Publication date: November 10, 2026
Clinical research, diagnostic testing and commercialisation under Polish and EU law
Law as at 5 November 2026
Abstract
A change in an epigenetic clock may justify further investigation of a medicine. Its value as evidence of benefit depends on what the clock measures, the population in which it has been validated and whether treatment effects on the score predict effects on health. The same assay may be used to analyse archived samples, select participants for treatment or sell a test to consumers. Each use raises a different legal question. This article traces those questions from trial design through to commercial use, with particular attention to Polish law on medical experiments, performance studies, access to medical records and the use of data from non-commercial clinical trials.
Keywords ageing biomarkers, geroprotectors, clinical trials, IVDR, biobanks, genetic data
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Publication date: November 10, 2026
10 November 2026
From 11 November 2026, telecommunications undertakings in Poland must meet new technical and operational requirements for the interfaces that give law enforcement and security agencies access to communications and related data. Interfaces already running under existing agreements may stay on the previous standard, but for no longer than 36 months. The new rules add 5G standards, real-time delivery and a dedicated interface for retained data.
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Publication date: November 04, 2026
Technical debt, GDPR and NIS2 – how yesterday’s shortcuts turn into tomorrow’s liability
Why technical debt arises
Technical debt is a phenomenon that sooner or later affects almost every IT project. It consists in choosing a solution that is quicker to deliver but inferior in technical quality. A team usually “takes out” this loan under pressure from the business side, for which the key metric is time-to-market – the sooner the product reaches the market, the better.
In the short term this brings a quick win, but in the future the company has to start paying the “interest”. It shows up as ever higher system maintenance costs, a slowdown in the pace of work, and the mounting frustration of developers who, instead of developing the product, must keep fixing the same defects over and over. Although the term “technical debt” appears nowhere in legislation, concepts such as due diligence and the adequacy of technical measures in practice force companies to keep that debt from spiralling out of control.
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Publication date: November 02, 2026
A growing number of businesses are investing in artificial intelligence and expect to recover the cost of those projects through the research and development (R&D) tax relief. The Polish tax authorities and the Supreme Administrative Court, however, draw a clear line: integrating an off-the-shelf AI model or implementing a commercially available system – however advanced or “self-learning” – is not R&D activity. The relief is available only to those who create new technology themselves and bear genuine research risk. We explain how the tax authorities’ “two-step test” works, what the Frascati Manual and the case law of the Supreme Administrative Court say, which costs in IT projects qualify and which are traps – and how to document the work so that the deduction survives a tax audit.
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Publication date: October 05, 2026
The loss or corruption of data in a business is rarely “just” a technical problem. In practice it is a serious legal and financial crisis: production downtime, loss of trust among business partners and, in extreme cases, administrative fines running into millions. The scope of liability, however, depends above all on what kind of data has been lost or corrupted. The law treats the loss of source code or technical documentation quite differently from a leak of employee records or a customer database. The first step in assessing liability for a breach of the integrity or availability of data is therefore its unambiguous legal classification.
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