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KIELTYKA GLADKOWSKI CONTRIBUTED TO BioLawEurope SURVEY ON Digital Therapeutix DTx

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.

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KIELTYKA GLADKOWSKI KG LEGAL participates in the 10th European Cybersecurity Standardization Conference – ENISA 2026

Publication date: February 5, 2026

We are pleased to announce that we will be participating in the 10th European Cybersecurity Standardization Conference, which will take place on March 12, 2026. The conference is jointly organized by the European standards organizations CEN, CENELEC, and ETSI, in cooperation with ENISA, the European Union Agency for Cybersecurity.

What is ENISA?

ENISA – The European Union Agency for Cybersecurity is a specialized European Union agency responsible for supporting member states, EU institutions, and the private sector in improving cybersecurity in Europe. Its mandate was strengthened under the Cybersecurity Act, which made ENISA a permanent pillar of the EU’s digital security architecture and entrusted it with a key role in the development of the European cybersecurity certification framework.

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LIFE SCIENCE CLUSTER POLAND – BIOTECH ACT AND PHARMA PACKAGE

Publication date: February 2, 2026

The European life science sector is entering a phase of profound and systemic regulatory changes that will significantly impact research, innovation development, and commercialization in the coming years. On January 29, 2026, our colleague, Zofia Kubic had the opportunity to participate in the LifeScience Kraków Cluster meeting, representing the KG Legal Kiełtyka Gładkowski law firm, a member of the cluster. During the meeting, key European Union initiatives were discussed, setting a new direction for pharmaceutical, biotechnology, and medical device manufacturers.

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LifeScience Kraków Cluster meeting

Publication date: January 16, 2026

On January 15, 2026, our colleague, Zofia Kubic, had the opportunity to participate in the LifeScience Kraków Cluster meeting, representing the KG Legal Kiełtyka Gładkowski law firm, a member of the cluster. The meeting was held as a Cluster Breakfast and was concise and strategic in nature, focusing primarily on the organization’s development plans for the coming year and beyond. Additionally, 2026 was considered a special year in the Cluster’s history, marking its 20th anniversary.

During the meeting, it was emphasized at the outset that the Cluster would continue its activities in its existing key areas. These included: bioeconomy, healthcare technology, innovative therapies and medical devices, diagnostics, and preventive healthcare. Emphasizing these areas was intended to confirm the continuity of the Cluster’s strategy and further direct its activities, including through the development of roadmaps and the development of cooperation between partners operating in these sectors.

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Longevity biotech investing in a healthier future, Regulation in the biotech industry: key issues for investors and innovators in Poland and globally

Publication date: October 23, 2025

KIEŁTYKA GŁADKOWSKI KG LEGAL participated in the conference “Longevity Biotech: Investing in a healthier future”. As part of its life science specialisation, our biotech and pharma lawyers offer comprehensive legal services to its clients in many areas of law, including extensive legal services to companies operating in the longevity biotech sector and biotech companies engaged in life extension and human health. Within this specialism our law firm offers assistance in respect of trademark protection and patent issues, regulatory law, certification, contractual, and litigation and arbitration issues. At KG Legal, we know that a key role in the biotechnology sector is innovation and responsiveness to changing market needs. Therefore, we offer our clients a proactive approach, flexibility and efficiency in action. All these qualities of our firm make us recognized as one of the leading law firms in Poland and the world, especially in the field of cross-border specialization and knowledge.

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