No wonder, AI has made it possible to accomplish tasks that were once thought to be out of our league. Right from controlling the traffic to assisting the surgeons in performing the various medical procedures, AI has carved a niche for itself. What has always been a hot topic of discussion is the Regulation aspect of AI. On that note, The EU Commission adopted a proposal for the first legal framework on AI recently. This aims at imposing obligations on businesses across multiple sectors, including that of the life sciences (the Regulation).
AI, under the Regulation, is defined as the "software that is developed with one or more of [certain] approaches and techniques and can, for a given set of human-defined objectives, generate outputs such as content, predictions, recommendations, or decisions influencing the environments they interact with."
The legal framework that has recently made its presence felt has a crystal clear objective – to ensure a level of trust in AI systems that are made available. Well, that is not all. There is more to it. It adopts a risk-based approach.
The risk-based approach throws light on the different risk categories. They are –
All of these apply to the providers of high-risk AI systems as well as the manufacturers of products that include high-risk AI systems. As far as the distributors, importers, users and other third parties are concerned, will be subject to the provider's obligations if –
In a nutshell, the Regulation is all set to have a significant impact across all sectors. Since the complete legislative process is not yet done, the businesses will now have to wait to see how the principles set out in the Regulation.
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