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French Health Data Hosting Law (HDS)

View Law Text
Maximum Fine
€300,000
Scope
Industry-Specific
Regulator
ANS
Certification
Required

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Overview

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

Certification Violations
Up to €300,000
Operating without valid HDS certification
Security Breaches
Up to €100,000
Failure to maintain required security measures
Non-Compliance
Up to €50,000
Failure to meet operational requirements

Example Cases

Healthcare Provider
€150,000
2022 - Operating without valid HDS certification
Data Center
€75,000
2023 - Security measures below required standards

Additional Measures

ANS can impose corrective measures beyond monetary penalties.

Penalty Categories

Service Suspension
Operations Halt
Temporary suspension of hosting services
Certification Withdrawal
Status Loss
Withdrawal of HDS certification
Mandatory Audits
Cost of Audit
Required third-party security audits

Example Cases

Cloud Provider
Service Suspension
2023 - Critical security vulnerabilities
Hosting Company
Mandatory Audit
2022 - Required to undergo additional security assessments