As a CEO of a startup in the healthcare space, understanding regulatory compliance is crucial for your organization’s success and reputation. Two key frameworks to consider are HIPAA and HITRUST, each serving a vital role in safeguarding patient information.

The Health Insurance Portability and Accountability Act (HIPAA) is a US law that establishes national standards for safeguarding sensitive patient health information. In contrast, the Health Information Trust Alliance (HITRUST) is a third-party global framework that encompasses various security and privacy standards, including those set by HIPAA, to manage data, information risk, and compliance.

In this blog, we’ll explore the key differences between HIPAA and HITRUST, helping you determine the best path forward for your organization’s compliance strategy.

Section 1: Understanding HIPAA and HITRUST

What is HIPAA?

HIPAA is a law designed to safeguard the privacy and security of Protected Health Information (PHI). The US Department of Health and Human Services’ Office for Civil Rights (OCR) enforces it.

HIPAA sets forth regulations that govern how healthcare providers, insurers, and other covered entities must handle protected health information. The law emphasizes the importance of patient privacy and mandates security measures to protect this data from unauthorized access, breaches, and misuse. 

Compliance with HIPAA is not optional; failure to adhere to its provisions can result in significant fines and reputational damage.

It includes three key rules that organizations must follow: Privacy, Security, and Breach Notification.

HIPAA applies to:

• Covered entities: Healthcare providers, health plans, and healthcare clearinghouses.
• Business associates: Organizations that perform work for covered entities and handle ePHI on their behalf.

These safeguards involve meeting specific organizational requirements, policies, procedures, and documentation standards to protect the confidentiality, integrity, and availability of PHI. 

HIPAA also requires periodic evaluations to ensure compliance, though there is no formal certification process. Compliance is reported through risk assessments and control documentation.

Non-compliance and violations are investigated by the Office for Civil Rights (OCR), leading to the imposition of penalties.

Also read: HIPAA-covered entities

What is HITRUST?

While HIPAA sets federal compliance standards, HITRUST is an organization that developed the HITRUST CSF (Common Security Framework) in 2009. Originally focused on protecting ePHI and PHI in the healthcare sector, HITRUST has since expanded to serve various industries.

The framework encompasses control categories, objectives, and specifications across multiple assessment domains. To achieve HITRUST certification, organizations must meet specific scoring levels based on their chosen certification type. 

There are two primary options: 

• The i1 certification, a self-assessment intended for smaller organizations or those just beginning their compliance journey
• The r2 certification involves a more rigorous third-party assessment suitable for organizations handling sensitive data. 

Each option has distinct requirements and scoring criteria that organizations must fulfill to demonstrate compliance with HITRUST standards.

Organizations can tailor their requirements during the assessment process based on factors like size, type, and legal regulations. HITRUST also offers a self-assessment option for internal evaluation, though engaging with a qualified CSF assessor can provide valuable insights and recommendations. This can be particularly beneficial if you plan to pursue a certifiable assessment later.

HITRUST’s comprehensive nature makes it an appealing option for meeting multiple compliance needs through a single audit, offering efficiencies and streamlined processes.

Also read:  How to get compliant with HIPAA

Section 2: Key similarities between HIPAA vs HITRUST

Understanding the foundations and similarities of HIPAA and HITRUST can help you make informed decisions about how to best protect your organization and its valuable patient data.

1. Focus on data protection

Both HIPAA and HITRUST share a fundamental goal: to safeguard sensitive health information. 

While HIPAA provides the legal framework, HITRUST offers a structured approach to implementing security measures, ensuring that sensitive health information remains confidential and secure.

2. Compliance requirements

Both frameworks encompass rigorous compliance requirements that address key areas such as privacy, security, and breach notification. 

HIPAA sets the baseline standards for how healthcare organizations must protect patient data, while HITRUST builds upon these standards by providing a more detailed and prescriptive set of controls.

3. Audit and assessment

An essential component of both HIPAA and HITRUST is the audit and assessment process. 

HIPAA requires organizations to conduct regular evaluations to ensure compliance with its rules, while HITRUST mandates comprehensive assessments against its control framework to achieve certification. 

For startups, undergoing these assessments can enhance operational resilience and demonstrate a commitment to data protection to stakeholders and clients alike.

Also read: HIPAA Audit Trail Requirements

Section 3: Key differences between HIPAA vs HITRUST

Recognizing the key differences between a HITRUST certification vs HIPAA can help CEOs make informed decisions about their organization’s compliance strategy, balancing legal obligations with the need for comprehensive security practices.

1. Scope and coverage

HIPAA is specifically tailored to healthcare organizations and their business associates, focusing solely on the protection of PHI. In contrast, HITRUST takes a broader approach, encompassing a variety of industries while integrating multiple standards, such as HIPAA, NIST, and ISO.

Practical Consideration: For healthcare startups, adhering to HIPAA is non-negotiable, as it is a legal requirement. However, if your organization aims to expand into other sectors or seek partnerships with companies outside the healthcare industry, obtaining HITRUST certification may provide a competitive edge by demonstrating comprehensive security practices that meet diverse regulatory demands.

