What Is HiTRUST Compliance?

Data protection is an increasing concern in all industries, but none more so than the healthcare sector. To complicate matters, the regulatory environment surrounding data protection is a complex hodgepodge of global, federal, state, and industry-specific laws. The HiTRUST framework is the gold standard for helping organizations develop a system to manage regulatory compliance and risk management. 

HiTRUST Compliance 101

Regulatory compliance in healthcare is a complicated issue. HiTRUST doesn’t make it simple, but it does provide a comprehensive, flexible framework security document that organizations can use to make sure they’ve implemented all of the relevant security and data protection protocols. 

Definition of HiTRUST

HiTRUST stands for Health Information Trust Alliance, a not-for-profit organization founded in 2007. It developed the HiTRUST Common Security Framework (CSF), a certifiable framework that provides organizations with an efficient approach to regulatory compliance and risk management. The HiTRUST CSF combines the requirements of existing standards and regulations, including federal, such as HIPAA and HITECH, state, and third-party, such as PCI and COBIT, frameworks. It’s designed to address the multitude of security, privacy, and regulatory challenges facing healthcare companies that handle sensitive health information, offering them a structured methodology to ensure the confidentiality, integrity, and availability of this data.

The Evolution and Purpose of HiTRUST in Healthcare

Since its inception, HiTRUST has continuously evolved to address the increasing challenges in healthcare data security and compliance. Initially, it aimed to consolidate and streamline the compliance efforts by integrating the requirements of various standards and regulations. Over the years, it has updated its CSF to reflect changes in regulations, emerging threats, and advancements in technology. The framework has expanded to incorporate global standards and is increasingly adopted by organizations outside the U.S., making it a comprehensive benchmark for information security in healthcare worldwide.

The primary purpose of HiTRUST is to make sure that healthcare organizations can effectively manage the security and privacy of patient data in a way that complies with all relevant regulations. This is particularly challenging in the healthcare industry due to the sensitive nature of the information involved and the complex regulatory landscape. HiTRUST provides a standardized approach to security that helps organizations mitigate risks, protect patient privacy, and achieve compliance more efficiently and effectively than would be possible through managing multiple standards and regulations separately. 

What Is the HiTRUST CSF (Common Security Framework)?

The HiTRUST CSF is a comprehensive security framework specifically designed for the healthcare industry to protect sensitive data and meet a wide range of regulatory requirements. It provides healthcare providers with a structured approach to managing data security and compliance. 

Key Components of the HiTRUST CSF

The key components of the HiTRUST compliance requirements include the following: 

• Control categories: The framework is organized into 19 control categories that cover various aspects of information security and privacy. These categories range from access control and audit logging to incident management and risk management.
• Control objectives and specifications: For each category, the CSF outlines specific control objectives and detailed control specifications that organizations must meet. These objectives are designed to guarantee that the necessary security measures are in place to protect health information effectively.
• Maturity model: The CSF includes a maturity model that evaluates the effectiveness of the implemented controls. This model assesses five levels of maturity — Policy, Procedure, Implemented, Measured, and Managed — so organizations can continuously improve their security and compliance posture.
• Risk factors: The framework takes a risk-based approach, allowing organizations to tailor their security measures based on specific risk factors such as organizational, system, and regulatory ones. This customization makes the framework applicable to a wide range of organizations with varying sizes, types, and risk profiles.
• Certification and assurance program: HiTRUST offers a certification program so organizations can demonstrate their compliance with the CSF. The certification process involves a rigorous assessment conducted by HiTRUST-approved assessors so stakeholders can be confident that the organization meets the highest standards of data protection.

