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Act on the Financial Instrument for Increasing Safety SAFE – systemic and legal-financial analysis

Publication date: February 26, 2026

Introduction

The Act of 13 February 2026 on the SAFE Financial Instrument for Enhancing Security is the national legislature’s response to the European Union’s establishment of a new financial mechanism aimed at strengthening the defense capabilities of Member States. The SAFE Instrument (Strategic Technologies for Europe Platform) was established pursuant to a regulation of the Council of the European Union of 27 May 2025 as an emergency measure to accelerate investment in the European defense industry and increase the interoperability and readiness of the armed forces of EU Member States.

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AI Cartels

Publication date: February 26, 2026

Pricing API language models, collaboratively restricting access to the most advanced models, blocking interoperability, collaborative lobbying for regulations that hinder startup entry – is market ready for this?

An AI cartel is a situation in which AI-developing companies secretly or openly cooperate in a way that restricts competition—for example, by fixing prices, blocking access to technology, or jointly eliminating smaller players from the market.

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CHIPS AND DIGITALIZATION

Publication date: February 12, 2026

The EU Chips Act is a major European legislative package launched to boost the EU’s semiconductor industry, aiming to double its global market share to 20% by 2030, enhance supply chain resilience, and reduce reliance on external chipmakers. The EU Chips Act 2.0 is a proposed follow-up to the 2023 Chips Act, driven by a coalition of EU member states (including Germany, France, Netherlands) in late 2025 to shift from crisis management to long-term industrial strategy. It aims to secure supply chains, boost competitiveness, and accelerate investment by simplifying regulations and targeting R&D.

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EMA and FDA set common principles for AI in medicine development – January 2026

Publication date: February 12, 2026

In recent years, the importance of artificial intelligence (AI) in drug development, evaluation, and monitoring has grown significantly. AI technologies have the potential to accelerate research, improve predictions of drug efficacy and safety, and reduce the need for animal testing. At the same time, their use presents new challenges. AI models can make errors, be susceptible to unforeseen risks, or use data in a non-transparent manner. To fully realize the benefits of AI while minimizing risks, it is essential to establish clear and common principles for the use of these technologies. In response to these challenges, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly developed ten principles of good practice for the use of AI in the drug lifecycle. This document is fundamental and a framework, not a binding legal regulation – it provides general directions and guidelines that should guide drug manufacturers, applicants, and regulators. These principles indicate how AI should be designed and used to ensure it is ethical, safe, transparent, and based on reliable data. The ten principles also identify areas where international regulators, standards-setting organizations, and other collaborating entities can work together to promote good practice in drug development. These areas of collaboration include: conducting scientific research, creating educational tools and resources for market participants, international harmonization, and developing consensus standards. To facilitate initial analysis, these principles can be grouped into three logical pillars. Principles 1-3 address organizational foundations and people, focusing on interdisciplinary team expertise and ensuring that AI remains under human control within specific, established governance processes. Principles 4-7 address technical quality and model integrity, addressing the “heart” of the technology. Principles 8-10 address accountability and lifecycle, defining standards for documentation, clear communication with users, and continuous monitoring of the model after its implementation. Below is a detailed summary of the 10 principles of good practice for AI in the drug lifecycle:

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Who are cybersecurity certificates for? – The Act on the National Cybersecurity Certification System – What’s Worth Knowing

Publication date: February 6, 2026

Cybersecurity certifications are designed for IT professionals, including system and network administrators, security specialists, engineers, and those aspiring to these roles, to validate their knowledge and practical skills in protecting against digital threats. The certification also covers ICT products, services, and processes, and aims to inform consumers about the level of digital security and support Polish companies in European markets.

On August 28, 2025, the Act of June 25, 2025, on the national cybersecurity certification scheme entered into force, implementing Regulation (EU) 2019/881 of the European Parliament and of the Council of April 17, 2019, on ENISA (the European Union Agency for Cybersecurity) and cybersecurity certification in information and communication technologies, and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.06.2019, p. 15 and OJ L 2025/37, 15.01.2025).    

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