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		<title>KG Legal Contributes to techUK’s Tech &#038; Innovation Focus Week 2026: Agentic AI, Governance and Responsible Adoption</title>
		<link>https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/kg-legal-contributes-to-techuks-tech-innovation-focus-week-2026-agentic-ai-governance-and-responsible-adoption/</link>
					<comments>https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/kg-legal-contributes-to-techuks-tech-innovation-focus-week-2026-agentic-ai-governance-and-responsible-adoption/#respond</comments>
		
		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Tue, 02 Jun 2026 12:46:40 +0000</pubDate>
				<category><![CDATA[IT, NEW TECHNOLOGIES, MEDIA AND COMMUNICATION TECHNOLOGY LAW]]></category>
		<category><![CDATA[Agentic AI]]></category>
		<category><![CDATA[AI Compliance]]></category>
		<category><![CDATA[AI Governance]]></category>
		<category><![CDATA[AI Risk Management]]></category>
		<category><![CDATA[Autonomous AI Systems]]></category>
		<category><![CDATA[Public Sector AI]]></category>
		<category><![CDATA[Responsible AI]]></category>
		<category><![CDATA[UK AI Regulation]]></category>
		<category><![CDATA[UK GDPR]]></category>
		<guid isPermaLink="false">https://www.kg-legal.eu/?p=8798</guid>

					<description><![CDATA[<p>Publication date: June 2, 2026 We are pleased to announce that KG Legal Kiełtyka Gładkowski contributes to techUK’s annual Tech &#38; Innovation Focus Week, taking place from 15–19 June 2026. The initiative brings together industry leaders, technology experts and innovators to discuss the transformative technologies shaping the future of the UK economy. LINK: https://www.techuk.org/resource/call-for-contributions-techuk-s-2026-tech-innovation-focus-week.html For [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/kg-legal-contributes-to-techuks-tech-innovation-focus-week-2026-agentic-ai-governance-and-responsible-adoption/">KG Legal Contributes to techUK’s Tech &#038; Innovation Focus Week 2026: Agentic AI, Governance and Responsible Adoption</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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<p><strong>Publication date: June 2, 2026</strong></p>



<p>We are pleased to announce that KG Legal Kiełtyka Gładkowski contributes to techUK’s annual Tech &amp; Innovation Focus Week, taking place from 15–19 June 2026. The initiative brings together industry leaders, technology experts and innovators to discuss the transformative technologies shaping the future of the UK economy.</p>



<p>LINK: <a href="https://www.techuk.org/resource/call-for-contributions-techuk-s-2026-tech-innovation-focus-week.html" target="_blank" rel="noreferrer noopener">https://www.techuk.org/resource/call-for-contributions-techuk-s-2026-tech-innovation-focus-week.html</a></p>



<span id="more-8798"></span>



<p>For this year&#8217;s focus week, we submitted a contribution under the Agentic AI theme, exploring both the opportunities and challenges associated with the deployment of increasingly autonomous AI systems across public and private sectors.</p>



<p>Drawing on our experience at the intersection of technology, law and regulatory compliance, our article examines how organisations can move beyond experimentation and implement AI agents in a practical, secure and accountable manner. Particular attention is given to the role of Agentic AI in the public sector, where intelligent automation has the potential to improve administrative efficiency, service delivery and decision-support processes.</p>



<p>The article goes beyond the discussion of technological capabilities alone. It highlights the legal and governance frameworks that are essential for responsible AI adoption, including UK GDPR compliance, AI governance structures, accountability mechanisms and regulatory obligations that organisations must address when deploying AI-driven systems.</p>



<p>We also discuss the growing importance of internationally recognised standards and frameworks, including ISO/IEC 42001 and the NIST AI Risk Management Framework, which provide organisations with practical tools for managing AI-related risks and building trustworthy systems.</p>



<p>A central theme of our contribution is the importance of data security, auditability, traceability and meaningful human oversight. As AI agents become increasingly capable of taking actions autonomously and interacting with multiple digital environments, organisations need robust governance mechanisms to ensure transparency, control and accountability.</p>



<p>In our view, the future of Agentic AI depends not only on technological innovation but also on the ability to balance innovation with responsibility. Sustainable adoption requires practical governance frameworks that enable organisations to realise the benefits of AI while maintaining trust, compliance and effective risk management.</p>



<p>We are delighted to contribute to this important conversation and look forward to supporting organisations as they navigate the evolving legal and regulatory landscape surrounding AI technologies.</p>



<p>KG Legal Kiełtyka Gładkowski</p>



<p>Technology, AI &amp; Digital Regulation Practice Group</p>



<p><em>See the full text of the contribution here:</em></p>



<h2 class="wp-block-heading"><strong>Agentic AI in the UK: Unlocking Sectoral Opportunities While Building the Foundations for Responsible Adoption</strong></h2>



<p>Artificial intelligence is entering a new phase of development. While recent years have been dominated by generative AI systems capable of producing text, images, and code, the next wave of innovation is increasingly focused on agentic AI &#8211; systems that can plan, reason, take actions, and interact with digital tools to achieve defined objectives with varying degrees of autonomy. Rather than merely responding to prompts, AI agents can execute multi-step tasks, coordinate workflows, and support decision-making processes across organisations.</p>



<p>For the United Kingdom, agentic AI represents a significant opportunity to improve productivity, strengthen public services, and enhance competitiveness across strategically important sectors. However, the successful deployment of these technologies at scale will depend not only on technological progress but also on the development of appropriate governance frameworks, organisational capabilities, and regulatory safeguards.</p>



<p>One of the most promising areas for adoption is <strong>the public sector</strong>. Government departments, local authorities, and public agencies manage large volumes of administrative processes that are often repetitive, time-consuming, and highly procedural. Agentic AI systems could support public servants by processing applications, managing case files, drafting correspondence, coordinating information across departments, and responding to routine citizen enquiries. In healthcare, AI agents could assist with patient triage, clinical documentation, appointment scheduling, and care coordination, helping to reduce administrative burdens and allowing healthcare professionals to focus on activities that require human expertise and judgement. At a time when public services face increasing demand and resource constraints, such efficiencies could have a meaningful impact on service delivery.</p>



<p>The financial and professional services sector, one of the UK&#8217;s most important economic strengths, also presents substantial opportunities. Banks, insurers, law firms, accounting practices, and consulting businesses rely heavily on information-intensive workflows that are often governed by detailed regulatory requirements. Agentic AI could automate compliance monitoring, support anti-money laundering investigations, review contracts, process insurance claims, conduct due diligence exercises, and assist with regulatory reporting. By reducing the time spent on routine analysis and documentation, organisations could improve operational efficiency while enabling skilled professionals to focus on higher-value strategic work.</p>



<p>Significant potential also exists in life sciences and healthcare innovation. Drug discovery, clinical research, pharmacovigilance, and regulatory compliance involve complex processes requiring the analysis and management of vast amounts of information. AI agents could help researchers identify relevant scientific literature, support clinical trial management, monitor safety data, and streamline documentation requirements. Given the UK&#8217;s strong research institutions and established life sciences ecosystem, agentic AI could contribute to both improved healthcare outcomes and economic growth.</p>



<p>Beyond knowledge-intensive industries, agentic systems could support manufacturing, infrastructure, transport, and energy. Applications may include predictive maintenance, supply chain optimisation, resource allocation, operational planning, and infrastructure monitoring. In the energy sector, AI agents could assist in balancing increasingly complex electricity networks, improving efficiency and supporting the integration of renewable energy sources. As the UK continues to modernise critical infrastructure and pursue net-zero objectives, intelligent automation may become an increasingly valuable tool.</p>



<p>While the opportunities are substantial, the widespread adoption of agentic AI will depend on overcoming a range of technical and organisational challenges. Autonomous systems must be reliable, secure, and capable of operating within clearly defined boundaries. Organisations will need robust mechanisms for evaluating agent performance, monitoring behaviour, identifying failures, and ensuring that human oversight remains available when necessary. The quality, accessibility, and interoperability of data will also be critical, as AI agents are only as effective as the information and systems with which they interact.</p>



<p>However, technology alone will not determine success. Many organisations continue to view AI as a standalone innovation initiative rather than a catalyst for broader transformation. Effective adoption will require the redesign of workflows, investment in workforce skills, and the establishment of clear governance structures. Employees must understand how AI systems operate, where their limitations lie, and when human intervention is required. Equally important is the allocation of responsibility for decisions made or influenced by AI systems. As autonomy increases, organisations must ensure that accountability remains clearly defined.</p>



<p>These governance considerations are becoming increasingly important as agentic AI systems move from experimentation to operational deployment. Although the UK has generally adopted a flexible and innovation-oriented approach to AI regulation, organisations deploying AI agents are already subject to a range of existing legal and regulatory obligations.</p>



<p>Unlike the European Union, which has introduced a dedicated regulatory framework through the EU AI Act, the United Kingdom has largely favoured a principles-based approach that relies on existing regulators and legal frameworks. This means that organisations deploying AI agents must consider how established laws apply to new technological capabilities rather than expecting a single comprehensive AI statute to provide all the answers.</p>



<p>Data protection law is particularly relevant where agentic systems process personal information. Under the UK GDPR and the Data Protection Act 2018, organisations must ensure lawful processing, transparency, accountability, and appropriate safeguards for automated decision-making. As AI agents increasingly influence decisions affecting individuals, issues such as explainability, fairness, and meaningful human oversight become more significant. Depending on the sector and use case, organisations may also need to consider obligations arising under consumer protection law, financial services regulation, employment law, equality legislation, cyber security requirements, and professional conduct rules.</p>



<p>Alongside formal regulation, an increasingly influential body of soft law is shaping expectations around responsible AI deployment. Guidance issued by the Information Commissioner&#8217;s Office (ICO), the Alan Turing Institute, the Centre for Data Ethics and Innovation (CDEI), and government bodies has helped establish practical principles relating to transparency, fairness, accountability, and human-centred design. While these instruments do not carry the same legal force as legislation, they are increasingly used as benchmarks by regulators, procurement authorities, and stakeholders when assessing whether organisations have deployed AI responsibly.</p>



<p>International standards are also beginning to play an important role. Frameworks such as ISO/IEC 42001, the first international management system standard specifically designed for AI governance, provide organisations with structured approaches to managing AI-related risks and responsibilities. Similarly, the NIST AI Risk Management Framework has emerged as an influential reference point for identifying, assessing, and mitigating risks throughout the AI lifecycle. Together, these frameworks are contributing to the development of a common governance language that may facilitate trust, interoperability, and regulatory compliance across jurisdictions.</p>



<p>For agentic AI specifically, governance challenges are amplified by the ability of systems to take actions, access external tools, and interact with multiple digital environments. Organisations will therefore need mechanisms that support auditability, traceability, incident management, and human escalation. Comprehensive logging, approval workflows, access controls, and continuous monitoring are likely to become essential features of responsible deployment. In practice, successful adoption may depend as much on governance design as on technical capability.</p>



<p>Ultimately, the UK&#8217;s opportunity lies not simply in adopting more AI, but in deploying increasingly capable systems in ways that generate measurable economic and societal value. The greatest benefits are likely to emerge where agentic AI is embedded within complex, high-volume workflows across both public and private sectors. Yet sustainable adoption will require more than innovation alone. It will depend on a careful balance between technological ambition, organisational readiness, and robust governance. Those organisations that invest early in accountability, risk management, and trust-building measures are likely to be best positioned to capture the benefits of agentic AI while navigating an increasingly complex regulatory and ethical landscape.</p>



<p>Prepared by KG LEGAL KIELTYKA GLADKOWSKI, iSTART1</p>
<p> </p>


<p>Artykuł <a href="https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/kg-legal-contributes-to-techuks-tech-innovation-focus-week-2026-agentic-ai-governance-and-responsible-adoption/">KG Legal Contributes to techUK’s Tech &#038; Innovation Focus Week 2026: Agentic AI, Governance and Responsible Adoption</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>The right of pre-emption on the auction market for cultural goods and the limits of its permissible exercise</title>
		<link>https://www.kg-legal.eu/info/cross-border-cases/the-right-of-pre-emption-on-the-auction-market-for-cultural-goods-and-the-limits-of-its-permissible-exercise/</link>
					<comments>https://www.kg-legal.eu/info/cross-border-cases/the-right-of-pre-emption-on-the-auction-market-for-cultural-goods-and-the-limits-of-its-permissible-exercise/#respond</comments>
		
		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Mon, 01 Jun 2026 20:03:14 +0000</pubDate>
				<category><![CDATA[CROSS BORDER CASES]]></category>
		<category><![CDATA[ArtLaw]]></category>
		<category><![CDATA[ArtMarket]]></category>
		<category><![CDATA[CulturalHeritageLaw]]></category>
		<category><![CDATA[CulturalProperty]]></category>
		<category><![CDATA[UnfairCompetition]]></category>
		<guid isPermaLink="false">https://www.kg-legal.eu/?p=8788</guid>

					<description><![CDATA[<p>Publication date: June 1, 2026 Practical application – the case of a museum as a bidder Can an entity endowed with a statutory right of first refusal simultaneously influence the price it ultimately pays? In the historical monuments auction market, this question is no longer merely a theoretical dilemma. The active participation of registered museums [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/cross-border-cases/the-right-of-pre-emption-on-the-auction-market-for-cultural-goods-and-the-limits-of-its-permissible-exercise/">The right of pre-emption on the auction market for cultural goods and the limits of its permissible exercise</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
]]></description>
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<p><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color"><strong>Publication date: June 1, 2026</strong></mark></p>



<p><em>Practical application – the case of a museum as a bidder</em></p>



<p><strong>Can an entity endowed with a statutory right of first refusal simultaneously influence the price it ultimately pays? In the historical monuments auction market, this question is no longer merely a theoretical dilemma. The active participation of registered museums in auctions, combined with the possibility of later exercising their right of first refusal, raises serious questions regarding auction transparency, the equality of participants, and the limits of permissible exercise of public law rights. This article examines this issue at the intersection of civil law, cultural heritage protection, and fair market principles.</strong></p>



<span id="more-8788"></span>



<h2 class="wp-block-heading"><strong>Introduction</strong></h2>



<p>Statutory pre-emption rights – a safety net, a tool for manipulation, or a weapon aimed at the values underlying fair trade? These doubts emerge in the context of the functioning of the auction market for historical objects. In such cases, we may encounter a situation where a registered museum enters the auction hall, actively bids on an object, driving up its price – and when another participant wins, it immediately files a declaration of exercising its pre-emption rights and acquires the object at the price bid by its rivals. Is this permitted? The regulations do not explicitly prohibit it. The more important question, however, is: is this fair? There are serious doubts here.</p>



<p>The problem, however, is not the mere existence of the right of pre-emption for monuments, which is held by registered museums – it is a legitimate tool for protecting cultural heritage. The problem lies in the lack of clearly defined limits on the exercise of this right in auction settings and the impact of such a mechanism on market transparency and the equality of bidders. Can an entity entitled to pre-emption also determine the price it will pay? Does a private auction participant – acting in good faith, without knowledge of a competitor&#8217;s privileged position – have the right to any protection? Polish law is silent on the issue of specifying the conditions for the exercise of pre-emption by registered museums, but market practice calls for answers to these questions. This article is an attempt to answer this call.</p>



<p><strong>The auction market as a space of conflict between public and private interests</strong></p>



<p>An auction is, by its very nature, a price discovery mechanism. Its essence lies in the fact that independent participants, acting in their own interests and based on the same information (time, location, item, and auction terms) mandatorily provided by the organizer in the auction announcement – in accordance with Article 70 § 1 of the Civil Code – compete with each other, leading to the selection of the most advantageous bid. This mechanism only functions properly if all bidders play by the same rules. When one participant holds special rights allowing them to purchase a given item based on a different legal title or placing them in a better position than other auction participants, while actively intervening in the auction&#8217;s price setting, we may raise serious concerns about the compliance of such conduct with the essence of the auction and good commercial practices. This entity, if it takes advantage of its privileged position, can &#8220;step into&#8221; the winner&#8217;s shoes, and other bidders, being unaware of this possibility, are unable to fully adapt their offers to the situation &#8211; information symmetry is therefore fundamentally disturbed.</p>



<p>This is precisely the situation that occurs in the Polish auction market when a registered museum participates in an auction for a historical object, possessing the statutory right of first refusal under Article 20 of the Act of 21 November 1996 on Museums. This right is broad: the museum may submit a declaration of its exercise immediately after the auction of a specific object, but no later than the end of the entire auction, purchasing the object at the price bid by the winning bidder. The legislator&#8217;s intention is clear – to protect cultural heritage from leaving national public collections. <strong>However, a problem arises when a museum not only observes the auction but also actively </strong>participates, and then withdraws just before the winning bid, exercising its statutory right of first refusal. The heritage protection tool then becomes <strong>an instrument of market competition</strong>, the rules of which are unknown to the other auction participants.</p>



<p>This article asks whether such a practice is legally permissible and commercially fair. The answer requires examining the construction of pre-emption rights in Polish civil law and in the context of historical monument protection laws, understanding the specifics of the historical monument auction market, and examining the impact of museums&#8217; active participation on the auction process and the situation of private buyers.</p>



<h2 class="wp-block-heading"><strong>THE CONCEPT OF “ARCHIVAL MATERIAL” in terms of auction items in the auction slot.</strong></h2>



<p><strong>The privileged position of registered museums, state archives and separate archives in the art market</strong></p>



<p><strong>The right of pre-emption in the Act on National Archival Resources</strong></p>



