LEGAL & REGULATORY COMPLIANCE

Medical data protection is part of the workflow.

Digitalix Diagnostic Exchange is designed to support secure diagnostic case exchange. Final compliance depends on implementation, contracts, local law and the healthcare provider's organisational procedures.

European framework

Support for privacy-by-design, lawful processing, data minimisation and restricted access.

  • GDPR
  • NIS2 governance
  • eIDAS where applicable
  • EU MDR where applicable

Technical safeguards

Encrypted communication, token-based access and traceable operations.

  • HTTPS/TLS
  • Time-limited tokens
  • Password protection
  • Audit trail
  • Retention controls

Healthcare standards

Integration is based on established medical interoperability standards and information-security principles.

  • DICOM / DICOMweb
  • HL7 / FHIR readiness
  • ISO 27001 principles
  • ISO 27799 principles

Controlled workflow

Case creation, consultant access, OHIF analysis, structured reporting and report return remain parts of one controlled process.

Roles and responsibilities

The healthcare provider defines controller and processor roles, lawful basis, retention, access levels, contracts and incident procedures.

Cross-border use

International collaboration requires assessment of transfer mechanisms, infrastructure location, contractual clauses and professional licensing rules.

Important notice

This page describes design capabilities and is not legal advice or proof of certification. Legal, security and organisational assessment is required before production deployment.