HITRUST Vs. SOC 2? Choosing the Right Compliance Fit

Posted in HIPAA

In healthcare and digital health, security audits are non-negotiable and critically important. However, choosing between competing compliance frameworks can be overwhelming due to their distinct approaches and implications. This is especially evident when healthcare organizations are weighing HITRUST vs. SOC 2. Both frameworks are designed to establish trust and validate security postures, but that’s where their similarities end. From control design and audit methodology to alignment with HIPAA and NIST standards, HITRUST and SOC 2 differ significantly in how they approach risk, compliance, and certification.

This blog breaks down the nuances of SOC 2 vs. HITRUST, focusing on what truly matters to digital health stakeholders: technical control depth, audit scope, regulatory mapping, implementation effort, and real-world suitability. Whether you’re a digital health startup preparing for payer integrations or a mature organization strengthening its compliance roadmap, this comparison will help you decide which path aligns with your operational goals. We also explore how each framework supports long-term scalability, risk mitigation, and trust-building with partners, regulators, and end-users, helping you make a decision that’s not just compliant but strategically sound.

High-Level Comparison Table of HITRUST Vs SOC2

See how HITRUST vs SOC 2 compare across key compliance dimensions in the table below.

For a full breakdown of what SOC 2 compliance entails, explore our SOC 2 Compliance Guide.

HITRUST Tiers Overview: e1, i1, and r2

HITRUST offers three certification tiers. When evaluating HITRUST vs SOC 2, it’s important to consider which HITRUST tier aligns with your risk profile. The e1 assessment is entry-level, designed for low-risk environments with basic cybersecurity needs. The i1 tier provides moderate assurance through a fixed set of best-practice controls, ideal for digital health vendors seeking quicker validation. 

When comparing HITRUST  vs SOC 2, i1 offers more prescriptive structure, while SOC 2 allows flexibility but requires custom mapping to frameworks like HIPAA. The r2 assessment is the most rigorous, risk-based, and suited for healthcare providers and enterprise platforms managing sensitive data. It’s often chosen by organizations that need deeper alignment with regulations and advanced healthcare data analytics capabilities for continuous monitoring.

Architecture of the Frameworks

Understanding the underlying architecture of HITRUST vs SOC 2 frameworks is essential for evaluating how they’ll impact your technical operations, audit readiness, and internal governance, especially for organizations managing complex Microsoft Dynamics 365 healthcare, NetSuite for healthcare, or Epic integration projects 

SOC 2: Flexible, Principle-Based Structure

SOC 2 is built on the AICPA Trust Services Criteria, which are divided into five core principles:

• Security (mandatory)
• Availability
• Confidentiality
• Processing Integrity
• Privacy

Organizations pursuing SOC 2, particularly Type 2 reports, are required to design and implement controls that align with these principles. The flexibility of SOC 2 lies in its organization-defined controls: you determine how you meet each criterion based on your unique environment and risk profile. This flexibility is a key differentiator in the HITRUST vs SOC 2 discussion.

HITRUST: Unified Control Framework with Rigid Mapping

HITRUST, on the other hand, is built upon the HITRUST CSF (Common Security Framework), a certifiable framework that integrates controls from multiple authoritative sources, including:

• HIPAA
• NIST SP 800-53
• ISO/IEC 27001
• PCI-DSS

HITRUST assessments follow a more centralized and formal process. Organizations must work with a HITRUST Authorized External Assessor who conducts the evaluation based on HITRUST’s Control Framework (CSF). Once the assessment is complete, it must be submitted to HITRUST itself for final review and certification approval. 

This adds a layer of standardization and consistency, which can increase trust among partners and regulators, especially for HIPAA-compliant healthcare solutions.

HITRUST Vs. SOC 2: Control Depth & Coverage

When comparing HITRUST vs SOC 2, one of the most significant differentiators is how deeply each framework dives into control requirements and how those controls span across security domains.

SOC 2: Outcome-Focused with Flexibility

SOC 2 takes an outcomes-based approach. It focuses on whether an organization’s environment meets the objectives outlined in the Trust Services Criteria. As SOC 2 is flexible and principle-based, control coverage can vary significantly between organizations. For example, a cloud-native healthtech startup might implement lighter access controls than a hospital network, yet both can achieve SOC 2 if their controls effectively address the Trust Services Criteria. 

While this flexibility supports innovation and diverse architectures, it also means SOC 2 offers less prescriptive guidance.

HITRUST: Prescriptive Controls with Risk-Based Variations

HITRUST offers deeper control granularity through its CSF, which includes hundreds of specific controls mapped across domains such as access control, audit logging, network protection, endpoint security, and incident response.

