Regulatory Compliance

Meeting the highest standards for healthcare technology in Namibia and internationally

Namibian MoHSS Compliant
International Standards
ISO 27001 Ready

Regulatory Framework

Comprehensive compliance with healthcare regulations and data protection laws

Namibian Healthcare Regulations

Full compliance with the Ministry of Health and Social Services (MoHSS) regulations for healthcare technology systems and patient data management.

  • Health Professions Act compliance
  • Medical aid fund regulations
  • Patient rights and data protection
  • Healthcare facility licensing requirements

Data Protection Laws

Adherence to Namibian data protection principles and alignment with international privacy standards including GDPR-equivalent protections.

  • Data Protection and Privacy Bill alignment
  • Cross-border data transfer protocols
  • Consent management frameworks
  • Data subject rights implementation

Medical Device Regulations

Compliance with medical device software regulations and healthcare technology standards as applicable to our platform.

  • Medical device software classification
  • Quality management systems
  • Risk management processes
  • Post-market surveillance

International Standards Compliance

Aligning with global best practices for healthcare technology

ISO 27001

Information Security Management

Implementation of comprehensive information security management systems to protect healthcare data.

Implementation in Progress

GDPR Principles

Data Protection Regulation

Privacy by design, data minimization, and individual rights protection following GDPR principles.

Compliant

HIPAA-Equivalent

Healthcare Privacy Standards

Implementation of HIPAA-equivalent controls for healthcare information protection and privacy.

Compliant

WHO Standards

World Health Organization

Alignment with WHO digital health standards and immunization data reporting requirements.

Compliant

Audit and Monitoring

Continuous compliance monitoring and regular auditing processes

Continuous Monitoring

24/7 automated compliance monitoring with real-time alerts for any deviations from regulatory requirements.

Regular Audits

Quarterly internal audits and annual third-party compliance assessments to ensure ongoing adherence to standards.

Compliance Reporting

Comprehensive compliance reports for regulatory bodies and stakeholders with detailed metrics and evidence.

Compliance Metrics

100%
Data Encryption
99.9%
Audit Trail Completeness
24/7
Compliance Monitoring
Zero
Compliance Violations

Data Governance Framework

Our comprehensive data governance framework ensures that healthcare data is managed, protected, and used in accordance with all applicable regulations and best practices.

🔐 Data Security

Multi-layered security controls protecting data at rest, in transit, and in use.

🎯 Data Quality

Automated data validation and quality assurance processes ensuring data integrity.

📋 Data Lineage

Complete traceability of data from source to destination with full audit trails.

⚖️ Data Ethics

Ethical use of healthcare data with patient consent and privacy protection.

Governance Layer

Policies Procedures Standards

Management Layer

Data Stewards Quality Control Access Control

Technical Layer

Encryption Monitoring Backup

Compliance Training and Awareness

Ensuring all team members understand and follow compliance requirements

Staff Training

Comprehensive compliance training for all employees covering healthcare regulations, data protection, and security protocols.

  • Quarterly compliance workshops
  • Role-specific training modules
  • Certification requirements

Partner Training

Training programs for healthcare partners and clients to ensure proper use of our platform in compliance with regulations.

  • Implementation training
  • Best practices workshops
  • Ongoing support and updates

Documentation

Comprehensive documentation and resources to support compliance efforts and provide guidance on regulatory requirements.

  • Compliance manuals
  • Standard operating procedures
  • Regular updates and notifications

Compliance and Regulatory Affairs

For questions about our compliance programs, regulatory matters, or to report compliance concerns, please contact our dedicated compliance team.

Compliance Officer

compliance@health264.com

General compliance inquiries

Regulatory Affairs

regulatory@health264.com

Regulatory questions and updates

Audit Requests

audit@health264.com

Third-party audit coordination