HIPAA is federal law that requires healthcare organizations to protect patient data. HITECH (2009) strengthened HIPAA with higher penalties and EHR requirements—it's now part of HIPAA compliance. HITRUST is a voluntary certification framework that helps you prove your compliance.
Think of it this way: HIPAA/HITECH tells you what to protect, and HITRUST tells you how to prove you're protecting it.
Each framework serves a different purpose in the healthcare compliance landscape.
Health Insurance Portability and Accountability Act
The foundational federal law requiring healthcare organizations to safeguard patient data. HIPAA defines the 'what' of healthcare compliance.
Up to $2.13M per violation category per year
HHS Office for Civil Rights (OCR)
Health Information Technology for Economic and Clinical Health Act
Strengthened HIPAA enforcement and promoted adoption of electronic health records. HITECH modernized HIPAA for the digital age.
Tiered penalties up to $2.13M per violation category
HHS Office for Civil Rights (OCR)
Health Information Trust Alliance Common Security Framework
A voluntary certification framework that provides a standardized approach to demonstrating compliance. HITRUST is the 'how' to HIPAA's 'what'.
No legal penalties (contractual consequences only)
HITRUST Alliance (private organization)
A detailed comparison of HIPAA, HITECH, and HITRUST across key dimensions.
| Aspect | HIPAA | HITECH | HITRUST |
|---|---|---|---|
| Legal Status | Federal law | Federal law (amends HIPAA) | Private framework |
| Year Established | 1996 | 2009 | 2007 |
| Mandatory? | Yes | Yes | No (but often contractually required) |
| Applies To | Covered Entities & BAs | Covered Entities & BAs | Any organization seeking certification |
| Certification Available | No official certification | No official certification | Yes (3 levels) |
| Government Enforced | Yes (HHS OCR) | Yes (HHS OCR) | No |
| Audit Requirement | Self-compliance required | Self-compliance required | Third-party assessment required |
| Cost to Comply | Varies (internal costs) | Varies (internal costs) | $40,000 - $200,000+ for certification |
| Timeline | Ongoing | Ongoing | 6-12 months for initial certification |
These frameworks complement each other to create a comprehensive compliance approach.
Establishes the legal requirements for protecting patient health information.
The LawStrengthens HIPAA with increased penalties and breach notification requirements.
The EnforcementProvides a certifiable framework to demonstrate compliance with HIPAA and more.
The ProofThe January 2025 HIPAA Security Rule updates make HIPAA more prescriptive, with mandatory MFA, encryption, and annual audits. These changes align HIPAA closer to frameworks like HITRUST. Organizations that have already implemented HITRUST controls will likely find the new HIPAA requirements easier to meet.
Not necessarily. HIPAA compliance is legally required, but HITRUST certification is voluntary. However, many healthcare organizations, payers, and partners now require HITRUST certification as a condition of doing business. If your customers or partners require it, you'll need to pursue certification regardless of your HIPAA compliance status.
HITECH is technically a separate law, but it amended and strengthened HIPAA. Today, when people refer to 'HIPAA compliance,' they're really talking about HIPAA as modified by HITECH. You don't need to think of them as separate compliance obligations—HITECH is baked into modern HIPAA requirements.
No. There is no official HIPAA certification issued by the government. Organizations self-certify their compliance by implementing required safeguards and maintaining documentation. However, you can get HITRUST certified, which demonstrates your compliance with HIPAA and other frameworks.
Start with HIPAA/HITECH compliance—it's legally required. Once you have solid HIPAA controls in place, consider HITRUST if your business partners require it or if you want third-party validation of your security posture. HITRUST builds on HIPAA, so the work overlaps significantly.
HITRUST provides a prescriptive, certifiable framework that maps directly to HIPAA requirements. While HIPAA tells you what to protect, HITRUST tells you exactly how to protect it with specific controls. A HITRUST certification provides documented evidence that you've implemented appropriate safeguards.
The January 2025 HIPAA Security Rule updates include mandatory multi-factor authentication (MFA), encryption requirements for all ePHI, 24-hour breach notification to HHS, annual security audits, and network segmentation requirements. These updates make HIPAA more prescriptive and align it closer to frameworks like HITRUST.
Learn more from authoritative sources.
Official HIPAA information from the U.S. Department of Health and Human Services.
Official HITECH enforcement information from HHS.
Official HITRUST CSF framework and certification information.
Comprehensive guide to the HITECH Act and its requirements.