Two Regulatory Frameworks, One Goal
Healthcare software that serves both US and international patients may need to comply with HIPAA and the EU's General Data Protection Regulation (GDPR). While both aim to protect personal/health data, they differ in scope, requirements, and enforcement. Understanding both helps you build compliant systems for global healthcare.
Scope and Applicability
HIPAA
Applies to covered entities (health plans, providers, clearinghouses) and business associates in the US. Protects individually identifiable health information (PHI) held or transmitted by these entities.
GDPR
Applies to organizations processing personal data of EU/EEA residents, regardless of where the organization is located. Health data is a special category requiring heightened protection.
Key Differences
AspectHIPAAGDPR
ConsentUses and disclosures permitted for TPO (treatment, payment, operations) without consentGenerally requires explicit consent or another legal basis for processing
Right to ErasureNo general "right to be forgotten"Right to erasure in many circumstances
Data MinimizationMinimum necessary standardExplicit data minimization principle
Breach Notification60 days to HHS and affected individuals72 hours to supervisory authority; notify individuals when high risk
PenaltiesUp to $1.5M per violation tierUp to 4% of global annual revenue or €20M
Overlap and Harmonization
Both require technical and organizational measures to protect data. Encryption, access controls, audit logging, and vendor agreements (BAA / GDPR-compliant DPA) are common. A well-designed security architecture can support compliance with both.
Practical Steps
- Conduct a data mapping exercise for both regulations
- Implement consent management where GDPR applies
- Document legal bases for processing under GDPR
- Ensure data processing agreements with vendors meet both HIPAA and GDPR requirements
- Plan breach response procedures for both 60-day (HIPAA) and 72-hour (GDPR) timelines
Conclusion
HIPAA and GDPR can coexist. Focus on strong security foundations—encryption, access control, audit trails—and layer regulation-specific requirements (consent, erasure, breach timelines) on top. When in doubt, consult legal counsel with expertise in both regimes.
Building healthcare software for US and international markets? Contact TWO44 for healthcare technology development that considers global compliance.
