HIPAA
A US federal law regulating PHI. Sets a minimum bar of administrative, physical, and technical safeguards (§164 Security Rule). No certification body.
- Who needs it
- Anyone handling US patient data
- Authority
- HHS / Office for Civil Rights
- Issued as
- No certification — internal docs + OCR enforcement
HITRUST CSF
A commercial certification (HITRUST Alliance) that maps to HIPAA + ISO 27001 + NIST + many others. Three assurance levels (e1, i1, r2). Auditor-issued; CSF i1 ~3 months, r2 ~9-12 months.
- Who needs it
- Healthtech selling to major hospital systems / payers
- Authority
- HITRUST Alliance
- Issued as
- Third-party certified report
Similarities
- Both target healthcare data protection.
- Both cover administrative, physical, technical safeguards.
- HITRUST CSF includes a HIPAA crosswalk — passing CSF substantially evidences HIPAA.
Where they differ
| Axis | HIPAA | HITRUST CSF |
|---|---|---|
| Legal status | Federal law (mandatory) | Voluntary commercial certification |
| Specificity | High-level safeguards | Prescriptive — hundreds of specific control statements |
| Certification | None | Yes — third-party HITRUST authorized assessor |
| Cost | No exam fee | $60k–$200k+ for r2 certification (assessor fees + tools) |
| Timeline | Ongoing program | i1: ~3 months; r2: 9-12 months |
| Renewal | Continuous | i1 annual; r2 biennial with interim assessment |
| Customer demand | Required for healthcare | Required by some hospital systems / payers |
Which do you need?
Pick HIPAA if…
You're a healthtech startup that handles PHI. This is non-negotiable; you cannot opt out.
Add HITRUST CSF if…
A major hospital system or health plan customer requires it (they will say so explicitly in procurement).
Pick i1 first, then r2 if…
You need HITRUST but want a shorter path to certified status. i1 in ~3 months unlocks most enterprise deals; r2 adds rigor.
Skip HITRUST if…
You're early-stage and HIPAA-compliant. The $60k+ price tag is hard to justify without a specific deal demanding it.
Frequently asked
- Does HITRUST replace HIPAA?
- No. HITRUST is a private framework; HIPAA is federal law. HITRUST CSF certification substantially evidences HIPAA compliance, but you still owe HIPAA independently.
- Is HITRUST CSF native in KollGuard?
- No — KollGuard maps to HITRUST CSF via a CROSSWALK from SOC 2 and HIPAA. We're explicit about this. Auditors who scrutinize HITRUST will rightfully push back on crosswalk-only assertions. CIS Controls is our best candidate for the next native assertion.
- i1 vs r2?
- i1 (Implemented) = 1-year certification, ~180 control assessments, ~3 months. r2 (Risk-based, 2-year) = full r2 with hundreds of controls, ~9-12 months. r2 is the gold standard; i1 is the on-ramp.
- What about HITRUST e1?
- e1 (Essentials) is HITRUST's lightweight tier for ≈45 controls, suitable for very small organizations. Less commonly accepted by enterprise buyers.
