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Proposal for a regulation laying down harmonised rules on Artificial Intelligence


Proposal for a regulation laying down harmonised rules on Artificial Intelligence – Impact on the healthcare sector and the medical device industry

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Client Briefing

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19 July 2021

On 21 April 2021, the European Commission published a proposal for the world’s first legal framework on Artificial Intelligence (“AI Proposal“). The AI Proposal is intended to strengthen and secure Europe’s position in the development of a human-centric, sustainable, secure, inclusive and trustworthy AI. The proposal follows a risk-based regulatory approach, laying down a methodology to define “high-risk” AI systems that pose significant risk to the health and safety of natural persons. High-risk AI systems shall be subject to a strict regulatory framework, and the AI Proposal provides for strict obligations for AI system providers.

Supplementing Clifford Chance’s briefing on the AI Proposal “The Future of AI Regulation and its Global Impact” this briefing draws special attention to the impact of the AI Proposal on the healthcare sector.

Among others, the AI Proposal focuses on manufacturers of medical devices and in vitro diagnostics which use AI systems. And as AI will increasingly be used in the healthcare sector, it is not unlikely that further areas will still be included in the scope of application of the planned Regulation in the further legislative proceedings.

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