AI Act Adopted by the Council of the EU

On 21 May 2024, the Council approved the Artificial Intelligence Act (AI Act). The AI legislation follows a ‘risk-based’ approach, with stricter rules for higher-risk applications. It aims to foster safe, trustworthy AI in the EU, respect fundamental rights and support research.

The Act provides for certain exemptions to high-risk classification when it comes to military, defence, and AI research systems. Penalties for violations of the AI act are determined either as a percentage of the company's global annual turnover in the preceding financial year or a predetermined amount, whichever is greater.

Following signature by the presidents of the European Parliament and the Council, the legislative act will be published in the EU’s Official Journal, taking effect twenty days after. The regulation will come into full force two years after its enactment, with certain provisions subject to exceptions.

The most relevant parts in the legislation, with an impact on healthcare and the pharmaceutical sectors, are:

  • The categorisation of AI by risk, with light transparency obligations for limited-risk AI and strict requirements for high-risk AI to access the EU market.
  • The ban on AI systems with unacceptable risks, such as cognitive behavioural manipulation, social scoring, predictive policing, and biometric categorization by race, religion, or sexual orientation.
  • The establishment of an innovation-friendly legal framework by promoting evidence-based regulatory learning and enabling AI regulatory sandboxes for real-world testing and validation of innovative AI systems.

Date: 02/07/2024 | Tag: | News: 1592 of 1596
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