HITRUST vs HIPAA: Key Differences Explained
In the healthcare and life sciences industry, protecting sensitive patient information is not just a regulatory requirement but also a cornerstone of building trust. Safeguarding patient data is fundamental to trust in the healthcare and life sciences sector, and it goes far beyond regulatory compliance. Organizations managing electronic health records (EHRs), medical billing, or any protected health information (PHI) must adhere to strict data protection standards. Two of the most recognized names in this space are HIPAA and HITRUST.
While often mentioned together, these frameworks serve distinct roles. HIPAA establishes the legal foundation for protecting health information, whereas HITRUST provides a certifiable framework that helps organizations operationalize and demonstrate compliance with HIPAA and other security standards.
Key Takeaways:
HIPAA = mandatory U.S. law for healthcare entities protecting patient data.
HITRUST = voluntary, certifiable framework covering HIPAA plus other standards.
HIPAA is the baseline, HITRUST builds on it to create audit-ready, trusted compliance.
Non-healthcare companies often choose HITRUST to strengthen security and attract healthcare clients.
Together, they form a robust compliance strategy that mitigates risk and builds trust.
What Is HITRUST?
The Health Information Trust Alliance (HITRUST), founded in 2007, is best known for creating the HITRUST Common Security Framework (CSF). This certifiable framework was designed to simplify compliance and strengthen data protection in healthcare and other industries handling sensitive information.
Unlike single-standard approaches, the HITRUST CSF combines elements from multiple well-recognized regulations and frameworks, including:
HIPAA – Health Insurance Portability and Accountability Act
NIST – National Institute of Standards and Technology
ISO 27001/27002 – International security management standards
PCI DSS – Payment Card Industry Data Security Standard
GDPR – General Data Protection Regulation
COBIT and CMMC – Governance and cybersecurity models
By integrating these requirements, HITRUST offers a comprehensive, prescriptive, and adaptable framework that organizations can rely on to address compliance obligations more efficiently.
Key aspects of HITRUST CSF include:
Scalability – Designed for organizations of all sizes and industries, with requirements adjusted based on risk levels and scope.
Certification – A rigorous process involving independent assessments and risk evaluations to verify that privacy and security controls are effectively implemented.
Credibility and trust – Certification demonstrates a strong commitment to safeguarding data, often improving credibility with partners, patients, and regulators.
Operational efficiency – Reduces the complexity of managing multiple compliance requirements separately by consolidating them into one structured approach.
In essence, HITRUST provides both a roadmap and a stamp of assurance, helping organizations not only meet regulatory demands but also demonstrate a proactive stance on risk management and data protection.
What Is HIPAA?
The Health Insurance Portability and Accountability Act (HIPAA) is a U.S. federal law enacted in 1996 to protect the privacy and security of patient health information. Administered by the Department of Health and Human Services (HHS), HIPAA establishes national standards for how medical data is stored, accessed, and shared.
HIPAA applies to both covered entities, such as healthcare providers, health plans, and healthcare clearinghouses, and their business associates, which may include billing companies, cloud service providers, lawyers, and other third parties handling protected health information (PHI).
The law introduced several key rules that organizations must follow to remain compliant:
Privacy Rule – Limits who can access and share PHI.
Security Rule – Requires administrative, physical, and technical safeguards to protect electronic PHI (ePHI).
Breach Notification Rule – Mandates notification of affected individuals within 60 days of discovering a breach.
Enforcement Rule – Outlines the procedures for investigating violations and applying penalties.
Omnibus Rule – Expands patient rights by giving individuals greater control over their health records.
At its core, HIPAA is designed to ensure the confidentiality, integrity, and availability of sensitive health information. Compliance is not optional; organizations that fail to meet HIPAA requirements face significant legal and financial consequences, along with reputational risks.
Learn more about: Understanding Reputational Risk: Definition, Causes, and Effects
Achieving HITRUST and HIPAA Compliance: Pathways and Benefits
Meeting the requirements of HITRUST and HIPAA may feel daunting at first, but a clear approach can make the process manageable. While both frameworks share the goal of safeguarding sensitive health information, the way organizations achieve compliance differs significantly. Understanding these paths, along with the benefits they unlock, helps healthcare providers, insurers, and business partners strengthen their security posture while building trust.
How to Achieve HITRUST Compliance
HITRUST, unlike HIPAA, is a certifiable framework. To achieve certification, organizations undergo a validated assessment. This process requires partnering with an authorized external assessor who conducts a thorough audit of security practices, controls, and policies. The findings are then submitted to the HITRUST Alliance, which reviews the results and issues certification if the organization meets the required standards.
Benefits of HITRUST Compliance:
Streamlined compliance management: HITRUST’s CSF consolidates multiple frameworks into one, supporting the principle of “assess once, report many.” This reduces the burden of managing overlapping compliance requirements.
