HITRUST Compliance Checklist: Certification Process and How It Compares to SOC 2

HITRUST is the certification healthcare buyers trust most — yet it remains one of the least understood frameworks outside the healthcare industry. If your customers include hospitals, health plans, or health tech companies, this checklist is your roadmap.

A HITRUST compliance checklist is essential for healthcare technology companies, business associates, and any organization that needs to demonstrate robust security to healthcare customers. The HITRUST Alliance's Common Security Framework (CSF) harmonizes requirements from HIPAA, ISO 27001, NIST, PCI DSS, and dozens of other standards into a single certifiable framework. With over 80% of hospitals and major health plans accepting HITRUST certification, it has become the de facto security standard in healthcare.

This guide covers what HITRUST is and why it matters, the three certification types, a practical compliance checklist, head-to-head comparisons with SOC 2 and HIPAA, certification timeline and cost expectations, and how to get started.

What Is HITRUST?

The HITRUST Alliance (Health Information Trust Alliance) was founded in 2007 by a consortium of healthcare, technology, and information security leaders who recognized that the healthcare industry needed a more prescriptive and certifiable approach to security than HIPAA alone provided.

The result was the HITRUST CSF — a comprehensive security framework that incorporates and harmonizes requirements from over 40 authoritative sources including HIPAA, NIST SP 800-53, ISO 27001, PCI DSS, COBIT, and state-specific regulations. Rather than treating each standard separately, HITRUST maps overlapping requirements together, allowing organizations to satisfy multiple regulatory obligations through a single assessment.

Why Healthcare Companies Choose HITRUST

• Customer demand — Major health plans (UnitedHealth, Anthem, Humana) and hospital systems increasingly require HITRUST certification from their vendors
• Prescriptive guidance — Unlike HIPAA's flexible "addressable" approach, HITRUST specifies exact control requirements, reducing ambiguity
• Risk-based scoping — The framework tailors control requirements based on organizational factors (size, data volume, regulatory environment)
• Certification credibility — HITRUST certification undergoes rigorous QA review by the HITRUST organization itself, adding a quality layer beyond the assessor

HITRUST Certification Types

HITRUST offers three assessment types, each designed for different assurance needs:

Dimension	e1 (Essentials)	i1 (Implemented)	r2 (Risk-Based)
Controls	~44 essential controls	~182 controls	300+ risk-based controls
Assurance Level	Basic	Moderate	High
Validity	1 year	1 year	2 years
Assessment Effort	2-4 months	4-8 months	6-12 months
Relative Investment	Lower	Moderate	Higher
Best For	Low-risk vendors, initial assurance	Most healthcare SaaS companies	Organizations with stringent customer requirements, handling sensitive PHI
Assessor	External assessor required	External assessor required	External assessor required

Which Type Do You Need?

e1 is appropriate for organizations just starting their HITRUST journey or those with lower-risk profiles (no direct PHI access, limited data volume). It demonstrates basic security hygiene.

i1 is the most common choice for healthcare SaaS companies and business associates. It provides substantial assurance across 182 controls — enough for most health plan and hospital vendor security requirements.

r2 is the gold standard. Required by some of the largest health plans and recommended for organizations handling large volumes of PHI or operating in high-risk environments. The 2-year validity period reduces assessment frequency.

HITRUST Compliance Checklist

Pre-Assessment Preparation

• Register with HITRUST and gain access to the MyCSF portal
• Define your assessment scope (systems, applications, data flows handling PHI)
• Select your assessment type (e1, i1, or r2) based on customer requirements and risk profile
• Engage an authorized HITRUST external assessor
• Complete organizational and system characterization in MyCSF (this determines your tailored control requirements)

Information Protection and Access Management

• Implement role-based access controls for all systems handling PHI
• Deploy multi-factor authentication for remote access and privileged accounts
• Establish user provisioning and de-provisioning procedures
• Implement password policies aligned with HITRUST requirements
• Configure session timeout and automatic screen lock
• Document and enforce data classification policies

Endpoint and Network Security

• Deploy endpoint protection (EDR/antivirus) on all endpoints accessing PHI
• Implement network segmentation isolating PHI environments
• Configure firewalls and intrusion detection/prevention systems
• Establish secure remote access (VPN with MFA)
• Implement mobile device management for devices accessing PHI

Risk Management and Compliance

• Conduct a formal risk assessment covering all in-scope systems
• Maintain a risk register with treatment plans for identified risks
• Establish a vulnerability management program (scanning, patching, remediation SLAs)
• Implement a change management process for all in-scope systems
• Document and test business continuity and disaster recovery plans

