The Problem
A growth-stage company in healthcare or healthcare-adjacent SaaS reaches a point where customers start asking for security certifications. The CTO asks the question: SOC 2, HITRUST, HIPAA — which one do we need?
The answer is usually “it depends on who you sell to,” which is unsatisfying. A more useful version of that answer below.
The Approach
The three frameworks are not interchangeable. Each one was designed to signal something specific, and the right choice depends on what your buyers are signaling for.
SOC 2
A SOC 2 report is an auditor’s opinion on whether your organization meets the AICPA’s Trust Services Criteria. There are five criteria: Security (always required), Availability, Processing Integrity, Confidentiality, and Privacy (all optional). Most reports cover Security plus one or two others.
Two report types: Type I is a point-in-time snapshot (“on January 1, these controls were designed and in place”). Type II is an operating-period assessment (“from January 1 through December 31, these controls were operating effectively”). Type II is what enterprise buyers actually want; Type I is a stepping stone.
What it proves: That your company has thought about security in a structured way, has documented controls, and an independent auditor confirmed the controls operate as documented over a multi-month period.
Who asks for it: Enterprise SaaS buyers. Procurement teams. Cybersecurity insurance underwriters. Investors during diligence.
Cost: $20-60K per cycle for a Type II report, plus internal time. The first cycle is the expensive one (3-6 months of readiness work plus the audit period); subsequent cycles are roughly half.
Timeline: 6-12 months from “we want SOC 2” to delivering a Type II report. The bottleneck is the operating period: the auditor needs to see controls running for at least 6 months (often 12) before they can issue Type II.
HITRUST
The HITRUST CSF (Common Security Framework) is a prescriptive control set developed specifically for healthcare. It synthesizes HIPAA, NIST 800-53, ISO 27001, and several other frameworks into a single integrated control framework with three levels: r2 (rigor 2, the most common), r1 (rigor 1, lighter), and e1 (essentials).
What it proves: Your security posture meets the specific control set healthcare organizations expect from their vendors. HITRUST is much more prescriptive than SOC 2: a checklist of 60-100+ controls (depending on level) that you either implement or you don’t.
Who asks for it: Hospital systems. Health plans (payers). Healthcare data exchanges. The HITRUST stamp is the dominant security signal in healthcare procurement.
Cost: $80-150K for an r2 certification cycle, plus significantly more internal time than SOC 2. Reassessment every 2 years.
Timeline: 12-18 months for first certification. The long pole is control implementation: most organizations need months of work to close the gaps before the assessment.
HIPAA “Attestation”
Important clarification: HIPAA itself has no certification. The Security Rule says you must have a “compliance program.” It does not say you must obtain a certificate of compliance. There is no government-issued HIPAA certification.
What exists are third-party assessments that map your controls to HIPAA Security Rule requirements. Common forms:
- HIPAA Security Rule Compliance Assessment by a third-party auditor produces a report you can share with customers.
- HITRUST CSF certification includes HIPAA mappings, so HITRUST is often used as HIPAA evidence.
- SOC 2 + HIPAA. Some auditors offer a combined report that overlays HIPAA mappings on a SOC 2 Type II.
What it proves: That you’ve engaged seriously with the HIPAA Security Rule and an independent assessor has reviewed your controls against it.
Who asks for it: Healthcare buyers who haven’t standardized on HITRUST. Smaller healthcare organizations. Business associate agreements often require attestation of some kind.
Cost: Highly variable. $10-30K for a standalone HIPAA assessment; usually packaged with another framework.
Timeline: 3-6 months for an assessment cycle.
ISO 27001
A related framework you might encounter: ISO 27001. International, prescriptive ISMS (Information Security Management System) certification. Popular with EU buyers and global enterprises.
Cost: $40-100K for first certification; 3-year cycle with annual surveillance.
Timeline: 6-12 months for first certification.
Skip this unless your sales motion includes significant European or global enterprise customers. For US-only healthcare or fintech, SOC 2 carries equivalent or stronger signal at lower cost.
The Decision Matrix
Based on your primary buyer, here’s where to start:
| Primary buyer | First framework to pursue | Second framework (if expanding) |
|---|---|---|
| Mid-market SaaS buyers | SOC 2 Type II | ISO 27001 (if going global) |
| Hospital systems | HITRUST r2 | SOC 2 (for non-hospital buyers) |
| Health plans / payers | HITRUST r2 | SOC 2 |
| Federal healthcare / state Medicaid | HITRUST + HIPAA assessment | SOC 2 (separate buyers) |
| Healthcare-adjacent SaaS (selling to providers) | HITRUST r2 OR HIPAA assessment + SOC 2 | — |
| General enterprise + occasional healthcare | SOC 2 Type II with HIPAA mapping | HITRUST (if healthcare grows) |
| Global enterprise (EU + US) | SOC 2 + ISO 27001 | Add HITRUST if healthcare in mix |
The most common sequencing for a US healthcare-adjacent SaaS: SOC 2 first (to cover the largest buyer pool), then HITRUST when healthcare deals start losing on “you don’t have HITRUST.”
Timeline & Cost Summary
Rough numbers for first-cycle:
| Framework | First-year cost | Internal time | Time to first report | Renewal cadence |
|---|---|---|---|---|
| SOC 2 Type II | $30-60K | 200-400 hours | 9-12 months | Annual |
| HITRUST r2 | $80-150K | 400-800 hours | 12-18 months | Every 2 years |
| HIPAA assessment | $10-30K | 100-200 hours | 3-6 months | Annual or biennial |
| ISO 27001 | $40-100K | 300-500 hours | 9-12 months | 3-year cycle + annual surveillance |
Internal time estimates assume a competent engineering team and one designated compliance owner. Without a dedicated owner, multiply by 2-3x; the work expands to fill the calendar.
The Template
Use this cheat-sheet to make the decision:
Step 1: Identify your top 3 active deals (or top 3 target accounts).
Step 2: For each, find their security requirements in writing. Either ask the buyer, or look at their published vendor security expectations.
Step 3: Tally which frameworks appear:
- SOC 2: ____ deals
- HITRUST: ____ deals
- HIPAA assessment: ____ deals
- ISO 27001: ____ deals
- Other: ____ deals
Step 4: Apply the rule: pursue the framework that unblocks the most current revenue. If the tally is unclear, default to SOC 2 first — it has the broadest applicability and the most reusable artifacts.
Step 5: Set a realistic timeline. Most teams over-commit on the first cycle. Add 30% buffer to the auditor’s estimate.
Step 6: Budget for it — both dollars and internal time. The single most common reason compliance projects fail is that internal time gets reallocated to product work mid-cycle.
Operating Notes
Don’t pursue all three frameworks at once. The artifacts overlap heavily (a control documented for SOC 2 is 80% reusable for HITRUST), but the audit cycles and assessor relationships are distinct. Trying to run two cycles simultaneously in a team of fewer than 100 engineers usually means both slip.
The first framework you obtain is the expensive one. Subsequent frameworks share the readiness work — the policies, the evidence pipelines, the security training program, the vendor management process all carry forward. Plan as if SOC 2 → HITRUST is half the work of SOC 2 alone.
The framework you have is less important than the operating muscle you build around it. The team that meaningfully runs SOC 2 — quarterly access reviews, monthly evidence collection, annual control updates — is the team that will pass HITRUST easily. The team that scrambled to pass SOC 2 once and forgot about it will fail HITRUST and then fail SOC 2 renewal.
Compliance is a continuous practice, not a project.