Compliance & Standards
Our comprehensive compliance framework ensures the highest standards of data protection, security, and regulatory adherence in medical AI analysis.
Core Compliance Framework
We adhere to the most stringent international standards for healthcare technology and data protection
GDPR Compliance
General Data Protection Regulation
We process only essential data required for medical analysis, with no unnecessary data collection or storage.
All user data is automatically deleted immediately after analysis completion - no permanent storage.
Processing based on legitimate interest for educational health information with explicit user consent.
Built-in privacy protections from system architecture to user interface design.
ISO 27001 Security
Information Security Management
Systematic identification, assessment, and mitigation of information security risks.
Role-based access controls with multi-factor authentication and least privilege principles.
AES-256 encryption for data at rest and TLS 1.3 for data in transit with perfect forward secrecy.
24/7 security monitoring with automated threat detection and incident response procedures.
HIPAA Alignment
Health Information Protection
Comprehensive policies and procedures governing access to and use of health information.
Secure cloud infrastructure with physical access controls and environmental protections.
Advanced encryption, audit logs, and automatic logoff to protect electronic health information.
Comprehensive incident response plan with breach notification procedures and user communication.
Medical Device Readiness
EU MDR & FDA Preparation
Systematic risk analysis and mitigation for AI-based medical software systems.
Quality management system designed for medical device development and maintenance.
Medical device software development processes with validation and verification protocols.
Ongoing clinical evidence collection and evaluation framework for AI performance assessment.
Advanced Data Protection
Multi-layered security architecture ensuring complete protection of sensitive medical information
End-to-End Encryption
Zero Trust Architecture
Data Lifecycle Management
Privacy Controls
Incident Response
Audit & Compliance
AI Ethics & Governance
Responsible AI development with ethical guidelines and transparent governance frameworks
Ethical AI Framework
Beneficence & Non-maleficence
AI systems designed to benefit patients while preventing harm through comprehensive safety testing and risk mitigation.
Autonomy & Informed Consent
Respecting user autonomy with clear consent processes and transparent information about AI limitations and capabilities.
Justice & Fairness
Ensuring fair and unbiased AI performance across diverse populations with ongoing bias monitoring and mitigation.
Transparency & Explainability
Providing clear explanations of AI decisions and maintaining transparency about model performance and limitations.
Governance Structure
AI Ethics Committee
Independent committee with medical professionals, ethicists, and technologists overseeing AI development and deployment.
Clinical Advisory Board
Board-certified physicians and specialists providing clinical oversight and validation of AI interpretations and recommendations.
Data Protection Officer
Dedicated DPO ensuring GDPR compliance and overseeing all data protection activities and privacy impact assessments.
Quality Assurance
Continuous quality monitoring with regular performance evaluations and improvement recommendations.
Regulatory Roadmap
Our planned regulatory compliance milestones and certification timeline
2024 Q4
GDPR Compliance Implementation
Full GDPR compliance framework with privacy by design architecture and data protection protocols.
2025 Q1
IN PROGRESSISO 27001 Certification
Information security management system certification with comprehensive security controls and audit processes.
2025 Q2
CE Marking Preparation
EU Medical Device Regulation (MDR) compliance preparation for CE marking as Class I medical device software.
2025 Q3
PLANNEDFDA Pre-Submission
FDA Pre-Submission meeting for De Novo classification pathway for novel AI-based medical device software.
2025 Q4
SOC 2 Type II Certification
SOC 2 Type II audit completion for security, availability, processing integrity, confidentiality, and privacy controls.
Compliance Resources
Access our compliance documentation, policies, and contact information for regulatory inquiries
Documentation
Certifications
Contact & Support
Questions About Our Compliance?
Our compliance and legal teams are here to answer your questions about data protection, security, and regulatory adherence.