HITRUST certification: What is it and how does it relate to HIPAA compliance?

The healthcare industry is among the most frequently targeted by cybercriminals. Hospitals, private practices, insurance companies, and medical suppliers are all regularly targeted.

Ransomware attacks can disrupt patient care while data breaches expose millions of medical records, making the consequences of a breach extend far beyond financial losses.  

Maintaining smooth operations and protecting personal health information have never been more important, and compliance with healthcare security standards is a top priority for providers, insurers, and the organizations that support them.

Two of the most commonly discussed frameworks in healthcare cybersecurity are HIPAA and HITRUST. Although they are closely related, they serve different purposes. HIPAA establishes the legal requirements for protecting protected health information (PHI), while HITRUST provides a certifiable framework that helps organizations implement and validate the security controls needed to meet those requirements.

This guide explains the differences between the two, who needs HITRUST certification, how it supports HIPAA compliance, and why combining compliance with a Zero Trust security strategy can help organizations better defend against today's evolving cyber threats.

What is HITRUST?

HITRUST (Health Information Trust Alliance) is a widely recognized cybersecurity and risk management certification framework. It incorporates other internationally accepted security frameworks, such as ISO 27001 and NIST 800-53, to create a baseline set of security and privacy controls tailored to your organization.

The HITRUST Common Security Framework (CSF) is universal, comprehensive, and flexible, able to map a broad set of critical control frameworks. It is designed to work with any number of sectors, at any risk level and is regularly updated to keep up with the quick changing threat landscape.

Key benefits:

Risk management ‍

HITRUST, powered by its cyber threat adaptive framework, enables organizations to identify, manage, and stay ahead of emerging threats. Its controls ensure every action contributes to reducing risk and strengthening cybersecurity posture.

Security standardization

HITRUST standardizes security via the Common Security Framework, which is a comprehensive and certifiable standard that is strengthened together with over 60 cybersecurity and privacy regulations such as HIPAA, ISO, NIST, and GDPR.

Third-party validation

Every certification is tested by an accredited firm and reviewed by HITRUST. This process results in trusted reporting and certification that stakeholders can rely on for business decisions.

Alignment with other frameworks

HITRUST maps overlapping controls from other frameworks which allows organizations to map once and comply with many frameworks helping to reduce duplicate audits across multiple frameworks. For instance, a significant portion of ISO 27001 requirements overlap with HITRUST controls. NIST compliance reports are also offered as an add-on.

HITRUST originated in the healthcare sector and maps specific and actionable controls directly to HIPAA’s administrative, physical, and technical safeguards. And while not legally required, HITRUST certification has become a gold standard for data protection.  

As a result, many major hospitals, health systems, and insurance companies highly recommend and sometimes require their vendors and partners to obtain HITRUST certification.

What is HIPAA?

HIPAA (Health Insurance Portability and Accountability Act) is a U.S. federal law establishing requirements to protect sensitive patient health information and regulate how it can be used and disclosed.

HIPAA does not have an official government certification, but HITRUST offers formal, rigorous third-party assessment and certification. It is industry agnostic, providing detailed and prescriptive technical, physical, and administrative controls tailored to organizational risk.

HIPAA (Health Insurance Portability and Accountability Act) was created in 1996 and established a federal law designed to protect sensitive patient health information and prevent it from being disclosed without the patient’s consent or knowledge.

Key regulations include:

Privacy Rule

A federal standard that protects an individual’s medical records and personal health information (PHI). It restricts how healthcare providers, health plans, and clearinghouses can use or disclose sensitive patient data without authorization, while also giving individuals explicit rights to access and correct their health records.

Security Rule

Establishes national standards to protect electronic protected health information (ePHI). It mandates that covered entities and business associates implement comprehensive administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of patient data.

Breach Notification Rule

Requires covered entities and business associates to report breaches of unsecured protected health information (PHI) to affected individuals, the U.S. Department of Health and Human Services (HHS), and sometimes the media.