<p>State archives have the right of first refusal to purchase archival materials under the Act of 14 July 1983 on National Archival Resources and Archives (consolidated text: Journal of Laws of 2020, item 164), specifically under Article 9 thereof. This right applies to archival materials included in unregistered non-state archival resources. This right applies to transfers by agreement and is therefore not limited to auctions. However, this right of first refusal does not apply if the archival materials are offered for purchase to organizational units listed in Article 22, paragraph 2 of this Act, if they supplement the currently held historical archival resources of these units.</p>



<p><strong>Two powers under Article 20 of the Museums Act</strong></p>



<p>Article 20 of the Museums Act grants registered museums two separate rights, which are sometimes confused in practice. Both rights are non-transferable and absolute &#8211; they cannot be contractually excluded, and their violation results in the invalidity of the sales contract. The exercise of both rights depends solely on the museum&#8217;s activity- neither the seller nor the auction organizer is obligated to inform the museum about the offered items or to request the exercise of its rights. It is the museum, assessing the value and significance of a given item, that decides whether to declare an intention to purchase under the right of first refusal or to submit a declaration of exercise of the right of first refusal.</p>



<p>The first right &#8211; the right of priority &#8211; operates outside the auction context and allows a museum to acquire a monument offered by an entity conducting business of offering monuments for sale, at a price agreed upon at the time the museum notifies its intention to purchase. It should be emphasized that this provision covers only sellers who have made offering monuments for sale their professional activity &#8211; antique shops, art galleries, or auction houses &#8211; and not private individuals who occasionally sell a single object. A museum&#8217;s notification of intention creates a kind of reservation &#8211; an option to purchase the monument for a period of 14 days. During this time, the seller cannot sell the item unconditionally, and the museum&#8217;s inaction during this period results in the expiration of the right (A. Barbasiewicz, Commentary to Article 20 of the Museum Act, [in:] The Act on Museums. Commentary, 1st ed., Warsaw 2021).</p>



<p>The second right &#8211; the right of pre-emption in the strict sense &#8211; is the proper subject of this article. It is triggered in the auction setting and involves the right to purchase an item at the price bid by the winning bidder. The right of pre-emption applies to any type of auction, regardless of the bidding model adopted. Although Polish market practice is primarily based on traditional oral auctions, there is no basis to exclude online auctions, whose market share is steadily growing, from this provision. The obligation to enable a museum to exercise its right of pre-emption rests with the auction organizer &#8211; regardless of its legal form, meaning both professional business entities and individuals. It is irrelevant whether the organizer acts as the owner of the item being auctioned or merely as an intermediary selling it on behalf of a third party. A declaration of exercise of the right of pre-emption must be submitted immediately after the auction of the item concerned, but no later than before the auction closes. The museum then acquires the item at the price achieved by the winning bidder. If more than one museum wishes to exercise the right of first refusal, the order in which the declarations are submitted will be decisive. The regulations do not provide any specific requirements regarding the form; in auction practice, declarations are usually made orally.</p>



<p>The scope of these rights is precisely defined. The right of first refusal is granted only to registered museums, i.e., those entered in the State Register of Museums, which is maintained by the minister responsible for culture (Articles 13–14 of the Act on Museums). This entry is not automatic &#8211; the minister evaluates each application based primarily on the importance of the collections, staffing levels, premises, and financial stability of the institution. The procedure is initiated by the museum organizer, director, or advisory board, and the application must be fully documented &#8211; statutes, regulations, financial statements, information about the collections, and exhibition activities. Before issuing a decision, the minister consults a qualification committee composed of ten museum experts, although this opinion is advisory in nature and not binding on the minister. A negative decision may be appealed for reconsideration and then appealed to the administrative court. The register includes entities of a very diverse nature &#8211; state, local government, and private museums, as well as those without legal personality. The status of a registered museum can therefore be obtained by both a large cultural institution and a museum run by an individual or foundation. At the end of the first decade of the 21st century, just over 130 entities were listed. The entry itself is primarily prestigious and carries with it tangible privileges – the most important of which is the right of pre-emption and the right of priority under Article 20 of the Act on Museums (A. Barbasiewicz, Commentary to art. 13 MuzeaU, [in:] The Act on Museums. Commentary, 1st ed., Warsaw 2021). The material scope is determined by the definition of a monument under Article 3 item 1 of the Act of 23 July 2003 on the Protection and Care of Monuments (consolidated text: Journal of Laws of 2024, item 1292, as amended): it is movable or immovable property created by humans, constituting testimony to a bygone era and possessing historical, artistic, or scientific value. Article 20 of the Act on Museums de facto excludes immovable monuments, to which the municipality has the right of pre-emption pursuant to Article 109 of the Act of 21 August 1997 on Real Estate Management (consolidated text: Journal of Laws of 2026, item 399).</p>



<p><strong>The museum&#8217;s pre-emptive rights and their civil law basis</strong></p>



<p>The museum&#8217;s right of pre-emption is based on a general provision of the Civil Code, applied with modifications resulting from the specific provisions of the Act on Museums. There are three key consequences of this relationship. First, pursuant to Article 600 § 1 of the Civil Code, the exercise of the right of pre-emption results in the conclusion of a sales contract with the same content as the contract with the original purchaser &#8211; that is, at the same price and under the same terms. The museum steps into the shoes of the auction winner, without renegotiating the price. Second, the museum is obligated to pay not only the winning bid price but also any additional fees charged to the buyer under the auction rules: the auction fee and any applicable droit de suite fees. Third, and this is of crucial practical importance, Article 20 of the Act on Museums states that a declaration of exercise of the right of pre-emption should be submitted immediately after the auction of the item, but no later than the end of the entire auction. This deadline is shorter and different in its structure from the one-week deadline provided for in the general provisions of the Civil Code, which do not apply in this respect (A. Barbasiewicz, Commentary to art. 20 MuzeaU, [in:] The Act on Museums. Commentary, 1st ed., Warsaw 2021).</p>



<p>It is also worth noting that a specific regulation contained in the Museums Act excludes the application of Article 598 § 1 and 2 of the Civil Code and Article 599 § 1 of the Civil Code. The seller is therefore not obliged to notify the museum of a conditional sale or to observe the one-week deadline for exercising the right of pre-emption. The consequences of violating the right of pre-emption are also different – this issue is explicitly addressed by Article 20 § 4 of the Museums Act, which provides for the invalidity of any sale conducted in violation of this right.</p>



<p>In auction house practice, the issue of conditionality of a contract concluded through a knockdown auction is not clearly resolved by the legislature, which in itself constitutes a source of risk. <strong>A dispute in the legal literature concerns whether an auction contract is conditional by operation of law until the deadline for the museum to submit a declaration, or whether this effect does not occur automatically, and any contract concluded without stipulating the condition is simply invalid</strong>. Market practice, however, has developed a pragmatic solution: most auction houses include a clause in their regulations directly citing Article 20 of the Act on Museums, treating the transaction as conditional. This is a manifestation of market self-regulation where the law is silent.</p>



<h2 class="wp-block-heading"><strong>The Antique Auction Market – Structure and Asymmetries</strong></h2>



<p>Understanding the legal problem requires placing it in a market context. The Polish auction market for historical artifacts is dominated by the commission model: the auction house acts as a commission agent, concluding the transaction in its own name but on behalf of the commissioner &#8211; the owner of the object. There are virtually no institutional investors, including actively purchasing museums. The market is shallow, dominated by private collectors and wealthy individual buyers, as described in detail by Professor W. Szafrański in his study &#8220;Current Problems and Threats Related to the Trade in Cultural Property on the Art Market in Poland from the Perspective of Legal Protection of Historical Monuments,&#8221; published in Santander Art and Culture Law Review 2019, No. 1 (5), pp. 41–68.</p>



<p>This structural feature of the market has a twofold significance for the problem under analysis. On the one hand, it means that the entity obligated under the right of first refusal &#8211; the one to whom the museum submits the declaration &#8211; is not the owner of the object (the commissioner), but the auction house, acting as a commission agent on its own behalf. It is the commissioner who bears the responsibility for enabling the museum to submit the declaration and for the proper conduct of the conditional suspension procedure. On the other hand, in the absence of strong institutional players on the buyers&#8217; side, the appearance of a museum with the right of first refusal at the auction is a distinctive event, potentially having a significant impact on the bidding dynamics and the information symmetry of auction participants.</p>



<p>The auction market for cultural goods is also characterized by structural information asymmetry. This is not a coincidence, but an inherent feature of the trade in unique objects, whose value depends on expert knowledge, provenance, and rarity. In this environment, intermediaries &#8211; auction houses, galleries, and antique shops &#8211; by nature possess better information than buyers. A private bidder typically does not know the full history of the object, is unaware of the financial capabilities of competitors, and – significantly &#8211; is not always aware of the presence of an entity with pre-emptive rights at the auction. <strong>It is this latter ignorance that carries significant risk </strong>(see W. Szafrański, Aktualne produkty&#8230;, pp. 41–68).</p>



<p><strong>The museum as a bidder and at the same time an executor of the right of first refusal: a mechanism that should not exist</strong></p>



<p><strong>Description of the practice and its legal admissibility de lege lata</strong></p>



<p><em><u>The practice that is the central question of this article proceeds as follows: a registered museum actively participates in an auction, bidding on the item up to a certain threshold, inflating the price. When the price exceeds a certain threshold, the museum withdraws from the auction. Victory goes to a private bidder. Immediately after the winning bid, the museum declares its right of first refusal and acquires the item at the price determined during the auction.</u></em></p>



<figure class="wp-block-image size-full"><img fetchpriority="high" decoding="async" width="378" height="223" src="https://www.kg-legal.eu/wp-content/uploads/2026/06/image.jpg" alt="" class="wp-image-8789" srcset="https://www.kg-legal.eu/wp-content/uploads/2026/06/image.jpg 378w, https://www.kg-legal.eu/wp-content/uploads/2026/06/image-300x177.jpg 300w" sizes="(max-width: 378px) 100vw, 378px" /></figure>



<p>The literal wording of Article 20, Section 2 of the Act on Museums does not prohibit the conduct described. <strong>The provision is silent on whether a museum may or may not participate </strong>in an auction before exercising its right of pre-emption. This legislative gap could lead to the hasty conclusion that, since the prohibition is not expressly stated, the practice is permitted. This position is also reflected in the commentary on the Act by A. Barbasiewicz (Commentary on Article 20 of MuzeaU, 1st ed., Warsaw 2021). In the opinion of the author of this article, however, such a conclusion is too hasty and could cause numerous legal problems in practice. After all, we know of many situations in which, although the law does not expressly prohibit certain conduct, it is inconsistent with its general principles.</p>



<p><strong>Impact on the auction pricing mechanism</strong></p>



<p>The fundamental problem with this practice lies in its impact on price setting. An auction is a mechanism that is designed to determine the final price. Each bid sends an informational signal to other participants, suggesting that the bidder estimates the item&#8217;s value at least at the current bid amount. Private auction participants, observing another bidder&#8217;s actions, calibrate their decisions based, among other things, on this observation—the presence of a determined, wealthy competitor encourages higher bids, or, conversely, creates a freeze effect, effectively discouraging other bidders from taking action.</p>



<p>When this competitor is a museum with pre-emptive rights, this perception is false. The museum knows that regardless of the auction outcome, it can acquire the object at the final price, provided it submits a declaration before the auction closes. Its incentive to bid is therefore structurally different from that of a regular bidder: the museum can bid &#8220;for show&#8221;, driving the price above the level it would otherwise have reached, and then withdraw and profit from this game. Private bidders bear the costs of this asymmetry: they pay for the object a price determined by a participant who, at no stage, played on a common and equal footing.</p>



<p>The phenomenon also has a reverse effect. A museum&#8217;s withdrawal from an active auction &#8211; especially if it was previously a strong bidder &#8211; can confuse other participants and lead to a paradoxical downward effect: other bidders, interpreting the museum&#8217;s withdrawal as a signal that the item is overvalued or that the museum has lost interest, refrain from bidding further. The final price is then lower than in a model without museum participation, which works to the seller&#8217;s detriment and to the museum&#8217;s advantage, benefiting from the preemptive right.</p>



<h2 class="wp-block-heading"><strong>Information asymmetry, the problem of transparency and the so-called chilling effect</strong></h2>



<p><strong>Information asymmetry is a persistent feature of the auction market</strong>, but its specific form &#8211; the lack of knowledge of the presence of a person entitled to pre-emption &#8211; is an asymmetry that can and should be remedied. However, current regulations do not require auction organizers to inform participants that an entity with pre-emption rights is among the bidders or observers. This is a regulatory shortcoming with real market consequences.</p>



<p>The scale of these effects is much broader than it might seem at first glance, as they extend beyond the individual transaction and its parties, indirectly influencing the behavior of participants in the entire economic cycle. Collectors and private market participants, aware that museums can actively participate in the auction, influence the price, and then exercise their right of first refusal and &#8220;enter&#8221; into the negotiated transaction, may begin to limit their participation in auctions. Investing time and resources in expertise, due diligence, or transport becomes economically irrational if the fruit of this effort is likely to be seized by the museum. This chilling effect threatens to cause private buyers to bid less actively or to forgo auctions altogether for objects that may be of interest to cultural institutions. Consequently, this may weaken the entire auction market for cultural goods and negatively impact the level of turnover and competitiveness – to the detriment not only of sellers but also of the market itself as a platform for the effective valuation and circulation of cultural goods.</p>



<p>A private bidder, when deciding to purchase, doesn&#8217;t really know whether a contract is realistic. They invest time and resources in due diligence, and sometimes incur transportation and insurance costs. Even if they win the auction, they may be deprived of the object due to a declaration made by the museum before the auction ends. They will recover the amount if they have already paid it. This can be achieved through the institution of unjust enrichment, as the contract under which the price was paid becomes legally null and void upon the exercise of the right of first refusal. Therefore, they lose their legal title to the sum paid. However, they will not recover the auction fee, expert fees, due diligence costs, or any other transaction expenses incurred in the belief that the transaction will be completed. De lege lata, a private buyer has no clear basis for a claim for damages for loss incurred in connection with entering into an unconditional contract &#8211; Article 599 of the Civil Code, which governs liability for damages in the event of a breach of the right of pre-emption, is excluded in the case of museum law due to a specific provision in the form of Article 20, Section 4 of the Act on Museums, which provides only for the invalidity of a contract concluded in violation of the right of pre-emption. In practice, adopting such an approach would deprive the buyer of the right to seek compensation for damages resulting from entering into an unconditional contract with the auction organizer. Therefore, it remains an open question whether a buyer who acted in good faith and was not informed of the right of pre-emption should be entitled to compensation, even for transaction costs.</p>



<p><strong>Analogy with the practices questioned by the Office of Competition and Consumer Protection</strong></p>



<p>The information mechanism for this problem is structurally similar to the practice questioned by the President of the Office of Competition and Consumer Protection following investigations into five large Polish auction houses. Four of these entities reserved in their regulations the right for their own employees to participate in auctions, with the employees posing as regular customers and bidding on items up to the reserve price.</p>



<p>The President of the Office of Competition and Consumer Protection (UOKiK) explicitly pointed out that buyers may not have known they were bidding against auction house employees, and that any bid they made could have been interpreted as genuine interest in the work and a genuine offer to purchase it &#8211; which could have altered the auction dynamics and artificially shaped the prices of the items being auctioned. These practices were classified as potentially infringing on the collective interests of consumers, and auction houses have adapted their regulations to reflect the Office&#8217;s comments (a sample announcement from the President of the UOKiK is available at: <a href="https://uokik.gov.pl/prezes-uokik-porzadkuje-zasady-licytacji-w-domach-aukcyjnych">https://uokik.gov.pl/prezes-uokik-porzadkuje-zasady-licytacji-w-domach-aukcyjnych </a>).</p>



<p>This analogy is legally incomplete &#8211; a museum generally operates within the bounds of its statutory authority, which does not address the issue of assessing conduct from the perspective of potential evidence of a sham auction. Nevertheless, the information distortion mechanism is identical: the private bidder is unaware of the presence of a uniquely positioned entity on the other side and treats each activity as a reflection of independent market interest. The difference in the subjective motivations of the entity does not change the objective market effect &#8211; the distortion of price signals and the disruption of the symmetry of the auction participants.</p>



<p>The Office of Competition and Consumer Protection&#8217;s (UOKiK) conduct also sheds another important light on the issue. The competition authority has recognized that the transparency of the auction mechanism is a legally protected value, the violation of which can be assessed in terms of protecting the collective interests of consumers. This raises the question of whether the lack of clear information for auction participants about the museum&#8217;s ability to exercise its right of first refusal, let alone its active participation in the bidding, should not be viewed by the regulator as a similar irregularity in the market practices of auction houses.</p>



<h2 class="wp-block-heading"><strong>Assessment in the light of the general principles of civil law</strong></h2>



<p>The right of pre-emption, both in doctrine and in the statutory construction, is an instrument of protection, the essence of which is to enable intervention in the sale of specific goods &#8211; in the form of &#8220;entering&#8221; into the agreed price and contractual terms &#8211; rather than a tool for actively controlling market processes by influencing the price of the item. The entitled party does not participate in price negotiations between the obligated party and a third party &#8211; if it did, the institution would be meaningless. In the auction context, the &#8220;price negotiation&#8221; is precisely the bidding itself. Active participation by the museum in this phase therefore negates the classic role of the entitled party under pre-emption. This institution serves as a safety net &#8211; it is a right, not an obligation, and gives the entitled party the opportunity to acquire specific goods with priority over other interested parties. However, the right of pre-emption does not grant entities the ability to actually influence the terms of sale.</p>



