HITRUST
Understanding the Framework for Security and Compliance in Regulated Industries Including Healthcare and Software Supply Chain Management
HITRUST is a certifiable security and privacy framework that consolidates requirements from HIPAA, PCI DSS, GDPR, ISO 27001, and NIST into a single compliance program. It is maintained by the Health Information Trust Alliance. HITRUST certification is used primarily by healthcare organizations, software vendors serving regulated industries, and enterprises that need to demonstrate compliance with multiple security standards through one assessment rather than managing each regulation separately.
HITRUST certification is available at three levels: e1 (essential), i1 (implemented), and r2 (risk-based). The r2 assessment is the most rigorous and is typically required for enterprise contracts in healthcare and financial services. Organizations that achieve HITRUST certification can replace dozens of individual vendor security questionnaires with a single validated report, reducing procurement friction and accelerating sales cycles in regulated markets.
The HITRUST Common Security Framework (CSF) has become a benchmark for demonstrating comprehensive risk management and regulatory compliance across multiple industries. It serves as both a certifiable standard and a practical roadmap for DevSecOps teams managing complex security requirements. For software supply chain security teams, HITRUST addresses third-party risk management, SBOM requirements, dependency security, and vendor assessment processes that are central to protecting modern application environments.
What Is HITRUST? Definition and Core Framework Components
The HITRUST framework is a certifiable security and privacy framework that consolidates multiple regulatory requirements, industry standards, and business needs into a single comprehensive structure. Created by the Health Information Trust Alliance, HITRUST addresses the complexity organizations face when trying to comply with regulations simultaneously — including HIPAA, PCI DSS, GDPR, and various state and federal requirements that impact how development teams build, deploy, and maintain secure software systems.
Alternative names and related terms: HITRUST CSF (Common Security Framework), HITRUST Alliance, HITRUST certification, HITRUST assessment.
At its foundation, the HITRUST CSF provides a standardized approach to managing security controls across 14 different control categories. These categories cover access control, endpoint protection, vulnerability management, and secure software development practices. For DevSecOps leaders, the framework offers a structured methodology that aligns security practices with business objectives while meeting regulatory obligations that can otherwise become overwhelming when managed separately.
The framework operates on a risk-based approach. Organizations implement controls proportionate to their specific threat landscape and compliance requirements. This scalability makes HITRUST valuable for mid-size and enterprise businesses (typically 200–10,000+ employees) that need to demonstrate security maturity without implementing unnecessary controls that do not address their actual risk profile. A startup handling patient data faces different risks than an enterprise health system, and HITRUST accommodates these differences through its prescriptive and risk-based assessment options.
The Three-Tiered HITRUST Certification Levels: e1, i1, and r2
HITRUST certification operates across three distinct levels, each designed for different organizational maturity levels and compliance needs.
HITRUST e1 (Essential): The foundational assessment covering 44 core security controls. Designed for organizations beginning their compliance journey or smaller vendors that need to demonstrate baseline security practices. Typical timeline: 3–6 months. Cost range: $20,000–$50,000 including assessor fees.
HITRUST i1 (Implemented): An implementation-level certification covering 182 controls that validates security practices are actively in place. Suitable for organizations with established security programs that serve as vendors to larger enterprises with HITRUST requirements. Typical timeline: 6–9 months. Cost range: $40,000–$80,000.
HITRUST r2 (Risk-Based): The most rigorous certification level, covering up to 2,000+ controls based on the organization's risk factors. Required for organizations that handle the most sensitive information or face strict regulatory scrutiny. Involves on-site assessments, detailed technical testing, and comprehensive validation. Typical timeline: 9–18 months. Cost range: $80,000–$200,000+. Reassessment required every 2 years.
For DevSecOps teams, achieving i1 or r2 certification typically means security has been integrated throughout the software development lifecycle, with automated controls, regular testing, and documented processes that prove consistent adherence to security requirements.
How Does HITRUST Address Software Supply Chain Security?
For organizations focused on software supply chain security, HITRUST provides a framework that addresses third-party risk management, vendor security assessments, and the security of software components throughout the development and deployment pipeline. The framework recognizes that modern applications consist of hundreds or thousands of dependencies, open-source components, and integration points that each represent potential security vulnerabilities requiring systematic management.
The HITRUST approach to supply chain security requires organizations to:
- Maintain inventories of all software components (including transitive dependencies)
- Assess the security posture of vendors and suppliers
- Implement controls that protect against tampering or compromise at any stage of the software lifecycle
- Generate and maintain software bills of materials (SBOMs)
- Perform vulnerability scanning of all dependencies
- Verify the integrity of code throughout the build and deployment process
This becomes particularly relevant when development teams use container registries, package managers, and automated build pipelines that pull code from multiple sources. Each of these touchpoints requires verification, monitoring, and controls that HITRUST helps organizations implement systematically rather than haphazardly.
