HITRUST compliance: a checklist

HITRUST (Health Information Trust Alliance) is a standards organization that developed the Common Security Framework (CSF) specifically for the healthcare IT industry. The framework provides a comprehensive, prescriptive set of security controls designed to help healthcare organizations protect sensitive patient data and comply with various regulatory requirements. It combines elements from multiple existing frameworks including HIPAA, NIST, and ISO 27001 to create a unified approach to healthcare cybersecurity.

The HITRUST CSF offers a risk-based approach that allows organizations to tailor their security implementations based on their specific risk factors, such as organization size, type, and systems used. Organizations can undergo HITRUST certification through validated assessments that evaluate their adherence to the framework's requirements. This certification process provides third-party validation of an organization's security posture and demonstrates compliance with industry best practices.

HITRUST certification has become increasingly important for healthcare organizations and their business associates as it provides assurance to stakeholders, clients, and regulators about data protection capabilities. The framework is regularly updated to address evolving threats and regulatory changes, ensuring it remains relevant and effective. Many healthcare organizations now require HITRUST certification from their vendors and partners as a prerequisite for doing business, making it a valuable credential in the healthcare marketplace.

HITRUST compliance steps

Initial Preparation and Scope Definition: Begin by establishing a clear scope for your HITRUST certification, defining which systems, processes, and data flows will be included in the assessment. Conduct a gap analysis against the HITRUST Common Security Framework (CSF) to identify current security posture and areas requiring improvement. Select the appropriate assessment level (e1, i1, or r2) based on your organization's risk profile, complexity, and stakeholder requirements. Engage leadership support and allocate necessary resources, including budget, personnel, and timeline commitments for the certification process.

Control Implementation and Documentation: Implement the required security controls according to your chosen HITRUST assessment level, focusing on the 19 control domains that span administrative, technical, and physical safeguards. Document all security policies, procedures, and technical configurations to demonstrate compliance with the framework's control specifications. Ensure that evidence collection processes are established to support the assessment, including logs, screenshots, policy documents, and procedural evidence. Conduct internal testing and validation of implemented controls to verify they are operating effectively before the formal assessment.

Third-Party Assessment Execution: Select and engage a HITRUST Authorized External Assessor to conduct the independent validation required for certification. Coordinate the assessment activities, providing assessors with necessary documentation, system access, and personnel interviews to validate control implementation. Work collaboratively with assessors to address any identified gaps or findings during the assessment process. Prepare for the comprehensive review process that includes testing of controls, validation of evidence, and evaluation of your organization's overall security posture.

Certification and Ongoing Maintenance: Complete remediation activities for any assessment findings and undergo the HITRUST quality assurance review process, which typically takes 6-8 weeks after assessment completion. Once certified, establish ongoing monitoring and maintenance processes to ensure continued compliance with HITRUST requirements throughout the certification period. Plan for recertification activities, including interim assessments for r2 certifications and annual renewals for e1 and i1 certifications. Leverage your HITRUST certification for stakeholder communications, business development, and to demonstrate compliance with other frameworks like HIPAA.

HITRUST Compliance Checklist:

• Establish comprehensive access controls and user management - Example: Implement role-based access controls where a nurse can only access patient records for their assigned patients, while billing staff cannot access clinical notes
• Deploy continuous monitoring and logging capabilities - Example: Configure SIEM tools to automatically log and alert on suspicious activities like multiple failed login attempts or unusual data access patterns outside business hours
• Implement robust data encryption for data at rest and in transit - Example: Encrypt all patient health records stored in databases using AES-256 encryption and ensure all data transmissions use TLS 1.3 protocols
• Develop and test incident response procedures - Example: Create a documented process for responding to data breaches that includes notification timelines, containment procedures, and conduct quarterly tabletop exercises with key personnel
• Conduct regular vulnerability assessments and penetration testing - Example: Perform monthly vulnerability scans of all network-connected systems and annual penetration testing of web applications handling sensitive data
• Establish vendor risk management and third-party access - Example: Require all cloud service providers to provide HITRUST or SOC 2 certifications and conduct annual security reviews of critical vendors
• Implement physical security controls for facilities and equipment - Example: Install badge-controlled access to server rooms, security cameras in data centers, and secure disposal procedures for hard drives containing sensitive information
• Maintain comprehensive security awareness training programs - Example: Require all employees to complete annual cybersecurity training including phishing simulations and provide specialized training for IT staff on secure coding practices

Common challenges

Organizations pursuing HITRUST compliance often struggle with the complexity and comprehensive nature of the framework itself. The HITRUST CSF incorporates controls from over 60 different standards and regulations, creating a web of interconnected requirements that can be overwhelming to navigate. Many organizations find it challenging to understand how these various control requirements map to their specific operational environment and risk profile.

Resource allocation and expertise gaps present significant hurdles for many organizations seeking HITRUST certification. The assessment process requires dedicated personnel with specialized knowledge of cybersecurity frameworks, risk management, and compliance methodologies. Organizations frequently discover they lack the internal expertise to properly implement controls or conduct thorough gap assessments, forcing them to invest in external consultants or delay their certification timeline while building internal capabilities.

The ongoing maintenance and continuous monitoring requirements of HITRUST compliance create persistent operational challenges. Unlike static compliance checkboxes, HITRUST demands that organizations maintain their security posture through regular monitoring, updates to threat-adaptive controls, and preparation for interim assessments. Organizations must balance the costs and effort of maintaining certification with other business priorities, while ensuring their security programs remain effective against an evolving threat landscape.

Simplifying HITRUST compliance with an Enterprise Browser

HITRUST compliance involves the proper treatment and care of protected healthcare information (PHI) to ensure patient privacy, and navigating its complex requirements can be daunting. With the Island Enterprise Browser, businesses can simplify compliance while maintaining security and productivity — directly through the browser.

By creating secure application boundaries and embedding robust controls, Island ensures PHI information stays within authorized systems, reducing audit scope and risk.

Frequently asked questions

Q: What are the different HITRUST assessment levels and how do I choose the right one?

A: HITRUST offers three assessment levels: e1 (basic), i1 (intermediate), and r2 (comprehensive). Your choice should be based on your organization's risk profile, complexity, and stakeholder requirements. e1 is suitable for lower-risk organizations, while r2 is designed for high-risk organizations handling large volumes of sensitive data.

Q: How long does the HITRUST certification process typically take?

A: The certification process varies depending on your organization's readiness and chosen assessment level. After the assessment is completed, the HITRUST quality assurance review process typically takes 6-8 weeks. Organizations should plan for several months of preparation before the formal assessment begins.

Q: What happens after I receive HITRUST certification - is it permanent?

A: HITRUST certification is not permanent and requires ongoing maintenance. You'll need to maintain continuous monitoring processes, conduct annual renewals for e1 and i1 certifications, and undergo interim assessments for r2 certifications to keep your certification active.

Q: Do I need specialized expertise to implement HITRUST compliance?

A: Yes, HITRUST implementation requires specialized knowledge of cybersecurity frameworks, risk management, and compliance methodologies. Many organizations either invest in training internal staff or engage external consultants with HITRUST expertise to navigate the complex requirements effectively.

Q: How does HITRUST certification benefit my healthcare organization beyond compliance?

A: HITRUST certification provides third-party validation of your security posture, can be used for stakeholder communications and business development, demonstrates compliance with multiple frameworks including HIPAA, and is increasingly required by healthcare organizations as a prerequisite for vendor partnerships.