Registry Security

Security Requirements for Global Cell Therapy Patient Registry

1. Data Protection and Privacy Compliance

International Regulatory Framework

Must comply with GDPR (EU), HIPAA (US), PIPEDA (Canada), and other relevant national healthcare data protection regulations
Implementation of data protection measures meeting the highest common denominator across all participating jurisdictions
Regular compliance audits and certifications

Data Classification and Handling

All patient data must be classified as highly sensitive
Strict controls on data access, transmission, and storage
Implementation of data minimization principles
Clear data retention and destruction policies aligned with international requirements

2. Access Control and Authentication User Authentication

User Authentication

Multi-factor authentication (MFA) mandatory for all users
Biometric authentication for high-risk operations
Regular password rotation with complexity requirements
Session management with automatic timeouts
IP-based access restrictions where appropriate

Role-Based Access Control (RBAC)

Granular permission levels based on user roles
Separate roles for data entry, viewing, analysis, and administration
Geographic access restrictions based on jurisdiction
Regular access reviews and certification
Automated access revocation upon role change or termination

3. Data Security

Encryption

End-to-end encryption for all data transmission
AES-256 or equivalent encryption for data at rest
Hardware Security Module (HSM) for key management
Regular encryption key rotation
Secure key storage and backup procedures

Data Integrity

Digital signatures for all data entries
Blockchain or similar technology for audit trails
Checksums for data verification
Version control for all records
Regular data integrity checks

4. Infrastructure Security

Network Security

Segmented network architecture
Next-generation firewalls
Intrusion Detection/Prevention Systems (IDS/IPS)
Regular vulnerability scanning
DDoS protection
Web Application Firewall (WAF)

Server Security

Hardened operating systems
Regular security patches
Anti-malware protection
File integrity monitoring
Secure configuration management
Regular security assessments

5. Audit and Monitoring

Activity Logging

Comprehensive audit trails for all data access and modifications
Secure log storage with encryption
Real-time alerting for suspicious activities
Regular log analysis and review
Automated anomaly detection

Compliance Monitoring

Continuous compliance monitoring
Regular internal audits
Third-party security assessments
Penetration testing
Vulnerability assessments

6. Incident Response and Recovery

Incident Management

Documented incident response procedures
Dedicated incident response team
Regular incident response drills
Clear communication protocols
International incident reporting procedures

Business Continuity

Regular data backups
Geographically distributed redundancy
Disaster recovery procedures
Recovery Time Objectives (RTO) and Recovery Point Objectives (RPO)
Regular disaster recovery testing

7. Third-Party Management

Vendor Security

Security requirements for all third-party vendors
Regular vendor security assessments
Contractual security obligations
Monitoring of vendor access
Right-to-audit clauses

Data Sharing Agreements

Clear data sharing protocols
International data transfer agreements
Standard contractual clauses for cross-border transfers
Regular review of sharing arrangements

8. Training and Awareness

Security Training

Mandatory security awareness training
Role-specific security training
Regular security updates and briefings
Phishing awareness campaigns
Compliance training

Documentation

Comprehensive security policies and procedures
Regular policy reviews and updates
Clear documentation of all security controls
User guides and security manuals
Incident response playbooks