SOC 2 for European health-tech selling into US healthcare.
US hospitals and payors require SOC 2 for vendor onboarding. Combined with HIPAA (for PHI) and GDPR/MDR (for European operations), health tech faces a triple compliance stack. Matproof maps all three to one evidence pipeline.
Why this matters now
US health system procurement is tightening vendor attestations post-2024 breach wave. European health-tech with US ambition can't defer SOC 2 any longer.
- SOC 2 + HIPAA + GDPR is three overlapping but distinct frameworks
- PHI handling requires more than SOC 2 Security criterion — needs HIPAA Security Rule + Privacy Rule
- European health-tech also pursues MDR for software-as-medical-device
- AWS/GCP BAAs required for HIPAA compliance add subservice-org complexity
How Matproof covers SOC 2 for Health Tech & Digital Health
Triple mapping: SOC 2 + HIPAA + GDPR
Single control library spans SOC 2 Common Criteria, HIPAA Security Rule (45 CFR 164.306-318), and GDPR Art. 32. One evidence artifact satisfies all three audit regimes.
Business Associate Agreement (BAA) tracking
HIPAA requires BAAs with subservice organizations handling PHI. Matproof tracks BAA status, renewal dates, and subservice SOC 2 reports in one vendor register.
PHI-specific controls
Access logs for PHI, minimum-necessary access reviews, breach-notification chains (60-day HIPAA vs 72h GDPR), and patient-rights request handling.
MDR / 510(k) / CE-marking alignment
If you're software-as-medical-device, quality management system controls (ISO 13485, IEC 62304) map to many SOC 2 controls. Don't duplicate.
In scope
- Digital health and telehealth platforms
- Electronic health records and clinical information systems
- Medical imaging and radiology software
- Remote patient monitoring and wearables
- AI-powered diagnostic and decision-support tools
- Pharmacy tech and medication management SaaS
Frequently asked questions
Do I need HIPAA if I'm European and don't operate in the US?+
HIPAA applies extraterritorially to any handling of PHI from US covered entities (hospitals, insurers, clearinghouses). If you process US patient data, you're subject to HIPAA regardless of where your company is based. European health-tech with any US customers typically needs HIPAA + GDPR + SOC 2 in parallel.
Does SOC 2 cover HIPAA automatically?+
No — they're distinct frameworks. SOC 2 Common Criteria overlap ~60-70% with HIPAA Security Rule, but HIPAA has specific requirements around PHI handling, breach notification, and Business Associate Agreements that SOC 2 doesn't cover. You need both. Matproof cross-maps them so one control implementation covers both.
How do we handle AI-powered diagnostic tools under these frameworks?+
SOC 2 covers the SaaS controls. HIPAA covers PHI handling. GDPR covers European patient data. MDR covers the software-as-medical-device aspect — regulatory obligations for clinical validation, post-market surveillance, adverse-event reporting. The EU AI Act adds further obligations for high-risk AI in health. Matproof's AI governance module covers EU AI Act alongside SOC 2/HIPAA/GDPR.
Ready to start with SOC 2?
30-minute demo tailored to Health Tech & Digital Health. We show you exactly how Matproof covers SOC 2 for your sector.