EU AI Act Enacted: New Rules for AI Risk and Oversight

  • userPAICON

  • calendarJanuary 23, 2024

  • clock2 min read

A New Era in Artificial Intelligence Regulation

The EU AI Act, introduced in June 2023, is a significant milestone in regulating artificial intelligence within the European Union. It builds upon the existing General Data Protection Regulation for data privacy and introduces tailored regulations for AI technology.

Unlike the GDPR, which primarily focuses on personal data protection, the EU AI Act specifically regulates AI systems, categorizing them by risk levels and imposing human oversight and compliance requirements. High-risk AI systems used in healthcare, transportation, and critical infrastructure are subject to stringent requirements, including mandatory human oversight. The EU AI Act also necessitates transparent data usage, obtaining explicit consent for AI-related activities, and prioritizes patient safety, data quality, and ethical AI use in the healthcare sector. The regulation was agreed upon by the Parliament and Council of the European Union on 9 December 2023, with publication expected this year.


PAICON is a medical software company based in Heidelberg. PAICON was founded by doctors and researchers with the aim to provide a digitized environment that encourages entrepreneurship, global collaboration and the development of certified medical products and applications especially in the science and healthcare sector. We simplify processes and enable medical researchers to focus on our shared passion – improving people’s lives through data.

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