Efficient third-party risk management: Certification enables participation in the HITRUST Third-Party Assurance Program, which simplifies vendor risk assessments and helps maintain stronger supply chain security.
Cost advantages in cybersecurity insurance: Because HITRUST is widely recognized as a rigorous standard, certified organizations may qualify for reduced premiums or more favourable terms in their cyber insurance policies.
How to Achieve HIPAA Compliance
HIPAA does not offer a certification process but instead requires organizations to demonstrate ongoing adherence to its rules. Compliance depends on the size, complexity, and function of each entity, but generally includes:
Conducting annual self-audits to identify compliance gaps.
Developing and implementing remediation plans for those gaps.
Documenting clear policies and procedures aligned with HIPAA standards.
Providing annual training to staff on compliance practices.
Establishing business associate agreements with vendors who handle PHI.
Maintaining an incident management plan that follows the Breach Notification Rule.
To prove compliance, many organizations work with external audit firms for independent assessments and attestations. Non-compliance can lead to heavy fines, reputational damage, and in severe cases, even criminal penalties.
Benefits of HIPAA Compliance:
Standardized transactions: HIPAA requires standardized formats for electronic claims, eligibility checks, and payments, reducing administrative errors and enhancing efficiency across the healthcare ecosystem.
Improved data privacy and access control: The framework provides clear guidelines for protecting PHI while ensuring necessary access for authorized care providers and insurers, which supports more effective healthcare delivery.
Enhanced protection against cyber threats: By mandating security safeguards, HIPAA helps organizations defend PHI against theft, breaches, and unauthorized exposure, thereby strengthening resilience against growing cyber risks.
HITRUST and HIPAA: Advantages and Disadvantages
Both HIPAA and HITRUST play important roles in safeguarding sensitive health information, but each comes with its own set of strengths and challenges. Understanding these can help organizations decide how to align compliance with their operational and security goals.
Advantages of HIPAA
Streamlined administration
HIPAA was instrumental in modernizing the healthcare industry by moving away from paper records to secure electronic systems. It introduced operating rules, unique identifiers, and standardized code sets that simplified healthcare transactions. This standardization not only increased efficiency but also reduced administrative costs by enabling smoother communication between providers, insurers, and other stakeholders.
Protection of PHI
At its core, HIPAA is designed to safeguard Protected Health Information (PHI). Compliance reduces the risk of mishandling and theft of sensitive data, strengthening patient trust and fostering a culture of accountability. HIPAA-compliant organizations are also better equipped to detect and respond to data breaches, limiting their liability, reducing risk exposure, and minimizing recovery costs when incidents occur.
Must read: How to Prevent Data Breaches in Healthcare
Disadvantages of HIPAA
Complexity of compliance
While HIPAA sets critical standards, achieving compliance is not straightforward. It intersects with multiple other frameworks, including ISO, NIST, PCI-DSS, and HITECH, making it difficult for organizations to map and align their controls. This complexity demands considerable effort, resources, and expertise, often leaving organizations vulnerable to compliance gaps.
No official certification
One of the biggest challenges of HIPAA is the absence of an official certification mechanism. Although organizations can demonstrate compliance through audits and internal processes, there is no universally accepted certification to validate compliance. This makes it harder to instill confidence in business partners and can create difficulties during regulatory reviews or investigations.
Advantages of HITRUST
Unified and comprehensive framework
HITRUST integrates HIPAA requirements along with other widely recognized standards into a single, certifiable framework. Instead of assessing compliance with multiple regulations separately, organizations can rely on HITRUST to provide a holistic risk management program. This streamlining significantly reduces the complexity of compliance efforts.
Flexibility and scalability
HITRUST is not a one-size-fits-all framework. It can be adapted to organizations of varying sizes and maturity levels, making it accessible to both small providers and large healthcare systems. This scalability ensures that organizations can align their compliance strategies with their resources and security objectives.
Certification and competitive advantage
Unlike HIPAA, HITRUST offers a certifiable standard. Achieving HITRUST certification provides external validation of an organization’s commitment to protecting patient data. This not only strengthens trust with patients and partners but also offers a competitive edge in industries where data protection is paramount.
Disadvantages of HITRUST
High implementation costs
Achieving HITRUST certification is resource-intensive. It may require significant investment in technology upgrades, staff training, and process restructuring. For many organizations, particularly smaller ones, the cost of implementation can be a major barrier.
Need for ongoing oversight
HITRUST certification is not a one-time achievement. Organizations must commit to continuous oversight, including detailed documentation, periodic testing of controls, and robust governance policies. While this ensures a stronger compliance posture, it also adds to the operational burden of maintaining the program.
Ultimately, choosing between HIPAA and HITRUST often comes down to whether an organization wants to meet the minimum regulatory baseline or pursue a more robust, certifiable framework that demonstrates a higher level of commitment to data protection.
At Auditive, we recognize that navigating compliance frameworks can be complex and resource-heavy. Our expertise lies in simplifying this journey by aligning your security practices with industry standards while ensuring your organization remains agile and resilient.
Difference Between HIPAA vs HITRUST
Although HIPAA and HITRUST are closely associated with healthcare data protection, they are not interchangeable. Each serves a unique purpose, and understanding the distinction between them is essential for organizations aiming to build a robust compliance and security program.
1. Type and Nature
HIPAA is a federal law passed in 1996 to safeguard patient health information. Compliance is mandatory for all covered entities, such as hospitals, clinics, insurance companies, and government health programs, as well as their business associates, like consultants, law firms, and IT providers. Violations can lead to financial penalties, lawsuits, or even criminal charges, depending on severity.
HITRUST, however, is not a law but a certifiable security framework created by a private organization. It provides a structured set of controls through its Common Security Framework (CSF), which integrates standards from HIPAA, ISO, NIST, SOC 2, PCI DSS, and more. Unlike HIPAA, HITRUST can be applied across industries, not just healthcare.
In essence, HIPAA is the rule book, while HITRUST is the toolkit to help organizations apply those rules effectively and prove compliance.
2. Scope of Compliance
HIPAA has five core titles, with Title II being the most relevant for data privacy and security. It covers rules on privacy, transactions and code sets, unique identifiers, security, and enforcement. Its scope is healthcare-specific, focusing solely on Protected Health Information (PHI).
HITRUST goes beyond healthcare. Its CSF incorporates multiple standards, giving organizations a comprehensive, prescriptive framework to manage not just PHI but any sensitive or regulated data. HITRUST certification demonstrates a mature, industry-recognized security posture that aligns with multiple compliance obligations at once.
3. Certification and Validation
HIPAA does not provide a certification pathway. Organizations can only strive for HIPAA compliance, validated either internally or through third-party audits, but there is no official recognition of being “HIPAA certified.”
HITRUST is different. It offers a formal certification process, where an organization undergoes a rigorous review of controls, documentation, and practices by accredited assessors. The certification comes in tiers: e1 (basic), i2 (moderate), and r2 (comprehensive), allowing flexibility based on organizational needs and complexity.
This makes HITRUST especially valuable for companies that want proof of compliance to share with clients, partners, or regulators.
Also look into: Third Party Contract Management: Steps and Best Practices
4. Enforcing Body
HIPAA is enforced by the Office for Civil Rights (OCR) under the U.S. Department of Health and Human Services (HHS). Non-compliance is met with fines that can range from thousands to millions of dollars, depending on the nature and severity of the violation.
HITRUST, by contrast, is developed and governed by HITRUST Alliance, a private company headquartered in Texas. It works with industry stakeholders to evolve the CSF, but enforcement is voluntary; organizations choose to pursue certification, and non-compliance carries no legal penalty.
5. Application and Implementation
HIPAA compliance is ongoing. Covered entities must conduct periodic risk analyses, establish administrative, technical, and physical safeguards, and maintain documentation to demonstrate compliance if audited by OCR.
HITRUST certification is more structured and time-intensive. The process generally spans 6–18 months, involving four stages: gap analysis, remediation, assessment, and validation. The HITRUST MyCSF portal allows organisations to perform self-assessments, assign controls, and undergo external audits for certification.
6. Cost Considerations
HIPAA and HITRUST also differ significantly in cost:
HIPAA Costs (Typical Estimates)
Small entities:
Risk analysis: ~$2,000
Remediation: $1,000–$8,000
Training and policies: $1,000–$2,000
Medium to large entities:
On-site audit: $40,000+
Risk management: $20,000+
Vulnerability scans: ~$800
Penetration testing: from $5,000
Training and policies: $5,000+
HITRUST Costs (Typical Estimates)
e1 Basic: 44 controls, ~5–6 months, approx. $10,000
i2 Moderate: 182 controls, ~5–6 months, approx. $25,200
r2 Comprehensive: 250+ controls, 6–9 months, base $25,000 for 250 controls, then $50 per additional control
While HIPAA costs are tied to compliance activities like audits and training, HITRUST costs are directly linked to the certification level chosen.
Quick Comparison: HIPAA vs HITRUST
| Factor | HIPAA (Law) | HITRUST (Framework) |
|---|---|---|
| Nature | Federal law, mandatory | Private framework, voluntary |
| Industry Scope | Healthcare-specific (PHI) | Multi-industry, broad data security |
| Certification | No official certification | Formal certification (e1, i2, r2) |
| Enforcement | U.S. HHS OCR | HITRUST Alliance (private body) |
| Application | Ongoing compliance obligations | Structured certification process |
| Cost Range | $2,000 – $40,000+ (varies by size) | $10,000 – $25,000+ depending on controls |
Navigating these differences can be overwhelming, especially for organizations that must satisfy multiple regulatory and framework requirements simultaneously.
Similarities Between HITRUST and HIPAA
While HIPAA and HITRUST are distinct in structure and scope, they share a common goal: safeguarding sensitive health information and ensuring that it is managed responsibly. Both frameworks are built around principles that help organizations strengthen their security posture and maintain patient trust.
1. Focus on data security and privacy
At the heart of both HIPAA and HITRUST is the protection of Protected Health Information (PHI). Each framework sets standards and expectations for how PHI should be collected, stored, and shared, ensuring confidentiality, integrity, and availability are maintained at all times.
2. Emphasis on risk management
Risk assessment and management are central to both approaches. HIPAA requires covered entities to conduct regular risk analyses to uncover vulnerabilities, while HITRUST provides a structured, repeatable methodology for ongoing risk management and continuous security improvement.
Also read: How to manage risk in new business strategies
3. Organizational accountability
Both frameworks demand clear accountability when it comes to handling PHI. This includes implementing administrative, technical, and physical safeguards, establishing policies and procedures, training staff, and adopting technologies that protect sensitive data from threats or misuse.
4. Reliance on audits and assessments
Assessment plays a critical role in ensuring compliance. HIPAA compliance is verified through audits conducted by regulatory bodies, whereas HITRUST requires organizations to undergo a formal certification process. Despite these differences, both involve ongoing evaluation to confirm that standards are being met and that security practices remain effective.
Together, HIPAA and HITRUST create overlapping layers of protection that push organizations to prioritize data security, transparency, and accountability in healthcare operations.
Which One Should You Choose? HIPAA or HITRUST
When considering HITRUST vs HIPAA, it’s important to understand that the choice is not a simple either-or. Each serves a distinct purpose, and the right approach depends on your organization’s industry, obligations, and long-term security goals.
HIPAA compliance is mandatory for healthcare providers, insurers, and business associates operating in the United States. It establishes the legal minimum standards for safeguarding patient health information.
HITRUST certification is voluntary, but it goes beyond HIPAA by incorporating multiple frameworks into a single, certifiable model. This makes it valuable for organizations that want to demonstrate a higher level of security maturity.
For many healthcare entities, HIPAA compliance forms the foundation of their data protection program, while HITRUST provides an additional layer of assurance. Non-healthcare organizations, meanwhile, may not be legally bound by HIPAA but often adopt HITRUST to:
Strengthen internal security controls
Build credibility with healthcare clients and partners
Demonstrate alignment with industry-recognized standards
The real decision lies in whether to pursue HITRUST on top of HIPAA. Organizations bound by HIPAA cannot avoid compliance, but HITRUST can transform compliance into a certifiable, auditable process that gives partners and stakeholders greater confidence.
In practice, most forward-looking organizations view HIPAA as the baseline and HITRUST as the framework that enables them to operationalize compliance, reduce risks of penalties or breaches, and stay competitive in a landscape where trust and data security are central to success.
Conclusion
Choosing between HITRUST and HIPAA is not about selecting one over the other, but about understanding how they complement each other in a compliance strategy. HIPAA sets the minimum legal requirements for protecting patient information, while HITRUST offers a certifiable framework that brings consistency, auditability, and trust to your compliance program.
For healthcare organizations, HIPAA compliance is non-negotiable. However, adding HITRUST certification can elevate your posture by showing partners and regulators that your security practices go beyond the baseline.
At Auditive, we help businesses navigate this complex landscape with confidence. From streamlining vendor risk management to guiding organizations through our Trust Center, we ensure that compliance frameworks like HIPAA and HITRUST are not just checkboxes, but enablers of resilience and trust.
Ready to strengthen your compliance strategy and reduce risks? Let’s build your path to secure, certifiable compliance today.
FAQs
1. Is HIPAA compliance mandatory for all organizations?
No. HIPAA compliance is mandatory only for healthcare providers, insurers, and business associates handling protected health information in the United States.
2. Can an organization be HIPAA compliant without HITRUST certification?
Yes. HIPAA compliance can be achieved without HITRUST. However, HITRUST provides a certifiable framework that helps demonstrate compliance more effectively.
3. Does HITRUST replace HIPAA?
No. HITRUST does not replace HIPAA. Instead, it incorporates HIPAA requirements along with other frameworks, creating a more comprehensive compliance model.
4. Why would a non-healthcare company pursue HITRUST?
Non-healthcare organizations often pursue HITRUST to strengthen their security framework, align with industry-recognized standards, and build trust with healthcare partners.
5. What are the benefits of adding HITRUST certification on top of HIPAA compliance?
HITRUST certification brings structured assessments, enhanced credibility, and a competitive advantage. It also reduces the likelihood of non-compliance penalties or data breach risks.
