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Swiss Federal Act on Data Protection (FADP)

Overview​

The revised Swiss Federal Act on Data Protection (FADP), effective September 1, 2023, significantly modernizes Switzerland's data protection framework, aligning it more closely with the EU GDPR while maintaining Swiss-specific provisions. This comprehensive guide covers Healthcare Manufaktur's compliance obligations under Swiss law.

Key Changes from Old DSG​

Enhanced Data Subject Rights​

  • Right to data portability: New right aligned with GDPR
  • Profiling protections: Expanded rights regarding automated decisions
  • Information obligations: More detailed transparency requirements
  • Breach notification: New mandatory notification system

Increased Penalties​

  • Criminal penalties: Up to CHF 250,000 for individuals
  • Administrative fines: Potential penalties for organizations
  • Enforcement mechanisms: Strengthened supervisory powers
  • Professional liability: Increased accountability for data processors

Expanded Scope​

  • Territorial application: Processing data of persons in Switzerland
  • Representative obligations: Non-Swiss entities may need representation
  • Cross-border transfers: Strengthened adequacy and safeguard requirements
  • Data Processing Agreements: Mandatory for controller-processor relationships

🌍� Fundamental Principles​

Good Faith and Proportionality​

  • Principle of good faith: Processing must be conducted honestly and fairly
  • Proportionality: Processing must be proportionate to the purpose
  • Purpose limitation: Data used only for declared purposes
  • Necessity: Only necessary data may be processed

Lawfulness and Transparency​

  • Legal basis requirements: Clear legal foundation for all processing
  • Transparency obligations: Clear information about data processing
  • Data subject notification: Proactive information provision
  • Processing records: Comprehensive documentation requirements

Data Security​

  • Appropriate security measures: Technical and organizational measures
  • Risk-based approach: Security measures proportionate to risk
  • Data breach prevention: Proactive security management
  • Access controls: Strict access limitation principles

� Legal Basis for Processing​

FADP Requirements:

  • Free, specific, informed, and unambiguous
  • Explicit consent for sensitive personal data
  • Revocable at any time
  • Documented and verifiable

Healthcare Applications:

  • Patient treatment consent
  • Research participation
  • Data sharing agreements
  • Marketing communications

Overriding Interests​

Legitimate Interests Equivalent:

  • Processing necessary for legitimate interests
  • Interests must not be outweighed by data subject interests
  • Balancing test documentation required
  • Regular reassessment obligations

Healthcare Examples:

  • Medical research in public interest
  • Healthcare system administration
  • Quality improvement initiatives
  • Patient safety monitoring

Statutory Requirements:

  • Swiss healthcare law obligations
  • Medical professional duties
  • Public health reporting
  • Insurance requirements

Vital Interests​

Emergency Situations:

  • Medical emergencies
  • Life-threatening circumstances
  • Unconscious patient treatment
  • Public health crises

Contract Performance​

Healthcare Services:

  • Patient care agreements
  • Insurance processing
  • Service provider contracts
  • Employment relationships

🌍� Sensitive Personal Data (Health Data)​

Definition and Scope​

FADP Article 5(c) Coverage:

  • Health and illness information
  • Genetic and biometric data
  • Medical treatment records
  • Healthcare provider notes
  • Pharmaceutical data

Enhanced Protections​

Additional Requirements:

  • Explicit consent or statutory authorization
  • Heightened security measures
  • Restricted access controls
  • Enhanced breach notification
  • Special transfer requirements

Healthcare Professional Privilege​

Medical Confidentiality:

  • Professional secrecy obligations
  • Patient-physician privilege
  • Data sharing limitations
  • Third-party disclosure restrictions
  • Research and statistics exceptions

✅ Data Subject Rights​

Right to Information (Article 19)​

Information Requirements:

  • Controller identity and contact details
  • Processing purposes and legal basis
  • Data categories and recipients
  • Storage periods and criteria
  • Data subject rights and complaint procedures
  • Transfers to third countries
  • Automated decision-making information

Healthcare Specifics:

  • Patient-friendly language
  • Treatment-related disclosures
  • Research participation information
  • Insurance processing notices
  • Emergency treatment notifications

Right of Access (Article 8)​

Process Requirements:

