Ethics and Compliance
The Compliance section outlines regulatory requirements, ethical considerations, and traceability essential for medical AI applications like Neolens.
📜 Regulatory Framework
Neolens adheres to:
- GDPR for health data protection
- Medical Device Regulation (MDR) EU 2017/745
- FDA guidelines for Software as a Medical Device (SaMD)
🔒 Data Privacy (GDPR)
- Patient data is anonymized and encrypted.
- Data processing consent is mandatory.
- Data retention policies comply with legal standards.
🤖 Ethical AI Use
- Transparency in AI decision-making.
- Mitigation of biases and fairness monitoring.
- Clear communication of AI limitations to users.
📊 Traceability and Auditability
- All API calls and model outputs are logged securely.
- Enables post-hoc review and error investigation.
- Supports clinical accountability and legal compliance.
🧩 Responsibility
- AI assists but does not replace clinical judgment.
- Final decisions rest with qualified healthcare professionals.
warning
Use Neolens responsibly, respecting ethical and legal boundaries.
Misuse can lead to harm and liability.