Phase | Recommendation | Key Operations | Examples |
---|---|---|---|
Design | Engage 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 | |
Development | Collect 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 | |
Evaluation | External 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 | |
Deployment | Local 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 |