French Health Data Hosting Law (HDS)
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The Health Data Hosting (HDS) certification framework establishes strict requirements for organizations hosting personal health data in France, ensuring high standards of security and availability.
Key Facts
- Mandatory certification for health data hosts
- Enforced by ANS (French Digital Health Agency)
- Regular certification renewal required
Key Principles
HDS Certification
Mandatory certification for hosting health data in France.
Requirements
- Obtain HDS certification
- Regular certification renewal
- Maintain compliance documentation
- Staff certification training
- Continuous monitoring
Examples
- Certification documentation
- Compliance records
- Training materials
- Audit reports
Security Requirements
Specific security measures for health data protection.
Requirements
- Physical security controls
- Logical access controls
- Encryption implementation
- Backup procedures
- Incident response plans
Examples
- Security protocols
- Access control systems
- Encryption standards
- Backup systems
Availability and Continuity
Ensuring continuous access to health data services.
Requirements
- High availability systems
- Disaster recovery plans
- Business continuity measures
- Regular testing
- Performance monitoring
Examples
- Redundancy systems
- Recovery procedures
- Test schedules
- Monitoring tools
Compliance Requirements
HDS Certification Process
Steps required to obtain and maintain HDS certification.
Implementation Steps
- Select certification body
- Complete certification audit
- Address audit findings
- Obtain certification
- Annual surveillance
Required Documentation
- Certification application
- Audit reports
- Corrective actions
- Certification records
- Surveillance reports
Technical Infrastructure
Technical requirements for health data hosting.
Implementation Steps
- Implement secure infrastructure
- Configure monitoring systems
- Deploy security controls
- Establish backup systems
- Test recovery procedures
Required Documentation
- Infrastructure diagrams
- Security configurations
- Monitoring setup
- Backup procedures
- Test results
Operational Procedures
Day-to-day operational requirements for health data hosting.
Implementation Steps
- Define operational procedures
- Train staff on procedures
- Monitor operations
- Handle incidents
- Regular reviews
Required Documentation
- Procedure manuals
- Training records
- Monitoring logs
- Incident reports
- Review documentation
Enforcement & Penalties
Administrative Sanctions
The French National Agency for the Security of Health Information Systems (ANS) can impose various sanctions.
Penalty Categories
Example Cases
Additional Measures
ANS can impose corrective measures beyond monetary penalties.