For security directors, HITRUST provides a framework that connects these technical practices to business risk and regulatory requirements in ways that executive leadership can understand and support.
How Does HITRUST Integrate with DevSecOps Practices and Tooling?
Implementing HITRUST within a DevSecOps environment requires translating framework controls into automated processes that do not impede development velocity while still providing the rigor necessary for certification. Many HITRUST controls map directly to capabilities in modern DevSecOps toolchains, including automated security testing, policy-as-code implementations, and continuous compliance monitoring.
Key areas where HITRUST and DevSecOps intersect:
- Automated vulnerability management: Continuous scanning of containers, dependencies, and infrastructure-as-code templates to identify security weaknesses before they reach production
- Access control enforcement: Least-privilege access through automated provisioning systems that grant permissions based on role and need
- Change management and audit trails: Git-based workflows and deployment automation that create immutable records of what changed, when, and who authorized the modification
- Secure configuration management: Policy enforcement engines that prevent deployment of resources that do not meet HITRUST-defined security baselines
- Incident response automation: Automated detection and response capabilities that trigger predefined playbooks
- Continuous monitoring and logging: Centralized logging infrastructure that captures security-relevant events across the full application stack
The challenge for DevSecOps teams lies in implementing these capabilities in ways that satisfy HITRUST assessors while maintaining development productivity. This typically requires close collaboration between security teams who understand framework requirements and engineering teams who understand the technical implementation options. Assessors need evidence that controls are not just implemented but consistently maintained and monitored — documentation of both policy and practice is critical.
6 Steps to Implement HITRUST Certification in Your Organization
Pursuing HITRUST certification requires a structured approach. The following steps provide a practical roadmap from initial scoping through certification and ongoing compliance.
Step 1: Define your certification scope. HITRUST allows scoped assessments that focus on specific systems, applications, or business units. For software companies, this might mean initially certifying a specific product or service before expanding. Start narrow to manage cost and complexity.
Step 2: Conduct a gap assessment. Compare your existing controls against HITRUST requirements for your target certification level (e1, i1, or r2). Identify areas where additional controls, documentation, or technical implementations are needed.
Step 3: Build a cross-functional implementation team. Include representatives from security, compliance, engineering, operations, and business teams. Successful HITRUST implementations require collaboration across all functions — security requirements that conflict with operational realities or business risks will stall the process.
Step 4: Remediate gaps and implement controls. Address identified deficiencies. For DevSecOps teams, this means embedding security controls into CI/CD pipelines, automating evidence collection, and documenting both policies and their technical implementation.
Step 5: Select and engage a HITRUST-authorized assessor. Look for assessors with experience in your industry and familiarity with your technology stack. The assessment involves documentation review, staff interviews, and technical testing of control implementation. Assessors will observe actual development and deployment processes, review code repositories, and validate that automated controls function as documented.
Step 6: Complete assessment and maintain certification. After passing assessment, establish continuous compliance processes. Monitor controls, address deficiencies promptly, and prepare for periodic reassessment (every 2 years for r2).
HITRUST vs. Other Security Frameworks: How Do They Compare?
The following comparison table outlines key differences between HITRUST and other commonly used security and compliance frameworks.
Key takeaway: HITRUST is most valuable when an organization operates in healthcare or financial services, serves customers with multiple regulatory requirements, or wants to replace repetitive vendor security questionnaires with a single comprehensive certification. SOC 2 is more common in SaaS and technology. ISO 27001 provides broader international recognition. NIST CSF works well as an internal risk management framework but is not certifiable on its own.
How Does HITRUST Address Cloud Security and Modern Infrastructure?
HITRUST has evolved to address cloud computing, containers, microservices, and other modern infrastructure patterns. The framework includes specific guidance for cloud environments, recognizing that organizations operate in multi-cloud environments where responsibility for security is shared between cloud providers and their customers.
Shared responsibility model: HITRUST allows organizations to inherit certain controls from certified cloud providers (such as AWS or Azure) rather than assessing those controls independently. For example, physical security controls are the cloud provider's responsibility, allowing organizations to focus their assessment on controls they actually manage.
Kubernetes and container security: Container orchestration platforms present specific challenges for HITRUST compliance due to their dynamic nature. Organizations must demonstrate they:
- Secure container images before deployment
- Manage container runtime security
- Protect orchestration control planes
- Maintain network segmentation between containers
- Apply vulnerability management, access control, and monitoring to containerized environments
Infrastructure as code (IaC): HITRUST recognizes that securing the code that defines infrastructure is as important as securing the infrastructure itself. Organizations must demonstrate controlled access to infrastructure code repositories, change review processes, and audit trails of infrastructure modifications. These requirements align with GitOps practices where infrastructure changes flow through version control and automated deployment pipelines.
What Role Does HITRUST Play in Vendor Risk Management Programs?
