Artificial Intelligence (AI) is a fast-growing field. This is evidenced by the number of global publications, more than 334K in 2021 (Daniel Zhang, 2022), and the number of global AI patents, estimated above 142K in 2021(Daniel Zhang, 2022). As AI methods have already been implemented in different industries such as in the automotive sector through the use of AI Computer Vision and consumer products that harvest Natural Language Processing Algorithms (NLPs), considerations are raised on the Ethical and Trustworthy aspects of AI. BSI has witnessed the rapid growth in the implementation of AI in Medical Devices (MDs) and In Vitro Diagnostics (IVDs). Although mature and strict regulatory frameworks as well as standards exist for such industries, they were not designed to address AI specific challenges.
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