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aACP

Approval policies for modifications to machine learning‐based software as a medical device: A study of bio‐creep, Biometrics, 2020. https://onlinelibrary.wiley.com/doi/10.1111/biom.13379 http://arxiv.org/abs/1912.12413.

Installation

Create a python virtualenv using the required packages in requirements.txt. Create a scratch directory in this folder. Also install the required R packages optparse and ldbounds.

To run the simulation scripts, install SCons. The simulation scripts live in the folders prefixed with "simulation." Then you can run each simulation using scons <simulation_folder_name>.

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Automatic Algorithm Change Protocols for regulating AI/ML-based Software as a Medical Device

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