HITRUST certification has become a standard requirement in vendor risk management programs across healthcare, financial services, and insurance. Organizations purchasing software or services increasingly require their vendors to hold HITRUST certification, viewing it as evidence the vendor maintains appropriate security controls and can demonstrate regulatory compliance.
For software vendors serving regulated industries: HITRUST certification can open market opportunities and accelerate sales cycles by satisfying procurement requirements upfront. Rather than navigating separate security reviews for each customer, vendors present a single HITRUST certification. This is particularly valuable for growth-stage companies (Series A through Series C) moving upmarket to enterprise customers with formal vendor risk management programs.
Inherited controls: When a vendor holds HITRUST certification, customers can inherit certain controls from the vendor rather than assessing those controls independently. This creates efficiency for both parties. The customer still must assess how they use the vendor's services and implement controls for areas remaining in their responsibility, but the overall vendor risk assessment is streamlined.
Important limitation: HITRUST certification from a vendor does not eliminate the need for vendor risk management. It changes the focus from assessing whether a vendor has basic security controls to evaluating whether those controls address the specific risks associated with how the vendor's services are used. Organizations should still assess integration points, data flows, and specific vulnerabilities relevant to their environment.
How Can Organizations Maintain HITRUST Compliance During Rapid Development Cycles?
Maintaining HITRUST compliance while supporting rapid development cycles (teams deploying 10–100+ times per day) requires embedding security and compliance into automated pipelines rather than treating them as separate validation steps.
Policy as code: Organizations define HITRUST control requirements as executable policies that automatically evaluate system configurations, code repositories, and runtime environments. This provides continuous compliance assurance rather than relying on periodic manual assessments that only offer point-in-time validation.
Automated evidence collection: Rather than manually gathering screenshots and configuration exports during annual assessments, organizations implement systems that continuously collect and store evidence of control effectiveness. This includes access control logs, vulnerability scan results, and change management audit trails. When assessment time arrives, evidence is already available.
Risk-tiered change management: Automated approval workflows where low-risk changes flow through pipelines quickly while high-risk changes receive additional scrutiny. The key is defining clear criteria for what constitutes high-risk versus low-risk changes and automating the routing logic rather than requiring manual evaluation of every change.
Managing open-source dependencies at scale: HITRUST requires assessing risks from third-party vendors and service providers, which becomes complex in environments with hundreds or thousands of open-source packages. Most organizations address this by categorizing dependencies based on risk:
- Critical dependencies (handle sensitive data or provide core functionality): Full security assessments
- Standard dependencies (common libraries with active maintenance): Automated vulnerability scanning and monitoring
- Low-risk dependencies (minimal attack surface, well-established): Basic monitoring only
The key is demonstrating a systematic, risk-proportionate approach to dependency management rather than treating each dependency identically.
To address these software supply chain security challenges, request a demo from Kusari to see how modern supply chain security tools can help maintain HITRUST compliance while supporting rapid development cycles and complex dependency management.
When HITRUST May Not Be the Right Choice: Limitations and Edge Cases
HITRUST certification is not suitable for every organization. The following scenarios describe when alternative frameworks or approaches may be more appropriate.
Cost is prohibitive for early-stage companies. HITRUST r2 certification can cost $80,000–$200,000+ and take 9–18 months. Startups with fewer than 50 employees and limited compliance budgets may find SOC 2 Type II (typically $20,000–$60,000) a more practical starting point.
Primary customers are not in healthcare or financial services. HITRUST is most recognized and most frequently required in healthcare, insurance, and financial services procurement. Organizations selling primarily to technology companies, government agencies, or international markets may find SOC 2, ISO 27001, or FedRAMP more directly useful.
Cloud-native architectures require interpretation. The HITRUST framework was originally designed for traditional IT operations. While it has evolved, mapping controls to serverless architectures, ephemeral infrastructure, and microservices still requires interpretation and adaptation. Organizations with highly dynamic cloud-native environments should expect additional effort to translate framework requirements into their operational context.
Fast-moving startups may struggle with documentation overhead. HITRUST requires documentation of policies, processes, and evidence of control effectiveness. Teams deploying infrastructure changes hundreds of times daily may find traditional documentation approaches impractical. Policy-as-code and automated evidence collection can address this, but require upfront investment.
International organizations may need additional frameworks. HITRUST maps to GDPR requirements but is primarily recognized in the United States. Organizations operating in the EU, Asia-Pacific, or other regions may need ISO 27001 or region-specific certifications alongside or instead of HITRUST.
Frequently Asked Questions About HITRUST
What is HITRUST certification?
HITRUST certification is a third-party validated assessment that demonstrates an organization meets security and privacy requirements from multiple regulatory frameworks (HIPAA, PCI DSS, GDPR, NIST, ISO 27001) through a single unified program. It is maintained by the Health Information Trust Alliance and requires assessment by HITRUST-authorized external assessors.
