As the use of Artificial Intelligence (AI) and machine learning methods expand in medical devices and HealthIT software, an oft asked question is whether the data sets used for training should be retained as part of the design history file (DHF) or other long term storage mechanisms. SoftwareCPR partners Alan Kusinitz, Sherman Eagles, John Murray, and Brian Pate recently met to discuss this topic and arrived at several guiding principles that may be useful to manufacturers as they consider specific policy with regard to retaining training data sets.
We went into our roundtable discussion making the following assumptions . . .
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