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Rudolf Wagner's avatar

I am working in the Software as a Medical Device (SaMD). Software / AI is heavily regulated already since 3 yrs. In US 182 AI models are approved and in EU so far 52, some of which I certified for customers I consulted. In VERY short words, you need to have a lot of documentation ready, a valid QMS for developement, verification and validation. You need to have unbiased and evaluated (diverse) clinical training data and then for the validation of your trained LLM a SECOND independent Data Set with independent assessment (usually by doctors). You then need to have a study and test it in the wild with predefined expected outcomes and trust levels. Many companies are currently working on it or are in certification. My current assignment we got Class IIb EU MDR (the first company) which allows using algorithms for any kind of disease and patient condition and treat or diagnose for up to serious condition patients.

I am happy to guide everybody through it. For a start, pls. Google „MDCG2019-11“

Rudolf (Quality and Regulatory affairs expert ;-) )

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Vincent's avatar

Isn't that just like Med-PaLM 2 Google is working on? In my opinion a medical LLM is the most complicated as a single hallucination or wrong answer could potentially kill a person.

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