Incident Management

• Develop and document an incident response plan
• Define incident severity levels and escalation procedures
• Establish breach notification procedures aligned with HIPAA requirements
• Conduct incident response testing (tabletop exercises) at least annually
• Implement security monitoring and alerting capabilities

Third-Party Management

• Maintain an inventory of vendors with access to PHI
• Conduct vendor risk assessments for all critical vendors
• Execute Business Associate Agreements (BAAs) with all vendors handling PHI
• Monitor vendor compliance on an ongoing basis

Documentation and Training

• Maintain a comprehensive policy suite covering all HITRUST control domains
• Conduct security awareness training for all workforce members
• Document all control implementations with evidence
• Maintain audit logs and access records per retention requirements

HITRUST vs. SOC 2

This is the comparison healthcare organizations ask about most frequently:

Dimension	HITRUST	SOC 2
Approach	Prescriptive (specific control requirements)	Principles-based (flexible implementation)
Framework Source	Harmonizes 40+ standards (HIPAA, NIST, ISO, PCI)	AICPA Trust Service Criteria
Industry Focus	Healthcare-dominant	Industry-agnostic
Output	HITRUST certification letter	SOC 2 report (Type I or Type II)
Validity	1-2 years (depending on assessment type)	Report covers specific period (typically 12 months)
QA Process	HITRUST reviews all assessments for quality	No centralized quality review
Market Recognition	Dominant in healthcare	Universal across industries
Cost	$20,000-$250,000+	$20,000-$100,000+
Timeline	2-12 months	3-9 months

Which should you pursue? If your primary customers are in healthcare, HITRUST is likely required or strongly preferred. If you serve customers across industries, SOC 2 is more universally recognized. Many healthcare SaaS companies pursue both — SOC 2 for general market credibility and HITRUST for healthcare-specific requirements.

For a detailed comparison of SOC 2 and HIPAA compliance, see our SOC 2 vs. HIPAA comparison. For healthcare-specific SOC 2 guidance, see our guide on SOC 2 for healthcare SaaS.

HITRUST vs. HIPAA

HITRUST and HIPAA are complementary, not competing:

• HIPAA is the law — it requires covered entities and business associates to protect PHI but provides flexible, principles-based guidance on how
• HITRUST is a certification framework that provides prescriptive controls satisfying HIPAA requirements (and many more)

Achieving HITRUST certification demonstrates HIPAA compliance through a verified, third-party-assessed process. Many organizations use HITRUST as their mechanism for demonstrating HIPAA compliance to customers and regulators.

However, HITRUST certification does not provide legal HIPAA compliance — that depends on your overall privacy and security practices beyond the technical controls HITRUST assesses. For HIPAA-specific guidance, see our HIPAA compliance guide for startups.

Certification Timeline and Cost

Timeline by Assessment Type

Phase	e1	i1	r2
Preparation and readiness	1-2 months	2-4 months	3-6 months
External assessment	2-4 weeks	4-8 weeks	6-12 weeks
HITRUST QA review	4-8 weeks	6-12 weeks	8-16 weeks
Total	2-4 months	4-8 months	6-12 months

The HITRUST QA review phase is unique to HITRUST and often catches organizations off-guard. After your external assessor submits findings, the HITRUST organization conducts its own quality review, which can result in additional questions or required clarifications that extend the timeline.

Cost Components

Your HITRUST certification investment includes several components that scale with assessment type:

• MyCSF access and platform fees — Required subscription for using the HITRUST assessment platform. Fees increase with assessment complexity (e1 is the least expensive, r2 the most)
• External assessor fees — Your authorized HITRUST assessor charges for the assessment engagement. Scope and assessment type drive the fee
• Readiness consulting — Optional but recommended, especially for first-time assessments. Helps identify gaps before the formal assessment
• Remediation — Variable based on your current gap. Organizations with existing security programs (especially those already SOC 2 certified) face less remediation

How to Get Started

1. Assess customer requirements — Determine which assessment type your customers require or will accept
2. Register on MyCSF — Create your organizational profile and begin scope definition
3. Conduct a readiness assessment — Engage a consultant or use MyCSF's self-assessment capabilities to understand your current gap
4. Select an external assessor — Choose an authorized HITRUST assessor organization
5. Remediate and prepare — Address gaps, build documentation, collect evidence
6. Begin the assessment — Work with your assessor through the formal assessment process

For organizations also considering HITRUST alongside other frameworks, see our multi-framework compliance strategy.

Ready to pursue HITRUST certification? Contact Agency for a readiness assessment and implementation roadmap tailored to your healthcare compliance needs.