<p>Without directly ruling on the illegality of the practice in question &#8211; the applicable provisions do not expressly prohibit it &#8211; one should strongly point to arguments based on general principles, which qualify it as at least seriously problematic, and in specific factual circumstances &#8211; as an abuse of a subjective right within the meaning of Article 5 of the Civil Code. According to the commentary by Professor P. Machnikowski to Article 5 of the Civil Code (E. Gniewek, P. Machnikowski (eds.), Civil Code. Commentary, 12th ed., Warsaw 2025), both criteria for assessing the behavior of the entitled person &#8211; contradiction with the socio-economic purpose of the law and contradiction with the principles of social coexistence &#8211; are objective in nature. Whether the behavior falls within the limits of a subjective right is therefore determined not by the mental attitude of the entity, its motives or its intended purpose, but by an objective assessment of the effects of this behavior in the light of the aforementioned criteria. The fact that the museum subjectively acts in the public interest and without the intention of harming other bidders remains irrelevant for the qualification under Article 5 of the Civil Code. The first basis for qualification is a contradiction with the socio-economic purpose of the right. Professor Machnikowski&#8217;s commentary indicates that this clause expresses the legislator&#8217;s preference for the use of subjective rights that serves the social and economic goals for which a given type of subjective right was established, and its application is all the more justified when the special purpose of the right is specifically assigned by statute &#8211; which directly refers to the right of pre-emption in Article 20 of the Act on Museums. The purpose for which the legislator granted the registered museum the right of pre-emption is to protect cultural heritage from the removal of monuments from public collections &#8211; not to create an instrument for active interference in the market process of price setting. The right of pre-emption, in its classic construction, assumes neutrality of the rightholder with respect to the price formation process: the rightholder enters the fixed price set by independent market participants. The museum&#8217;s active participation in the auction, combined with the subsequent exercise of the right of pre-emption, contradicts this very logic &#8211; the museum co-determines the price, which it then pays itself, benefiting from a privileged position unavailable to other participants. This is an example of using one&#8217;s right beyond the purposes for which it was granted, and therefore may be considered contrary to the socio-economic purpose of that right. The second ground is a contradiction with the principles of social coexistence. In Professor Machnikowski&#8217;s view, the principles of social coexistence encompass moral norms regulating the conduct of some individuals towards others. The overarching imperative behind these norms is the approval of conduct dictated by &#8220;just goodwill towards others&#8221;. The functioning of modern society is based on the trust that the decisions and actions of participants in the marketplace are based on the assumption of specific, favorable reactions from their partners, and engaging in conduct inconsistent with the legitimate expectations of another person can be considered contrary to the principles of social coexistence. An auction participant has a justified expectation that each of their competitors is bidding solely in their own interest and that the winner of the knockdown will become the owner of the item. By actively bidding, the museum creates precisely this expectation &#8211; and then disappoints it by withdrawing, only to later acquire the auction item based on its right of first refusal. Importantly, the doctrine cited above clearly indicates that the principles of social coexistence apply not only to natural persons, <strong>but also to legal persons and organizational units to which the law grants legal capacity </strong>&#8211; therefore, a registered museum cannot invoke its public character as a circumstance excluding the application of Article 5 of the Civil Code.</p>



<p>Regardless of the above, participation in the auction by an entity that knows that it may ultimately purchase the item regardless of the auction result may violate good commercial practice in relations between market participants, within the meaning of Art. 3 of the Act of 16 April 1993 on Combating Unfair Competition (consolidated text: Journal of Laws of 2022, item 1233) &#8211; whereby the good practice clause and the social coexistence clause perform, as the doctrine indicates, the same function and have the same meaning, constituting different names for moral assessments and the norms of conduct justified by them.</p>



<h2 class="wp-block-heading"><strong>Practical risks and the proposed model of conduct</strong></h2>



<p><strong>Risks for the auction house</strong></p>



<p>The auction organizer operates as a commission agent under the commission model, and therefore bears the obligations arising from the museum&#8217;s right of first refusal. The first and most serious risk is allowing a sales agreement to be concluded without securing the exercise of the right of first refusal &#8211; such an agreement is absolutely invalid under Article 20, Section 4 of the Museums Act. The auction house is then exposed to claims from both the seller (commissioner) and an uninformed buyer acting in good faith.</p>



<figure class="wp-block-image size-full"><img decoding="async" width="358" height="286" src="https://www.kg-legal.eu/wp-content/uploads/2026/06/image.gif" alt="" class="wp-image-8790"/></figure>



<p><strong>The second risk is reputational and regulatory. Allowing a practice in which a museum actively bids and then exercises its right of first refusal places the auction house in the role of an unwitting participant in a mechanism that distorts auction transparency. </strong>The lack of clear rules in the regulations &#8211; including, above all, the lack of an obligation to inform auction participants of the presence of an entity holding the right of first refusal &#8211; is a loophole that, in light of the conclusions drawn from the Office of Competition and Consumer Protection (UOKiK) proceedings, may become a subject of interest for competition and consumer protection authorities.</p>



<p>The third, practical risk is the need to manage the &#8220;domino effect&#8221; following the exercise of the pre-emptive right: refund of the purchase price to the buyer, currency conversion of auction fees, and settlement with the consignor. The higher the transaction value, the more serious the operational and financial consequences of improperly executing the procedure.</p>



<h3 class="wp-block-heading"><strong>Risks for a private buyer</strong></h3>



<p>The private bidder is the weakest party in the entire mechanism, both informationally and legally. The fundamental risk is obvious: even after winning the auction, they may be deprived of the item due to a declaration made by the museum within minutes of the auction closing. This results in the loss not only of the purchased item but also of transaction costs &#8211; the auction fee, consulting fees, expert opinions, transportation, and insurance. Furthermore, the definition of an artifact is relatively broad, and its classification is determined not by the register, but by the item&#8217;s characteristics. A buyer who purchases an item unaware of its legal status may be surprised by the exercise of their pre-emptive right by a specialized museum.</p>



<h3 class="wp-block-heading"><strong>The proposed model of conduct</strong></h3>



<p>A fair interpretation of the right of first refusal, consistent with its function and general principles of trade, requires the adoption of a dichotomous model. A museum intending to acquire an object at auction should choose one of two methods, but cannot combine them. If participating in the auction as a bidder, it should bid up to the price it is actually willing to pay and purchase the item under general terms &#8211; or not purchase if the price exceeds its means. If, on the other hand, it intends to exercise its right of first refusal, it should refrain from actively participating in the auction and merely observe its outcome.</p>



<p>This model is consistent with the essence of pre-emption law, protects the integrity of the auction mechanism, and eliminates the accusation of exploiting a privileged position. However, it requires either voluntary discipline on the part of museums &#8211; which cannot be assumed given the budgetary pressures and competition for valuable objects &#8211; or explicit statutory regulation, which seems to be a more permanent solution.</p>



<p>This proposal also aligns with a broader analysis of the state of legal regulations in the area of trade in cultural goods. The current regulations constitute a conglomeration of norms scattered across several acts, additionally based on general institutions borrowed from the Civil Code and supplemented by specific provisions. There is a lack of consistent rules of conduct for intermediaries &#8211; auction houses and antique shops &#8211; in exercising the right of first refusal: there is no obligation to inform auction participants in advance of their right of first refusal, there is no clearly defined procedure for the organizer to verify the status of items, and there is no mechanism to guarantee the protection of the buyer&#8217;s good faith. These gaps should be filled by the legislature before market practice necessitates further intervention by the competition authority.</p>



<p>The right of first refusal of a registered museum is a legitimate instrument from the perspective of cultural heritage protection. The problem lies not in its existence, but in the manner in which it is exercised. An auction is a pricing mechanism, not simply an organizational form of sale. Its integrity requires protection regardless of the participant.</p>



<p>A museum&#8217;s combination of an active bidder role with the subsequent exercise of a right of first refusal is a practice that &#8211; though not explicitly prohibited &#8211; violates the very essence of the institution of first refusal, distorts the price discovery mechanism, and disadvantages private market participants. In the case where the museum&#8217;s participation drives the price above market level, the private buyer loses the object at a price determined by the entity that ultimately acquires it. In the opposite case, the seller receives a lower price for the object because the museum&#8217;s presence has confused bidders. In neither scenario does the auction mechanism function as intended.</p>



<p>The analogy with the practices questioned by the President of the Office of Competition and Consumer Protection shows that auction transparency is a value protected by the legal system.</p>



<h3 class="wp-block-heading">Legal basis and literature:</h3>



<h3 class="wp-block-heading">Legal acts:</h3>



<ol class="wp-block-list">
<li>Act of 23 July 2003 on the protection and care of monuments (consolidated text: Journal of Laws of 2024, item 1292, as amended);</li>



<li>Act of 21 November 1996 on museums (consolidated text: Journal of Laws of 2022, item 385);</li>



<li>Act of 21 August 1997 on real estate management (consolidated text: Journal of Laws of 2026, item 399);</li>



<li>Act of 14 July 1983 on national archival resources and archives (consolidated text: Journal of Laws of 2020, item 164);</li>



<li>Act of 23 April 1964 – Civil Code;</li>



<li>Act of 16 April 1993 on Combating Unfair Competition (consolidated text: Journal of Laws of 2022, item 1233)</li>
</ol>



<h3 class="wp-block-heading">Literature:</h3>



<ol class="wp-block-list">
<li>Barbasiewicz A., Commentary to Article 20 of the Museum Act [in:] The Act on Museums. Commentary, 1st ed., Warsaw 2021.</li>



<li>Civil Code, Osajda series editor/Borysiak volume editor 2025, 34th edition, commentary to articles 596–602 of the Civil Code Machnikowski P., Commentary to article 5 of the Civil Code [in:] E. Gniewek, P. Machnikowski (eds.), Civil Code. Commentary, 12th edition, Warsaw 2025.</li>



<li>Szafrański W., Current problems and threats related to the trade in cultural goods on the art market in Poland from the perspective of legal protection of monuments, &#8220;Santander Art and Culture Law Review&#8221; 2019, no. 1 (5), pp. 41–68.</li>
</ol>



<p>Other sources : Announcement of the President of the Office of Competition and Consumer Protection regarding explanatory proceedings against auction houses: https://uokik.gov.pl/prezes-uokik-porzadkuje-zasady-licytacji-w-domach-aukcyjnych.</p>










<p>Artykuł <a href="https://www.kg-legal.eu/info/cross-border-cases/the-right-of-pre-emption-on-the-auction-market-for-cultural-goods-and-the-limits-of-its-permissible-exercise/">The right of pre-emption on the auction market for cultural goods and the limits of its permissible exercise</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>KG Legal KIELTYKA GLADKOWSKI Shortlisted for The Legal 500 Central and Eastern Europe Awards 2026</title>
		<link>https://www.kg-legal.eu/info/kg-legal-news/kg-legal-kieltyka-gladkowski-shortlisted-for-the-legal-500-central-and-eastern-europe-awards-2026/</link>
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		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Mon, 01 Jun 2026 19:34:24 +0000</pubDate>
				<category><![CDATA[KG LEGAL NEWS]]></category>
		<category><![CDATA[#CentralAndEasternEurope]]></category>
		<category><![CDATA[#HealthcareLaw]]></category>
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					<description><![CDATA[<p>Publication date: June 1, 2026 We are proud to announce that KG Legal Kieltyka Gladkowski has been shortlisted for the prestigious Central and Eastern Europe Awards 2026, organised by The Legal 500, in the category Healthcare &#38; Life Sciences Firm of the Year. This distinction places our firm among the leading legal practices recognised for [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/kg-legal-news/kg-legal-kieltyka-gladkowski-shortlisted-for-the-legal-500-central-and-eastern-europe-awards-2026/">KG Legal KIELTYKA GLADKOWSKI Shortlisted for The Legal 500 Central and Eastern Europe Awards 2026</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color"><strong>Publication date: June 1, 2026</strong></mark></p>



<figure class="wp-block-image size-full"><img decoding="async" width="768" height="432" src="https://www.kg-legal.eu/wp-content/uploads/2026/06/CEE-Awards-shortlisted-linkedin-768x432-1.webp" alt="" class="wp-image-8786" srcset="https://www.kg-legal.eu/wp-content/uploads/2026/06/CEE-Awards-shortlisted-linkedin-768x432-1.webp 768w, https://www.kg-legal.eu/wp-content/uploads/2026/06/CEE-Awards-shortlisted-linkedin-768x432-1-300x169.webp 300w" sizes="(max-width: 768px) 100vw, 768px" /></figure>



<p>We are proud to announce that KG Legal Kieltyka Gladkowski has been shortlisted for the prestigious Central and Eastern Europe Awards 2026, organised by The Legal 500, in the category Healthcare &amp; Life Sciences Firm of the Year. This distinction places our firm among the leading legal practices recognised for excellence in the healthcare, pharmaceutical, medical devices, biotechnology, and life sciences sectors across the region. Being shortlisted by The Legal 500 is considered one of the most significant recognitions in the legal market, reflecting not only legal expertise but also market reputation, client feedback, innovation, and the impact of a firm&#8217;s work.</p>



<p><a href="https://www.legal500.com/events/central-eastern-europe-awards-2026">https://www.legal500.com/events/central-eastern-europe-awards-2026</a></p>



<span id="more-8785"></span>



<p>The Legal 500 is one of the world&#8217;s most respected and influential legal directories, conducting independent research into law firms and lawyers in more than 150 jurisdictions. Its rankings and awards are based on an extensive evaluation process that includes submissions from law firms, interviews with legal practitioners, analysis of representative matters, and, importantly, direct feedback from clients and market participants. The Central and Eastern Europe Awards recognise outstanding achievements across the CEE region and are founded on the same rigorous research methodology that underpins The Legal 500&#8217;s annual rankings. Winners and shortlisted firms are selected by the editorial team responsible for Legal 500&#8217;s coverage of Central and Eastern Europe, ensuring a highly competitive and independent assessment process.</p>



<p>The category Healthcare &amp; Life Sciences Firm of the Year is dedicated to law firms demonstrating exceptional performance in advising clients operating within highly regulated healthcare and life sciences industries. The category encompasses legal work involving pharmaceuticals, biotechnology, medical devices, healthcare providers, clinical trials, regulatory compliance, market access, reimbursement, product liability, healthcare transactions, data protection in medical environments, and innovative health technologies. The award recognises firms that combine sector-specific expertise with a deep understanding of the evolving regulatory and commercial challenges facing healthcare and life sciences businesses. Legal 500&#8217;s own healthcare rankings highlight the breadth and complexity of matters considered within this practice area, ranging from pharmaceutical regulation and medical devices to compliance, clinical research, financing, and strategic transactions.</p>



<p>Being shortlisted means that KG Legal Kieltyka Gladkowski has been selected as one of a very limited number of firms considered finalists for this award following Legal 500&#8217;s extensive regional research. The distinction is particularly meaningful because the award is not granted within a local ranking exercise alone; it forms part of a regional competition covering Central and Eastern Europe, where leading firms from numerous jurisdictions compete for recognition. The shortlist therefore represents an acknowledgement that our healthcare and life sciences practice stands among the most highly regarded and competitive teams in the region. Previous editions of the awards have featured only a select group of nominated firms in each category, underlining the exclusivity of the recognition.</p>



<p>For KG Legal Kieltyka Gladkowski, this nomination is an important confirmation of our long-standing commitment to supporting healthcare, pharmaceutical, biotechnology, and medical technology clients with sophisticated legal and regulatory advice. It reflects the trust placed in us by our clients, the quality of our work, and our contribution to the development of one of the most dynamic and strategically important sectors of the economy. Being shortlisted for Healthcare &amp; Life Sciences Firm of the Year at the Central and Eastern Europe Awards 2026 is therefore not only a significant professional achievement but also a recognition of our firm&#8217;s position within the broader Central and Eastern European legal market.</p>
<p> </p>


<p>Artykuł <a href="https://www.kg-legal.eu/info/kg-legal-news/kg-legal-kieltyka-gladkowski-shortlisted-for-the-legal-500-central-and-eastern-europe-awards-2026/">KG Legal KIELTYKA GLADKOWSKI Shortlisted for The Legal 500 Central and Eastern Europe Awards 2026</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>CE marking</title>
		<link>https://www.kg-legal.eu/info/cross-border-cases/ce-marking/</link>
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		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Wed, 13 May 2026 13:13:17 +0000</pubDate>
				<category><![CDATA[CROSS BORDER CASES]]></category>
		<category><![CDATA[CE]]></category>
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					<description><![CDATA[<p>Publication date: May 13, 2026 The CE marking was introduced as part of the harmonization of product marking processes within the EU. It is intended to replace all existing conformity markings. The marking itself indicates that the product meets the requirements of the applicable regulations. It is affixed to products intended for introduction into the [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/cross-border-cases/ce-marking/">CE marking</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p><strong><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color">Publication date: May 13, 2026</mark></strong></p>



<p>The CE marking was introduced as part of the harmonization of product marking processes within the EU. It is intended to replace all existing conformity markings. The marking itself indicates that the product meets the requirements of the applicable regulations. It is affixed to products intended for introduction into the EEA and Turkish markets, regardless of where they were manufactured.</p>



<span id="more-8780"></span>



<p class="has-luminous-vivid-amber-background-color has-background has-medium-font-size">Main regulations</p>



<p>The main acts that regulate the CE marking of products and the conformity testing that must accompany this process are: Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (consolidated text: OJ L 218, 2008, p. 30, as amended) as well as Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (consolidated text: OJ L 218, 2008, p. 82).</p>



<p class="has-luminous-vivid-amber-background-color has-background has-medium-font-size">CE marking</p>



<p>Although the mark is generally believed to be an abbreviation of the French expression &#8220;<em>Conformité Européenne&#8221;</em>, no EU legal act provides such an expansion of this abbreviation.</p>



