Comparison

SOC 2 vs HIPAA

Different problems, different audits, different costs. SOC 2 is a US B2B trust signal for SaaS; HIPAA is a federal law for protected health information. Most healthtech startups eventually need both — but rarely at the same time, and rarely from the same vendor.

SOC 2

A CPA-issued attestation under AICPA SSAE 18 that a service organization meets the Trust Services Criteria (Security, Availability, Processing Integrity, Confidentiality, Privacy). It is voluntary; it is not a law.

Who needs it
US SaaS selling to enterprise
Authority
AICPA / CPA firms
Issued as
Attestation report

HIPAA

A US federal law (1996, amended by HITECH 2009) regulating the protection of patient health information (PHI). It defines covered entities, business associates, and required safeguards.

Who needs it
Anyone handling US patient data
Authority
HHS / Office for Civil Rights
Issued as
No certification — internal documentation + OCR enforcement

Similarities

  • Both expect documented policies, workforce training, access controls, audit logs, and incident response.
  • Both have substantial overlap on technical controls (encryption in transit, MFA, change management).
  • Both reward consistency and documentation more than perfection.

Where they differ

AxisSOC 2HIPAA
TypeVoluntary attestationFederal law (mandatory if you handle PHI)
ScopeYour service organization controlsPHI handling specifically
Report?Yes — CPA-signed Type 1 or Type 2No certification — internal evidence + OCR-audit-ready documentation
EnforcementContractual (customers ask for it)Federal fines + criminal penalties for willful neglect
Cost$5k–$50k auditor + $200–$3k/yr toolNo exam fee, but breach fines run into millions
RenewalAnnually (Type 2)Continuous; OCR can audit anytime
Sub-processor chainVendor risk review optionalBAA required with every PHI sub-processor

Which do you need?

Pick SOC 2 if…

You're SaaS selling to US enterprises and procurement keeps asking for it. SOC 2 unlocks deals; HIPAA does not.

Pick HIPAA if…

Your product touches patient health information from a US covered entity. HIPAA is a legal requirement, not a sales asset — but it's table-stakes for healthtech.

Pick both if…

You sell healthtech SaaS. SOC 2 closes enterprise deals; HIPAA keeps you out of federal enforcement.

Pick neither if…

You're not selling to enterprises and you're not handling PHI. Build the product first; come back when a customer asks.

Frequently asked

Does SOC 2 cover HIPAA?
Not really. There's overlap on technical controls, but SOC 2 doesn't require BAAs or specific PHI handling. Some auditors offer a SOC 2 + HIPAA mapping that bundles both — convenient but doesn't replace HIPAA compliance work.
Can I get a SOC 2 without HIPAA?
Yes — most SaaS does. SOC 2 is purely about your controls; you can have a clean SOC 2 with PHI you never touch.
Is HIPAA harder than SOC 2?
Different hard. HIPAA's technical bar is lower; the documentation + workforce-management bar is higher. SOC 2's technical bar is broader; the auditor expects more breadth across controls.
Cost: SOC 2 vs HIPAA?
SOC 2 has a defined cost: tool + auditor. HIPAA has no exam fee but unbounded risk (breach fines run into millions). Most healthtech treats HIPAA as a non-negotiable cost of doing business.

Related comparisons

Scan against both at once

KollGuard maps every finding to 12 frameworks — including SOC 2 and HIPAA.