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:
More
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).
More
Publication date: February 6, 2026
In cross-border trade, businesses often opt for alternative dispute resolution (ADR) methods, such as international arbitration. This solution ensures, above all, a more neutral, faster, more flexible, and highly professional procedure. Naturally, in such a situation, the parties do not want to be at the mercy of a domestic court, foreign laws, unfamiliar traditions, doctrines, and established interpretations. Hence the need to submit the dispute to resolution by one or more arbitrators appointed by the parties from among global experts in their respective fields of business. The fundamental condition for such a solution is an arbitration agreement (the terms “arbitration court” and “arbitral tribunal” are often used interchangeably and refer to the same body resolving disputes through arbitration), included either in the initial agreement or in a separate agreement between the parties, which specifies the legal relationship from which the dispute arises or may arise. Obtaining an arbitration award does not, however, definitively conclude the case, but rather initiates the sometimes problematic issue of enforcing such an award in domestic courts. A foreign creditor who obtains an arbitration award that obligates a Polish entity to pay can generally expect its recognition and enforcement in a Polish domestic court.
More
Publication date: February 6, 2026
Some hard numbers reveal the paradox: the EU has a highly developed research sector vs. the EU is a region with a challenging commercialization environment compared to other global leaders.
Biotechnology is one of the fastest-growing research and innovation sectors in the world today, and the European Union plays a significant role in this process. Over the past decade, the number of biotechnology researchers in the EU has nearly doubled, from approximately 42,000 in 2012 to over 81,000 in 2021, and the share of employment in this field has reached 17.2% of total R&D employment. These figures confirm that Europe has a strong scientific base and is systematically building capacity in technologies critical to health, industry, and food security.
More
Publication date: February 6, 2026
We have been very pleased to contribute to BioLawEurope comparative survey on Digital Therapeutics and its legal status across Europe. KG LEGAL Kiełtyka Gładkowski prepared the entry on Poland and its standing on DTx.
The results can be seen here:
https://www.biolaweurope.com/blog
Digital Therapeutics ( DTx ) is evidence-based clinical software that prevents, manages, or treats diseases through digital programs installed on smartphones, computers, or other devices. Unlike typical health apps, these apps must undergo clinical trials and often meet medical device criteria.
More