What makes HITRUST unique is that it tailors the required controls based on the organization’s risk level. For example, a small startup may not need to meet as many requirements as a large healthcare provider managing sensitive patient data (ePHI). However, all required controls are mandatory, and organizations must show proof of policy, implementation, and how they measure effectiveness. 

The outcomes-based approach is often cited in HITRUST vs SOC 2 debates.

Implementation & Assessment Process in HITRUST Vs SOC 2

The process of preparing for and completing a security audit isn’t just about ticking boxes; it affects internal workflows, team bandwidth, and go-to-market timelines. Here’s how the implementation and assessment journeys differ in HITRUST vs SOC 2.

SOC 2: Independent and Lightweight in Structure

SOC 2 implementation typically begins with an internal gap analysis followed by the development of required policies, procedures, and technical controls. Since SOC 2 is organization-defined, companies have the flexibility to:

• Build controls that align with their tech stack
• Phase rollout based on resource availability
• Engage auditors once operational maturity is reached

Assessment is conducted by a licensed CPA firm, with a Type 2 report covering control performance over 3–6 months. There’s no central body issuing the report, the CPA signs off, and the company owns the deliverable. This decentralized model offers agility but can lead to variability in rigor depending on the auditor.

HITRUST: Formalized, Centralized, and Resource-Heavy

HITRUST implementation is considerably more involved. Organizations must first license the HITRUST CSF, complete a readiness assessment (often with an advisor), and begin remediating gaps, a process that often includes:

• Deploying technical controls according to predefined specifications
• Documenting policies for each control requirement
• Demonstrating consistent operational use and measurement

HITRUST Authorized External Assessor performs a formal, validated assessment, which is then submitted to HITRUST’s central certification body for review. The full process often spans 9–18 months from planning to certification. Understanding the implementation journey is critical in the HITRUST vs SOC 2 evaluation.  

Audit Process Comparison: HITRUST vs SOC Type 2 

In the HITRUST vs SOC 2 quest, understanding the audit process behind each is critical. While both aim to demonstrate security and trustworthiness, their certification pathways differ significantly in scope, duration, and rigor.

SOC 2 Type 2: Observational & Outcome-Based

SOC 2 Type 2 focuses on how effectively a company operates its internal controls over a defined observation window, typically ranging from 3 to 12 months. It’s not just about whether controls exist, but whether they function as intended over time.

• Audit Scope: Based on the AICPA’s Trust Services Criteria (TSC) – security, availability, processing integrity, confidentiality, and privacy.

• Process:

  • Define control objectives
  • Collect evidence across the testing period
  • An independent CPA firm performs the audit

• Outcome: A detailed audit report validating operational effectiveness of controls during the specified period.

This approach is often favored by digital health startups and telemedicine providers who need to prove trust quickly and cost-effectively. Learn more about how we support secure, scalable solutions in our Telemedicine Services portfolio.

HITRUST: Prescriptive & Assessor-Driven

HITRUST certification involves a prescriptive audit conducted by an authorized third-party assessor. It evaluates compliance against the HITRUST CSF, a comprehensive framework harmonizing NIST, HIPAA, ISO, and more.

• Audit Scope: Varies based on selected tier (e1, i1, or r2), organization type, and risk level.

• Process:

  • Control scoping and readiness
  • Detailed evidence submission
  • On-site or virtual assessor audit
  • Quality assurance review by HITRUST

• Outcome: A certification attesting compliance and risk maturity, valid for 12–24 months based on tier.

The HITRUST route demands deeper documentation, resource allocation, and organizational maturity, but offers stronger assurances for payers and enterprise healthcare providers.

Scalability & Suitability

As digital health organizations scale, whether from seed-stage startup to enterprise vendor or from clinic-based provider to multi-state network,  the question of SOC 2 vs HITRUST becomes increasingly strategic. The right framework should not only satisfy current compliance needs but also support long-term scalability and market fit.

SOC 2: Agile Fit for Growth-Stage Companies

SOC 2’s flexibility makes it particularly well-suited for early to mid-stage healthtech startups, especially those with SaaS or API-based delivery models. Its principle-driven structure allows companies to:

• Tailor controls to current operational maturity
• Avoid the overhead of unnecessary documentation
• Align compliance efforts with product development timelines

SOC 2 Type 2 reports are often considered a minimum expectation by B2B buyers in healthcare, making it a logical starting point for those entering the payer or provider vendor ecosystem. As your company grows, SOC 2 controls can be matured and extended without a full framework overhaul.