2. Certification vs. regulation

HIPAA is a legal requirement that comes with strict penalties for non-compliance, which can include hefty fines and legal repercussions. This regulatory nature necessitates a serious commitment to compliance, often requiring significant resources to maintain. 

On the other hand, HITRUST is a voluntary certification that focuses on implementing comprehensive security practices. While not mandated by law, achieving HITRUST certification can enhance your organization’s credibility and help mitigate risks.

Practical Consideration: Startups should evaluate their business priorities when deciding between the two. If compliance is driven by legal obligations, HIPAA must be prioritized. However, if your organization seeks to bolster its security posture and appeal to a broader market, pursuing HITRUST certification can be a strategic advantage.

3. Implementation and management

HIPAA requires organizations to adhere to specific regulations, conduct regular risk assessments, and undergo periodic audits to ensure compliance. This can be a complex and resource-intensive process.

In contrast, HITRUST provides a more integrated framework that aligns with multiple standards, making it easier to implement a cohesive security strategy. The HITRUST CSF allows organizations to address not only HIPAA compliance but also other regulatory requirements within a single, streamlined approach.

Practical Consideration: For startups with limited resources, leveraging the HITRUST framework can simplify the compliance journey. By adopting HITRUST, you can manage various compliance requirements more efficiently, reducing duplication of effort and enhancing overall security management.

4. Flexibility and adaptability

When it comes to flexibility and adaptability, HIPAA is often perceived as more rigid in its requirements. The law outlines specific measures that organizations must implement, which can sometimes be difficult to navigate, especially for startups that may not have the resources to comply fully.

In contrast, HITRUST is designed to be more adaptable, allowing organizations to modify their security practices in response to evolving threats and industry standards. This adaptability is particularly beneficial in a rapidly changing cyber landscape, where new vulnerabilities can emerge at any time.

Practical Consideration: Startups should consider their capacity for change when choosing between HIPAA and HITRUST. If your organization is agile and can pivot quickly to address new challenges, HITRUST may provide the flexibility you need. However, a solid understanding of HIPAA is essential to ensure that you are meeting the foundational legal requirements of your industry.

Practical implications for organizations adhering to HIPAA or HITRUST

Also read: Who enforces HIPAA?

Section 4: Which to pick: HIPAA vs HITRUST?

When deciding between HITRUST vs HIPAA, it’s essential to align your choice with your organization’s specific needs and priorities. 

Here’s a breakdown to guide your decision:

1. For regulatory compliance

Choose HIPAA if your primary concern is adhering to U.S. federal regulations for healthcare data. 

Why?

• As a legal requirement, HIPAA ensures that your organization is compliant with essential standards for protecting patient information. 
• If you are a healthcare provider or a business associate handling PHI, compliance with HIPAA is not just beneficial—it’s mandatory. 
• The focus on regulatory compliance will help you avoid potential penalties and safeguard your reputation in the healthcare industry.

2. For comprehensive security management

Choose HITRUST if you seek a more robust, integrated approach to security and compliance that encompasses multiple standards. 

Why?

• HITRUST certification addresses various compliance requirements, not just those dictated by HIPAA. 
• This comprehensive approach is particularly valuable for organizations looking to implement strong security measures that go beyond basic regulatory compliance. 
• By choosing HITRUST, you can enhance your organization’s credibility and build a more resilient security posture against emerging threats.

3. Considering industry needs

• HIPAA: Essential for healthcare providers, health plans, and business associates dealing with PHI. If your organization operates solely within the healthcare sector, HIPAA is non-negotiable for maintaining legal compliance and protecting patient information.
• HITRUST: Suitable for organizations seeking broad compliance across various standards and industries. If your startup plans to expand its operations or collaborate with partners outside the healthcare sector, obtaining HITRUST certification can demonstrate your commitment to comprehensive security practices.

Also read: Scrut Automation featured in HITRUST Products and Services Directory

Do you need both HIPAA and HITRUST?

In many cases, organizations benefit from adopting both HIPAA and HITRUST. HIPAA compliance is fundamental for any healthcare entity, while HITRUST certification can provide an additional layer of security and a streamlined approach to managing multiple regulatory requirements. 

By implementing both frameworks, you not only meet legal obligations but also enhance your overall security strategy, positioning your organization as a trusted partner in the healthcare ecosystem.

Ultimately, the decision between HITRUST vs HIPAA—or the choice to pursue both—should be informed by your organization’s specific goals, resources, and operational landscape. 

Understanding the implications of each option will empower you to make a choice that strengthens your compliance framework and supports your growth in a competitive market.

Also read: What’s the difference between SOC 2 and HIPAA?

Wrapping up

Both HIPAA and HITRUST play vital roles in safeguarding sensitive health information, but the choice between them depends on your organization’s specific needs, industry requirements, and compliance goals. 

CEOs should carefully assess their security and compliance strategies to determine which framework best aligns with their objectives. 

To explore how Scrut can support your journey toward robust compliance and security, reach out for a consultation today.

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