AI as a Medical Device

Written By

sophie vo Module
Sophie Vo

Associate
UK

I am an Associate in the Intellectual Property Group in London with a particular focus on the life sciences and healthcare sectors.

Last month, the Medicines & Healthcare products Regulatory Agency (“MHRA“) published guidance on “Software and Artificial Intelligence (AI) as a Medical Device”. It didn’t necessarily provide for any new regulatory approach to AI in the therapeutic space, but it brought together some important material during this period of increasing interest in AI to effectively remind software providers of their compliance obligations in the life sciences and healthcare space.

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