Hello
I don't know specifically about the use of OpenAI and ChatGPT, But we have seen a lot of activity in the AI/ML space over the last several years. FDA has approved/cleared over 500 medical devices based on AI/ML.
The regulatory approach is still evolving. I have focused mostly on the US market. FDA has provided many resources in this area, including a recent draft guidance for pre-market submissions.
Here is useful webpage on FDA's site
Artificial Intelligence and Machine Learning in Software as a Medical Device
Recently, I wrote a review article on my Let's Talk Risk! newsletter. You are welcome to take a look here
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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
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Original Message:
Sent: 08-Jun-2023 14:41
From: Anonymous Member
Subject: Open AI and Chat GPT
This message was posted by a user wishing to remain anonymous
Hi folks, I was interested if anyone knows of a medical device that is already on the market using Open AI or ChatGPT?
I would like to hear thoughts on the regulatory approach for such models, especially in the EU
Thanks!