The Path to HITRUST Certification May Be a Rocky Road if You're Not Prepared

HITRUST readiness is a critical step to smooth, successful certification

An undisputed leader in cybersecurity assurance, HITRUST offers a complete and efficient approach to regulatory compliance and security risk management. Becoming HITRUST certified inspires confidence among your customers, partners, and other stakeholders. By demonstrating your all-in commitment to data security, HITRUST Certification enhances your credibility and provides a keen competitive edge. Small wonder that HITRUST Certification is considered the gold standard for healthcare cybersecurity and third-party assurance.

This blog explores important aspects of HITRUST Certification to help you determine HITRUST is right for you, and will guide you in preparing for HITRUST Certification.

Who Should Consider HITRUST Certification, and Why

HITRUST was founded in 2007 to help organizations manage the security and privacy of sensitive data and comply with information security regulations. To address the complexity of healthcare regulatory requirements, one of the first HITRUST Frameworks was developed to facilitate healthcare data security and HIPAA compliance. The scope of HITRUST expanded over time to include multiple industries with similar needs.

Vigilant about keeping the Framework fully current and accurate, HITRUST continues to add revised HIPAA regulations and other new compliance requirements as they arise. As a result, HITRUST remains highly relevant for organizations who handle personally identifiable information (PII), as well as healthcare entities responsible for protected health information (PHI), including:

• Healthcare providers and payers,
• Health technology companies and software-as-a-service firms,
• Business associates responsible for PHI/ePHI,
• Life sciences, biotech, and pharmaceutical companies.

Along with other leading cybersecurity frameworks, such as CMMC and NIST, the HITRUST CSF has increasingly focused on improving security among third-party suppliers to address vulnerabilities in the supply chain. More than a few high-profile data breaches have been traced to security lapses in supplier and vendor organizations in recent years. According to HITRUST, fewer than one percent of certified organizations reported data breaches in 2024.

While there is no doubt that HITRUST Certification facilitates cybersecurity and compliance, it is also useful under the following circumstances:

• To meet a customer or partner request for official certification.
• To further differentiate your organization in an increasingly competitive environment, or in a new market.
• To streamline your compliance with multiple applicable security standards, such as HIPAA and NIST, for example, or FISMA and GLBA.
• To demonstrate compliance with regulations, such as HIPAA, or frameworks such as PCI DSS, where formal certification is not offered to members of the industry.

Choosing the HITRUST Certification That's Right for You

The HITRUST CSF incorporates more than 60 authoritative sources, ranging from NIST and ISO to HIPAA and PCI and well beyond. The Framework also leverages documented threat intelligence to address emerging threats.

One of many benefits of the HITRUST CSF is that it is not a one-size-fits-all framework. Instead, it offers three levels of risk assurance tailored to your organization’s size, risk profile, and business goals. To earn HITRUST Certification at any level, a distinct Validated Assessment option is required for that level.

Choosing the right level of assurance starts with understanding your evolution, environment, risks, and stakeholder expectations:

• Essentials 1-Year (e1) is an entry-level framework with foundational security controls, requiring renewal each year.
• Implemented 1-Year (i1) provides moderate security assurance, is adaptable to cyber threats, and requires recertification annually.
• Risk-Based, 2-Year (r2) represents the highest level of security assurance, and requires recertification every two years.

In addition to these three assurance levels, in December 2024, HITRUST introduced a new AI Security Assessment for deployed AI systems as an add-on to any of the three primary Validated Assessments and their corresponding certifications. Specifically:

• The AI1 (ai1) assessment may be combined with an e1 or i1 Validated Assessment and certification.
• The AI2 (ai2) assessment may be combined with an r2 Validated Assessment and certification.

Another fairly recent update to the HITRUST Framework enables organizations to upgrade from one assurance level to the next as their needs change, building on previous certification steps without wasting time or repeating redundant activities.

To earn HITRUST Certification at any of the three levels (e1, i1, or r2), a Validated Assessment is required and can only be performed by an Authorized HITRUST External Assessor. For either i1 or r2 certification, HITRUST recommends that a Readiness Assessment be performed by a HITRUST Readiness Licensee to prepare you for the official Validated Assessment.

Why is HITRUST Readiness Assessment So Important?

Your journey to HITRUST Certification may be a rocky road unless you are fully prepared for the Validated Assessment — the lynchpin of the HITRUST Certification process. A HITRUST Readiness Assessment is a vital step in preparing for HITRUST Certification and will help ensure a smooth and successful certification experience.

Very few organizations begin their HITRUST journey in full compliance with the regulations that apply to them. A Readiness Assessment enables you to evaluate the security of your organization, identify compliance gaps and security vulnerabilities, and remediate them prior to undergoing your Validated Assessment. It provides a clear path to full compliance and significantly improves your opportunity to successfully achieve certification.

It is far more economical and efficient to resolve issues during the preparation or readiness phase of the certification process than after the Validated Assessment has been completed by a qualified External Assessor. Without a Readiness Assessment, organizations may fail to meet all applicable security requirements, resulting in having to perform costly rework and facing delays in certification.

Remember: HITRUST Certification represents a strategic investment in your organization’s security and reputation. A Readiness Assessment ensures that your investment pays off.

Key Resources Available to Help  

In preparing for HITRUST Certification and successfully achieving that goal, two key resources are available to assist you.

Readiness Licensees are organizations authorized by HITRUST to conduct Readiness Assessments and provide consulting on the HITRUST Framework and approved methodologies. A Readiness Assessment will help you identify compliance gaps and security vulnerabilities — and remediate them before you engage an External Assessor to conduct the Validated Assessment.

External Assessors are organizations approved by HITRUST to perform assessment services and conduct HITRUST Validated Assessments using the HITRUST Framework and methodology. They are trained and vetted resources that organizations of any size can depend on to assess performance and compliance with security control requirements and, when needed, help you develop corrective action plans.

The HITRUST website enables you to search for Readiness Licensees and External Assessors by industry or by name. You can also find numerous other resources to assist and guide you.

Summary

The HITRUST CSF has been adopted by thousands of organizations as the most efficient means to achieve, demonstrate, maintain, and assure effective cybersecurity and compliance with security regulations that apply to their organizations. 

Thoroughly preparing for HITRUST Certification is essential. To paraphrase an old adage, an ounce of readiness is worth a pound of failure. The following questions will help determine if your organization is ready for HITRUST Certification:

• Have we clearly defined why we want HITRUST Certification?
• Do we know which level (e1, i1, or r2) best suits our situation?
• Do we need to include one of the AI assessments?
• When was our most recent security risk assessment completed?
• Have we remediated all identified gaps and vulnerabilities?
• Do we have written policies and procedures in place?
• Are our employees trained to follow them consistently?
• Is our documentation complete and able to withstand an audit?
• Do we possess the internal capabilities and external resources to manage this effort?

As a highly experienced cybersecurity and compliance firm, 24By7Security can help you answer these questions and chart a course for successful HITRUST Certification. And as a HITRUST Readiness Licensee, we are authorized to assist you with your Readiness Assessment and related activities to prepare you for a smooth HITRUST journey. Contact us for a complimentary HITRUST Readiness briefing or to talk about your next steps.