Approval policies for modifications to machine learning‐based software as a medical device: A study of bio‐creep

DOI10.1111/biom.13379zbMath1520.62195arXiv1912.12413OpenAlexW3089324918WikidataQ100296472 ScholiaQ100296472MaRDI QIDQ6094186

Jean Feng, Scott S. Emerson, Noah Robin Simon

Publication date: 9 October 2023

Published in: Biometrics (Search for Journal in Brave)

Full work available at URL: https://arxiv.org/abs/1912.12413

zbMATH Keywords

AI/ML-based SaMDalpha-investinggate-keepinggroup-sequentialonline hypothesis testing

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10)

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Discussion on “Approval policies for modifications to machine learning‐based software as a medical device: A study of biocreep” by Jean Feng, Scott Emerson, and Noah Simon

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