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:
