Ed,
I have experienced this before having used terms, probably my first choice Asymptomatic, but depending on the exact data you are looking at should reflect the status of the patients reviewing. So other words might consider is normal, neutral, non-diagnosed, non-controlled, or something like that. You are right probably not to use "healthy" if the assessment of the patient was not done for this characteristic.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Nov-2023 15:25
From: Ed Panek
Subject: Subject Population Name
We captured data from subjects undergoing a clinical trial for various diseases and used this data to create an AI that can predict future patient biometrics in the future. During COVID-19, we also used this device to measure temporary employees to alert us to biometric changes indicative of COVID-19 infection. We didn't intend to do anything with this data and it only contains raw biometric data and ZERO PHI or grouping information the regulators usually request for Age, BMI, Race, Gender, etc.
What we did with this data was run it through our algorithm to see if we were able to predict biometric changes using this AI. We are submitting this to a regulatory body and are considering the group name. It can't be a healthy patient group because we didn't screen for illness. Some of the employees did suffer illness which our AI predicted correctly so we want to use it.
Our current data groups are Cancer type A, type B, Type C, etc with a large volume of data for each broken down by all the demographics we need
What can we name this employee group for our regulatory submission aside from "healthy?" "Asymptomatic?" "No indicators at the start of measurements?"
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
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