A healthcare AI company is developing a model that predicts sepsis onset 6 hours before clinical presentation. The model will recommend prophylactic antibiotic administration when it detects high sepsis risk. What governance structure is MOST appropriate for this model given its clinical impact?
Select an answer to reveal the explanation.
Short Explanation and Infographic
Here's the deal — b is correct because an AI that recommends specific drug administration (prophylactic antibiotics) based on predictive risk scores functions as a Software as a Medical Device (SaMD) and requires FDA regulatory clearance in the United States, along with prospective clinical validation, physician oversight to prevent autonomous drug administration, and post-market surveillance for patient safety. Standard IT change management (A) is wholly inadequate for a clinical treatment recommendation system.
Full explanation below image
Full Explanation
B is correct because an AI that recommends specific drug administration (prophylactic antibiotics) based on predictive risk scores functions as a Software as a Medical Device (SaMD) and requires FDA regulatory clearance in the United States, along with prospective clinical validation, physician oversight to prevent autonomous drug administration, and post-market surveillance for patient safety. Standard IT change management (A) is wholly inadequate for a clinical treatment recommendation system. Ethics board review and publication (C) are important elements but do not fulfill regulatory requirements. The clinical decision support exemption (D) does not apply to systems that recommend specific treatment actions.