SOC2 for Healthcare & Health Tech
HIPAA and SOC2 serve different audiences but overlap significantly. This guide explains what health tech companies actually need, when you need both, BAA requirements, and how to find an auditor with real healthcare experience.
HIPAA vs SOC2 — What Covers What
| Requirement | HIPAA | SOC2 Security | SOC2 Privacy TSC |
|---|---|---|---|
| Access controls | Required | [+] | [ ] |
| Audit logs / monitoring | Required | [+] | [ ] |
| Encryption in transit + at rest | Required | [+] | [ ] |
| Incident response plan | Required | [+] | [ ] |
| PHI minimum necessary use | Required | [ ] | [+] |
| Patient right to access data | Required | [ ] | [+] |
| Privacy notice requirements | Required | [ ] | [+] |
| Data retention / disposal | Required | partial | [+] |
| BAA with business associates | Required | [ ] | [ ] |
| Breach notification (72-hour rule) | Required | [ ] | [ ] |
| HIPAA workforce training | Required | [ ] | [ ] |
| Vendor risk management | Required | [+] | [ ] |
Which TSC Should Health Tech Companies Include?
Mandatory for all SOC2 reports. Covers access controls, encryption, vulnerability management.
Required if you store PHI or PII. Maps directly to HIPAA privacy principles. Essential for hospital and payer contracts.
Add if clinical workflows depend on your uptime. Downtime = patient safety risk. Required by most health system procurement teams.
Add if you handle confidential clinical records (not just de-identified data). Common for EHR integrations.
Add if your platform drives clinical decisions (dosing, diagnostics). Less common for general health tech.
Business Associate Agreements (BAA)
If you handle PHI, you need BAAs with every vendor who touches that data. Key BAA requirements for health tech companies:
Frequently Asked Questions
Do healthcare SaaS companies need both SOC2 and HIPAA?
HIPAA compliance is legally required if you handle Protected Health Information (PHI) as a covered entity or business associate. SOC2 is commercially required by enterprise customers. They serve different audiences: HIPAA satisfies your legal obligation; SOC2 satisfies enterprise procurement teams. Most health tech companies that sell to hospital systems or health plans need both. SOC2 with Privacy TSC has meaningful overlap with HIPAA, but HIPAA has specific technical safeguards (audit logs, transmission security, PHI disposal) that SOC2 does not explicitly require.
What is a Business Associate Agreement and do I need one with my auditor?
A Business Associate Agreement (BAA) is a contract required by HIPAA when a vendor handles PHI on behalf of a covered entity. If your SOC2 auditor will have access to your systems during the audit — and those systems contain PHI — you technically need a BAA with them. Most HIPAA-experienced audit firms have standard BAAs ready. Always ask upfront: 'Will you sign a BAA if needed for the engagement?'
Does SOC2 Privacy TSC cover HIPAA compliance?
Partially. SOC2 Privacy TSC covers notice, choice, collection limitation, use/retention/disposal, access, disclosure to third parties, quality, and monitoring. This aligns with many HIPAA privacy principles. However, HIPAA has specific PHI safeguards that go beyond SOC2 Privacy TSC, including minimum necessary standard, workforce training requirements, and breach notification timelines. Getting SOC2 with Privacy TSC demonstrates strong privacy practices but does not make you HIPAA-compliant.
Which SOC2 Trust Services Criteria are most important for health tech?
Security (CC) is mandatory. For health tech, strongly consider adding Privacy (P) — it directly maps to PHI protection expectations. Availability (A) is important if hospital clients rely on your platform for clinical operations (downtime = patient safety risk). Confidentiality (C) is relevant if you handle confidential patient records. Processing Integrity (PI) is relevant if your platform processes clinical data that drives treatment decisions. Most health tech companies do Security + Privacy + Availability.
How much does SOC2 cost for a health tech company?
Health tech SOC2 costs more than standard SaaS for two reasons: (1) Healthcare-experienced auditors charge a premium for specialized knowledge, and (2) broader TSC scope (Security + Privacy + Availability is common vs Security-only). Expect $25,000–$60,000 for Type 2 at a seed-to-Series A company. Factor in a separate HIPAA risk assessment ($5,000–$15,000) if you need that documented for covered entity contracts.