Placeholder chapter page. Sections are produced by the book-skills pipeline.
Sections
- 34.1 SaMD and the FDA framework
- 34.2 Predetermined change control plans (PCCP) for learning models
- 34.3 Clinical trial and prospective validation design
- 34.4 Biometric leakage and re-identification from physiological signals
- 34.5 Consent, data governance, and de-identification
- 34.6 Fairness and equity in health sensing
- 34.7 Documentation: datasheets, model cards, and audit trails
Lab 34
write a validation-and-privacy plan for a wearable health model, including a re-identification risk check.