Rayscape
Rayscape is an AI solution for radiology, enhancing imaging accuracy with features like lung nodule detection and COVID evaluation for radiologists.
Independent assessment across data handling, compliance, security and transparency.
Risk factors
3- Cloud-based service with sensitive medical data
- Potential training on user-uploaded imaging data
- Data may be shared with third-party services
Recommendations
4- Require BAA and HIPAA compliance documentation before any deployment
- Verify FDA 510(k) clearance or CE marking status for clinical use
- Conduct thorough clinical validation before operational use
- Engage legal and compliance teams; standard IT approval process insufficient
Data handling
- Storage
- Medical imaging data processed in cloud or on-premises
- Retention
- Must comply with HIPAA retention requirements if BAA in place
- Training on inputs
- Medical data potentially used to improve AI models; BAA governs permissibility
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