Rejoinder to Discussions on "Approval policies for modifications to machine learning-based software as a medical device: A study of bio-creep".
Sign Up to like & getrecommendations! Published in 2020 at "Biometrics"
DOI: 10.1111/biom.13380
Abstract: We thank the discussants for sharing their unique perspectives on the problem of designing automatic algorithm change protocols (aACPs) for machine learning-based software as a medical device. Both Pennello et al. and Rose highlighted a number… read more here.
Keywords: machine learning; learning based; software medical; medical device ... See more keywords
‘Software as Medical Device’ Regulation: What the US Can Teach to the EU for a Fairer Balance Towards Its Digital Sovereignty?
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DOI: 10.1163/15718093-bja10109
Abstract: The AI presence in healthcare (e.g., telemedicine platforms and Software as Medical Devices) is uncontroversial by now. Beyond the Big Tech already for some time large investors in this field, the States, repeatedly accused to… read more here.
Keywords: software medical; balance; regulation; digital sovereignty ... See more keywords
Virtual Biopsy: Just an AI Software or a Medical Procedure?
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DOI: 10.2967/jnumed.121.263749
Abstract: functional arti cial intelligence (AI) management the the the of and biopsy it the possibility of another tool to the s toolbox the aspiration that the biopsy, a crucial procedure in the diagnosis of disease,… read more here.
Keywords: medical procedure; software medical; biopsy software; virtual biopsy ... See more keywords