HITRUST vs. HIPAA: The Similarities and Differences

If you work in healthcare technology, compliance, or administration, you likely live in fear of one acronym: HIPAA. It is the federal law that governs how Protected Health Information (PHI) must be handled. But in recent years, a second acronym has taken center stage in vendor contracts and board meetings: HITRUST.

A common source of confusion for healthcare leaders is determining where the law ends and the framework begins. Is HITRUST just “HIPAA on steroids”? If you are HITRUST certified, does that mean you are automatically HIPAA compliant?

This blog breaks down the critical distinctions between the two (HITRUST vs HIPAA), why the industry is shifting toward HITRUST, and how they work together to protect patient data.

The Foundation: What is HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law enacted in 1996. While it covers many things, the industry focuses primarily on Title II, which mandates the protection of health data.

The core challenge with HIPAA is that it is descriptive, not prescriptive. The regulations tell you what to achieve (e.g., “protect against reasonably anticipated threats”), but they rarely tell you exactly how to do it.

The “Addressable” Ambiguity

HIPAA contains “required” specifications (you must do them) and “addressable” specifications. “Addressable” does not mean optional; it means you can implement an alternative measure if the primary one is not “reasonable and appropriate” for your organization.

For example, encryption of data at rest is an “addressable” implementation specification under HIPAA. A small clinic might argue that encryption is too expensive and rely on physical locks instead. However, if a laptop is stolen, federal regulators (the Office for Civil Rights, or OCR) may decide that encryption was reasonable after all, resulting in massive fines.

Crucially, there is no such thing as “HIPAA Certification.” The federal government does not certify organizations. You can only be “compliant”—a self-assessed state that is only truly tested when you get audited.

The Solution: What is HITRUST?

The HITRUST Common Security Framework (CSF) is a certification framework created by the healthcare industry (including giants like Anthem and UnitedHealth) to fix the ambiguity of HIPAA.

Where HIPAA is vague, HITRUST is prescriptive. It aggregates over 60 authoritative sources—including HIPAA, NIST, ISO, and PCI—into a single set of specific controls. If HIPAA is the law telling you to “drive safely,” HITRUST is the driving instructor telling you exactly where to place your hands on the wheel and when to brake.

Closing the Loophole

HITRUST effectively removes the “addressable” gray area. If you want HITRUST certification, the framework’s risk engine calculates your requirements based on your organization’s size and data volume. If the framework says you need encryption, you generally must implement it. You cannot simply opt out because it is inconvenient.

HITRUST vs HIPAA: The Core Differences

While HIPAA and HITRUST are often mentioned in the same breath within the healthcare sector, they serve fundamentally different roles. HIPAA is a mandatory U.S. federal regulation that establishes the legal baseline for protecting sensitive patient data. It is enforced by the Office for Civil Rights (OCR) and relies primarily on self-attestation, as no formal government “HIPAA certification” actually exists. Because the law includes “addressable” specifications, it offers high flexibility for organizations to determine how they meet requirements, but it remains relatively static, requiring an Act of Congress for major changes.

In contrast, HITRUST is a voluntary, private industry framework designed to simplify compliance by mapping multiple standards—including HIPAA, ISO, and NIST—into a single set of controls. Unlike HIPAA, HITRUST offers a validated certification through third-party assessors, providing a “seal of approval” that HIPAA lacks. It is much more prescriptive and less flexible than the law, but it is dynamic, with frequent updates like version 11 to keep pace with emerging threats. Though HITRUST is not a legal requirement, it has become a “commercially mandatory” benchmark, as many major healthcare payers and providers now require this certification before signing contracts with business associates.

The Commercial Reality: Why You Need Both

While HIPAA compliance keeps you out of jail, HITRUST certification helps you stay in business.

Major payers and hospital systems realized years ago that they couldn’t audit every single vendor individually. Instead, they adopted the “Assess Once, Report Many” approach. They require vendors to obtain HITRUST certification as proof of security. This transfers the cost of validation to the vendor and provides a higher level of assurance than a simple HIPAA self-attestation.

The Tiers of Certification

Historically, HITRUST faced criticism for its high barrier to entry, particularly for startups with limited budgets. To address this, the organization introduced a tiered assessment portfolio that scales based on an organization’s size and risk profile. The e1 (Essentials) assessment serves as an entry point for startups and low-risk vendors; it consists of 44 fixed controls and is valid for one year. It is an ideal option for smaller companies looking to demonstrate “good hygiene” to prospective hospital clients without the six-figure price tag typically associated with higher-level certifications.

For mid-market organizations facing moderate risk, the i1 (Implemented) assessment offers a more robust middle ground with approximately 182 fixed controls and a one-year validity period. At the top of the spectrum is the r2 (Risk-Based) assessment, designed for large enterprises and high-risk environments. The r2 is highly comprehensive, with a variable scope ranging from 200 to over 1,000 controls, and while it requires the most effort to obtain, it remains valid for two years. This tiered approach allows organizations to grow their compliance posture as their business scales.

The “Safe Harbor” Legal Shift

For years, the main criticism of HITRUST was that it held no legal weight. That changed in 2021 with Public Law 116-321.

This amendment to the HITECH Act requires the HHS to consider “recognized security practices” as a mitigating factor when assigning fines or audit durations. Because HITRUST maps directly to NIST standards (which are cited in the law), a valid HITRUST certification is now widely accepted as definitive proof of these practices. If you suffer a breach but can hand the regulators a HITRUST r2 report, you may face significantly lower fines than an organization that has nothing but internal policies.

Conclusion

The difference, HITRUST vs HIPAA is the difference between a goal and a plan. HIPAA sets the goal: protect patient privacy. HITRUST provides the rigorous, verifiable plan to achieve it. In today’s threat landscape, relying solely on HIPAA self-attestation is a liability. Adopting HITRUST not only satisfies commercial demands but now offers a shield against federal penalties.

Frequently Asked Questions (FAQ)

1. Does getting HITRUST certified guarantee I am HIPAA compliant?

No private certification can legally guarantee HIPAA compliance, as that is a judgment made solely by federal regulators (OCR) during an investigation. However, HITRUST is widely considered the most rigorous demonstration of compliance. If you meet HITRUST standards, you have almost certainly exceeded the minimum requirements of HIPAA.

2. Can I just be “HIPAA Certified” instead of paying for HITRUST?

No. There is no such thing as an official “HIPAA Certification.” Any badge or certificate sold by a consultant is for marketing purposes only and has no legal standing with the government. HITRUST is the only widely recognized, third-party validated certification in the healthcare industry.

3. How much does HITRUST certification cost?

It varies by assessment type. A startup pursuing an e1 (Essentials) assessment might spend $20,000 to $50,000 (including fees and tools). A large enterprise pursuing the comprehensive r2 certification can spend between $150,000 and over $1 million depending on remediation needs and scope.

4. How often do I need to renew my certification?

The e1 and i1 assessments are valid for one year. The r2 certification is valid for two years, provided you pass an interim assessment at the one-year mark to ensure you haven’t degraded your security controls.

5. I use AWS or Azure; does that make me HITRUST compliant?

Not automatically. This is a “Shared Responsibility” model. AWS handles the security of the cloud (data centers, power), but you are responsible for security in the cloud (passwords, encryption). However, HITRUST allows you to “inherit” AWS’s scores, which can reduce your testing workload by up to 40%.