KIELTYKA GLADKOWSKI KG LEGAL PARTICIPATED IN THE LIFE SCIENCE CLUSTER WEBINAR – THE IMPACT OF THE AI ACT ON LIFE SCIENCES MARKET

Publication date: February 20, 2025

Today (February 20) we had participated in the webinar organised by the Life Science Cluster, devoted to the impact of the AI Act regulation on the life science sector – its importance and consequences for entrepreneurs.

The AI Act is a new European Union regulation regulating artificial intelligence (AI), including its applications in the life science sector. The aim of the regulation is to ensure the safety, transparency and compliance of AI systems with EU law. The meeting brought the participants closer to issues such as:

Key assumptions of the AI Act:

• The AI Act introduces a classification of AI systems according to risk level: prohibited, high risk, limited risk and minimal risk;
• AI systems in the life science sector are often high-risk, requiring certification and compliance with strict standards;
• The regulation applies to entities inside and outside the EU if they introduce AI systems to the EU market.

Dates of entry into force:

• August 1, 2024 – entry into force of the AI Act ;
• February 2, 2025 – first regulations on prohibited AI practices;
• August 2, 2025 – General Purpose AI Regulations enter into force;
• August 2026 – Compliance obligation for high-risk AI systems.

Obligations of entities using AI:

• Act compliance requirements ;
• Ensuring human oversight and transparency of AI operations;
• Maintaining technical documentation and reporting incidents;
• Compliance with other regulations such as GDPR, MDR, IVDR.

How to comply with the AI Act and avoid regulatory pitfalls:

1. Determining the risk class of the AI system.
2. Analyzing the impact of AI on users and patients.
3. Ensuring transparency of the AI system and implementing human supervision.
4. Patient data protection.
5. Documentation and monitoring of regulatory compliance.

The AI Act introduces new standards for the life science sector, requiring AI systems to comply with strict legal requirements. Risk monitoring and compliance with EU regulations are key. Organizing meetings to familiarize interested parties with this topic will certainly make it easier for entities implementing EU regulations. KIELTYKA GLADKOWSKI KG LEGAL actively participates in the trainings and updates organised by the Life Science Cluster.