  • Identity verification procedures
  • 30-day response timeline
  • Free provision of information
  • Reasonable requests assessment
  • Third-party data protection

Healthcare Considerations:

  • Medical record access
  • Treatment history provision
  • Provider communication records
  • Insurance claim information
  • Research data participation

Right to Rectification (Article 32)​

  • Correction of inaccurate data
  • Completion of incomplete information
  • Medical record updates
  • Notification to third parties
  • Documentation requirements

Right to Deletion (Article 32)​

Grounds for Deletion:

  • Purpose fulfillment
  • Consent withdrawal
  • Unlawful processing
  • Legal deletion obligation

Healthcare Limitations:

  • Medical record retention requirements
  • Legal preservation obligations
  • Insurance claim needs
  • Research data value
  • Public health interests

Right to Data Portability (Article 28)​

Requirements:

  • Structured, machine-readable format
  • Direct transmission where feasible
  • Personal data scope only
  • Technical feasibility assessment
  • Healthcare interoperability standards

Right to Object to Profiling (Article 21)​

Automated Decision-Making:

  • Profiling definition and scope
  • Right to human intervention
  • Objection procedures
  • Medical decision safeguards
  • Risk assessment requirements

🌍

International Data Transfers

Adequacy Assessment​

Federal Council Decisions:

  • EU/EEA adequacy maintenance
  • Third country adequacy list
  • Sector-specific adequacy
  • Regular adequacy reviews
  • Adequacy withdrawal procedures

Current Adequate Jurisdictions:

  • European Union member states
  • European Economic Area
  • United Kingdom
  • Selected other countries per FDPIC list

Appropriate Safeguards​

Standard Contractual Clauses:

  • Swiss-specific SCC adoption
  • Transfer impact assessments
  • Supplementary measures evaluation
  • Regular effectiveness reviews
  • Documentation requirements

Other Safeguard Mechanisms:

  • Binding corporate rules
  • Codes of conduct
  • Certification mechanisms
  • Ad hoc contractual clauses
  • Professional rules compliance

Exceptions and Derogations​

Limited Transfer Grounds:

  • Explicit consent after information
  • Contract performance necessity
  • Important public interests
  • Vital interests protection
  • Legal claims establishment
  • Public register disclosures

=� Data Breach Management​

Breach Notification to FDPIC​

Notification Requirements:

  • High-risk breach notification within 72 hours
  • Breach description and affected categories
  • Controller contact information
  • Likely consequences assessment
  • Mitigation measures taken
  • Risk assessment documentation

Data Subject Notification​

High-Risk Scenarios:

  • Immediate notification required
  • Clear, understandable language
  • Specific breach information
  • Protective measures advised
  • Contact information provided
  • Exception for protective measures

Healthcare Breach Considerations​

  • Patient safety implications
  • Medical confidentiality preservation
  • Healthcare provider coordination
  • Insurance notification requirements
  • Professional body reporting
  • Media and public communication

🌍� Federal Data Protection and Information Commissioner (FDPIC)​

Supervisory Powers​

Investigation Authority:

  • Compliance investigations
  • Information requests
  • On-site inspections
  • Document examinations
  • Interview conduct
  • Expert consultations

Corrective Measures​

Administrative Actions:

  • Processing prohibitions
  • Data deletion orders
  • Security measure requirements
  • Certification withdrawals
  • Publication of violations
  • Cooperation with foreign authorities

Healthcare Sector Oversight​

  • Medical data processing monitoring
  • Healthcare provider inspections
  • Patient complaint investigations
  • Professional body coordination
  • Research oversight activities
  • International cooperation

=� Compliance Implementation​

Data Protection Officer (DPO)​

Appointment Criteria:

  • Large-scale systematic monitoring
  • Large-scale sensitive data processing
  • Core activity risk assessment
  • Professional qualification requirements
  • Independence and expertise
  • Contact information publication

Privacy Impact Assessments​

Assessment Requirements:

  • High-risk processing identification
  • Systematic impact evaluation
  • Necessity and proportionality review
  • Risk mitigation measures
  • FDPIC consultation procedures
  • Regular review requirements

Healthcare Applications:

  • New medical technologies
  • Large-scale patient monitoring
  • Genetic data processing
  • AI/ML implementation
  • Cross-border data sharing
  • Research project initiation

Records of Processing Activities​

Documentation Requirements:

  • Processing purpose and legal basis
  • Data categories and subjects
  • Recipient information
  • Transfer documentation
  • Retention periods
  • Security measures description

Healthcare-Specific Records:

  • Patient care activities
  • Research processing
  • Quality improvement programs
  • Insurance processing
  • Provider communications
  • Emergency treatment procedures

= Technical and Organizational Measures​

Security Requirements​

Risk-Based Approach:

  • Threat assessment procedures
  • Vulnerability management
  • Access control implementation
  • Encryption requirements
  • Audit logging systems
  • Incident response procedures

Healthcare Security Standards​

Medical Data Protection:

  • Electronic health record security
  • Telemedicine platform protection
  • Medical device cybersecurity
  • Healthcare network segmentation
  • Backup and recovery procedures
  • Physical security measures

Data Minimization​

Processing Limitation:

  • Purpose-specific data collection
  • Regular data inventory reviews
  • Automated deletion procedures
  • Anonymization techniques
  • Pseudonymization implementation
  • Data lifecycle management

=� Healthcare-Specific Considerations​

Medical Professional Obligations​

Professional Secrecy:

  • Hippocratic Oath compliance
  • Professional body requirements
  • Patient confidentiality duties
  • Interdisciplinary communication
  • Treatment coordination needs
  • Emergency disclosure provisions

Swiss Healthcare System​

Cantonal Variations:

  • Regional healthcare laws
  • Hospital governance structures
  • Insurance system integration
  • Professional licensing requirements
  • Quality assurance programs
  • Public health mandates

Clinical Research​

Research Framework:

  • Human Research Act compliance
  • Ethics committee approvals
  • Good Clinical Practice standards
  • International research collaboration
  • Data sharing agreements
  • Publication requirements

Telemedicine and Digital Health​

Remote Healthcare:

  • Cross-cantonal treatment provision
  • International consultation services
  • Digital platform compliance
  • Patient identity verification
  • Secure communication requirements
  • Remote monitoring systems

🌍� Training and Awareness​

Staff Training Requirements​

Comprehensive Programs:

  • FADP awareness training
  • Role-specific compliance education
  • Healthcare sector requirements
  • Incident response procedures
  • Patient rights education
  • Continuous professional development

Patient Education​

Transparency Initiatives:

  • Privacy notice distribution
  • Consent process explanation
  • Rights awareness campaigns
  • Complaint procedure information
  • Digital literacy support
  • Multilingual resources

=� Compliance Checklist​

Immediate Implementation​

  • Update privacy policies and notices
  • Implement consent mechanisms
  • Establish breach notification procedures
  • Create processing records
  • Conduct risk assessments
  • Review vendor agreements
  • Train staff on FADP requirements
  • Establish FDPIC relationship

Ongoing Compliance​

  • Regular compliance audits
  • Privacy impact assessments
  • Staff training updates
  • Policy review cycles
  • Incident response testing
  • Vendor monitoring
  • Patient rights fulfillment
  • Regulatory monitoring

Healthcare-Specific Actions​

  • Medical confidentiality procedures
  • Patient consent processes
  • Healthcare provider agreements
  • Insurance processing compliance
  • Research data governance
  • Telemedicine platform security
  • Medical device data protection
  • Emergency treatment protocols

=� Resources and References​

Official Sources​

Healthcare Guidance​

  • Swiss Medical Association Guidelines
  • Swiss Hospital Association Recommendations
  • Cantonal Health Department Guidance
  • Medical Professional Body Requirements

Implementation Tools​

  • FADP Compliance Templates
  • Privacy Notice Generators
  • Consent Form Libraries
  • Breach Notification Templates
  • Training Materials

International Cooperation​

  • EU-Swiss Data Exchange Mechanisms
  • Adequacy Decision Monitoring
  • International Healthcare Standards
  • Cross-Border Transfer Procedures

This framework is maintained by Healthcare Manufaktur's Legal & Compliance team. For Swiss FADP questions, contact: swiss-compliance@healthcare-manufaktur.com

Last Updated: January 2025

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