HITRUST vs. HIPAA: What’s the difference?

HIPAA is a legal requirement for hospitals, healthcare providers, insurance providers, and their vendors, but it is not a certification. It is enforced by the HHS.

HITRUST is a certifiable framework that maps controls to HIPAA requirements to help demonstrate compliance. While not legally required, it is often recommended for vendors for hospitals, health systems, and insurance companies.

How does HITRUST support HIPAA compliance?

The HITRUST CSF directly maps to HIPAA regulations, providing a prescriptive and auditable blueprint. HIPAA specifies what outcomes are required, while HITRUST provides a more prescriptive approach to how those outcomes can be achieved.

Here are the HIPAA safeguards and how HITRUST achieves them:

• Access controls: HITRUST requires strong password policies, role-based access, multi factor authentication, and session timeouts which align with HIPAA’s technical safeguards for access management.
• Risk assessments: HIPAA requires organizations to perform risk analysis, while HITRUST provides a more formalized and rigorous methodology to identify threats, assess vulnerabilities, and document mitigation steps.
• Data protection: HITRUST requires appropriate encryption controls for data both at rest and in transit, policies on secure data disposal, and how data is classified. It extends beyond HIPAA by incorporating additional best practices from NIST and ISO.
• Incident response: HITRUST requires organizations to have a documented and tested incident response plan. The plan includes procedures for identifying, mitigating, and communicating breaches, matching HIPAA’s Breach Notification Rule requirements.
• Monitoring and auditing: HITRUST requires continuous audit logging, log review, and system activity monitoring to prevent unauthorized modifications to electronic protected health information (ePHI).

Who needs HITRUST certification?

If your organization handles sensitive data, especially protected health information (PHI) in the healthcare field, obtaining HITRUST certification should be a top priority.  

This includes healthcare providers, insurance companies, healthcare technology companies, and cloud and SaaS providers.

It is considered the gold standard for data protection and incorporates several other cybersecurity frameworks. HITRUST offers different assessments and certifications depending on your organization’s risk profile and security maturity.

While HITRUST still is not required, many U.S. health insurance companies and hospital systems have come to expect their vendors to hold HITRUST certification.

How to achieve HITRUST certification

To obtain HITRUST certification, your organization must undergo a detailed audit conducted by an authorized external assessor. This assessor evaluates your security controls against the HITRUST CSF. The appropriate assessment type is selected based on your organization’s data profile, and the assessor helps define the scope, perform the assessment, and validate the results.

Using the HITRUST MyCSF platform, your organization evaluates its internal controls to identify any gaps. You must then address these gaps by implementing the necessary policies, procedures, and technical controls. Once implemented, controls must operate for a defined observation period, typically 60 to 90 days before testing.

The assessor reviews the results, assigns control maturity scores across domains, and submits the finalized documentation to HITRUST for quality assurance. Upon approval, HITRUST issues the certification.

Types of assessments

HITRUST assesses information security based on six core principles: transparency, scalability, consistency, accuracy, integrity, and efficiency. It has multiple options for assessment levels and certifications. The appropriate assessment type should be selected based on the organization’s risk profile and customer requirements.

HITRUST e1

A one-year assessment that expands beyond the e1 with 182 curated controls mapped to evolving cyber risks.

HITRUST r2

A certification made for organizations that manage highly sensitive data or operate critical systems. This certification is aligned with the most demanding cybersecurity and regulatory requirements and is the gold standard for scalable, threat adaptive assurance.\

HITRUST AI Security

Designed to provide AI platform and service providers with relevant, practical security controls and methodologies to confidently adopt and secure AI technology. AI Security assessments and certifications are available as a standalone certification or paired with e1, i1, or r2.

HITRUST AI Risk Management

Offers insights based on 51 AI risk management controls. This assessment provides an efficient control specification that allows organizations to understand and report on their performance in ISO and NIST terms.

