PhaseRecommendationKey OperationsExamples
DesignEngage stakeholders- Identify stakeholders
- Set communication channels
- Organize cocreation meetings
Patients, GPs, ethicists; Regular meetings; 15-stakeholder workshops
Define user requirements- Clinical need assessment
- Interface specifications
Risk prediction tools; Data upload interfaces
Assess data heterogeneity- Equipment/protocol analysis
- Operator variability assessment
Multi-vendor MRI differences; Technician experience levels
DevelopmentCollect representative data- Demographic/clinical variation inclusion
- Artificial data enhancement
Age/ethnicity balancing; Noise augmentation 127130
Ensure data privacy- Deidentification techniques
- Cybersecurity measures
Federated learning; Differential privacy 137139
Implement risk mitigation- Bias correction
- Domain adaptation
Data resampling; Transfer learning
EvaluationExternal validation- Multi-center testing
- Benchmark comparisons
Cancer Imaging Archive datasets; Radiologist vs AI comparisons 152149
Fairness assessment- Statistical parity metrics
- Bias correction evaluation
Age/sex subgroup analysis; Equalized odds postprocessing 146
Clinical utility testing- Randomized trials
- Cost-benefit analysis
Diagnosis time reduction; Overtreatment reduction 167172
DeploymentLocal validation- Site-specific testing
- Workflow integration assessment
Hospital PACS integration; Local population calibration 148191
Continuous monitoring- Drift detection
- Periodic model audits
Biannual accuracy checks; Data distribution dashboards 148200
Regulatory compliance- Certification processes
- Documentation management
FDA SaMD requirements; EU MDR compliance 206207