How long does HITRUST certification take?
Timeline depends on the certification level. HITRUST e1 typically takes 3–6 months. HITRUST i1 takes 6–9 months. HITRUST r2, the most comprehensive level, takes 9–18 months. Organizations with mature security programs and existing documentation can often complete the process faster.
How much does HITRUST certification cost?
Costs vary by certification level and organization size. HITRUST e1 ranges from $20,000–$50,000 including assessor fees. HITRUST i1 ranges from $40,000–$80,000. HITRUST r2 ranges from $80,000–$200,000+. These estimates include assessor fees, tooling, and internal staff time but can vary based on scope and remediation needs.
What is the difference between HITRUST and SOC 2?
HITRUST is a prescriptive, certifiable framework that consolidates 40+ regulatory standards into one assessment. SOC 2 is an attestation report based on trust service criteria with more flexibility in how controls are implemented. HITRUST is most common in healthcare and financial services. SOC 2 is more common in SaaS and technology. HITRUST provides more standardized comparison between organizations because control requirements are specific, while SOC 2 implementation details vary between companies.
Does HITRUST certification replace HIPAA compliance?
HITRUST certification does not replace the legal requirement to comply with HIPAA. However, HITRUST maps its controls to HIPAA requirements, and achieving HITRUST certification demonstrates that an organization has implemented controls aligned with HIPAA security and privacy rules. Many healthcare organizations accept HITRUST certification as evidence of HIPAA compliance for vendor assessment purposes.
How does HITRUST handle cloud and container environments?
HITRUST allows organizations to inherit certain controls from certified cloud providers (such as AWS and Azure) through the shared responsibility model. For containers and Kubernetes, organizations must demonstrate they secure container images, manage runtime security, protect orchestration control planes, and maintain network segmentation. Infrastructure as code is recognized as a valid approach, with requirements for access control, change review, and audit trails on infrastructure code repositories.
How often does HITRUST certification need to be renewed?
HITRUST e1 and i1 certifications are valid for 1 year. HITRUST r2 certification is valid for 2 years. Organizations must undergo reassessment before their certification expires. Between assessments, organizations are expected to maintain continuous compliance and may be subject to interim reviews if material changes occur.
Can small companies or startups achieve HITRUST certification?
Yes, but the investment may not be justified for every organization. HITRUST e1 was designed for smaller organizations and covers 44 core controls. Startups with fewer than 50 employees and limited budgets may find SOC 2 Type II a more practical starting point, then pursue HITRUST as customer requirements demand. Organizations serving healthcare enterprises as vendors are most likely to need HITRUST regardless of their size.
What is the HITRUST shared responsibility model?
HITRUST recognizes that cloud environments involve shared security responsibilities between the cloud provider and the customer. Organizations can inherit controls from their certified cloud providers for areas the provider manages (such as physical security and network infrastructure), allowing them to focus assessment efforts on controls they directly manage (such as application security, access management, and data protection).
How does HITRUST support software supply chain security?
HITRUST requires organizations to maintain inventories of software components, assess vendor and supplier security posture, generate SBOMs, perform vulnerability scanning of dependencies, and verify code integrity throughout build and deployment processes. The framework addresses third-party risk management requirements that are central to modern software supply chain security programs.
Strengthening Your Security Posture with HITRUST Principles
Organizations pursuing security excellence in regulated industries will find HITRUST provides a comprehensive roadmap connecting technical security controls to business risk and regulatory requirements. The framework's value extends beyond certification itself to the systematic security improvements organizations make during implementation. By following HITRUST guidance, DevSecOps teams develop mature security practices that protect against real-world threats while satisfying auditors and regulators.
The investment required for HITRUST certification pays dividends through reduced vendor assessment burden, improved security posture, and access to markets that require demonstrated compliance. For security directors and team leads, HITRUST provides a framework for explaining security investments to executive leadership in terms of risk reduction and business enablement rather than technical necessity alone.
As software supply chain attacks continue to increase in frequency and sophistication, frameworks like HITRUST that address vendor risk management and supply chain security become increasingly relevant — even for organizations outside traditionally regulated industries. The systematic approach to identifying dependencies, assessing their security, and implementing controls to manage supply chain risks provides value regardless of specific regulatory requirements. Organizations implementing HITRUST principles develop resilience against supply chain compromises that threaten organizations across all sectors.
For teams building and securing modern applications, HITRUST certification demonstrates a commitment to security that resonates with customers, partners, and regulators. The framework provides structure for security programs while remaining flexible enough to accommodate diverse technology stacks and deployment models. As healthcare and other regulated industries continue adopting cloud-native technologies and modern development practices, HITRUST evolves to address emerging security challenges while maintaining the comprehensive approach that makes it valuable for risk management and compliance.