HITRUST: Built for Complex, Regulated Environments

In contrast, HITRUST is ideal for organizations operating in high-assurance environments, such as enterprise health systems, national payers, or digital health platforms managing large volumes of PHI. Its centralized, cross-framework approach ensures deep alignment with HIPAA, NIST, and other mandates, making it a strategic choice for companies:

• Bidding for large payer or provider contracts
• Managing integrations with hospital systems or clearinghouses
• Seeking to demonstrate an enterprise-level security posture

While SOC 2 offers a strong foundation, HITRUST becomes more viable as operational complexity and regulatory pressure increase.

Cost & Resource Commitment

When evaluating HITRUST vs SOC 2, understanding the time, cost, and resource implications is crucial, especially for compliance teams working with limited budgets or tight go-to-market timelines. 

SOC 2: Faster, Leaner, and Easier to Phase

For most digital health organizations, especially those new to audits like pharmacy ERP solutions, SOC 2 Type 2 offers a more accessible starting point. Timelines typically fall between 3 to 6 months, depending on readiness, tooling, and the audit scope. With minimal dependencies on third parties (besides the CPA firm), internal teams can phase out remediation tasks and audit prep more easily.

• Estimated Time: 3–6 months

• Internal Resource Load: Moderate

• Cost: $10,000 to $60,000+, depending on scope and tooling

SOC 2 can also be repeated annually without requiring a complete overhaul, making it ideal for iterative compliance programs. Budgeting for HITRUST vs SOC 2 should account for both direct and indirect resource commitments.

HITRUST: Longer Duration and Heavier Investment

In contrast, HITRUST certification requires a much more rigorous process. Most organizations spend 9 to 18 months preparing for and completing the certification cycle. In addition to technical remediation and documentation, teams must manage assessments through authorized CSF assessors and HITRUST’s review portal.

• Estimated Time: 9–18 months

• Internal Resource Load: High

• Cost: $80,000 to $200,000+, depending on CSF version, assessor, and gap remediation

This includes licensing fees, portal access, assessor hours, and potential investments in governance tools. While more costly, HITRUST’s depth can deliver strategic value, especially for pharmaceutical ERP vendors looking to partner with payers, hospitals, or enterprise-scale networks where security and compliance assurances are non-negotiable. 

Control Overlap: HITRUST vs SOC 2 Mapping

While HITRUST vs SOC 2 represent different approaches to compliance, there is meaningful overlap in their control structures. HITRUST CSF integrates the AICPA Trust Services Criteria used in SOC 2, which means many SOC 2-aligned controls can serve as a foundation when pursuing HITRUST.

In practice, HITRUST certification often satisfies SOC 2 audit expectations, but the reverse isn’t always true. SOC 2 reports tend to be more flexible, while HITRUST demands rigorous documentation and assessor-led validation. Organizations looking to scale compliance across interoperability-heavy workflows like HL7 to FHIR or state-specific HIE integrations may benefit from HITRUST’s structured control mapping.

Mapping to HIPAA & Other Regulatory Standards

For health tech companies, Folio3 Digital Health offers alignment with healthcare-specific regulations. It’s essential to gaining trust from payers, providers, and enterprise partners. This is where the HITRUST vs SOC 2 comparison becomes highly nuanced, especially for organizations managing sensitive clinical data, HL7 workflows, or FHIR-based interoperability.

SOC 2: Indirect but Flexible Alignment

SOC 2 was not designed specifically for healthcare, but its Trust Services Criteria (TSC) can be mapped to HIPAA Security and Privacy Rules. Many organizations create a HIPAA-to-TSC crosswalk, often supported by compliance automation tools, to show auditors and partners how their SOC 2 controls address HIPAA’s requirements. However, this mapping is not formally recognized by regulators. 

HITRUST Vs SOC 2: Direct, Prescriptive HIPAA and NIST Mapping

HITRUST was built with healthcare in mind. Its Common Security Framework (CSF) integrates HIPAA, NIST SP 800-53, ISO/IEC 27001, and other standards directly into its control structure. 

For companies operating in heavily integrated healthcare systems or dealing with HL7 integration solutions, HITRUST offers clearer alignment with regulatory expectations and helps mitigate risks associated with interoperability and PHI exchange.

Market Perception & Third-Party Acceptance

Beyond technical scope and regulatory alignment, understanding how HITRUST vs SOC 2 are received in the market can clarify which one better fits your growth trajectory.

SOC 2:  Practical First Step in Security Certification

SOC 2 Type 2 has become the default baseline for most SaaS and tech-forward healthcare vendors. It signals that your organization maintains sound security practices and undergoes independent audits. As a result, many third-party risk management teams see SOC 2 as sufficient.