<p>The appearance and method of affixing the CE marking are specified in Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008, stating that it consists of the initials &#8220;CE&#8221; presented in the form specified in the regulation. Unless other regulations specify a different height, it shall be at least 5 mm. In all cases, the proportions of the mark must be maintained. It must be affixed so that it is visible, legible, and indelible from the product. The CE marking is followed by the identification number of the notified body, if it was involved in the production control phase. If the CE marking cannot be affixed to the product, it should be affixed to the packaging or accompanying documentation.</p>



<h2 class="wp-block-heading">Declaration of Conformity</h2>



<p>Union harmonisation legislation requires the manufacturer to draw up and sign an EU declaration of conformity before placing the product on the market.</p>



<p>The manufacturer or its authorized representative established within the EU is required to draw up and sign an EU declaration of conformity as part of the conformity assessment procedure provided for in Union harmonisation legislation. The EU declaration of conformity is a document stating that the product complies with all relevant requirements of the applicable legislation.</p>



<p>By drawing up and signing the EU declaration of conformity, the manufacturer takes responsibility for the product&#8217;s compliance with the regulations.</p>



<p>The EU declaration of conformity must be continuously updated and kept for ten years from the date the product is placed on the market, unless a different period is specified by law.</p>



<p>According to the model declaration in Decision No 768/2008/EC of 9 July 2008, the declaration should include:</p>



<p>1. unique product identifier,</p>



<p>2. name and address of the manufacturer or authorized representative issuing the declaration,</p>



<p>3. a statement that the declaration is issued under the sole responsibility of the manufacturer,</p>



<p>4. Subject of the declaration (product identifier enabling the reconstruction of its history. Where appropriate, it may include a photo),</p>



<p>5. all relevant provisions of Union harmonisation legislation that the product must comply with, referenced standards or other technical specifications (such as national standards and technical specifications) in a precise, complete and clearly defined manner,</p>



<p>6. Where applicable, name and number of the notified body that issued the certificate,</p>



<p>7. Additional information,</p>



<p>8. Date of issue of the declaration, signature and position or equivalent designation of the authorized person,</p>



<p class="has-luminous-vivid-amber-background-color has-background has-medium-font-size">Modules</p>



<p>The mark itself is intended to indicate that the product meets the requirements specified in the law. The product is marked with it by the manufacturer, either independently or with the participation of a national authority (conformity assessment body, notified body). For this purpose, the manufacturer assesses conformity using modules (described in the Commission Notice Blue Guide &#8211; Implementation of EU product regulations 2022 (i.e. OJ EU C. of 2022 No. 247, p. 1) and Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008). The modules refer to both the design and production phases. Conformity assessments can be performed using one or two modules. Assessment modules can refer to one of the phases (e.g. only to the production phase), or to both. If a module refers to only one phase, the assessment consists of two modules, while if it refers to both phases, the assessment consists of one.</p>



<p>There are eight modules in total, but with the addition of variants, their number increases to 16 (A, A1, A2, B, C, C1, C2, D, D1, E, E1, F, F1, G, H, H1). Each subsequent module contains further requirements, along with increasing risks posed by the product. In the &#8220;least demanding&#8221; module, A, the manufacturer only prepares technical documentation and takes all necessary measures to ensure the production process ensures compliance of manufactured products with the technical documentation, and then affixes the marking to the product. In the highest module, H1, the manufacturer must have an approved quality assurance system (approved by a notified body) for design, production, and inspection and testing of finished products. It is also subject to supervision by a notified body. The notified body may also pay unannounced visits to the manufacturer, during which it may conduct or commission product tests.</p>



<p class="has-luminous-vivid-amber-background-color has-background has-medium-font-size">Entities involved in conformity assessment</p>



<p>At the outset, it is worth noting that regardless of whether a notified body is involved in the conformity assessment procedure or not, the conformity assessment is the manufacturer&#8217;s responsibility, and the declaration of conformity is made under his sole responsibility.</p>



<p>There are three possibilities for the involvement of other entities in the conformity assessment procedure:</p>



<p>&#8211; No involvement of external entities. In such a case (and this usually applies to products that the legislator has deemed not to pose such a risk that the manufacturer cannot be entrusted with the independent conformity assessment), the manufacturer prepares the declaration itself (along with the appropriate tests and technical documentation), and conducts the tests, inspections, and guarantees compliance during production.</p>



<p>&#8211; Conformity assessment is carried out using an accredited in-house body, i.e., a part of the manufacturer. However, this body cannot perform any tasks other than conformity assessment. It must be independent of commercial, design, and manufacturing entities and must possess the same level of technical competence and impartiality as external assessment bodies. They may conduct assessments within the scope of modules A1, A2, C1, or C2.</p>



<p>&#8211; Conducting the assessment with the involvement of an external entity. If the legislator deems such intervention necessary, an external conformity assessment body will participate in the conformity assessment. This body must be impartial and fully independent of the organization or the product it assesses. It must not engage in any activities that might compromise its independence, and it must not have user or other interests in the product being assessed.</p>



<p>Member States are responsible for designating conformity assessment bodies. They must designate bodies (within their jurisdiction) that have the appropriate competence to assess product conformity.</p>



<p>Even though in-house bodies cannot be notified (i.e. they cannot be external conformity assessment bodies), they must demonstrate at least the same level of technical competence as external bodies through accreditation.</p>



<p>Notified bodies</p>



<p>Conformity assessment bodies (referred to as notified bodies in EU legislation) are entities designated by Member States. Appointed notified bodies must then be notified to the European Commission.</p>



<p>They play roles in the conformity assessment process, responsible for activities such as calibration, testing, certification, and inspection. To qualify as a notified body, a body must be a legal entity established in a Member State, but it may operate or employ personnel outside a Member State or even outside the EU.</p>



<p>The bodies must be accredited, which means that the relevant national accreditation body must confirm that the conformity assessment body meets the requirements set by the harmonised standards and any additional requirements for carrying out specific conformity assessment tasks.</p>



<p>Member States may designate a maximum of one national accreditation body. However, they may choose not to designate such a body and instead have accreditation performed in their territory by an accreditation body from another Member State. In both cases (designation or non-designation), Member States are required to notify the European Commission.</p>



<p>Notified bodies are subject to oversight by national notifying authorities and must keep them informed about their activities (including, for example, availability of resources, performance of conformity assessments, subcontracting of work, and conflicts of interest). They must provide, directly or through another body (e.g., a national accreditation body), all information concerning the proper implementation of the conditions under which they were notified, upon request, both to their notifying authorities and to the Commission.</p>



<p>The notifying authority is responsible for the activities of notified bodies. It must remain capable of ensuring monitoring. If such monitoring is not possible, the notifying authority must withdraw or limit the scope of the notification to the extent necessary.</p>



<p>It&#8217;s also worth mentioning that the independence requirement (which also means that notified bodies &#8220;are and must remain&#8221; third parties independent of their clients) does not mean that only state bodies can become notified bodies. On the contrary, both state and private entities can apply for this status, provided their independence, impartiality, and reliability are guaranteed, and they constitute independent legal entities with appropriate rights and obligations.</p>



<p>Product labeling requirement</p>



<p>The CE marking is not required for every product, only for those for which legislation requires it. Currently, these include toys, electrical products, machinery, personal protective equipment, and cranes. It is prohibited to affix the CE marking to products that are not covered by the CE marking regulations.</p>



<p>Changes in the law</p>



<p>There have been no significant recent changes to the legislation governing the CE marking. However, sector-specific regulations necessarily influence the use of the mark. Such as Regulation (EU) 2024/2847 of the European Parliament and of the Council of 23 October 2024 on horizontal cybersecurity requirements for products with digital elements and amending Regulations (EU) No 168/2013 and (EU) 2019/1020 and Directive (EU) 2020/1828 (Cyber Resilience Act) (OJ EU L 2024, item 2847, as amended) or Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904 and repealing Directive 94/62/EC (OJ EU L 2025, item item 40) and acts requiring CE marking of products such as Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) Text with EEA relevance (OJ L 1689, 2024).</p>



<p>In its Annex I, Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 lists Union harmonisation legislation.</p>



<p>In summary, the purpose of the CE marking is to signal that a product meets the requirements of the applicable regulations. It is affixed to the product by the manufacturer, either independently or with the involvement of accredited internal bodies or a notified body, following the conformity assessment module(s) appropriate for the level of risk posed by the product, and under their own responsibility.</p>



<p><strong>CE Marking – what really stands behind those two letters?</strong></p>



<p>CE marking is more than just a symbol on a product – it’s a legal declaration that the product complies with all applicable EU requirements and can be placed on the EEA and Turkish markets, regardless of where it was manufactured.</p>



<p>It is the result of a structured conformity assessment process defined in EU harmonisation legislation (including Regulation (EC) No 765/2008 and Decision No 768/2008/EC). Depending on the level of risk, this process may involve the manufacturer alone, internal accredited bodies, or independent notified bodies.</p>



<p>By affixing the CE mark, the manufacturer takes full responsibility for product compliance. In parallel, an EU Declaration of Conformity must be issued, maintained, and kept up to date, confirming that all relevant legal requirements have been met.</p>



<p>The system is built on risk-based modules – from basic self-assessment to highly controlled certification schemes involving external oversight. This ensures proportional control while maintaining product safety and market access across the EU.</p>



<p>In short: CE marking is not a quality label – it is a regulatory passport for products entering the European market.</p>
<p>#CEMarking #EUCompliance #RegulatoryAffairs #ProductCompliance #ConformityAssessment #CECertification #EURegulation #MarketAccess #ProductSafety #NotifiedBody #TechnicalDocumentation #QualityAssurance #ManufacturingCompliance #IndustrialCompliance #LegalMetrology #EUlaw #ProductTesting #DeclarationOfConformity #RiskAssessment #HarmonisedStandards #BlueGuide #RegulatoryCompliance #EngineeringCompliance #SupplyChainCompliance #ProductRegulations #ComplianceManagement</p>
<p> </p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/cross-border-cases/ce-marking/">CE marking</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>ELECTRONIC DELIVERY, ELECTRONIC POWER OF ATTORNEY – IMPORTANT CHANGES FOR LITIGATIONS IN POLAND CIVIL PROCEDURE</title>
		<link>https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/electronic-delivery-electronic-power-of-attorney-important-changes-for-litigations-in-poland-civil-procedure/</link>
					<comments>https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/electronic-delivery-electronic-power-of-attorney-important-changes-for-litigations-in-poland-civil-procedure/#respond</comments>
		
		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Wed, 13 May 2026 12:42:15 +0000</pubDate>
				<category><![CDATA[IT, NEW TECHNOLOGIES, MEDIA AND COMMUNICATION TECHNOLOGY LAW]]></category>
		<category><![CDATA[CivilProcedure]]></category>
		<category><![CDATA[PolandLaw]]></category>
		<guid isPermaLink="false">https://www.kg-legal.eu/?p=8771</guid>

					<description><![CDATA[<p>Publication date: May 13, 2026 The most significant changes that influence litigations in Poland will come into force on March 1, 2026. The amendments to the Code of Civil Procedure concern, among other things, powers of attorney, mediation, the computerization of civil proceedings (this element predominates in the amending act), and new rules for service [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/electronic-delivery-electronic-power-of-attorney-important-changes-for-litigations-in-poland-civil-procedure/">ELECTRONIC DELIVERY, ELECTRONIC POWER OF ATTORNEY – IMPORTANT CHANGES FOR LITIGATIONS IN POLAND CIVIL PROCEDURE</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p><strong><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color">Publication date: May 13, 2026</mark></strong></p>



<p>The most significant changes that influence litigations in Poland will come into force on March 1, 2026. The amendments to the Code of Civil Procedure concern, among other things, powers of attorney, mediation, the computerization of civil proceedings (this element predominates in the amending act), and new rules for service of documents. Many changes concern the use of an information portal in the proceedings, which is also the subject of an amendment to the Act on the System of Common Courts.</p>



<p>The amendment aims to be one of the first steps towards computerizing the entire justice system to meet the needs of the information society. Furthermore, the justification also includes intentions to standardize the use of IT systems across courts, eliminating differences, for example, between different divisions of common courts. For the time being, after all the changes contained in the amending act enter into force, documents filed via the Information Portal will still need to be printed for inclusion in the case file due to the lack of digital records in civil proceedings. However, this is only a temporary solution, as work on digital records is already underway. The legislative authority also emphasizes the importance of gradual implementation and development, so that judges and citizens have an appropriate transitional period to become familiar with these systems.</p>



<span id="more-8771"></span>



<p>The Act Amending the Code of Civil Procedure, the Civil Code, and Certain Other Acts introduces the most numerous changes to civil procedure, which are immediately apparent upon first glance, even without reading the entire text. Some of these changes take effect almost immediately, while others will remain in the vacatio legis period for up to a year. Article 12 of the Act establishes a presumption that all amendments will enter into force on March 1, 2026, but provides numerous exceptions to this rule. This provision establishes, in essence, five different effective dates for the new provisions in sections 1-4, and provides the main date mentioned earlier. These dates are March 1, 2027 (within the specified scope), September 10, 2025, June 1, 2026, and November 27, 2025.</p>



<p>The justification for the act also mentions another reason for its creation: the development of the Common Courts Information Portal. The text notes that initially, communication was only possible unilaterally, meaning courts served documents if they had an electronic version of the document being served. However, work on this portal has now enabled two-way electronic communication, which should be utilized to expedite and facilitate civil proceedings. As can be seen, the amending act aims to adapt institutions to technological advances and increasingly new solutions.</p>



<p>The legislator considered it justified to introduce certain transitional periods for the entry into force of new provisions and subjective and objective restrictions.</p>



<p>The first draft regulations requiring discussion are intended to address service. It is recommended that provisions be introduced to regulate this issue, ensuring that service is legally effective only in situations specifically provided for by law. In other words, the possibility of <strong>service via the Information Portal </strong>will only be effective if the type of document, situation, and circumstances correspond to the provisions in the given case that allow for service in this particular manner. It seems reasonable to specify the moment of service in this manner to avoid procedural problems during civil proceedings. According to the proposed Articles 125 § 1 of the Code of Civil Procedure in conjunction with Article 165 § 4 of the Code of Civil Procedure, the conditions for legally effective service are first to post the document in electronic form on the Information Portal of Common Courts, and then the court delivers to the sender a document confirming receipt of the document in this form.</p>



<p>In terms of service, it seems a good idea to first require professionals to serve documents using the discussed system, as these individuals are more familiar with the current functioning of the justice system and procedures, and therefore, it will be easier for them to familiarize themselves with these new regulations and the resulting solutions. Many professionals have undoubtedly already had frequent contact with the Information Portal of Common Courts in connection with serving their clients and other activities related to the practice of law. This scope of service is intended to cover attorneys, legal counselors, patent attorneys, the General Counsel to the Republic of Poland, and prosecutors (proposed Art. 125 <sup>1 </sup>§ 2 of the Code of Civil Procedure). Therefore, if the provision stipulates that delivery of a document via an electronic system is not possible, the document should be submitted via the Information Portal for the service to be legally effective.</p>



<p>In terms of the subject matter limitation, i.e. the indication of documents that will initially be served through the Common Courts Information Portal system, these are notifications of termination of a power of attorney, notifications referred to in Article 136 § 1, 4 and 5 of the Code of Civil Procedure and Article 387 <sup>1 </sup>§ 1 of the Code of Civil Procedure, declarations regarding consent to mediation, requests to conduct a remote hearing, appeals, complaints, complaints against a court registrar&#8217;s ruling, procedural documents in the course of proceedings resulting from the filing of an appeal, appeal, or complaint against a court registrar&#8217;s ruling, requests for service of a judgment together with a justification issued as a result of the examination of an appeal, appeal, or complaint against a court registrar&#8217;s ruling, as well as documents supplementing formal deficiencies of such requests. Submitting documents outside this subject matter scope will, however, result in the ineffectiveness of service of the documents in question pursuant to Article 125 <sup>3 </sup>§ 2 of the Code of Civil Procedure, which the chairman will be obliged to notify the person submitting the document in violation of the above-mentioned rules.</p>



<p>The obligation for the above-mentioned professional entities is to take effect after a one-year transitional period, during which future parties required to submit documents via the Information Portal will have the option to choose whether to submit the indicated document in writing or through the Portal. However, after this period, the submission of specifically designated documents will be mandatory (Article 125 <sup>1 </sup>§ 2). According to the legislator, this solution is necessary to ensure a compromise between streamlining civil proceedings and the well-being of the parties, as well as the regularity and stability of the proceedings.</p>



<p>The draft act also provides that it will not be possible to send documents via the Information Portal within a given type of proceedings, namely when filing documents before the Supreme Court (which does not use IT solutions) and within land and mortgage register and registration proceedings (Article 125 <sup>1 </sup>§ 3 of the Code of Civil Procedure and Article 511 <sup>1b </sup>of the Code of Civil Procedure).</p>



<p>The provisions of the amending act also address the limitations of the Common Courts Information Portal by introducing a specific exemption from the obligation to submit certain categories of documents through this IT system that, due to their technical parameters, are currently unsuitable for submission in this manner. These include, for example, attachments with excessive memory requirements, pursuant to the proposed Article 125 § 2 § 1 of the Code of Civil Procedure. A list of such documents will be specified, among other things, in a regulation issued pursuant to the statutory authorization in Article 125 § 4. Documents in formats not supported by the information portal, when their content cannot be converted to formats permitted by the regulation, attachments that cannot be digitized (e.g., material samples in cases involving product defects), and attachments whose legible digitization would require the contracting authority to acquire specialized office equipment (e.g., large-format documents), will also be listed.</p>



