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🇪🇺 GDPR/DSGVO Compliance Framework

Overview​

The General Data Protection Regulation (GDPR), or Datenschutz-Grundverordnung (DSGVO) in German, represents the cornerstone of data protection law in the European Union. This comprehensive framework governs how Healthcare Manufaktur processes personal data across all EU member states.

🎯 Key Principles​

Lawfulness, Fairness, and Transparency​

  • Lawful Basis: Every processing activity must have a valid legal basis
  • Fair Processing: Data must be processed in a fair manner
  • Transparency: Clear information about data processing must be provided

Purpose Limitation​

  • Data collected for specified, explicit, and legitimate purposes
  • Not further processed incompatibly with those purposes
  • Research and statistical purposes have special provisions

Data Minimization​

  • Adequate, relevant, and limited to what is necessary
  • Regular reviews of data collection practices
  • Deletion of unnecessary data elements

Accuracy​

  • Personal data must be accurate and kept up to date
  • Inaccurate data must be erased or rectified without delay
  • Processes for data subject correction requests

Storage Limitation​

  • Kept in identifiable form no longer than necessary
  • Clear retention periods defined and enforced
  • Regular deletion and anonymization processes

Integrity and Confidentiality​

  • Appropriate security measures against unauthorized processing
  • Protection against accidental loss, destruction, or damage
  • Technical and organizational measures implementation

Accountability​

  • Demonstrate compliance with all principles
  • Maintain comprehensive documentation
  • Regular compliance assessments and audits

📋 Legal Basis for Processing​

Consent (Article 6(1)(a))​

Requirements:

  • Freely given, specific, informed, and unambiguous
  • Clear affirmative action required
  • Easily withdrawable
  • Separate consent for different purposes

Healthcare Considerations:

  • Power imbalances in patient relationships
  • Consent for research purposes
  • Secondary use of health data
  • Genetic and biometric data consent

Contract (Article 6(1)(b))​

Application:

  • Processing necessary for contract performance
  • Pre-contractual steps at data subject's request
  • Employment contracts and healthcare services
  • Service level agreements

Legal Obligation (Article 6(1)(c))​

Examples:

  • Medical record retention requirements
  • Reporting to health authorities
  • Tax and accounting obligations
  • Court orders and legal proceedings

Vital Interests (Article 6(1)(d))​

Scenarios:

  • Medical emergencies
  • Life-threatening situations
  • Public health emergencies
  • Unable to give consent situations

Public Task (Article 6(1)(e))​

Healthcare Applications:

  • Public health monitoring
  • Disease prevention and control
  • Health system management
  • Research in public interest

Legitimate Interests (Article 6(1)(f))​

Balancing Test Requirements:

  1. Identify legitimate interest
  2. Assess necessity of processing
  3. Balance against data subject rights
  4. Document assessment results

🏥 Special Category Data (Health Data)​

Article 9 Requirements​

Health data requires additional protections:

  • Explicit consent for specified purposes
  • Occupational medicine provisions
  • Public health interest processing
  • Scientific research safeguards

Appropriate Safeguards​

  • Pseudonymization and encryption
  • Access controls and audit logs
  • Data protection impact assessments
  • Regular security reviews

Healthcare-Specific Provisions​

  • Patient care continuity
  • Medical professional obligations
  • Health insurance processing
  • Clinical trial regulations

👤 Data Subject Rights​

Right to Information (Articles 13-14)​

Privacy Notice Requirements:

  • Controller identity and contact details
  • DPO contact information
  • Processing purposes and legal basis
  • Recipients or categories of recipients
  • Transfer information
  • Retention periods
  • Data subject rights
  • Complaint procedures

Right of Access (Article 15)​

Process Requirements:

  • Identity verification procedures
  • 30-day response timeline
  • Free first copy provision
  • Electronic format preferences
  • Third-party data considerations

