HITRUST vs. HIPAA: Ensuring Data Security and Compliance

While both HITRUST and HIPAA have substantial relevance in ensuring data security in the healthcare sector, they are very different standards. HIPAA, or the Health Insurance Portability and Accountability Act of 1996, is a federal law, whereas HITRUST is a comprehensive control framework. In this article, we’ll explore what sets them apart while addressing two common questions: “What’s the difference between HIPAA and HITRUST, and if I adhere to one, does it imply compliance with the other?”

Designed by Freepik

HIPAA: An Overview

HIPAA, short for the Health Insurance Portability and Accountability Act, is a pivotal U.S. law established to safeguard the privacy and security of protected health information (PHI). It introduces three crucial rules applicable to covered entities and business associates: Privacy, Security, and Breach Notification.

Covered entities encompass healthcare providers, plans, and clearinghouses, while business associates are organizations contracted to handle ePHI on behalf of covered entities. Under HIPAA, these entities must adhere to three types of security safeguards: Physical, Technical, and Administrative.

Achieving compliance entails conforming to organizational requirements, policies, procedures, and documentation standards. Each of these components comprises specific standards and specifications designed to address risks concerning the confidentiality, integrity, and availability of PHI.

It’s noteworthy that HIPAA doesn’t offer an official certification process. Instead, compliance is demonstrated through risk assessments and control documentation. The enforcement of HIPAA falls under the jurisdiction of the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR), which investigates potential violations and levies penalties, including financial consequences and, in certain cases, criminal charges.

HITRUST: An Overview

On the contrary, HITRUST is an organization that introduced the HITRUST CSF (Common Security Framework) in 2009. Initially tailored to support the healthcare industry and protect ePHI and PHI, the HITRUST CSF has expanded to accommodate organizations from diverse sectors.

The HITRUST CSF amalgamates several compliance frameworks, including HIPAA, NIST, PSI, and ISO, alongside distinctive HITRUST requirements. It encompasses control categories, objectives, and specifications distributed across multiple assessment domains. Achieving HITRUST certification mandates meeting specific scoring levels for each assessment domain, with the choice between a 1-year (i1) or 2-year (r2) certification.

Organizations undergoing HITRUST assessments can customize their requirements based on organization type, size, systems, and applicable legal regulations. While self-assessment is an option, engaging a qualified CSF assessor organization is advisable, even for non-certifiable assessments. These assessors can identify strengths and weaknesses in your information security program and offer recommendations.

HITRUST vs. HIPAA: What Sets Them Apart?

• Penalties for Breaches/Non-Compliance:

HIPAA imposes defined penalties for security breaches, including fines and potential criminal consequences, depending on the violation. In contrast, HITRUST compliance doesn’t result in direct federal liability, although contractual and commercial repercussions may occur.

• Certification Options:

HIPAA lacks an official certification process, while HITRUST offers two certification options: Implemented (1-year) and Risk-based (2-year), providing organizations with flexibility in their compliance journey.

• Range/Applicability:

HIPAA’s requirements are sometimes considered subjective and vague, necessitating additional assessments like ISO or NIST for comprehensive compliance. HITRUST’s risk-based approach tailors requirements based on an organization’s specific risks, making it suitable for various industries and sizes.

While HITRUST aligns with many HIPAA requirements, achieving HITRUST certification doesn’t automatically ensure HIPAA compliance. HITRUST provides measurable criteria and objectives. However, due to potential variations in HIPAA’s vague language, organizations may still need to address additional aspects of the HIPAA Security Rule to achieve complete compliance.

How HIPAA and HITRUST Both Enhance Data Security and Compliance

HIPAA enhances data security through comprehensive regulations and practices that equip healthcare professionals and organizations with the tools and knowledge necessary to safeguard patient data. Here’s a summary of how HIPAA itself enhances data security:

• Cybersecurity Measures: HIPAA sets stringent standards for protecting electronic protected health information (ePHI). 
• Encryption: Under the current HIPAA Security Rule, encryption of ePHI at rest and in transit is an addressable implementation specification. Organizations must determine whether encryption is reasonable and appropriate for their environment. If it is not, they must document why and implement an equivalent alternative measure when reasonable and appropriate. HHS has proposed making encryption required, with limited exceptions, but that proposal has not been finalized (see how the proposed HIPAA Security Rule changes could affect healthcare compliance).
• Access Controls: HIPAA emphasizes access controls, including principles like least privilege and role-based access. It limits data access to authorized personnel and underscores the importance of unique user IDs, strong authentication methods, and regular audits to monitor access patterns and identify anomalies. 

HITRUST enhances data security through its adaptable framework, designed to address evolving healthcare mandates, laws, regulations, and emerging technologies. Here’s a summary of how HITRUST enhances data security:

• Adaptability: HITRUST CSF (Common Security Framework) was created to be adaptable to changing healthcare requirements. It can incorporate new mandates, laws, and regulations seamlessly. Healthcare organizations are increasingly requiring their business associates to be HITRUST certified, as it aligns with the HIPAA compliance framework and integrates relevant regulations into its framework.
• Comprehensive Security: HITRUST recognizes that the cybersecurity landscape continually evolves with new threats. To address this, HITRUST expands its framework to include more robust privacy controls and a wider security scope. It is flexible and versatile, adapting to various security standards and regulations, such as HIPAA, HITECH, GDPR, NIST, PDPA, and CCPA.
• Continuous Updates: HITRUST consistently updates its framework to remain current and effective in countering emerging security threats. This commitment to staying up-to-date ensures that healthcare organizations using HITRUST can adapt to the evolving security landscape and address new challenges effectively.
• Risk Assessment and Testing: To attain HITRUST certification, an organization must conduct periodic, in-depth risk assessments of its security operations using a structured methodology that evaluates various factors that may affect security. HITRUST certification necessitates the implementation of several technical controls to validate security measures. These controls encompass HITRUST penetration testing requirements and multiple other security assessments, which must be performed at least once a year.

HITRUST CSF v11.8.0 Expands Current Framework Mappings

HITRUST released CSF version 11.8.0 in May 2026. The release continues HITRUST’s effort to consolidate overlapping requirements while adding and refreshing mappings to current standards and regulatory sources.

Version 11.8.0 adds mappings for the OWASP Top 10 for LLM Applications 2025 and ISO/IEC 29100:2024, strengthening its coverage of AI application security and privacy frameworks. It also adds NIST SP 800-137 and Virginia SEC530 mappings while refreshing mappings for PCI DSS v4.0.1, the AICPA SOC 2 Trust Services Criteria, and the Texas Medical Records Privacy Act.

Leverage Centraleyes To Protect PHI and Enhance Your Data Security

Are you looking for a platform that can actualize your commitment to robust information and data security practices?

Centraleyes has disrupted the healthcare GRC market with its standout features that make risk and compliance management manageable.

• Save hundreds of hours by leveraging our cutting-edge platform’s 100+ pre-loaded frameworks and automation capabilities.
• Fully customize our enterprise risk register with your specific risks, controls, processes,

and use cases. 

• Quantify and manage inherent and residual risk across the organization.
• Oversee mitigation plans that are automatically created by the platform.
• Access data-rich insights and reporting tools.
• Maximize executive-level support and decision-making with intuitive reports that highlight cyber risk in business terms.