<p>Furthermore, it is necessary to discuss Article 125 § 2 and § 3 of the Code of Civil Procedure, which introduces certain guarantees for parties and their representatives in the event of a failure or maintenance work on the Information Portal, as well as other reasons for the inability to serve a document that are not the fault of the parties. The essence of the guarantees introduced by this provision is that if the court&#8217;s inability to file a document occurs on the last day of the deadline for a given procedural act, the deadline will be extended until the end of the next business day after the day on which the restrictions cease. This rule, it&#8217;s worth noting, will apply on that last day for the act regardless of when the obstacles arise. This legislative approach is intended to prevent an excessive number of requests for extension of the deadline, which would result in a slowdown in entire civil proceedings, and to alleviate the need for constant monitoring of the system&#8217;s proper operation and the rush associated with filing documents. In connection with the discussion of this draft provision, it should also be noted that there will be an obligation to substantiate the circumstances preventing the submission of a document via the Portal and the authority of the presiding judge to return the document, and the court to reject the document, in the event of failure to comply with this obligation by the attorney-in-fact.</p>



<p>Professional representatives (lawyers, legal advisors, and patent attorneys) registered in the ROBUS system (Register of Persons Taking Part in Court Proceedings) will also be required to include their number on the appropriate list in their power of attorney. This will, of course, no longer be necessary in subsequent submissions.</p>



<p>Further regulations also include changes to the designation of ex officio legal aid. The court will now be able to forward applications to regional legal counsel and bar associations through the Information Portal system, thereby communicating with these organizations.</p>



<p>The proposed Article 128, paragraph 2, of the Code of Civil Procedure also provides for the possibility of attaching copies of attachments to a document along with the document itself via the Information Portal. However, the certification of attachments will be optional, not mandatory, due to the fact that the party submitting the document may not always be able to do so.</p>



<p>Regarding attorneys, another change will be the ability for professional attorneys to electronically certify documents in an IT system or information portal (Article 129, Section 2). This is intended to simplify the process of certifying not only documents but also attachments for attorneys, as under current law, document certification currently occurs when a document is entered into the IT system. This may cause attorneys to have difficulty using attachments if they do not have the originals. Regarding issues related to original documents, changes are also introduced by Article 128, Section 3 of the Code of Civil Procedure, which regulates situations in which the original document must be submitted in written form. This change is intended to eliminate doubts about whether such a requirement should be considered obvious, or whether, for example, a scan of the document should be submitted despite the lack of such a regulation. However, the legislator introduces an exception to the requirement to submit documents via the Information Portal and requires that the document be submitted directly to the court in this required form, bypassing the technological process.</p>



<p>The amended Article 131 1a § 1 expands the list of entities to which the court will be obliged to deliver correspondence via the Information Portal to include court bailiffs and permanent mediators.</p>



<p>Significant changes are also to be introduced under the amending act regarding mediation. From the entry into force of the regulations, in certain categories of cases (commercial cases, construction contracts, and contracts closely related to the construction process for the performance of construction works), the court will refer the parties to a dispute to mediation before the first scheduled hearing. This is intended to promote mediation as a peaceful, effective method that ensures the implementation of agreements within its scope, and relieves courts of the burden of resolving disputes between the parties despite the possibility of reaching an agreement. As indicated in the explanatory memorandum, these changes will incorporate the principle of voluntary mediation by allowing a party to file an objection in the first procedural document following the referral to mediation. This objection will have the effect of relieving the court from referring the dispute to mediation for resolution. It should be noted that, in addition to defining specific categories of cases referred ex officio to mediation, the legislator also specifies that proceedings will be conducted in the types specified in the Act (i.e., cases heard in writ-of-payment proceedings, electronic writ-of-payment proceedings, and payment order proceedings, unless an objection or objection to a payment order has been filed). Court registrars will also be able to issue orders to refer a case to mediation pursuant to the added Article 183 <sup>8 </sup>§ 1 of the Code of Civil Procedure, second sentence. Furthermore, another measure will be introduced in the field of mediation, aimed at increasing the number of cases referred to mediation: the absence of a position regarding a decision to refer a case to mediation will not be treated as an objection to such a decision, but as implied consent. The deadline for taking such a position will be one week. Furthermore, the competent court, regardless of subject matter jurisdiction, will be the district court for approving the settlement. A similar solution is provided for agreements to refer a case to mediation. The bill also stipulates that if the settlement concerns claims covered by different court proceedings, the parties are required to list these proceedings in the settlement and designate the court that will conduct the settlement approval proceedings. If courts of different levels have jurisdiction, the case will be heard by a higher court. Furthermore, the above changes will introduce the possibility of court approval of a mediation settlement at a remote hearing without the parties&#8217; signatures.</p>
<p> </p>



<p>From March 1, 2026, Poland’s civil procedure enters a new era of digital-first justice — with sweeping reforms to electronic service of documents, electronic powers of attorney, and the expanded use of the Common Courts Information Portal.</p>



<p>This is not just a technical update. It’s a structural transformation of how litigation will function in practice.</p>



<p>Key changes include:</p>



<ul class="wp-block-list">
<li>Mandatory and expanded electronic delivery via the courts’ IT system</li>



<li>New rules on when electronic service is legally effective</li>



<li>Gradual obligations for professional representatives (lawyers, legal advisers, patent attorneys, prosecutors)</li>



<li>Transitional periods with multiple entry-into-force dates</li>



<li>New limitations, exceptions, and safeguards for system failures</li>



<li>Strong push toward full digital case files (beyond temporary paper-based solutions)</li>



<li>Expanded procedural use of mediation and remote communication</li>
</ul>



<p>While paper files still remain for now, the direction is clear: Poland is moving toward a fully digital civil justice system, with standardised IT infrastructure across courts.</p>



<p>For practitioners, this means one thing — adaptation is no longer optional.</p>



<p class="wp-block-heading">PolandLaw #CivilProcedure #Litigation #LegalTech #LawReform #DigitalJustice #EJustice #CourtProcedure #LegalInnovation #LawyersOfLinkedIn #AttorneyLife #LegalProfession #CourtSystem #ProceduralLaw #ElectronicService #EFililing #DigitalTransformation #LawAndTechnology #Compliance #Regulation #Mediation #DisputeResolution #PowerOfAttorney #LegalUpdates #FutureOfLaw</p>
<p> </p>


<p>Artykuł <a href="https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/electronic-delivery-electronic-power-of-attorney-important-changes-for-litigations-in-poland-civil-procedure/">ELECTRONIC DELIVERY, ELECTRONIC POWER OF ATTORNEY – IMPORTANT CHANGES FOR LITIGATIONS IN POLAND CIVIL PROCEDURE</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>Interplay Between the Data Act and the GDPR: A Practical Guide for Businesses</title>
		<link>https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/interplay-between-the-data-act-and-the-gdpr-a-practical-guide-for-businesses/</link>
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		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Wed, 13 May 2026 10:56:58 +0000</pubDate>
				<category><![CDATA[IT, NEW TECHNOLOGIES, MEDIA AND COMMUNICATION TECHNOLOGY LAW]]></category>
		<category><![CDATA[cybersecurity]]></category>
		<category><![CDATA[DataAct]]></category>
		<category><![CDATA[DataGovernance]]></category>
		<category><![CDATA[DataPrivacy]]></category>
		<category><![CDATA[EUDataAct]]></category>
		<category><![CDATA[gdpr]]></category>
		<category><![CDATA[LegalTech]]></category>
		<category><![CDATA[RegTech]]></category>
		<guid isPermaLink="false">https://www.kg-legal.eu/?p=8769</guid>

					<description><![CDATA[<p>Publication date: May 13, 2026 The entry into application of the EU Data Act on 12 September 2025 marks one of the most significant developments in European data regulation since the adoption of the General Data Protection Regulation (GDPR). While the GDPR established a comprehensive framework for the protection of personal data, the Data Act [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/interplay-between-the-data-act-and-the-gdpr-a-practical-guide-for-businesses/">Interplay Between the Data Act and the GDPR: A Practical Guide for Businesses</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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<p><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color"><strong>Publication date: May 13, 2026</strong></mark></p>



<p>The entry into application of the EU Data Act on 12 September 2025 marks one of the most significant developments in European data regulation since the adoption of the General Data Protection Regulation (GDPR). While the GDPR established a comprehensive framework for the protection of personal data, the Data Act introduces a new legal regime designed to improve access to and use of data generated by connected products and related digital services.</p>



<span id="more-8769"></span>



<p>For businesses operating in the European Union, the key challenge is not understanding each regulation in isolation, but determining how they interact in practice. Many organizations already have mature GDPR compliance frameworks, but the Data Act creates additional obligations that require them to share data with users and third parties. Where those datasets contain personal data, compliance with the Data Act must be reconciled with the GDPR.</p>



<p>This article explains the relationship between the Data Act and the GDPR in practical terms. It highlights the main legal issues and outlines the steps businesses should take to prepare.</p>



<p><strong>What Is the Data Act?</strong></p>



<p>The Data Act, Regulation (EU) 2023/2854, is part of the European Union&#8217;s broader strategy to build a single market for data. Its purpose is to ensure that users of connected products and related services can access the data they generate and, in certain circumstances, require that such data be shared with third parties.</p>



<p>The regulation is intended to rebalance the relationship between manufacturers, service providers and users. In many industries, companies that design connected products control large volumes of data generated through use of those products. The Data Act seeks to ensure that users are able to benefit from this data rather than being locked into a single ecosystem.</p>



<p>The regulation applies to both personal and non-personal data, which is one of the key differences from the GDPR.</p>



<p>Examples of products and services covered by the Data Act include smart watches, connected vehicles, industrial machinery, medical devices, smart home appliances, agricultural equipment and software applications that process the data generated by such products.</p>



<p><strong>What Is the GDPR?</strong></p>



<p>The GDPR governs the processing of personal data relating to identified or identifiable natural persons. Its objective is to protect privacy and ensure that personal data is processed lawfully, fairly and transparently.</p>



<p>The GDPR applies whenever data relates to an individual and a controller or processor carries out an operation such as collecting, storing, sharing or analyzing that data.</p>



<p>Unlike the Data Act, the GDPR does not grant a broad right of access to all data generated by products. It focuses solely on personal data and establishes rights such as access, rectification, erasure and portability.</p>



<p><strong>The Relationship Between the Data Act and the GDPR</strong></p>



<p>The Data Act expressly states that it is without prejudice to EU and national laws on personal data protection, privacy and confidentiality of communications. In practical terms, this means that the Data Act does not override the GDPR. If a company is required to provide data under the Data Act and the dataset contains personal data, the GDPR continues to apply in full.</p>



<p>This principle has several important consequences.</p>



<p>First, the Data Act does not create a new legal basis for processing personal data. A company cannot rely on the Data Act alone to justify collecting, disclosing or otherwise processing personal data.</p>



<p>Second, organizations must continue to comply with all GDPR principles, including purpose limitation, data minimization, storage limitation and security.</p>



<p>Third, where there is a conflict between the two regulations, the GDPR prevails in relation to personal data.</p>



<p><strong>Why This Matters in Practice</strong></p>



<p>Most data generated by connected products is not purely personal or purely non-personal. Instead, businesses often deal with mixed datasets.</p>



<p>A connected vehicle, for example, may generate information on speed, fuel consumption, component performance, geolocation and driver behavior. Some of this information clearly relates to an identifiable person and therefore qualifies as personal data. Other elements may be technical or operational in nature.</p>



<p>Where personal and non-personal data are inextricably linked, organizations should assume that the GDPR applies to the dataset as a whole unless the data can be effectively separated.</p>



<p>This means that compliance with the Data Act often requires a GDPR analysis before any disclosure can take place.</p>



<p><strong>Practical Example: Smart Watch Data</strong></p>



<p>A consumer uses a smart watch that collects heart rate, sleep patterns, exercise metrics and location information. The consumer wishes to transfer the data to a third-party health application.</p>



<p>Under the Data Act, the user may request access to the data generated by the device and ask the manufacturer to transmit the data to another provider.</p>



<p>Because the dataset contains information relating to an identifiable person, the GDPR applies.</p>



<p>In this scenario, the manufacturer must verify that the request is valid, ensure the transmission is secure and process the data in accordance with the GDPR. The Data Act creates the obligation to provide the data, but the GDPR determines how the transfer must be carried out.</p>



<p><strong>Practical Example: Industrial Equipment</strong></p>



<p>A manufacturing company leases connected machinery that generates data concerning temperature, output, wear and maintenance cycles. The company wants to share this data with an independent maintenance provider.</p>



<p>The Data Act allows the user to request access to the data and to require the data holder to share it with a third party.</p>



<p>If the dataset contains no personal data, the GDPR may not apply.</p>



<p>However, if the data includes operator IDs or logs that can identify employees, GDPR considerations arise. The data holder must assess whether a lawful basis exists for sharing those elements.</p>



<p><strong>Key Roles Under the Data Act and the GDPR</strong></p>



<p>The terminology used by the two regulations differs, but the concepts often overlap. Under the Data Act, the principal roles are the data holder, the user and the data recipient. Under the GDPR, the key roles are the controller and processor. In practice, a data holder will often act as a controller because it determines the purposes and means of processing personal data. A business user receiving data may also become a controller if it decides how the data will be used.</p>



<p>This distinction is important because the recipient of data under the Data Act may inherit independent GDPR obligations.</p>



<p><strong>Data Portability: How the Data Act Expands Existing Rights</strong></p>



<p>The GDPR grants individuals a right to data portability, but this right is limited to personal data provided by the data subject and processed on the basis of consent or contract. The Data Act significantly broadens this concept.</p>



<p>It applies to data generated through the use of connected products and related services, regardless of whether the data is personal or non-personal.</p>



<p>For businesses, this means that existing GDPR portability procedures will usually not be sufficient. Organizations may need entirely new technical and contractual frameworks to handle Data Act requests.</p>



<p><strong>Trade Secrets and Confidential Information</strong></p>



<p>One of the most common concerns raised by businesses is the protection of proprietary information. The Data Act recognizes that data may contain trade secrets and allows data holders to implement safeguards such as confidentiality agreements, access controls and contractual restrictions. However, trade secret protection is not an automatic ground for refusing access. A refusal is permitted only in exceptional circumstances where disclosure would likely cause serious economic harm and where protective measures are insufficient.</p>



<p>In practice, businesses should assume that most requests will need to be fulfilled, subject to appropriate safeguards.</p>



<p><strong>Smart Contracts</strong></p>



<p>The Data Act introduces specific requirements for smart contracts used to automate data sharing.</p>



<p>Where businesses use blockchain-based or automated systems to execute data-sharing arrangements, those systems must meet standards relating to security, integrity and the ability to terminate or interrupt execution where necessary. Although this aspect of the regulation may not affect all organizations, it is highly relevant to businesses deploying decentralized or automated contractual technologies.</p>



<p><strong>Cloud Switching and Digital Assets</strong></p>



<p>The Data Act also addresses switching between providers of data processing services, including cloud providers. Customers must be able to move digital assets such as applications, configuration files, metadata and access credentials to another provider more easily. Organizations that offer cloud or platform services should review their contractual and technical arrangements to ensure that customers can migrate without undue barriers.</p>



<p><strong>Legal Basis for Processing Personal Data</strong></p>



<p>A recurring misconception is that the Data Act itself authorizes disclosure of personal data. This is incorrect. Whenever personal data is involved, a valid legal basis under the GDPR remains necessary. The applicable legal basis will depend on the circumstances. In some cases, processing may be necessary for the performance of a contract. In others, consent or legitimate interests may be relevant. Where the user requesting the data is a business rather than the individual to whom the data relates, the requesting party may need to demonstrate that it has an independent lawful basis for processing the personal data.</p>



<p><strong>What Businesses Should Do</strong></p>



<p>Organizations should begin by identifying whether they fall within the scope of the Data Act. Businesses that manufacture connected products, provide related services, control access to product-generated data or offer cloud services are the most likely to be affected. The next step is to map the data generated by products and services. This exercise should identify what data is collected, whether it includes personal data, who controls it and with whom it may be shared.</p>



<p>Once the data landscape is understood, businesses should review the legal bases for processing any personal data contained in those datasets.</p>



<p>Policies and procedures should then be updated to address Data Act requests. Existing GDPR processes will rarely be sufficient because they are designed primarily for requests from individuals, not business-to-business data sharing.</p>



<p>Contracts with customers, partners and recipients should be revised to address data use restrictions, confidentiality obligations, trade secret protections and security measures.</p>



<p>Technical teams should ensure that systems can provide data in accessible formats, authenticate requesters, record disclosures and protect sensitive information.</p>



<p>Finally, legal, compliance, IT and customer support teams should be trained so that they understand how to manage requests consistently.</p>



<p><strong>Common Pitfalls</strong></p>



<p>Businesses preparing for the Data Act frequently make several mistakes. The first is assuming that the Data Act overrides the GDPR. In reality, the GDPR remains fully applicable whenever personal data is involved. The second is underestimating the complexity of mixed datasets. The third is relying too heavily on trade secret arguments to resist disclosure. The fourth is failing to update contracts and operational procedures.</p>



<p>The fifth is treating compliance as a purely legal issue rather than a multidisciplinary project involving legal, IT, security and commercial teams.</p>



<p><strong>Enforcement and Business Risk</strong></p>



<p>Failure to comply with the Data Act may result in regulatory investigations, disputes with customers and partners, and reputational damage. Where personal data is mishandled, GDPR enforcement risks also arise, including potentially significant administrative fines. For this reason, businesses should approach the Data Act as a strategic compliance project rather than a narrow contractual exercise.</p>



