Ensuring regulatory compliance is one of the most vital — and complex — task any healthcare organization and its business partners wrestle with. Failure to secure patient data can result in costly penalties and reputational damage. A time-consuming process, compliance requirements also can be vague. Additionally, many healthcare entities lack the resources and skills to implement the practices and controls to achieve compliance.

Because of the subjective nature of the Health Insurance Portability and Accountability Act (HIPAA) requirements, HITRUST is a standardized, common security framework that any HIPAA-covered entity can use to prove they align with the requirements. In short, HITRUST helps health organizations maintain compliance with HIPAA regulations more easily.

What Does HITRUST Stand For?

HITRUST stands for the Health Information Trust Alliance. Founded in 2007, HITRUST is a private organization that develops and maintains a cybersecurity framework to help organizations achieve HIPAA compliance requirements.

According to the HITRUST Alliance, HITRUST “was born out of the belief that information security should be a core pillar of, rather than an obstacle to, the broad adoption of health information systems and exchanges.”

A major compliance challenge for many organizations is balancing essential risk mitigation measures with their limited resources, skills, and budgets. HITRUST simplifies this process by breaking down and prioritizing the complete set of controls and requirements, implementing them in phases. This approach allows organizations to focus their compliance efforts on the most critical issues, spreading the costs and implementation over a more manageable timeframe.

The HITRUST CSF (Common Security Framework) combines aspects of several common security frameworks and compliance regulations — including HIPAA, PCI DSS, ISO, and NIST — and outlines a set of controls that meet their requirements. It has 135 specific controls mapped to specific HIPAA-compliant standards and specifications. Additionally, each CSF control has multiple levels with varying requirements. This was added to HIPAA to promote the adoption of health information technology and the use of electronic health records (EHRs), in particular, to streamline healthcare and reduce costs. Additional changes help ensure HIPAA-covered entities comply with any HITRUST requirement and how they are enforced.

Some of the changes introduced by the framework include

~ Tougher penalties for violation of the HIPAA security and privacy laws.

~ Mandatory security audits of all healthcare providers to determine if they meet minimum standards to comply with the security and privacy rules.

~ A four-step tiered system for assigning penalties for HIPAA violations. Organizations can be penalized even if they were unaware a violation occurred.

~ The extension of HIPAA Privacy and Security Rules directly applies to a healthcare organization’s business associates. This includes medical transcription companies, law firms, software vendors, collections companies, and other entities whose work allows them to access personal health information.

Because HITRUST is an expansion of HIPAA, HITRUST CSF moves organizations toward HIPPA compliance.

What Is HITRUST Certification?

Historically, healthcare organizations relied on signed agreements or verbal assurances to claim HIPAA compliance — promises that were often difficult to verify. HITRUST certification changes the game by providing a tangible, credible way to demonstrate adherence to HIPAA’s stringent security controls. It empowers healthcare organizations to build trust and credibility, positioning themselves as reliable and compliant business partners in the industry.

HITRUST offers a three-step process called the Degrees of Assurance to become HITRUST CSF Certified.

The first step is a HITRUST CSF assessment that uses the HITRUST myCSF tool. An organization answers a series of questions which leads to a customized HITRUST assessment that shows how well that business’s particular environment meets applicable compliance standards. The myCSF tool helps identify areas where the organization is in compliance with HITRUST criteria and where it needs improvement.

After completing the self-assessment and making any necessary corrective actions, the organization can take the second step, requesting a third party confirm they meet the relevant HITRUST criteria. A HITRUST-approved CSF Assessor then makes an on-site visit to verify the information the organization gathered during the HITRUST CSF assessment and issues a validated assessment.

For the final Degree of Assurance, the organization submits its validated assessment for HITRUST review and certification. HITRUST CSF Certification is good for up to two years, after which the organization’s compliance must be re-assessed.