SOC 2 reports are easily shareable, making it ideal for:

• Fast procurement cycles
• B2B sales enablement
• Early-stage credibility in sales conversations

HITRUST: The Gold Standard in Healthcare Procurement

In contrast, HITRUST is widely recognized across the U.S. healthcare ecosystem as a trusted and comprehensive validation. Many payers and large provider networks require HITRUST certification for third-party vendors that process, store, or transmit PHI.

This makes HITRUST particularly valuable when:

• Targeting enterprise healthcare buyers
• Pursuing integration with EMRs or clearinghouses
• Responding to RFPs from insurers and ACOs

The tradeoff? Higher effort and cost, but greater acceptance among top-tier players. This market perception of HITRUST vs SOC 2 often guides procurement and partnership decisions

Which One Should You Choose Between HITRUST Vs. SOC2?

Choosing between HITRUST vs SOC 2 isn’t about which framework is “better” overall; it’s about which one aligns with your organization’s maturity, client expectations, and regulatory exposure.

Choose SOC 2 If…

You’re a digital health startup or mid-sized vendor entering the market, especially if your customers include healthtech platforms, telehealth providers, smaller clinics or consumer-facing apps. SOC 2 is faster to implement, less expensive, and offers flexibility for dynamic environments. It’s a reliable entry point that establishes credibility, supports early sales efforts, and builds a compliance foundation you can evolve over time.

Choose HITRUST If…

Your organization operates in or plans to expand into enterprise healthcare, especially with payers and large provider networks, EHR integrations, and PHI-heavy workflows, or RFPs requiring evidence of HIPAA/NIST alignment. HITRUST certification is more prescriptive, resource-intensive, and costly, but delivers high assurance and industry trust.

Conclusion

Both SOC 2 and HITRUST are powerful tools for proving your organization’s commitment to data security, but they serve different purposes, audiences, and business levels. SOC 2 offers flexibility and speed, making it ideal for early-stage digital health companies aiming to build trust with smaller or tech-savvy buyers. HITRUST, on the other hand, is more rigorous and comprehensive, often preferred or required by payers, hospitals, and enterprise healthcare networks. 

Choosing the right framework depends on where you are today and where you’re going tomorrow. For some, SOC 2 is enough. For others, HITRUST is essential. And for many, a phased approach, starting with SOC 2 and scaling into HITRUST,  delivers the best balance of agility and assurance.

Frequently Asked Questions

What is the difference between HITRUST certification vs SOC 2?

HITRUST certification is a standardized, prescriptive framework built on the HITRUST CSF, integrating HIPAA, NIST, ISO, and other regulations. SOC 2, on the other hand, is a flexible attestation report based on the AICPA’s Trust Services Criteria. While both assess security, their methodology and assurance levels differ significantly.

Is SOC 2 Type 2 equivalent to HITRUST certification?

In a comparison of HITRUST vs SOC 2,  SOC 2 Type 2 evaluates your defined controls over a period of time, but it doesn’t validate regulatory alignment. HITRUST requires mapping to industry frameworks and includes a central review process, making it compliance-oriented.

Can organizations use both HITRUST and SOC 2 simultaneously?

Yes. Many healthcare and digital health companies pursue both frameworks: HITRUST vs SOC 2 isn’t always an either/or decision. SOC 2 supports early growth and partner trust, while HITRUST helps satisfy enterprise and regulatory demands.

How does HITRUST i1 vs SOC 2 compare in terms of assurance level?

HITRUST i1 vs SOC 2 is often compared for moderate assurance needs. HITRUST i1 is a curated, lower-effort certification ideal for cloud service providers and health vendors needing verified baseline security. SOC 2 offers similar assurance but with more flexibility in control design and testing.

Is HITRUST more expensive than SOC 2?

Yes. HITRUST includes framework licensing fees, assessor costs, and annual maintenance, making it substantially more expensive than SOC 2. SOC 2 requires fewer external fees and is often more budget-friendly for startups and SMBs in digital health.

Do clients in the healthcare industry prefer HITRUST over SOC 2?

In highly regulated healthcare segments, clients often prefer HITRUST vs SOC 2 due to its direct mapping to HIPAA and NIST. However, many smaller healthcare tech buyers still accept SOC 2 if it’s implemented rigorously and mapped to industry standards. As interoperability standards continue to evolve, frameworks like HL7 V2 vs FHIR also play a role in how compliance aligns with modern healthcare ecosystems.

 

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