Enacted in 1996, the Health Insurance Portability and Accountability Act (HIPAA) sets essential rules for protecting the privacy and security of medical information. While HIPAA continues to play a critical role in healthcare compliance, many organizations encounter confusion when comparing it to the Health Information Trust Alliance (HITRUST). HITRUST is often mistakenly thought to be the same as HIPAA. In this article, we’ll break down HITRUST vs HIPAA, explain their differences, and help you understand which framework applies to your organization.
What is HIPAA?
HIPAA, the Health Insurance Portability and Accountability Act, is the primary federal law protecting healthcare information. Enacted in 1996, it includes five titles that aim to:
- Ensure health insurance portability.
- Reduce fraud and abuse in healthcare.
- Establish standards for electronic billing and transactions.
In 2003, the U.S. Department of Health and Human Services (HHS) introduced the national data privacy rule under HIPAA. This rule:
- Grants individuals rights to access their protected health information (PHI).
- Defines how covered entities can use and disclose PHI.
- Requires written consent before sharing health information for purposes not allowed under the privacy rule.
Covered entities are also required to assess risks and implement measures to manage and mitigate them effectively. These entities include:
- Healthcare providers: Doctors, nurses, dentists, hospitals, nursing homes, urgent care clinics, and pharmacies that electronically transmit health information.
- Health plans: HMOs, insurance companies, employer-sponsored or government-backed plans.
- Healthcare clearinghouses: Intermediaries between providers and health plans.
HHS also introduced the HIPAA Security Rule and Enforcement Rule, which:
- Security Rule: Sets standards for protecting electronic healthcare information (ePHI).
- Enforcement Rule: Defines compliance requirements and penalties for violations.
HIPAA defines health information broadly, including data about a patient’s past, present, or future physical or mental health, treatments, and payment history. This information may exist in electronic, oral, or paper form. “Individually identifiable health information” includes details like name, date of birth, social security number, and address.
HIPAA also requires business associates, entities that perform services without direct patient interaction, to follow HIPAA standards through written contracts. Examples include:
- Actuarial, accounting, billing, or consulting services
- Data aggregation, analysis, or transmission
- Claims processing or administration
- Quality assurance and patient safety activities
Subcontractors of business associates must also comply with HIPAA regulations.
However, HIPAA compliance only applies to covered entities, their business associates, and subcontractors. Other organizations that handle health information, such as alternative medicine practitioners, fitness apps, schools, insurance companies, or law enforcement agencies, are not required to comply.
What is HITRUST?
HITRUST is an industry-led initiative designed to help healthcare organizations achieve HIPAA compliance through a unified and certifiable security framework. Unlike HIPAA, which is a federal law, HITRUST provides a structured program for organizations to demonstrate compliance with HIPAA and other standards.
Founded in 2007 as a non-profit organization, HITRUST developed the Common Security Framework (CSF). The CSF integrates HIPAA requirements with other widely recognized frameworks, including:
- NIST (National Institute of Standards and Technology)
- ISO (International Organization for Standardization)
The HITRUST CSF is organized into 19 domains covering key areas of information security and risk management:
- Access control
- Audit logging and monitoring
- Business continuity and disaster recovery
- Configuration management
- Data protection and privacy
- Endpoint protection
- Education, training, and awareness
- Information protection program
- Incident management
- Mobile device security
- Network protection
- Risk management
- Password management
- Physical and environmental security
- Portable media security
- Transmission protection
- Third-party security
- Vulnerability management
- Wireless protection
HITRUST also defines 135 specific controls and three implementation levels. To achieve a given level, an organization must satisfy all requirements from the preceding levels.
- Level 1: Foundational security requirements
- Level 2: Builds on Level 1 with more advanced protections
- Level 3: The most comprehensive level, requiring full implementation of all 135 controls
An organization achieves HITRUST CSF certification only after successfully meeting all applicable requirements across the chosen level, demonstrating robust protection of sensitive health information.
Bridging to HIPAA:
While HIPAA sets the legal standards for protecting patient data, HITRUST provides a structured, certifiable way to meet and exceed those standards. Understanding HITRUST vs HIPAA helps organizations determine which framework best suits their compliance and security needs.
Differences Between HITRUST and HIPAA
Understanding HITRUST vs HIPAA is essential for healthcare organizations navigating compliance and data security requirements. The differences can be grouped into two main areas: nature and compliance process.
1. Nature of the Regulation
The primary distinction is that HIPAA is a federal law, enacted in 1996, establishing mandatory standards for protecting healthcare information. Before HIPAA, there were no nationwide requirements for healthcare data security.
In contrast, HITRUST is a private, industry-led initiative composed of healthcare providers, hospitals, insurers, and other stakeholders. It developed the Common Security Framework (CSF), a certifiable framework that integrates HIPAA requirements with additional standards like ISO 27001 and NIST.
| Feature | HIPAA | HITRUST |
| Type | Federal law | Private certification framework |
| Purpose | Sets legal requirements for protecting PHI | Provides a structured process to demonstrate compliance with HIPAA and other frameworks |
| Scope | National, regulatory | Optional, organization-driven |
| Enforcement | HHS penalties for violations | Certification-based assurance |
2. Compliance Process
HIPAA Compliance:
- Requires covered entities to conduct annual risk analyses and implement reasonable safeguards for PHI.
- Risk analysis must consider:
- Flow of PHI within the organization
- Hardware, software, and storage handling PHI
- Third-party and business associate handling of PHI
- Human error and security vulnerabilities (e.g., phishing, misplacement)
- Organizations must implement a risk management plan, assign a compliance officer, conduct self-audits, and maintain staff training and documentation.
While HIPAA sets standards and guidelines, it does not provide a detailed blueprint for implementation. Organizations often struggle to translate the law into actionable security controls.
HITRUST Compliance:
- Provides a structured certification process that incorporates HIPAA, NIST, ISO, and other frameworks.
- Requires full implementation of the CSF controls to achieve certification levels 1–3.
- Offers a comprehensive governance and risk management approach, ensuring organizations not only meet HIPAA requirements but also exceed them.
- Designed for organizations seeking higher assurance and a documented, auditable process for security and compliance.
Key Takeaway:
- HIPAA sets the legal foundation for protecting PHI.
- HITRUST provides a certifiable, actionable framework to implement, manage, and prove compliance. Many organizations adopt HITRUST as a tool to meet and exceed HIPAA requirements.
Taking the First Step Towards HITRUST Compliance
In today’s healthcare industry, HITRUST compliance is widely recognized as a leading framework for managing data security and regulatory adherence. While HIPAA sets the legal standards for protecting health information, HITRUST provides a structured, certifiable process to implement and exceed those requirements.
HITRUST goes beyond HIPAA by offering a comprehensive framework and certification process, filling gaps where HIPAA’s directives may be unclear. This makes it an ideal solution for healthcare organizations seeking to strengthen their security posture, manage risk, and demonstrate compliance to regulators, partners, and patients.
Partnering with a certified HITRUST assessor, like RSI Security, can give your organization a competitive advantage—especially as cybercrime and data security threats continue to rise in the healthcare sector. With expert guidance, your organization can confidently navigate the HITRUST certification process and achieve measurable security and compliance outcomes.