The AI Act is (almost) here!

In part 2 of our series on artificial intelligence in medical technology, we looked at the topic of “Regulatory requirements”. We mentioned some of the standards on artificial intelligence and the committees involved. On 9 March 2021, the European Commission presented its goals for the digital transformation by 2030. In order to achieve these goals, more and more legislation on AI and digitalisation is being published, which poses a major challenge for research and development teams.

In April 2021, the European Commission published a proposal for a “Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) and amending certain Union acts” (Proposal EU AI Act). 
On 14 June 2023, MEPs held a partial vote, which became official at the end of 2023. The EPRS (European Parliamentary Research Service) has published a briefing on this (Artificial intelligence act (europa.eu)).

On 8 December 2023, the negotiators from the EU Parliament and Council reached a provisional agreement on the Artificial Intelligence Act (AI Act). This regulation aims to ensure that fundamental rights, democracy, the rule of law and environmental sustainability are protected from high-risk AI, while promoting innovation and making Europe a pioneer in this field (Artificial Intelligence Act: deal on comprehensive rules for trustworthy AI).

The new provisions of the AI Regulation will apply to:

• all providers of AI systems who develop an AI system or have one developed and then place it on the market or put it into operation;
• those who use AI systems under their own responsibility;
• Distributors outside the EU and EU importers;
• Providers and users of AI systems located in a third country if the output generated by these systems is used in the EU.
  
  

Further article at ⁣The AI Act is (almost) here! (seleon.com)