Thanks. This document certainly describes the high-level use of AI in healthcare including high-risk applications, however, the phrase "clinical" is absent from the document, and "application" is used without reference to the practical application of AI.
I would like to see a more hands-on practical approach document describing both the risk of "overfitting" of data sets, learning value vs overfitting, and novelty vs routine processes. I would also like to understand the use of AI in clinical studies.
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Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets -
https://www.twitch.tv/edosani------------------------------
Original Message:
Sent: 06-Aug-2021 09:25
From: Jennifer Neff
Subject: AI in healthcare
In late April 2021, the EU released its long-anticipated draft regulation for the use of artificial intelligence (AI), including in medical devices and in vitro diagnostics. Among other things, the proposal would mandate documented proof of safety and human oversight to ensure AI technology is safe and trustworthy.
As a member of the RAPS European Council (REC), I'm interested in learning if you think this draft goes far enough? Will it support or hamper the use of AI in healthcare?
For more information about the REC and RAPS in Europe, please visit https://www.raps.org/who-we-are/raps-europe.
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Jennifer Neff RAC
Head of Regulatory Affairs
Berlin
Germany
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