<p><strong>Conclusion</strong></p>



<p>The Data Act and the GDPR are complementary regulations that pursue different objectives. The GDPR protects individuals and their personal data. The Data Act promotes broader access to data generated by connected products and services. When those datasets contain personal data, organizations must apply both regimes simultaneously. The Data Act creates the obligation to make data available, while the GDPR determines the conditions under which personal data may be processed and shared.</p>



<p>Businesses that rely on connected products, IoT ecosystems, industrial data or cloud services should begin preparing well in advance.</p>



<p>Organizations that invest now in data mapping, contractual updates, technical controls and internal governance will be best positioned to comply with the new rules and to leverage data as a strategic asset.</p>



<p><strong>Client Alert</strong></p>



<p><strong>EU Data Act Applies from 12 September 2025: Is Your Business Ready?</strong></p>



<p>The EU Data Act introduces a new framework governing access to data generated by connected products and related services. It applies from 12 September 2025 and will affect manufacturers, software providers, cloud providers and businesses that rely on connected technologies.</p>



<p>The regulation grants users the right to access data generated by products they use and to request that such data be shared with third parties.</p>



<p>Where the data includes personal data, the GDPR remains fully applicable.</p>



<p>For many organizations, the Data Act will require updates to contracts, technical systems and operational procedures.</p>



<p>Businesses should begin by identifying whether they control product-generated data, determining whether datasets include personal data, and assessing whether existing systems can support secure and compliant data sharing.</p>



<p>Organizations should also review trade secret protections and update agreements with customers and business partners.</p>



<p>Companies that prepare early will be better positioned to meet legal obligations and capitalize on new opportunities arising from increased data portability.</p>



<p><strong>Data Act Implementation Checklist</strong></p>



<p>An effective implementation project should begin with a governance assessment to determine which internal teams will be responsible for legal analysis, technical implementation and operational oversight.</p>



<p>The organization should then conduct a comprehensive data mapping exercise covering all connected products, related services and cloud environments. This exercise should distinguish between personal data, non-personal data and mixed datasets.</p>



<p>A legal review should be undertaken to confirm the GDPR legal bases for processing personal data and to identify any restrictions arising from confidentiality obligations or trade secret protections.</p>



<p>Customer terms, data-sharing agreements, cloud contracts and internal policies should be revised to reflect Data Act requirements.</p>



<p>Technical teams should ensure that systems are capable of exporting data in usable formats, authenticating requesters, logging disclosures and protecting confidential information.</p>



<p>Operational procedures should be established for receiving, reviewing and responding to requests.</p>



<p>Training should be delivered to legal, compliance, IT, security and customer-facing teams.</p>
<p> </p>



<p><strong>The EU Data Act Meets the GDPR: What Businesses Need to Know</strong></p>



<p>With the EU Data Act becoming applicable from <strong>12 September 2025</strong>, we’re entering a new era of data regulation in Europe — one that doesn’t replace the GDPR, but fundamentally reshapes how it operates in practice.</p>



<p>For many organizations, the challenge is no longer <em>GDPR vs. Data Act</em>, but how both frameworks work together when data is shared, accessed, and reused.</p>



<p>The key reality?<br>Most data generated by connected products is <strong>mixed — personal and non-personal at the same time</strong>. And that changes everything.</p>



<h3 class="wp-block-heading">Key takeaway:</h3>



<p>The Data Act creates obligations to <strong>share data</strong>, but the GDPR still governs <strong>how personal data can be processed and transferred</strong>. The Data Act never overrides GDPR requirements.</p>



<h3 class="wp-block-heading">What this means in practice:</h3>



<ul class="wp-block-list">
<li>No new legal basis for processing personal data under the Data Act</li>



<li>GDPR principles (minimization, purpose limitation, security) still fully apply</li>



<li>Trade secrets don’t automatically block access requests</li>



<li>Data portability rights are significantly expanded beyond GDPR scope</li>



<li>Cloud and IoT ecosystems will need major technical and contractual updates</li>
</ul>



<h3 class="wp-block-heading">The real challenge for businesses</h3>



<p>Compliance is no longer just legal — it’s operational and technical.</p>



<p>Organizations will need to:<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Map all product-generated data<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Identify where personal data is involved<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Update contracts and data-sharing frameworks<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Build secure, auditable data access systems<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Align legal, IT, and compliance teams</p>



<h3 class="wp-block-heading">Bottom line:</h3>



<p>The Data Act doesn’t replace the GDPR — it adds a new layer of complexity on top of it. Companies that prepare early will not only reduce compliance risk but also gain a competitive advantage in the emerging EU data economy.</p>
<p> </p>


<p>Artykuł <a href="https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/interplay-between-the-data-act-and-the-gdpr-a-practical-guide-for-businesses/">Interplay Between the Data Act and the GDPR: A Practical Guide for Businesses</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>Can the company as the third party gain access to its shareholder’s bankruptcy proceedings files</title>
		<link>https://www.kg-legal.eu/info/investment-law-and-processes-in-poland/can-the-company-as-the-third-party-gain-access-to-its-shareholders-bankruptcy-proceedings-files/</link>
					<comments>https://www.kg-legal.eu/info/investment-law-and-processes-in-poland/can-the-company-as-the-third-party-gain-access-to-its-shareholders-bankruptcy-proceedings-files/#respond</comments>
		
		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Wed, 13 May 2026 10:36:34 +0000</pubDate>
				<category><![CDATA[INVESTMENT LAW AND PROCESSES IN POLAND]]></category>
		<category><![CDATA[corporategovernance]]></category>
		<category><![CDATA[CorporateStructure]]></category>
		<category><![CDATA[LegalPractice]]></category>
		<guid isPermaLink="false">https://www.kg-legal.eu/?p=8767</guid>

					<description><![CDATA[<p>Publication date: May 13, 2026 In the practice of commercial law, an event often occurs in which the legal status of one entity directly impacts the stability and functioning of another. A particular example is the bankruptcy of a shareholder in a commercial company. Although from a legal perspective, the bankruptcy of a shareholder affects [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/investment-law-and-processes-in-poland/can-the-company-as-the-third-party-gain-access-to-its-shareholders-bankruptcy-proceedings-files/">Can the company as the third party gain access to its shareholder’s bankruptcy proceedings files</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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<p><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color"><strong>Publication date: May 13, 2026</strong></mark></p>



<p>In the practice of commercial law, an event often occurs in which the legal status of one entity directly impacts the stability and functioning of another. A particular example is the bankruptcy of a shareholder in a commercial company. Although from a legal perspective, the bankruptcy of a shareholder affects their personal assets, in practice it undermines the very foundations of the company&#8217;s operations. Shares or stocks, previously part of a stable ownership structure, become part of the bankruptcy estate, over which the trustee assumes control. For the company, this means entering into a relationship with a new, compulsory &#8220;shareholder&#8221;, whose actions may be fundamental to the company&#8217;s future development. Some of the most important information regarding bankruptcy proceedings that a company may wish to obtain includes whether and when the trustee intends to liquidate the shares and who will exercise corporate rights at shareholder meetings. Despite such obvious interdependencies, a commercial company rarely has the formal status of a party to its shareholder’s bankruptcy proceedings. This situation creates a significant conflict between the principle of open court proceedings and the debtor&#8217;s privacy. Therefore, it is necessary to consider whether the commercial company has the right to access the bankruptcy case files concerning the shareholder.</p>



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<p><strong>Entities authorized to inspect bankruptcy proceedings files</strong></p>



<p>A key provision worth noting is Article 228, Section 1 of the Bankruptcy Law, which states that participants in the proceedings and anyone who sufficiently justifies the need to review court files shall be provided with access to these files via the IT system supporting court proceedings. Participants in bankruptcy proceedings, pursuant to Section III of the Bankruptcy Law, include creditors or their trustees, and the bankrupt, or a trustee appointed by the judge-commissioner if the bankrupt lacks capacity to sue and is not represented by a legal representative. The list of these entities is closed, meaning that only the categories of entities specified in the Act have the status of participant in the proceedings. A bankrupt is someone against whom a bankruptcy order has been issued, so in the example described, this would be a shareholder in a commercial company. A creditor is anyone entitled to satisfaction from the bankruptcy estate, even if the claim does not require filing. If a company is not a direct creditor of a shareholder, it is not included in the list of entities authorized to inspect the proceedings files. Consequently, it should be assumed that a commercial company will not have access to the bankruptcy proceedings files as a participant, due to the fact that it cannot be classified as a bankrupt (or a bankrupt&#8217;s trustee) or a creditor (or a creditor&#8217;s trustee).</p>



<p>Pursuant to § 6 sec. 1 of the Regulation of the Minister of Justice of November 18, 2021, on the method and procedure for maintaining files for filing claims and collections of documents, as well as for making these files and collections of documents available files for filing claims shall be made available to participants in the proceedings via publicly available IT networks. Additionally, § 6 sec. 2 of this Regulation provides for an expanded group of entities authorized to inspect files, according to which the trustee shall make files for filing claims available in the office or via the IT system to the persons referred to in sec. 1, after they have confirmed their identity, and also to other persons after they have <strong><u>sufficiently justified</u></strong> their need to familiarize themselves with these files, unless the provisions of the Act provide otherwise. This provision confirms the regulations provided for in the Bankruptcy Law and serves as an implementing act for these regulations.</p>



<p>Therefore, it would also be necessary to consider a situation in which a company meets the requirements for the second category of entities authorized to access the case files. This category encompasses entities that can sufficiently justify the need to review the files. The term &#8220;sufficiently justify&#8221; is of fundamental importance in this provision; as a vague concept, it does not indicate the specific requirements that must be met to meet this requirement. Case law and legal doctrine assume that this term means that it is not necessary to demonstrate this need with detailed evidence; instead, it is sufficient to indicate a real and rational reason why the interested party wishes to access the files. Therefore, it should be recognized that to obtain access to the case files, a company must demonstrate a factual interest, not necessarily a legal interest. The final decision on granting such access rests with the court reviewing the request for access to the files, which assesses whether the indicated reason constitutes a sufficient justification for granting access.</p>



<p><strong>The company as a participant in the bankruptcy proceedings of a shareholder</strong></p>



<p>Shareholder’s declaration of bankruptcy implies a number of consequences in bankruptcy proceedings, including that the bankrupt is obligated to designate and deliver all of their assets to the trustee. From the moment the trustee begins managing the bankrupt&#8217;s assets, which become the bankruptcy estate, all actions taken depend on their discretion. The bankruptcy estate includes assets belonging to the bankrupt on the date of the declaration of bankruptcy and acquired by the bankrupt during the bankruptcy proceedings, with some statutory exceptions. It should therefore be stated that the bankruptcy estate also includes the shareholder’s share in the commercial company. When the trustee takes over management of the shareholder’s assets, including their share, it is in the company&#8217;s best interest to continuously monitor the trustee&#8217;s actions, which may directly impact the exercise of corporate rights in the company. This situation has direct consequences for the company&#8217;s operations, particularly with regard to the exercise of shareholding rights and potential changes in the ownership structure. By seeking to determine who exercises corporate rights and whether the shares will be sold by the trustee, the company is pursuing a rational and objectively justified factual interest. Consequently, it should be recognized that such circumstances may constitute sufficient grounds for granting access to bankruptcy case files.</p>



<p>In the case of limited liability companies, shareholder’s declaration of bankruptcy does not constitute grounds for dissolving the company. Therefore, the company has an obvious interest in monitoring bankruptcy files, as the outcome of these proceedings may determine the continued legal existence of the company itself.</p>



<p><strong>A company that does not have the status of a participant in the bankruptcy proceedings of a shareholder</strong></p>



<p>The right to access case files generally applies to parties and participants in the proceedings. However, in bankruptcy proceedings, the circle of entities authorized to inspect files is broader, as it also includes entities that sufficiently justify the need to review the files. To determine whether a company has a factual interest justifying access to the files of bankruptcy proceedings conducted against its shareholder, even though it is neither a party nor a participant in those proceedings, the company&#8217;s reason for seeking access to the files should be considered and whether the indicated circumstance may be deemed by the court to constitute sufficient justification for granting such access.</p>



<p>Interested persons who are not participants in the proceedings may be considered to include persons interested in acquiring the bankrupt&#8217;s assets, persons interested in concluding contracts with the trustee, and persons interested in the assets of the bankrupt&#8217;s creditors, which may be subject to potential enforcement. In the case of a company whose shareholder has declared bankruptcy, the interest in inspecting the files may lie in determining who will exercise the share rights of the bankrupt shareholder, as well as in obtaining information on whether the trustee managing the bankruptcy estate intends to sell the shareholder&#8217;s shares. The company may have a legitimate interest in becoming familiar with these circumstances, particularly if it is considering acquiring these shares.</p>



<p>According to the literal wording of the judgment of the Voivodeship Administrative Court in Bydgoszcz of August 21, 2019, II SA/ Bd 402/19, in a situation where the complainant requested access to the files of the bankruptcy proceedings of a specific entity: a complete list of receivables with any supplements, the final plan for the distribution of the bankruptcy estate funds, and information regarding the value of the enterprise determined based on the description and valuation of the enterprise, requesting the provision of information under the public information procedure, the court indicated that this was not public information. Despite this, the court informed the complainant that his request was not inadmissible, but was filed on an incorrect legal basis and, therefore, under an incorrect procedure. In this case, the court found that the indicated information should not be considered public information, but access to the files is available in accordance with the procedure under the Bankruptcy Law. In this situation, the authority correctly pointed out that access to bankruptcy proceedings files, including those of interest to the complainant, was regulated by the provisions of the relevant procedure. As a non-party, after sufficiently justifying the need to review the files, it may do so under Article 228, Section 1 of the Act of 28 February 2003 – Bankruptcy Law, including the possibility of obtaining copies, extracts, and making its own photocopies.</p>



<p><strong>The company&#8217;s legal interest in accessing the files of its shareholder’s bankruptcy proceedings</strong></p>



<p>According to Article 75 of the Bankruptcy Law, on the date of declaration of bankruptcy, the bankrupt loses the right of management and the ability to use and dispose of the property included in the bankruptcy estate. These rights are transferred to the trustee, who acts in his or her own name but on the bankrupt&#8217;s behalf, administering the entire bankruptcy estate and taking steps to liquidate it or, in the case of arrangement proceedings, to satisfy creditors in accordance with the approved arrangement. Pursuant to Article 61 et seq. of this Act, the bankruptcy estate includes the assets belonging to the bankrupt on the date of declaration of bankruptcy, as well as assets acquired during the proceedings. However, the legislator has provided a list of exclusions (Articles 63–67a), including, in particular, assets exempt from enforcement under the Civil Procedure Code and the portion of the bankrupt&#8217;s remuneration for work not subject to seizure. In light of the above regulations, it should be assumed that a shareholder&#8217;s share in a commercial company generally forms part of the bankruptcy estate. There is no provision excluding such property rights from bankruptcy proceedings. This is also confirmed by a functional interpretation of the regulations, as the goal of bankruptcy proceedings is to fully satisfy creditors, which supports the inclusion of all assets with economic value in the bankruptcy estate. As a consequence of a shareholder declaring bankruptcy, the trustee acquires the authority to exercise the share rights associated with that share, including, in particular, voting rights, dividend rights, and other corporate and property rights. Importantly, the trustee may also dispose of the share, guided by the interests of the bankruptcy estate and the creditors. The possibility of the trustee disposing of shares has significant consequences for the company itself. In particular, it may lead to a change in the composition of the shareholders through the entry of an entity unacceptable to the existing shareholders, which in practice may impact the stability of the company, the manner in which its affairs are conducted, and even the implementation of its business strategy. For these reasons, it should be recognized that although the company is not formally a participant in the bankruptcy proceedings conducted against its shareholder, it has a specific and real legal interest in obtaining information about the progress of these proceedings. This interest stems from the direct impact of a shareholder&#8217;s bankruptcy on the company&#8217;s legal and factual situation, including its ownership structure and the manner of exercising corporate rights. The relationship between a shareholder&#8217;s bankruptcy and the company&#8217;s legal situation is therefore internal, not merely external. The outcome of bankruptcy proceedings, and in particular the trustee&#8217;s decisions regarding the exercise or disposal of shareholding rights, directly impacts the company&#8217;s operations, justifying the protection afforded to it by the ability to monitor the course of these proceedings.</p>



<p>In summary, a commercial company may be a participant in its shareholder&#8217;s bankruptcy proceedings, and thus automatically entitled to access the files if it is found to be a creditor of the shareholder. It may also be granted access to these files as a third party, provided it sufficiently justifies the need to review their contents by demonstrating a real and rational interest in the company&#8217;s operations. In practice, this interest may stem, in particular, from the need to determine how shareholder rights are exercised or the trustee&#8217;s intention to dispose of shares. It is crucial to emphasize that demonstrating a legal interest is not necessary to obtain access to bankruptcy files – demonstrating a rational justification for the need to review the files is sufficient. Granting access is discretionary and depends on the court&#8217;s judgment, which determines whether the circumstances presented by the applicant sufficiently justify such a request. It should also be emphasized that access to such information should be granted only in accordance with the provisions of the Bankruptcy Law, and not pursuant to regulations regarding access to public information.</p>
<p> </p>



<p>Can a company gain access to its shareholder’s bankruptcy proceedings files?</p>



<p>In practice, the bankruptcy of a shareholder rarely remains a “private” matter. Once shares become part of the bankruptcy estate, the trustee may influence voting rights, corporate governance, and even the future ownership structure of the company itself.</p>



<p>This raises an important legal question:<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/27a1.png" alt="➡" class="wp-smiley" style="height: 1em; max-height: 1em;" /> Does the company have the right to inspect the bankruptcy files of its shareholder?</p>



<p>Although a company is usually not a formal participant in such proceedings, Polish Bankruptcy Law allows access to entities that can sufficiently justify a real and rational interest in reviewing the files.</p>



