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AI System

AI System

In short: a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment.

From Article 3(1)(1) of the AI Act: 'AI system' means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments.

From Article 6(1) and 6(2) of the AI Act:

  1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:
    • (a) The AI system is intended to be used as a safety component of a product, covered by the Union harmonisation legislation listed in Annex I,
    • (b) The product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.
  2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk.

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About Ringholm bv

Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT. We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.