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
| Axis | SOC 2 | HIPAA |
|---|---|---|
| Type | Voluntary attestation | Federal law (mandatory if you handle PHI) |
| Scope | Your service organization controls | PHI handling specifically |
| Report? | Yes — CPA-signed Type 1 or Type 2 | No certification — internal evidence + OCR-audit-ready documentation |
| Enforcement | Contractual (customers ask for it) | Federal fines + criminal penalties for willful neglect |
| Cost | $5k–$50k auditor + $200–$3k/yr tool | No exam fee, but breach fines run into millions |
| Renewal | Annually (Type 2) | Continuous; OCR can audit anytime |
| Sub-processor chain | Vendor risk review optional | BAA 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.