HITRUST certification requirements

HITRUST certification evaluates an organization's security program across a broad range of administrative, technical, and physical controls. It assesses whether security policies are implemented, consistently enforced, and effective at protecting sensitive information.

While the specific requirements vary depending on the assessment type and an organization's risk profile, the following control categories form the foundation of most HITRUST assessments.

• Access Control: Requires unique user IDs and multi factor authentication for all access, as well as access reviews to ensure strict adherence to least privilege access. Lifecycle management establishes processes for onboarding, changes, and termination of employees.
• Risk Management: Regular assessments are performed to identify, analyze, and evaluate security threats and vulnerabilities. Documentation for corrective action plans to remediate high risk events and continuous monitoring over the risk environment and tracking accepted risks.
• Asset Management: Maintaining an accurate, updated inventory of all information assets and implementing data classifications. Policies and procedures for how to handle, store, and dispose of data and physical assets, along with an acceptable use policy for company owned assets.
• Incident Response: Formal documentation for incident response and remediation along with escalation paths. Regular training to validate the readiness of the response team and postmortem review of previous incidents.
• Security Monitoring: Implementing audit logs for user activity, system events, and security exceptions. Ensuring that the logs are safe and cannot be altered. Additional vulnerability scanning, along with patch management, is also required.
• Vendor Risk Management: For third parties, performing initial risk assessments and classifying them and what data they can access. Enforce contractual obligations that require vendors to uphold specific security and privacy standards. Finally, regular reassessments and reviews of third-party cyber risk profiles

How Zero Trust architecture supports HITRUST and HIPAA compliance

ThreatLocker’s Zero Trust platform is aligned to support HITRUST and HIPAA compliance through:

• Privileged access management: Limiting access to protected health information and enforcing least privileged access for compliance, reducing the attack surface and limiting opportunities for unauthorized access.
• Zero Trust cloud access: Neutralize phishing and token theft; access is denied unless the request originates from an approved device.
• Data storage access control :– stops data exfiltration by enforcing precise policy-based control over local folders, network shares, and cloud storage to prevent data breaches.
• Allowlisting: Block ransomware and any unapproved files from executing. Enforce deny-by-default application control for compliance.
• Ringfencing: Prevent trusted tools from launching unauthorized processes or reaching the internet, contain supply-chain compromises, and block fileless and tool-chaining attacks to limit how applications interact so attackers can’t pivot, escalate, or exfiltrate data.

Taking control of compliance with real-time audit visibility, ThreatLocker helps streamline HITRUST compliance by providing centralized insight into security activity across your environment.  

With all executable activity, file access, and network communications automatically logged and searchable, your team can easily demonstrate policy enforcement, monitor behavior, and validate security controls.

FAQs

What is HITRUST in simple terms?

HITRUST is a certification framework that incorporates other frameworks such as ISO, NIST, GDPR, amongst others to certify an organization’s cybersecurity posture.

Is HITRUST required by HIPAA?

No, but HITRUST is recognized as the gold standard for data protection within the healthcare industry, and many hospitals and insurance providers strongly recommend or require HITRUST certification from their vendors and partners.

What is the difference between HITRUST and HIPAA?

HIPAA is a legal requirement, but not a certification, for protected health information, while HITRUST is a certification that demonstrates information security controls.

How long does HITRUST certification take?

HITRUST certification typically takes between six to 12 months to complete all phases required. Timelines vary depending on which assessment is chosen and on organizational readiness.

• e1 uses a smaller subset of controls and takes between one to three months
• i1 uses moderate controls and takes between three to six months
• r2 is the most comprehensive and takes between six to 12 months

Who should pursue HITRUST certification?

HITRUST certification isn’t limited to the healthcare industry because it incorporates other frameworks, and it shortens the time in pursuing additional industry agnostic framework certifications. Any organization that handles protected sensitive information should pursue HITRUST certification.

Does HITRUST guarantee HIPAA compliance?

No, while HITRUST does not legally guarantee HIPAA compliance, the certification is widely considered the most rigorous standard in healthcare data security.