<p>For companies, this interest may include:<br>• determining who exercises shareholder rights during proceedings,<br>• monitoring the trustee’s actions,<br>• assessing the potential sale of shares,<br>• protecting corporate stability and ownership structure.</p>



<p>The article analyzes the balance between transparency of bankruptcy proceedings and the debtor’s privacy, while explaining when a company may successfully request access to bankruptcy files as a third party.</p>



<p>An important issue for corporate governance, restructuring practice, and investor protection.</p>



<p>#BankruptcyLaw #Insolvency #CorporateLaw #CommercialLaw #Restructuring #Shareholders #CorporateGovernance #LegalInsights #BusinessLaw #MergersAndAcquisitions #Trustee #CompanyLaw #Litigation #LegalUpdate #Compliance #CorporateStructure #InvestorRelations #LegalPractice #Governance #BusinessRisk #LawFirm #CorporateDisputes #FinancialRestructuring #PolishLaw #LegalAnalysis</p>
<p> </p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/investment-law-and-processes-in-poland/can-the-company-as-the-third-party-gain-access-to-its-shareholders-bankruptcy-proceedings-files/">Can the company as the third party gain access to its shareholder’s bankruptcy proceedings files</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>AI Influencer in the light of the law &#8211; scope of responsibility, regulatory obligations and legal risks</title>
		<link>https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/ai-influencer-in-the-light-of-the-law-scope-of-responsibility-regulatory-obligations-and-legal-risks/</link>
					<comments>https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/ai-influencer-in-the-light-of-the-law-scope-of-responsibility-regulatory-obligations-and-legal-risks/#respond</comments>
		
		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Wed, 13 May 2026 10:21:30 +0000</pubDate>
				<category><![CDATA[IT, NEW TECHNOLOGIES, MEDIA AND COMMUNICATION TECHNOLOGY LAW]]></category>
		<category><![CDATA[AI influencer]]></category>
		<category><![CDATA[EULaw]]></category>
		<guid isPermaLink="false">https://www.kg-legal.eu/?p=8765</guid>

					<description><![CDATA[<p>Publication date: May 13, 2026 Can an AI influencer be held legally accountable? Not directly — but the businesses and creators behind them certainly can. As AI-generated personas become a powerful tool in marketing, they also raise important legal questions around transparency, advertising disclosures, GDPR compliance, copyright, and the new obligations introduced by the EU [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/ai-influencer-in-the-light-of-the-law-scope-of-responsibility-regulatory-obligations-and-legal-risks/">AI Influencer in the light of the law &#8211; scope of responsibility, regulatory obligations and legal risks</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
]]></description>
										<content:encoded><![CDATA[
<p><strong><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color">Publication date: May 13, 2026</mark></strong></p>



<p><strong>Can an AI influencer be held legally accountable? Not directly — but the businesses and creators behind them certainly can.</strong></p>



<p class="has-luminous-vivid-amber-background-color has-background"><strong>As AI-generated personas become a powerful tool in marketing, they also raise important legal questions around transparency, advertising disclosures, GDPR compliance, copyright, and the new obligations introduced by the EU AI Act. In my latest article, I explore who bears responsibility for AI influencers, what regulatory requirements apply, and which legal risks companies should address before launching virtual brand ambassadors.</strong></p>



<p><strong>If your business is using AI to engage consumers, this is a topic you cannot afford to ignore.</strong></p>



<span id="more-8765"></span>



<p>The topic of AI in the legal community remains fraught with controversy, loopholes, and regulatory needs. The dynamic progress in this area is linked to the emergence of ever- new phenomena—with which the law cannot always keep pace—one of which are so-called AI influencers.</p>



<p>AI influencers are, in other words, figures created within algorithms using artificial intelligence. It may seem that their growing popularity is closely linked to economic and social aspects indicating the tendency to depart from traditional forms of marketing in favor of those generated by artificial intelligence.</p>



<p>This type of solution, however, is not outside the scope of applicable law. AI influencers, like other creators, are subject to requirements regarding liability, transparency, personal data protection, and compliance with EU and national regulations. However, to what extent, who is responsible for them, and what regulatory obligations apply to them are matters of consideration for this study.</p>



<p><a></a><strong>AI Influencer &#8211; a natural person, a legal person, or maybe something completely different?</strong></p>



<p>Under current regulations, an AI influencer lacks legal personality or the capacity to bear liability. They should be treated as a tool or technological product used by an entrepreneur. Consequently, all responsibility for content generated using them rests with the entity that decides on its publication, i.e., most often the entrepreneur or, alternatively, the entity implementing the system. The prevailing view is that even in situations of a high degree of AI system autonomy, liability is not transferred to the system, as it is not a legal entity.</p>



<p><strong>Can an entrepreneur avoid liability by relying on the autonomy of an AI system?</strong></p>



<p>In the context of civil law, it should be assumed that general principles of tort liability apply. According to Article 415 of the Civil Code, liability rests with the person who caused the damage through their own fault, while Article 355 § 2 of the Civil Code imposes on the entrepreneur an obligation to exercise due diligence, taking into account the professional nature of the activity. In practice, this means that the entrepreneur cannot rely on the autonomy of the AI system as a circumstance excluding liability if they failed to ensure adequate control over the generated content.</p>



<p><a></a><strong>AI Influencer and product promotion.</strong></p>



<p><a></a>influencer as commercial information is also crucial. Any message intended to promote a product or service is subject to the rigors of, among others, the Consumer Rights Act, particularly regarding disclosure obligations in distance contracts.</p>



<p><strong>Marking advertising content &#8211; not only the responsibility of AI influencers</strong></p>



<p>In light of the regulations on combating unfair commercial practices, it should be assumed that the lack of appropriate labeling of advertising content poses a significant legal risk. The Act implementing Directive 2005/29/EC introduces a ban on misleading practices and a so-called &#8220;blacklist&#8221; of practices prohibited under all circumstances, including surreptitious advertising. Pursuant to Article 7, Section 11 of this Act, it is prohibited to use editorial content to promote a product without clearly disclosing the commercial nature of the message.</p>



<p>In the decision-making practice of the President of the Office of Competition and Consumer Protection, it should be noted that this authority consistently considers the lack of advertising collaboration labeling to be a violation of the collective interests of consumers. Decisions issued emphasize that labeling must be unambiguous, legible, and understandable to the average consumer, and that the use of unclear labeling or concealment may result in the imposition of significant financial penalties. In light of these decisions, it should be assumed that similar standards will apply to content generated by AI influencers.</p>



<p><strong>Human, robot, or artificial creation – that is, misleading action.</strong></p>



<p>AI influencer as a real person is also particularly significant. It should be assumed that failing to disclose the artificial nature of such a persona may be considered misleading, particularly regarding the authenticity of consumer experiences. Such a practice may be classified as a violation of both unfair market practices regulations and transparency principles under EU law.</p>



<p>In this context the application of AI Act is crucial. It should be noted that this act introduces a taxonomy based on the classification of AI systems according to risk level: prohibited systems, high-risk systems, systems subject to transparency obligations, and systems with minimal risk. In the case of AI influencers, it should be assumed that, in principle, they will be classified as systems subject to transparency obligations, unless their functionality includes elements that could significantly influence consumer decisions in a manipulative manner, which could potentially lead to a more restrictive classification.</p>



<p><strong>Supplier and implementing entity &#8211; what does this mean for the entrepreneur?</strong></p>



<p>The AI Act clearly distinguishes the roles of the AI system provider and the implementer. The provider is responsible for designing and marketing the system and must meet a number of requirements, including documentation, risk management, and compliance. The implementer, in turn, i.e., the entrepreneur using the AI influencer , is responsible for its use, particularly for compliance with transparency obligations and for the legal consequences of published content.</p>



<p><a></a><strong>Article 50 of the AI Act and the information obligation</strong></p>



<p>In light of Article 50 of the AI Act, end users must be informed that they are interacting with content generated by artificial intelligence. Furthermore, manipulative practices, including the use of subliminal techniques or exploitation of particularly vulnerable groups, are prohibited. Violation of the regulation&#8217;s provisions may result in the imposition of severe administrative penalties, reaching up to tens of millions of euros or a specified percentage of a company&#8217;s annual turnover.</p>



<p><strong>Personal data protection</strong></p>



<p>In the area of personal data protection, the GDPR applies. In particular, attention should be paid to the obligation to conduct a data protection impact assessment (DPIA) pursuant to Article 35 of the GDPR where processing – particularly involving the use of AI – is likely to result in a high risk to the rights and freedoms of natural persons. This applies in particular to behavioral profiling and automated decision-making.</p>



<p><a></a><strong>The principle of privacy by design &amp; privacy by default in practice</strong></p>



<p>The principles of privacy by design and privacy by default require the controller to consider data protection at the system design stage and to use default settings that minimize the scope of data processing. In practice, this means that AI influencer mechanisms must be appropriately designed to limit interference with user privacy.</p>



<p><a></a><strong>Tailoring content to users and GDPR</strong></p>



<p>Content customization, or profiling, in accordance with Article 4(4) of the GDPR, is a particularly important element of AI influencer marketing activities. It should be assumed that the use of data regarding user preferences, behavior , or location to personalize messages requires meeting certain legal requirements, often including obtaining explicit consent. In the context of Article 22 of the GDPR, consideration should also be given to whether automated decision-making is taking place that produces legal effects or significantly affects a natural person in a similar manner.</p>



<p><a></a><strong>CJEU case law and the use of cookies</strong></p>



<p>In this regard, the judgment of the Court of Justice of the European Union in Case C-673/17 (Planet49) is particularly significant. It should be assumed that consent to the use of cookies must be expressed actively and knowingly, and the use of pre-selected consent is inadmissible. This ruling is fundamental to marketing practice, including activities carried out using AI influencers , as it confirms the need to obtain real, prior user consent for tracking and profiling activities.</p>



<p><a></a><strong>Law and ethics</strong></p>



<p>From an ethical perspective, however, considered in the context of legal norms, it is necessary to point out the growing importance of the so-called dark web issue. patterns and consumer manipulation. In light of applicable regulations, it should be assumed that designing interfaces or messages in a way that induces users to make decisions they otherwise would not have made may be classified as unfair market practices. In the case of AI influencers , this risk is particularly significant due to the ability to precisely tailor the message to the recipient&#8217;s psychological profile.</p>



<p><a></a><strong>The problem of AI and copyright</strong></p>



<p>In the field of intellectual property law, it should be assumed that protection is granted only to manifestations of human creative activity. Content generated solely by AI generally does not constitute a work under copyright law, unless the human exercised sufficiently significant control over the creative process to constitute individual creative input. In practice, this leads to the search for alternative forms of protection, such as trade secrets.</p>



<p>At the same time, the risk of violating third-party rights, including copyright and image rights, must be considered. Generating content that resembles existing works or real people may result in liability for damages under the terms of civil law and the Copyright and Related Rights Act.</p>



<p><a></a><strong>NIS2 and risk management obligations</strong></p>



<p>Additionally, the obligations arising from the NIS2 Directive should be noted, which focus on risk management, supply chain security, and ensuring system continuity. In the context of AI influencers, this means implementing appropriate security procedures, monitoring vulnerabilities, and developing incident response mechanisms. This directive places the burden of responsibility on the entrepreneur generating content via an AI influencer.</p>



<p><a></a>Summary</p>



<p>The use of AI influencers in business requires compliance with various legal regulations, including consumer law, personal data protection, artificial intelligence regulations, and civil law. Current mechanisms are applicable to AI influencer activities , but in an era of constantly evolving technologies and the ever-increasing importance of social marketing, it can be expected that AI influencer activities will also require new solutions.</p>



<p><a></a>Bibliography:</p>



<p>Regulation (EU) 2024/1689 of the European Parliament and of the Council (AI Act )</p>



<p>Regulation (EU) 2016/679 of the European Parliament and of the Council (GDPR)</p>



<p>Directive 2005/29/EC on unfair commercial practices</p>



<p>NIS2 Directive (Directive (EU) 2022/2555)</p>



<p>Act of 23 August 2007 on Counteracting Unfair Market Practices</p>



<p>Act of 16 April 1993 on Combating Unfair Competition</p>



<p>Act of 30 May 2014 on consumer rights</p>



<p>Act of 4 February 1994 on copyright and related rights</p>



<p>Civil Code</p>



<p>Planet49 judgment (C ‑ 673/17) of the Court of Justice of the European Union – regarding consent to cookies and direct marketing</p>



<p>Guidelines for labeling advertising content in social media issued by the Office of Competition and Consumer Protection</p>



<p>Decisions of the President of the Office of Competition and Consumer Protection regarding influencer marketing and surreptitious advertising (the body&#8217;s judicial practice, including cases concerning the lack of marking of commercial cooperation)</p>



<p>European Data Protection Board (EDPB) – Guidelines on Profiling and Automated Decision-Making</p>



<p>#AI #ArtificialIntelligence #AIAct #GDPR #InfluencerMarketing #LegalTech #Compliance #ConsumerProtection #Copyright #DataProtection #DigitalMarketing #TechnologyLaw #RiskManagement #NIS2 #EUlaw</p>
<p> </p>



<p>Can an AI influencer be held legally accountable? Not directly — but the businesses and creators behind them certainly can.</p>



<p>As AI-generated personas become a powerful tool in marketing, they also raise important legal questions around transparency, advertising disclosures, GDPR compliance, copyright, and the new obligations introduced by the EU AI Act.</p>



<p>In my latest article, I explore:<br>• who bears responsibility for AI influencers<br>• what regulatory requirements apply<br>• the legal risks companies should address before launching virtual brand ambassadors</p>



<p>AI influencers may not have legal personality, but entrepreneurs using them remain fully responsible for the content they generate and publish.</p>



<p>The article also discusses:<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> AI Act transparency obligations<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> misleading commercial practices and hidden advertising<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> GDPR and profiling risks<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> copyright and image rights issues<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> consumer protection requirements<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> NIS2 and cybersecurity obligations<br><img src="https://s.w.org/images/core/emoji/15.0.3/72x72/2714.png" alt="✔" class="wp-smiley" style="height: 1em; max-height: 1em;" /> ethical concerns related to manipulation and dark patterns</p>



<p>As AI-driven marketing evolves faster than regulation, businesses must ensure that innovation goes hand in hand with legal compliance and consumer trust.</p>



<p>If your company is already using AI to engage consumers — or plans to — this is a topic you cannot afford to ignore.</p>



<p>#AI #ArtificialIntelligence #AIAct #GDPR #LegalTech #Compliance #InfluencerMarketing #ConsumerProtection #Copyright #DataProtection #DigitalMarketing #TechnologyLaw #RiskManagement #NIS2 #EULaw #AIGovernance #AICompliance #CyberSecurity #Privacy #AdvertisingLaw #ContentCreators #VirtualInfluencers #EmergingTech #BusinessLaw #Innovation</p>
<p> </p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/it-new-technologies-media-and-communication-technology-law/ai-influencer-in-the-light-of-the-law-scope-of-responsibility-regulatory-obligations-and-legal-risks/">AI Influencer in the light of the law &#8211; scope of responsibility, regulatory obligations and legal risks</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>Resignation of the sole member of the management board of a limited liability company in Poland</title>
		<link>https://www.kg-legal.eu/info/cross-border-cases/resignation-of-the-sole-member-of-the-management-board-of-a-limited-liability-company-in-poland/</link>
					<comments>https://www.kg-legal.eu/info/cross-border-cases/resignation-of-the-sole-member-of-the-management-board-of-a-limited-liability-company-in-poland/#respond</comments>
		
		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Mon, 11 May 2026 18:59:38 +0000</pubDate>
				<category><![CDATA[CROSS BORDER CASES]]></category>
		<category><![CDATA[limited liability company]]></category>
		<category><![CDATA[Poland]]></category>
		<category><![CDATA[Resignation]]></category>
		<guid isPermaLink="false">https://www.kg-legal.eu/?p=8763</guid>

					<description><![CDATA[<p>Publication date: May 11, 2026 Resignation from the management board of a limited liability company is permissible at any time, regardless of the term of office. Therefore, a sole management board member is not obligated to serve until the end of their term and may terminate their position earlier either through their own resignation or [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/cross-border-cases/resignation-of-the-sole-member-of-the-management-board-of-a-limited-liability-company-in-poland/">Resignation of the sole member of the management board of a limited liability company in Poland</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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<p><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color"><strong>Publication date: May 11, 2026</strong></mark></p>



<p>Resignation from the management board of a limited liability company is permissible at any time, regardless of the term of office. Therefore, a sole management board member is not obligated to serve until the end of their term and may terminate their position earlier either through their own resignation or through dismissal by the relevant body. Each of these options leads to the expiry of their mandate, but they differ significantly in terms of procedure and practical consequences.</p>



<span id="more-8763"></span>



<p><strong>Legal nature of resignation</strong></p>



<p>Resignation from the management board constitutes a unilateral legal act. Its effectiveness does not depend on the consent or any action of the shareholder or the company. This is based on Article 202 § 5 of the Commercial Companies Code, which refers to the provisions of the Civil Code on termination of an assignment. The mandate holder may terminate the assignment at any time, and the declaration becomes effective upon the addressee having had the opportunity to become familiar with its content, as stipulated in Article 61 § 1 of the Civil Code. Therefore, the mandate expires by operation of law at the time specified by law, not only upon entry in the National Court Register. An entry in the register is solely declaratory in nature, confirming the existing legal status, but does not create it. Its absence does not affect the effectiveness of the resignation, although it may cause practical difficulties in relations with contractors and institutions.</p>



<p><strong>Special procedure for the resignation of the sole member of the management board of a limited liability company</strong></p>



