SOC 2 is faster and less expensive, making it the right starting point for most healthcare-adjacent SaaS companies. HITRUST is more rigorous, more expensive, and increasingly required by name in healthcare vendor contracts, particularly with health plans, PBMs, and large health systems. The honest answer for most companies isn’t “pick one”. It’s “start with SOC 2, and find out early whether your specific customers will eventually require HITRUST by name.”
The Core Difference
SOC 2 is an attestation issued by a licensed CPA firm, built around the AICPA’s Trust Services Criteria. It’s flexible, you scope which criteria apply (security is mandatory, the other four are optional) and your auditor tailors testing to your environment.
HITRUST is a certification issued by the HITRUST Alliance itself, conducted through an authorized external assessor using a fixed, prescriptive control framework. HITRUST harmonizes controls from HIPAA, NIST, PCI DSS, GDPR, and others into a single unified model, which is precisely why it carries more specific weight in healthcare procurement — the framework was effectively built to map onto HIPAA from the start.
HITRUST Isn’t One Thing — It’s Three Tiers
A common mistake is treating “HITRUST certified” as a single bar to clear. It’s actually three distinct certification levels, and choosing the wrong one is one of the most expensive mistakes a company can make.
e1 is the entry tier: 44 fixed controls, valid for one year, and appropriate for vendors whose customers require a HITRUST credential but haven’t specified i1 or r2, or for organizations pursuing HITRUST for the first time before scaling to a higher tier.
i1 is the middle tier and, in practice, the most commonly requested: approximately 182 controls, valid for one year, and — critically — if a contract says “HITRUST certification required” without specifying a level, procurement teams almost always mean i1.
r2 is the highest tier: a risk-based assessment typically scoped to 270–2,000+ controls depending on environment complexity, valid for two years with a required midpoint interim assessment. Federal contractor work, PBM contracts, and large health system integrations increasingly require r2, particularly as CAA 2026 enforcement accelerates this requirement specifically for PBMs.
The costly mistake: certifying at e1 when a customer actually requires i1, then having to redo the work six months later. Before committing to a tier, the right move is checking what your specific customer contracts actually specify, not guessing at the “safe” middle option.
Timeline and Cost, Side by Side
| SOC 2 Type II | HITRUST e1 | HITRUST i1 | HITRUST r2 | |
|---|---|---|---|---|
| Control count | Scoped to your environment | 44 fixed | ~182 fixed | 270–2,000+ (risk-based) |
| Typical timeline | 6–12 months (incl. observation period) | 1–3 months | 4–9 months | 6–18+ months |
| Typical all-in cost | $25K–$90K (readiness + audit) | $20K–$70K | $60K–$200K | $150K–$1M+ |
| Validity period | Annual re-audit | 1 year | 1 year | 2 years, with midpoint interim |
| Issued by | Licensed CPA firm | HITRUST Alliance, via authorized assessor | HITRUST Alliance, via authorized assessor | HITRUST Alliance, via authorized assessor |
SOC 2 is consistently the lower-cost, faster path. Even HITRUST’s lightest tier (e1) tends to run comparable to or above a full SOC 2 Type II engagement — and i1 or r2 represent a meaningfully larger investment in both time and budget.
So Which One Does Your Healthcare Client Actually Need?
The honest framework for deciding:
Choose SOC 2 if: your customers are primarily SaaS buyers, enterprise procurement teams, or investors — the general “prove you take security seriously” audience that doesn’t specifically operate inside healthcare payer or PBM contracting.
Choose HITRUST if: a specific contract, RFP, or vendor risk management program names HITRUST explicitly. This is common with health plans, PBMs, and large health system integrations — and increasingly, the request will specify the tier (i1 most commonly).
Plan for both if: you’re a healthcare-adjacent SaaS company scaling toward enterprise health system or payer contracts. Many companies start with SOC 2 to satisfy early-stage deals and investors, then move to HITRUST i1 or r2 once payer-side contracts specifically require it.
This is exactly the kind of situation where multi-framework control mapping matters most — SOC 2 and HITRUST share meaningful underlying control overlap (access management, risk assessment, incident response, encryption), so building your first framework with the second in mind avoids redoing foundational work later.
A Word of Caution on AI Features
If your platform includes AI-driven features handling PHI, this is worth flagging early: HITRUST now allows organizations to pair an AI-specific security add-on directly with their e1, i1, or r2 assessment rather than requiring a separate audit. If AI is part of your product and healthcare data is in scope, this is worth scoping into your HITRUST conversation from the start rather than treating it as a future add-on.
Not sure which framework — or which HITRUST tier — your specific customer contracts actually require? We’ll help you map it before you commit budget to the wrong one. →
FAQ SECTION
Q: Is HITRUST harder to get than SOC 2?
A: Generally yes, particularly at the i1 and r2 tiers. HITRUST e1 is comparable in scope to a focused SOC 2 engagement, but i1 typically takes 4–9 months and r2 can take 6–18+ months, both with correspondingly higher costs than most SOC 2 engagements.
Q: Do I need both HITRUST and SOC 2?
A: Many healthcare-adjacent SaaS companies eventually need both — SOC 2 for general enterprise and investor assurance, HITRUST for specific payer, PBM, or health system contracts that name it explicitly. Companies typically start with SOC 2 and add HITRUST once a specific customer contract requires it.
Q: What HITRUST level do most healthcare vendor contracts require?
A: If a contract says “HITRUST certification required” without specifying a level, procurement teams almost always mean i1. r2 is increasingly required for federal contractor work, PBM contracts, and large health system integrations specifically.
Q: How long is a HITRUST certification valid?
A: e1 and i1 certifications are valid for one year and require a new validated assessment for renewal. r2 is valid for two years, with a required interim assessment at the midpoint.
Q: Can SOC 2 controls be reused for HITRUST?
A: Significant overlap exists in areas like access management, risk assessment, incident response, and encryption. Building these controls with both frameworks in mind from the start avoids duplicating foundational work if you pursue HITRUST after SOC 2.
Q: Why does HITRUST cost so much more than SOC 2?
A: HITRUST involves platform fees paid directly to the HITRUST Alliance, report credit fees, and external assessor fees, on top of internal remediation work — and the i1 and r2 tiers test substantially more controls than a typical SOC 2 engagement, which drives both timeline and cost higher.