The Journey Toward CSF

The timeframe for completing HITRUST certification varies by organization depending on many factors. HITRUST requires organizations to show readiness against 135 CSF controls, which are divided into 19 different domains:

1. Information Protection Program

2. Endpoint Protection

3. Portable Media Security

4. Mobile Device Security

5. Wireless Protection

6. Configuration Management

7. Vulnerability Management

8. Network Protection

9. Transmission Protection

10. Password Management

11. Access Control

12. Audit Logging and Monitoring

13. Education, Training, and Awareness

14. Third-Party Security

15. Incident Management

16. Business Continuity and Disaster Recovery

17. Risk Management

18. Physical & Environmental Security

19. Data Protection and Privacy

How long the certification process takes depends on an organization’s maturity and complexity of its environment, as well as its resource availability, security program readiness, and remediation requirements. In general, the self-assessment and third-party validated assessment can each be completed within eight weeks. However, it can take up to 24 months for HITRUST to review the assessments and issue certification.

Cost is another consideration. Notably, organizations can expect to spend anywhere from $50,000 to $200,000, depending on their size and complexity. Typically, the decision to pursue certification is based on the requirements of doing business with a certain type of client or entering into a new market.

What Are the Benefits?

HITRUST certification offers numerous benefits to an organization. The most significant advantage is it positions the certified organization as a trusted business partner. In fact, many organizations pursue this certification due to customer demands. Demonstrating your organization meets or exceeds compliance requirements provides a competitive edge over those unable to prove their compliance.

One of the key advantages of the HITRUST certification process is its profound ability to elevate an organization’s security posture. Unlike other regulatory frameworks, the HITRUST CSF is more rigorous and prescriptive, driving organizations to implement exhaustive and detailed risk management procedures. This intensive process not only uncovers critical data security gaps but also ensures they are addressed, fortifying the organization’s overall security and resilience.

Additionally, the HITRUST certification process establishes clear standards for achieving HIPAA compliance. Unlike HIPAA and other compliance frameworks, which do not specify how to achieve and demonstrate compliance, the CSF provides organizations with clear, actionable guidelines to meet a variety of globally recognized standards. This helps remove uncertainty about the necessary steps to take.

Scalability is also a key advantage of HITRUST CSF. The CSF control set is customized for each business assessment based on the organization’s type, size, and complexity. This flexibility allows organizations to tailor the CSF to their specific needs, making it an effective solution for businesses of all sizes. Additionally, the CSF control set is tailored to each business assessment according to its type, size, and complexity. Organizations can adapt the CSF to its unique needs, making it a solution for businesses of all sizes.

How Do HITRUST and HIPAA Compare and Contrast?

Both HITRUST and HIPAA address regulatory compliance for any healthcare provider, so, understandably, some believe the two are interchangeable. It’s important to understand the differences between the two and how they work together so you can better meet your compliance responsibilities.

The key distinction lies in the fact that HIPAA is a federal law, enforced by government agencies, while the HITRUST framework was established by a private group of security experts. HITRUST CSF was specifically designed to help healthcare organizations, and their partners streamline and simplify the process of achieving HIPAA compliance, making it more efficient and accessible.

One key difference is that HIPAA leaves organizations to interpret the necessary practices and security controls for compliance, using often vague and nuanced language. This ambiguity makes it difficult for many companies to clearly identify the actions required. In contrast, HITRUST provides explicit guidance on the steps organizations must take and offers a certification process to verify compliance, ensuring greater clarity and accountability.

[Recommended Reading: HITRUST vs. HIPAA]

HITRUST Offers a Smoother Path to HIPAA Compliance

Data breaches pose a severe threat to healthcare organizations, and their frequency is increasing. For example, 2024 was the worst-ever year in terms of breached healthcare records, which jumped by 9.4% from 2023’s record-breaking total to 184,111,469 breached records, or 53% of the 2024 U.S. population

HITRUST CSF can help identify and remediate any security holes in your environment. It gives you greater confidence in your data security and demonstrates your compliance with applicable HIPAA requirements.

Managed security services are often the answer for healthcare organizations seeking to implement security controls and comply with regulations. A detection and response solution provides a variety of reports to demonstrate compliance with specific HITRUST CSF control categories and HIPAA regulations. Additionally, it highlights areas where compliance may be lacking, allowing you to take corrective action.

Choose Fortra’s Alert Logic managed services solutions to reach your compliance goals.

Additional Resources:

Alert Logic Helps Iodine Software Meet HITRUST Compliance Mandates | Case Study

Does PHI Require More Protection than PII? | Blog

HIPAA Turns 28: Key Changes, Failures, and Future Directions | Blog

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