<p>Article 201 § 2 of the Commercial Companies Code allows for the management board of a limited liability company to consist of one person. This is a dispositive provision, meaning that the company agreement may provide otherwise and, for example, require a larger number of management board members. Therefore, before taking any action, the content of the specific company agreement in this regard should be verified.</p>



<p>If the sole member of the management board resigns, no management board seat would be filled after their departure. The legislature anticipated this situation by introducing a separate procedure in Article 202 § 6 of the Commercial Companies Code. According to this procedure, the resignation is submitted to the shareholders, convening a shareholders&#8217; meeting. The resignation statement should be included in the invitation to the meeting or delivered to the shareholders together with the notice of its convening. The meeting is convened by registered mail, courier, or email (if the shareholder has previously consented in writing), sent at least two weeks before the shareholders&#8217; meeting. The procedure in such a case should be as follows:</p>



<p>1/ The member of the management board shall submit a declaration of resignation to the shareholders, and not to another body of the company, e.g. the supervisory board (if established in the company&#8217;s articles of association) or to a commercial proxy, if one has been appointed in the company.</p>



<p>2/ At the same time, it convenes a shareholders&#8217; meeting two weeks before the planned meeting, attaching the text of the resignation declaration to the invitation.</p>



<p>3/ The resignation becomes effective on the day following the date for which the meeting was convened. This occurs regardless of whether the meeting actually takes place or whether the shareholders adopt any resolutions.</p>



<p>4/ The effectiveness of the resignation does not depend on the shareholder&#8217;s participation in the meeting, the adoption of the resolution or the consent to the resignation.</p>



<p>5/ A subsequent entry in the National Court Register is of a declaratory nature and confirms the existing situation, but does not condition the effectiveness of the resignation.</p>



<p><strong>Who is the proper addressee of the declaration of resignation?</strong></p>



<p>A resignation declaration must be submitted to the shareholders, as they are the entities authorized to appoint and dismiss management board members. It cannot be submitted to the company as a whole, to the sole proxy (if appointed), as this is not the entity authorized to receive such declarations on behalf of the shareholder or the shareholders&#8217; meeting. Ineffective submission of the declaration, for example, to the wrong addressee, has no legal consequences. In such a case, the management board member&#8217;s mandate does not expire, and the person formally remains on the management board.</p>



<p><strong>The company with one shareholder</strong></p>



<p>In the case of a single-member company, i.e., one in which all shares are held by a single shareholder, convening a shareholders&#8217; meeting is formal. A physical meeting is not required. It is sufficient for the sole shareholder to receive notice of the meeting along with the content of the resignation declaration, as, pursuant to Article 156 of the Commercial Companies Code, in a single-member company, the powers of the shareholders&#8217; meeting are exercised independently by the sole shareholder. Therefore, there is no need to organize a formal meeting, as delivering the declaration in a manner that allows for review of its content is sufficient. However, for evidentiary purposes, it is recommended to document this action in writing. Proper delivery of the declaration to the shareholder is crucial. In practice, it is recommended to deliver it in a manner that allows for proof of this fact, e.g., by registered mail with acknowledgment of receipt, courier, or electronic means with acknowledgment of receipt. Proper delivery is a necessary condition for assessing the effectiveness of the resignation and its effective date.</p>



<p>The procedure is as follows:</p>



<p>1/ The member of the management board sends a declaration of resignation to the shareholder when convening the shareholders&#8217; meeting;</p>



<p>2/ Because the company has a single shareholder, there is no need to formally convene a shareholders&#8217; meeting. The sole shareholder exercises the powers of the shareholders&#8217; meeting independently.</p>



<p>3/ The resignation becomes effective on the day following the day for which the meeting was called, even though it does not have to be formally held.</p>



<p>4/ A subsequent entry in the National Court Register is of a declaratory nature and confirms the existing situation, but does not condition the effectiveness of the resignation.</p>



<p><strong>Can a company function after the resignation of the sole member of the management board?</strong></p>



<p>The resignation of the sole member of the management board leads to a situation in which no mandate on the management board is filled. This situation is referred to in legal doctrine as a &#8220;hull body.&#8221; A company without a management board, and therefore a representative body, generally cannot effectively enter into contracts, incur obligations, or sign documents requiring management board representation. However, Polish law permits a company to temporarily operate without a management board, provided that an independent commercial proxy is present. Commercial power of attorney does not automatically expire upon the dismissal or resignation of the management board, as Article 109 § 7 of the Civil Code enumerates the instances in which commercial power of attorney expires, and the absence of a management board is not one of them. This view is also reflected in the case law of the Supreme Court and in rulings of the Supreme Administrative Court, for example, in judgment V CZ 26/16.</p>



<p>An independent commercial proxy may, therefore, temporarily represent the company and manage its day-to-day affairs. However, this situation should be purely temporary. A commercial proxy acts within a limited scope; for example, they cannot sign the company&#8217;s financial statements, which can result in serious consequences for failing to submit financial statements for the financial year, such as dissolution of the company without liquidation proceedings if the financial statements are not submitted for two consecutive years. They also cannot grant a special power of attorney for actions that require it (sale or encumbrance of real estate, sale of an enterprise), as these actions are reserved by law exclusively for the management board. Such company representation may also pose a risk of suspension of proceedings, as common courts have varying views on this issue, with some courts suspending proceedings ex officio under Article 174 § 1 item 2 of the Code of Civil Procedure, considering the lack of a management board to be a deficiency that prevents the company from operating, as evidenced by opposing rulings by the District Court in Bydgoszcz, case file VIII Gz 218/19, and the Court of Appeal in Poznań, case file III AUz207/22. Moreover, a long-term lack of management may negatively impact the company&#8217;s credibility in the eyes of business partners, who may refuse to enter into contracts with a company represented solely by an independent proxy, fearing for the entity&#8217;s stability.</p>



<p><strong>Deletion of a management board member by the registry court and vacancy in the management board</strong></p>



<p>The registry court will remove a management board member from the National Court Register (KRS) based on a submitted application, even if the company does not yet have a new management board. As mentioned earlier, an entry in the National Court Register is declaratory in nature, and the removal of a management board member by the registry court is not a necessary condition for the expiry of their mandate due to resignation. In such a situation, the court cannot refuse to remove a management board member unless the company is in arrears with its financial statements. However, pursuant to Article 24, Section 1a, if the court finds that there is nobody authorized to represent the company or that the body&#8217;s composition is deficient, the court may set a deadline and summon the shareholders to appoint or elect this body, subject to a fine. This initiates enforcement proceedings, in which the court may impose a fine of up to PLN 10,000 on the company&#8217;s shareholders, which may be imposed multiple times up to a total of PLN 1 million. If new management board members are elected, any unpaid fines will be waived. The court may also, as a last resort, waive or discontinue the compulsory decision and initiate proceedings to dissolve the company without liquidation proceedings, provided that the company has no transferable assets or does not conduct actual business.</p>



<p><strong>Cancellation as an alternative to resignation</strong></p>



<p>Besides resignation, another way for a management board member to terminate their position is through dismissal by an authorized body. In a limited liability company, this is generally the shareholders&#8217; meeting, although this authority may be delegated to another body in the company agreement. In a company with a single shareholder, dismissal occurs by a shareholder resolution without convening a formal meeting. This immediately terminates the management board member&#8217;s mandate.</p>



<p>Sources:</p>



<p>P. Pinior, <em>Resignation of a member of a corporate body</em>, ABC.</p>



<p>A. Krokowski, K. Wielgus, <em>Resignation from the mandate by a member of the management board of a limited liability company after the amendment of November 9, 2018</em>, Rejent 2020, No. 5, pp. 65-100.</p>



<p>D. Marciniak, <em>Resignation of the sole member of the management board of a capital company</em>, PPH 2019, no. 12, pp. 52-58.</p>



<p>M. Dumkiewicz [in:] Commercial Companies Code <em>. Updated </em>commentary, Gdańsk 2026.</p>
<p> </p>



<p>Resignation of the sole member of the management board in a Polish limited liability company (sp. z o.o.) is possible at any time, but the procedure is more formalized than in the case of an ordinary board member.</p>



<p>Under Article 202 § 6 of the Commercial Companies Code, the last remaining board member must submit the resignation to the shareholders while simultaneously convening a shareholders’ meeting. The resignation becomes effective on the day following the date for which the meeting was convened — regardless of whether the meeting actually takes place.</p>



<p>Importantly:<br>• resignation is a unilateral legal act,<br>• KRS entry is only declaratory,<br>• incorrect delivery of the resignation may render it ineffective,<br>• a company may temporarily function without a management board if a commercial proxy (prokurent) has been appointed, although this creates significant practical and legal risks.</p>



<p>The issue remains highly relevant in practice, especially in single-shareholder companies and entities facing governance disputes.</p>



<p>#CorporateLaw #Poland #CompanyLaw #ManagementBoard #Resignation #SpZoo #CommercialLaw #KRS #Governance #PolishLaw</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/cross-border-cases/resignation-of-the-sole-member-of-the-management-board-of-a-limited-liability-company-in-poland/">Resignation of the sole member of the management board of a limited liability company in Poland</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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		<title>Legal Alert: Advising an AI-Powered Software as a Medical Device Developer on Clinical Investigation Agreements and Grant-Funded Innovation</title>
		<link>https://www.kg-legal.eu/info/kg-legal-news/legal-alert-advising-an-ai-powered-software-as-a-medical-device-developer-on-clinical-investigation-agreements-and-grant-funded-innovation/</link>
					<comments>https://www.kg-legal.eu/info/kg-legal-news/legal-alert-advising-an-ai-powered-software-as-a-medical-device-developer-on-clinical-investigation-agreements-and-grant-funded-innovation/#respond</comments>
		
		<dc:creator><![CDATA[jakub]]></dc:creator>
		<pubDate>Mon, 11 May 2026 18:33:13 +0000</pubDate>
				<category><![CDATA[KG LEGAL NEWS]]></category>
		<category><![CDATA[AI-Powered]]></category>
		<category><![CDATA[LegalAlert]]></category>
		<guid isPermaLink="false">https://www.kg-legal.eu/?p=8758</guid>

					<description><![CDATA[<p>Publication date: May 11, 2026 We recently advised a Polish medtech company developing an innovative artificial intelligence-powered Software as a Medical Device (SaMD) designed to support early detection of cardiovascular disease based on standard electrocardiogram (ECG) recordings. The client is developing software that performs automated analysis of resting ECG data and generates additional diagnostic insights [&#8230;]</p>
<p>Artykuł <a href="https://www.kg-legal.eu/info/kg-legal-news/legal-alert-advising-an-ai-powered-software-as-a-medical-device-developer-on-clinical-investigation-agreements-and-grant-funded-innovation/">Legal Alert: Advising an AI-Powered Software as a Medical Device Developer on Clinical Investigation Agreements and Grant-Funded Innovation</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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<p><strong><mark style="background-color:rgba(0, 0, 0, 0)" class="has-inline-color has-vivid-cyan-blue-color">Publication date: May 11, 2026</mark></strong></p>



<p>We recently advised a Polish medtech company developing an innovative artificial intelligence-powered Software as a Medical Device (SaMD) designed to support early detection of cardiovascular disease based on standard electrocardiogram (ECG) recordings.</p>



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="785" src="https://www.kg-legal.eu/wp-content/uploads/2026/05/legal-alert-1024x785.png" alt="" class="wp-image-8759" srcset="https://www.kg-legal.eu/wp-content/uploads/2026/05/legal-alert-1024x785.png 1024w, https://www.kg-legal.eu/wp-content/uploads/2026/05/legal-alert-300x230.png 300w, https://www.kg-legal.eu/wp-content/uploads/2026/05/legal-alert-768x588.png 768w, https://www.kg-legal.eu/wp-content/uploads/2026/05/legal-alert-1536x1177.png 1536w, https://www.kg-legal.eu/wp-content/uploads/2026/05/legal-alert-2048x1569.png 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>



<p>The client is developing software that performs automated analysis of resting ECG data and generates additional diagnostic insights for physicians. While the patient experience remains identical to a standard ECG examination, the software applies advanced signal processing and AI-driven analytics to extract significantly more information from the underlying electrical activity of the heart. The current version is intended for use in clinical settings, while a next-generation solution is being developed for home use, enabling remote screening and telemedicine-based monitoring.</p>



<span id="more-8758"></span>



<p><strong>Grant Funding and Project Scope</strong></p>



<p>The company obtained substantial non-dilutive funding under the SMART Pathway programme (Ścieżka SMART), financed through the European Funds for a Modern Economy programme and administered by the Polish Agency for Enterprise Development (PARP). The project is planned over a 36-month period and includes research and development activities, software engineering, regulatory certification, and a clinical investigation designed to validate the product’s use in home settings.</p>



<p>The grant financing enabled the company to expand its multidisciplinary team, including software engineers, clinicians, and regulatory specialists, and to accelerate product development and market preparation. According to the company, the funding has also created an opportunity to scale internationally following commercialization.</p>



<p><strong>Why the Technology Is Innovative</strong></p>



<p>The software represents a significant advancement in digital cardiology. Traditional ECG interpretation is based on a two-dimensional representation of cardiac electrical activity. By contrast, the client’s technology uses a proprietary analytical method that evaluates cardiac signals in a four-dimensional framework—capturing both spatial and temporal characteristics of myocardial activation.</p>



<p>The AI layer integrates this signal analysis with additional clinical data, such as patient history and supplementary diagnostic findings, to identify subtle abnormalities that may indicate elevated risk of future cardiovascular events, including myocardial infarction or heart failure.</p>



<p>This approach has the potential to:</p>



<ul class="wp-block-list">
<li>improve early detection of coronary artery disease and heart failure;</li>



<li>support population-level cardiovascular screening;</li>



<li>enable home-based diagnostic assessments;</li>



<li>reduce pressure on healthcare systems by prioritizing high-risk patients; and</li>



<li>enhance physicians’ diagnostic capabilities with automated decision support.</li>
</ul>



<p>The company ultimately envisions a model in which patients can perform ECG tests at home using a dedicated device and smartphone application, with data transmitted to a telemedicine centre for automated analysis and clinical review.</p>



<p><strong>Regulatory and Clinical Investigation Considerations</strong></p>



<p>As an AI-enabled medical device intended to support clinical decision-making, the software is subject to the EU Medical Devices Regulation (EU) 2017/745 (MDR). The product is undergoing conformity assessment and certification under the current MDR framework.</p>



<p>A key component of the funded project is a clinical investigation involving patients who will use the software in home settings. ECG recordings will be transmitted to a collaborating medical centre, where they will be analysed using the client’s software to assess the reliability, safety, and usability of the home-use model.</p>



<p><strong>Our Legal Support</strong></p>



<p>We advised the client on the preparation and negotiation of the clinical investigation agreement with the healthcare institution participating in the study.</p>



<p>This work included legal support on:</p>



<ul class="wp-block-list">
<li>allocation of responsibilities between the sponsor and the investigation site;</li>



<li>compliance with MDR requirements governing clinical investigations;</li>



<li>patient data processing and GDPR compliance;</li>



<li>ownership and use rights relating to clinical data and study results;</li>



<li>confidentiality and protection of proprietary algorithms;</li>



<li>insurance and liability arrangements;</li>



<li>publication rights; and</li>



<li>termination and post-study obligations.</li>
</ul>



<p>Particular attention was given to the contractual treatment of software-generated data and outputs, including rights to use clinical datasets for algorithm refinement and future regulatory submissions.</p>



<p><strong>Key Legal Challenges for AI-Based SaMD Companies</strong></p>



<p>The project illustrates several legal issues that are increasingly relevant for AI-enabled medtech businesses:</p>



<p><strong>1. Clinical Evidence Generation</strong></p>



<p>AI-based software must be supported by robust clinical evidence demonstrating safety and performance. Well-structured agreements with clinical partners are essential to secure access to data and ensure regulatory compliance.</p>



<p><strong>2. Data Governance</strong></p>



<p>Training and validating machine-learning models requires clear legal rights to process and reuse patient data while maintaining compliance with GDPR and ethical standards.</p>



<p><strong>3. Intellectual Property Protection</strong></p>



<p>Clinical collaborations should safeguard ownership of proprietary algorithms, software, and derivative models, while addressing rights to jointly generated study data.</p>



<p><strong>4. Grant Compliance</strong></p>



<p>Projects funded through public programmes involve specific contractual obligations relating to eligible costs, milestones, reporting, and dissemination.</p>



<p><strong>5. Transition to Home Use</strong></p>



<p>Moving from physician-supervised use to direct-to-consumer or home-based deployment raises additional regulatory and liability considerations, including usability, cybersecurity, and telemedicine integration.</p>



<p><strong>Conclusion</strong></p>



<p>This engagement highlights the legal and regulatory complexity involved in bringing AI-driven Software as a Medical Device solutions to market. The combination of innovative signal analysis, artificial intelligence, telemedicine, and grant-funded R&amp;D creates significant opportunities, but also requires careful legal structuring at every stage of development.</p>



<p>Our support helped the client establish a compliant contractual framework for its clinical investigation, enabling it to generate the evidence necessary to advance certification and prepare for commercialization in Poland and international markets.</p>
<p> </p>



<p></p>


<p>Artykuł <a href="https://www.kg-legal.eu/info/kg-legal-news/legal-alert-advising-an-ai-powered-software-as-a-medical-device-developer-on-clinical-investigation-agreements-and-grant-funded-innovation/">Legal Alert: Advising an AI-Powered Software as a Medical Device Developer on Clinical Investigation Agreements and Grant-Funded Innovation</a> pochodzi z serwisu <a href="https://www.kg-legal.eu">KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019</a>.</p>
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