, tickets, and reports to ensure design and operating effectiveness.

Third-party assessor requirements

Your assessor must be a HITRUST Authorized External Assessor organization. They follow standardized testing procedures, sampling guidance, and independence rules, and they must submit complete work papers that withstand HITRUST’s quality assurance review.

Levels of HITRUST Certification

HITRUST offers multiple assessment types so you can align effort to risk and stakeholder expectations.

e1 (Essentials, 1-year)

Focuses on foundational cyber hygiene. It is streamlined, quicker to execute, and well-suited to smaller scopes or organizations needing a rapid, credible baseline.

i1 (Implemented, 1-year)

Tests the consistent implementation of key security practices. It is threat-informed, commonly accepted for third-party risk management, and a strong fit for moderate-risk environments.

r2 (Risk-based, 2-year)

The most rigorous option, tailored by risk factors and organizational complexity. It carries a two-year certification with an interim review at 12 months and is preferred for high-risk or heavily regulated workloads.

How to choose

• Risk profile and data sensitivity (ePHI, PII, payment data, critical operations).
• Customer or contract obligations and third-party assessor requirements.
• Time-to-market needs versus depth of assurance demanded by partners.

Preparing for HITRUST Assessment

Lay the groundwork

• Establish executive sponsorship and define scope, boundaries, and in-scope vendors.
• Perform a readiness review and security gap analysis against the selected HITRUST CSF level.
• Create a compliance remediation plan with milestones, owners, and measurable outcomes.
• Harden technical controls (identity, endpoint, logging, encryption), and finalize policies and procedures.
• Centralize evidence (artifacts, screenshots, tickets, system exports) to streamline the validated assessment.
• Embed regulatory risk management by mapping obligations to requirement statements in scope.

Select the right assessor

Engage an Authorized External Assessor with proven experience in your industry, environment (cloud/on-prem), and assessment level. Clarify testing methods, sampling, reporting cadence, and readiness support before fieldwork begins.

Remediation and Quality Assurance

Use your security gap analysis to drive targeted compliance remediation. Close control design gaps, fix configuration findings, and update documentation so policies, procedures, and technical safeguards align. Prioritize high-risk items and those with the greatest scoring impact.

• Produce durable evidence: finalized policies, change tickets, vulnerability reports, and system configurations.
• Demonstrate operation over time with logs, monitoring outputs, and management reviews.
• Conduct an internal pre-QA check to catch inconsistencies before submission.

After the assessor’s internal QA, HITRUST performs an independent quality assurance review. You may receive QA comments requesting clarifications or additional artifacts. Once addressed, HITRUST finalizes scoring and issues the certificate. Maintain controls post-certification and complete interim activities as required for multi-year validations.

Benefits of HITRUST Certification

• Unified compliance: one HITRUST CSF validated assessment can satisfy many stakeholder questionnaires.
• Regulatory risk management: mapped controls help you track obligations and reduce overlap across laws and standards.
• Third-party risk acceleration: a widely recognized trust mark shortens sales and vendor due diligence cycles.
• Stronger security outcomes: maturity-based testing drives measurable improvements in policies and controls.
• Executive and board confidence: clear scoring and remediation plans support governance and reporting.
• Market differentiation: “High Trust” signals a rigorous, independently reviewed security posture.

Costs and Timeframe for Certification

Total effort depends on scope, assessment level, current maturity, and evidence readiness. Budget for internal labor, assessor fees, HITRUST licensing and submission costs, and any tools or remediation work needed to meet requirements.

• e1: often achievable in 4–12 weeks with comparatively lower external cost and limited remediation.
• i1: typically 3–6 months, reflecting deeper testing of implemented controls and broader evidence needs.
• r2: commonly 6–12+ months due to tailored scoping, extensive testing, and the rigor of QA review.

Cost ranges vary widely: small, well-scoped efforts may land in the low five figures for external services, while complex r2 programs can reach six figures before remediation. Timeline drivers include scope size, documentation quality, staff availability, assessor scheduling, and the number of QA cycles.

In short, becoming HITRUST Certified means proving—through a validated assessment and independent quality assurance review—that your security program meets a harmonized, risk-based standard. With clear scoping, disciplined remediation, and the right assessor, you can reach certification efficiently and sustain it with confidence.

FAQs

What is the HITRUST certification process?

You scope systems and obligations, run a security gap analysis, remediate priority issues, and undergo a validated assessment by an Authorized External Assessor. After the assessor’s QA, HITRUST conducts a quality assurance review and, if requirements are met, issues the certificate.

How long does HITRUST certification take?

Timelines vary by level and readiness. Many organizations complete e1 in 4–12 weeks, i1 in 3–6 months, and r2 in 6–12+ months. Existing control maturity, evidence quality, and QA cycles can speed up or extend these ranges.

What are the different HITRUST certification levels?

HITRUST offers e1 (Essentials, 1-year), i1 (Implemented, 1-year), and r2 (Risk-based, 2-year with an interim review). Each level aligns assurance depth to organizational risk and stakeholder expectations.

Is HITRUST certification mandatory for all organizations?

No. It is not a universal legal requirement, but many customers—especially in healthcare and adjacent industries—treat a HITRUST CSF validated assessment as a preferred or required condition for doing business.