Right to Rectification (Article 16)​

  • Correction of inaccurate data
  • Completion of incomplete data
  • Notification to recipients
  • Documentation requirements

Right to Erasure (Article 17)​

Grounds for Erasure:

  • No longer necessary
  • Consent withdrawn
  • Unlawful processing
  • Legal obligation to erase

Healthcare Exceptions:

  • Legal retention requirements
  • Public health interests
  • Medical claims defense
  • Research and statistics

Right to Restriction (Article 18)​

Applicable Scenarios:

  • Accuracy contested
  • Processing unlawful
  • Controller no longer needs data
  • Objection pending verification

Right to Portability (Article 20)​

Requirements:

  • Structured, commonly used format
  • Machine-readable format
  • Direct transfer where feasible
  • Consent or contract basis only

Right to Object (Article 21)​

  • Public task or legitimate interests basis
  • Direct marketing (absolute right)
  • Research and statistics (unless public interest)

Automated Decision-Making (Article 22)​

Protections:

  • Right not to be subject to automated decisions
  • Human intervention requirements
  • Explicit consent or necessity exceptions
  • Special category data restrictions

🔄 Cross-Border Data Transfers​

Within EEA​

  • Free flow of personal data
  • Same protection standards
  • No additional requirements

Adequacy Decisions​

Current Adequate Countries:

  • United Kingdom
  • Switzerland
  • Japan (limited)
  • South Korea
  • Others per EU Commission list

Appropriate Safeguards​

Standard Contractual Clauses (SCCs):

  • New SCCs (June 2021) implementation
  • Module selection based on transfer scenario
  • Transfer risk assessments required
  • Supplementary measures where needed

Binding Corporate Rules (BCRs):

  • Group-wide data protection policies
  • Supervisory authority approval
  • Enforcement mechanisms
  • Training and audit requirements

Derogations (Article 49)​

Limited use for:

  • Explicit consent after information
  • Contract performance
  • Important public interest
  • Vital interests protection
  • Legal claims
  • Public register transfers

🚨 Data Breach Management​

Breach Definition​

A breach of security leading to accidental or unlawful:

  • Destruction
  • Loss
  • Alteration
  • Unauthorized disclosure
  • Unauthorized access

Notification Requirements​

To Supervisory Authority (Article 33):

  • Within 72 hours of awareness
  • Describe nature of breach
  • Categories and numbers affected
  • DPO contact details
  • Likely consequences
  • Mitigation measures

To Data Subjects (Article 34):

  • Without undue delay
  • When high risk to rights and freedoms
  • Clear and plain language
  • Specific information requirements

Documentation Requirements​

  • Facts relating to breach
  • Effects and consequences
  • Remedial action taken
  • Decision-making rationale
  • Timeline of events

📊 Compliance Tools & Processes​

Privacy by Design and Default​

Implementation Requirements:

  • Proactive not reactive measures
  • Privacy as default setting
  • Full functionality with privacy
  • End-to-end security
  • Visibility and transparency
  • Respect for user privacy
  • Privacy embedded into design

Data Protection Impact Assessments (DPIA)​

When Required:

  • Systematic and extensive evaluation
  • Large scale special category processing
  • Systematic monitoring of public areas
  • New technologies with high risk

DPIA Process:

  1. Describe processing operations
  2. Assess necessity and proportionality
  3. Identify and assess risks
  4. Identify mitigation measures
  5. Document and review
  6. Consult DPA if high residual risk

Records of Processing (Article 30)​

Controller Records:

  • Organization details
  • Processing purposes
  • Data categories
  • Recipient categories
  • Transfers documentation
  • Retention periods
  • Security measures

Processor Records:

  • Controller details
  • Processing categories
  • Transfer documentation
  • Security measures

This framework is maintained by Healthcare Manufaktur's Legal & Compliance team. For GDPR-specific questions, contact: gdpr@healthcare-manufaktur.com

Last Updated: January 2025

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