How the HiTRUST CSF Integrates With Other Standards

HiTRUST simplifies compliance efforts for healthcare organizations by providing a unified framework that addresses multiple standards, including: 

• Federal regulations: The CSF incorporates the requirements of U.S. federal regulations such as HIPAA and the HITECH Act.
• International standards: It aligns with international standards such as the ISO/IEC 27001 series so organizations can meet global security best practices.
• Industry-specific standards: The framework includes controls from industry-specific standards and best practices, including the Payment Card Industry Data Security Standard (PCI DSS) for organizations that process payment card information.
• State regulations: It also considers state-specific regulations so that organizations can achieve compliance across different jurisdictions.

The Importance of HiTRUST Compliance in Healthcare

Healthcare is one of — if not the — most complex industries for compliance and risk mitigation. HiTRUST compliance gives healthcare facilities and their leaders the security of knowing they’ve implemented all of the necessary controls to meet regulatory standards. 

Enhance Data Security and Patient Privacy

The primary goal of HiTRUST compliance is to improve data security and safeguard patient privacy. Healthcare organizations deal with a vast amount of sensitive health information, including personal and medical records that are highly attractive to cybercriminals. A breach of this information can have devastating consequences, not just for the patients whose data is compromised but also for the organizations responsible for protecting it.

HiTRUST compliance includes comprehensive and strong security measures designed to protect health information across various platforms and technologies. By adhering to the HiTRUST CSF, organizations can:

• Implement best practices: The framework encompasses a wide range of security controls and best practices derived from global standards, so organizations are guaranteed to adopt a thorough approach to data security.
• Identify and mitigate risks: Through its risk-based approach, HiTRUST helps organizations identify potential vulnerabilities and threats to patient data and provides guidelines for mitigating these risks effectively.
• Promote a culture of security: Achieving HiTRUST compliance demonstrates an organization’s commitment to security, encouraging a culture of awareness and vigilance among staff and stakeholders.

Meet Regulatory and Risk Management Requirements

Healthcare organizations operate in a complex regulatory environment and must comply with numerous laws and regulations designed to protect patient information from bad actors. HiTRUST compliance helps healthcare organizations navigate this landscape by providing an overarching framework that covers the requirements of multiple standards and regulations by: 

• Simplifying compliance efforts: The HiTRUST CSF integrates the requirements of many regulatory and industry standards. This simplification allows organizations to meet the requirements of multiple regulations through a single compliance effort, reducing redundancy and inefficiency.
• Improving risk management: HiTRUST’s risk-based approach allows organizations to tailor their security and compliance programs based on specific risks so resources are allocated effectively and the highest priority threats are addressed first.
• Building trust with stakeholders: Compliance with HiTRUST is often seen as a badge of honor in the healthcare industry, signifying that an organization takes data protection seriously. This builds trust with patients, partners, regulators, and other stakeholders, potentially leading to competitive advantages.

Steps to Achieve HiTRUST Compliance

There’s no doubt that HiTRUST compliance is an extensive undertaking. However, achieving it will result in peace of mind that all of your risk exposures are covered and you haven’t made any critical oversights. The following HiTRUST compliance checklist will walk you through the process. 

Conduct a Readiness Assessment

The assessment process will allow you to evaluate your organization’s current security posture against the comprehensive requirements of the HiTRUST CSF. It identifies gaps in security and privacy controls and sets a baseline for compliance efforts so you can take a structured approach to achieving certification. 

Start by considering the types of data you handle, your organizational size, the complexity of your systems, and what specific HiTRUST CSF requirements apply. Determine which parts of your organization will be included in the HiTRUST assessment, which will depend on your operational structure and where sensitive information is stored, processed, or transmitted.

Next, collect detailed information about your security and privacy controls, including policies, procedures, and technologies in place that protect sensitive data and ensure privacy. With the HiTRUST CSF as a benchmark, evaluate your controls to identify where they align with the framework’s requirements and where there are gaps.

Develop a Remediation Plan

A well-structured remediation plan prioritizes the actions based on risk and sets clear timelines and responsibilities for implementation.

For each identified gap or vulnerability, define specific remediation actions you need to take to move toward compliance. You may need to implement new security controls, update policies and procedures, improve technical safeguards, or conduct training and awareness programs.

