GDPR Compliance for Healthcare Companies | Complete Guide
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Key Compliance Highlights
Data subject rights implementation and management
Lawful basis for processing documentation
Data Protection Impact Assessment (DPIA) procedures
Cross-border data transfer mechanisms
Data Processing Agreement (DPA) requirements
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Frequently Asked Questions
How does GDPR apply to health data?
Health data is a "special category" requiring explicit consent or specific exemptions (healthcare provision, public health, research). Article 9 conditions must be met alongside a standard lawful basis.
What's the relationship between GDPR and HIPAA?
They're separate frameworks with different scopes. GDPR is broader (all personal data, EU focus). HIPAA is US-specific for health information. Companies handling EU patient data need both.
How do we handle patient consent under GDPR?
Healthcare consent under GDPR must be freely given, specific, informed, and unambiguous. It must be as easy to withdraw as to give. Document consent clearly and provide easy withdrawal mechanisms.
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Disclaimer: Compliance costs and timelines are estimates based on market benchmarks (AICPA fee surveys, vendor pricing indices 2025). Actual auditor fees and internal effort will vary based on your specific control environment, system complexity, and auditor selection. Consult with a qualified CPA for a formal statement of work.