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.
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.
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.
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.