Assign clear responsibilities for each remediation action to specific individuals or teams. Designate a project lead or team responsible for overseeing the remediation efforts to provide accountability at all levels.

Establish realistic timelines for completing each remediation action based on the complexity, the availability of resources, and any external dependencies that could impact timelines. For larger or more complex remediation efforts, consider a phased approach that breaks down the project into manageable stages.

Implement Required Controls and Policies

Now you’re ready to take concrete actions to address identified gaps and vulnerabilities so you can align the organization’s practices with the HiTRUST CSF requirements. Determine the scope of implementation across the organization by identifying the departments, systems, and processes that will be affected by the new controls and policies. 

Next, assess and allocate the necessary resources for implementation, such as dedicating personnel, investing in new technologies, or allocating a budget for external support. Implement the technical controls, including encryption, access controls, intrusion detection systems, and other security technologies designed to protect sensitive information.

Develop or update policies and procedures to align with HiTRUST requirements. Formalize practices related to data protection, incident response, risk management, and other controls. These documents need to be accessible and communicated to all relevant personnel.

Conduct training and awareness programs to help your staff understand the new controls and policies, their roles and responsibilities, and the importance of compliance. Continuous education helps foster a culture of security and compliance throughout your organization.

Undergo HiTRUST Pre-Assessment

Undergoing a HiTRUST pre-assessment gives you an opportunity to gauge your readiness before the formal HiTRUST assessment. You can identify any gaps or weaknesses in your security and compliance frameworks you may not have fully addressed during the remediation plan implementation.

You can conduct risk assessments internally or seek assistance from external consultants or HiTRUST-certified assessors. External consultants can offer expertise and an objective view of your readiness. MyCSF is a cloud-based platform that helps with self-assessments, third-party assessments, and the submission process for HiTRUST Certification.

The pre-assessment should identify any gaps or areas where you don’t fully meet the HiTRUST CSF standards. For each identified gap, develop an action plan and implement improvements. You may want to repeat the pre-assessment after any changes to make sure you’re fully compliant before the formal procedure. 

Complete the Required Assessment Procedures

The HiTRUST audit procedures are as follows: 

• Select an assessor and determine scope: Choose an authorized HiTRUST assessor, preferably within your industry. An initial meeting will determine which systems, processes, and data will be evaluated to align with your organizational goals and regulatory requirements.
• Prepare documentation and gather evidence: Document evidence of the implementation of required controls, such as policies, procedures, system configurations, training records, and any other relevant documents. Along with your documentation, prepare evidence demonstrating the effectiveness of the implemented controls. This can include logs, reports, audit trails, and results from internal audits or testing.
• Onsite assessment: Depending on the assessment type and the assessor’s approach, they may conduct interviews, review documentation, and perform testing of controls to validate your compliance with the HiTRUST CSF. 
• Validate findings and draft report: After completing their review, assessors will compile their findings and validate the information. They’ll then draft a report detailing their findings, including any areas where you don’t meet the HiTRUST CSF requirements. 

Address Any Remaining Compliance Issues

Review the final report and create an action plan to remediate any areas of noncompliance. Keep detailed documentation of all remediation actions taken, including changes to policies and procedures, system configurations, training materials, and any other relevant information. If required, schedule a re-assessment with a HiTRUST-certified assessor to formally evaluate your compliance post-remediation. 

Obtain Your HiTRUST Certification

Once you meet all the HiTRUST CSF requirements, HiTRUST will issue your certification. HiTRUST certification is valid for two years, after which you’ll need to undergo reassessment to renew your certification. 

Leverage Our 25 Years of Success for Your Compliance

Achieving HiTRUST compliance requires that all of your cloud service providers and systems work together so you can have a comprehensive overview of your risk exposure. Consensus Cloud Solutions can help your compliance efforts with our suite of products, from real-time event notification to on-demand access to the most current clinical information. Reach out today for a free demo.