Healthtech serving US + EU markets needs both. HIPAA is sector-specific (US healthcare/PHI), GDPR is horizontal (all personal data, EU residents). Different definitions, different contracts (BAA vs DPA), different breach clocks. Side-by-side comparison + free audit for each.
If you already implement these for one framework, ~50% of the work for the other is already done.
Are you a US-based digital health / telehealth / EHR / billing SaaS?
→ HIPAAIf you touch PHI on behalf of any Covered Entity (hospitals, clinics, insurers), you ARE a Business Associate by statute. BAA + safeguards mandatory.
Do you serve EU patients or run a clinical trial with EU subjects?
→ GDPRHealth data on EU residents = Article 9 special category. Explicit consent + DPIA + DPO usually required.
Are you a global healthtech with US hospitals + EU clinical-trial sites?
→ HIPAA + GDPRStandard global healthtech stack. Run unified ISMS + dedicated HIPAA + GDPR controls, often with ISO 27799 (health-sector ISO 27001 extension).
B2C wellness app (not medical) collecting heart rate data?
→ GDPRUsually NOT a HIPAA Covered Entity or BA (no provider relationship). But heart rate = health data under GDPR Art. 9. CCPA's sensitive PI also applies in California.
December 2022 OCR bulletin explicitly named Meta Pixel + GA as HIPAA violations when on PHI pages. Same conduct violates GDPR e-Privacy + consent rules. Multi-million-dollar settlements have followed.
GDPR transfer mechanisms (SCCs/adequacy) get health data out of the EU lawfully. They do NOT make you HIPAA-compliant once it lands in the US — you still need a BAA + safeguards.
If a single breach affects both US patients and EU subjects, you have BOTH a 72-hour DPA notification AND a 60-day HHS notification. Most IR plans only document one.
No — GDPR adds to HIPAA, it doesn't replace it. For EU patients of a US Covered Entity, you must satisfy both: HIPAA safeguards + BAA chain AND GDPR Art. 9 basis + transfer mechanism + 72-hour breach notification.
No. HIPAA covers the controls; GDPR adds legal basis, DPA contracts, transfer mechanisms, DPO, DPIA, and stricter breach timing. AWS/Azure/GCP can provide both BAAs and DPAs but you still need to configure correctly and document.
Independent regulators, independent fines. OCR settled with Anthem at $16M (HIPAA); a similar breach with EU residents would add a separate DPA fine up to €20M / 4% turnover. Plus state AG settlements + CCPA private right of action.
Paste your current policy and get a clause-by-clause grade against either framework in 20 seconds. No signup. 3 audits/day.