SOC 2 for healthtech companies

Healthcare buyers ask for HIPAA and SOC 2, and the two are not substitutes. Here's how they fit together, when HITRUST enters the picture, and how to sequence the work.

HIPAA vs. SOC 2: not substitutes

HIPAA is a federal law governing protected health information (PHI) — there is no official HIPAA "certification." A HIPAA assessment checks your administrative, physical, and technical safeguards. SOC 2 is an auditor's opinion on your controls against Trust Services Criteria, delivered as a report your customers can read. Healthtech buyers typically want both: HIPAA for regulatory comfort, SOC 2 Type 2 for procurement.

When HITRUST enters the picture

HITRUST CSF certification is the heavyweight option — a prescriptive, scored assessment that large health systems and payers increasingly require. It's substantially more effort and cost than SOC 2. Rule of thumb: pursue SOC 2 + HIPAA assessment first; add HITRUST when a specific customer or contract requires it, not before. Firms like Schellman, 360 Advanced, and KirkpatrickPrice cover the SOC-to-HITRUST path.

Healthtech scoping advice

• Add the Confidentiality and Privacy criteria. PHI flows make these the whole point — Security-only SOC 2s undersell to healthcare buyers.
• Map every PHI system and vendor. EHR integrations, analytics pipelines, and subservice organizations (cloud, data warehouse) all belong in scope.
• Get BAAs signed before the audit. Business Associate Agreements with every vendor touching PHI are table stakes — auditors will ask.
• Coordinate, don't duplicate. One evidence set can support SOC 2, HIPAA assessment, and later HITRUST. Ask for a multi-framework proposal from the start — see our combined-audit guide for the pattern.