POLAND Law and Practice Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
There is also the the ‘black box’ problem. This is where the operation of an algorithm is difficult to understand and explain, and it is unclear exactly how the AI reached its conclusions (Article 72 of the AI Act). 1.3 Market Trends The main market trends in healthcare AI in Poland are: • Generative AI: Time-saving virtual assistants are using large language models (LLMs) to organise clinical notes and simplify how patient information is communicated between teams. • Simplifying complex diagnostics with AI: Cardiac CT scanning is easier to use, making it accessible to more facilities, providing better cardiac care to more patients. • Surgery using AI tools: Minimally invasive proce - dures are increasingly replacing traditional open surgery. • Tele-ultrasound: Telemedicine capabilities allow sonographers and patients in remote locations to connect virtually to discuss ultrasound results in real time. 2. Legal Framework for Healthcare AI 2.1 Regulatory Definition and Classification of Healthcare AI Healthcare AI systems should be explained starting from the basic definition of an AI system introduced by the AI Act. According to Article 3 of the AI Act, an AI system is “a machine-based system that is designed to operate with varying degrees of autonomy and that may exhibit adaptive capabilities after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments”. Importantly, AI systems are classified in terms of risk, which, according to Article 3 of the AI Act, is a com - bination of the probability of harm and its severity. The classification distinguishes four risk levels: unac - ceptable, high, limited and minimal. Any AI system deemed to pose a clear threat to human safety, liveli - hoods or rights is prohibited as an unacceptable risk.
Polish national legislation does not define AI in health - care per se. The AI Act does not directly regulate AI systems in healthcare, but it does include them under its umbrella if they meet certain criteria, for example, the criteria to be classified as high-risk systems. If an AI system qualifies as a medical device, Regulation (EU) 2017/745 (Medical Devices Regulation, MDR) and Regulation (EU) 2017/746 (In Vitro Diagnostic Medical Devices Regulation, IVDR) also apply, which are subject to harmonisation with the AI Act. In the context of data processing by such systems, data protection regulations are relevant, in particular Regulation (EU) 2016/679 (General Data Protection Regulation, GDPR), Regulation (EU) 2023/2854 (Data Act), Regulation (EU) 2022/868 (Data Governance Act) and the NIS Directives. The Clinical Trials Regu - lation (Regulation (EU) 536/2014) does not directly address AI, but it remains in effect in relation to clini - cal research. The European Health Data Space (EHDS) Regulation (Regulation (EU) 2025/327) also plays an important role, facilitating the secondary use of health data for research and innovation. From a regulatory perspective, the classification of AI systems in the healthcare sector depends primarily on their intended use and risk level under the MDR and the AI Act. Diagnostic and therapeutic systems, if they have a medical purpose, can be considered medical devices under the MDR. They are then clas - sified into one of four risk classes (I, IIa, IIb, III, where I is the lowest risk) (Article 51 (1) of the MDR), and only those deemed to belong to Class IIa or higher, requir - ing third-party conformity assessment, are considered The substantive regulatory core governing healthcare AI in the Polish jurisdiction is the AI Act, which will enter into force in Poland on 2 August 2026, although some provisions, including the general ones establish - ing, for example, the statutory definition of “AI sys - tem”, entered into force on 2 February 2025, while the regulatory portion applies from 2 August 2025, such as the classification of AI models set out in Chapter V of the AI Act. high-risk AI systems under the AI Act. 2.2 Key Laws and Regulations
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