POLAND Law and Practice Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
be established under the proposed Polish Act on Arti - ficial Intelligence Systems.
toring. Essential logs include usage timestamps, input data checks, and personnel involved in result verification, where applicable. • A requirement has been introduced to prepare a supervision system that will enable a human to control the AI system if necessary, in order to prevent and minimise risks to health, safety and fundamental rights. • Risk assessment under the AI Act should identify and analyse potential risks to health, safety or fun - damental rights, estimate and evaluate these risks, and adopt measures to manage them. • Bias is addressed in Article 15 in relation to sys - tems that continue to learn after being introduced to the market or put into service. They should be developed in such a way as to eliminate or miti - gate, to the greatest extent possible, the risk of potentially biased results influencing the input data used for future operations. • In terms of algorithmic transparency, the EHDS will facilitate non-discriminatory access to health data and the training of AI algorithms on these datasets in a secure, timely, transparent, reliable and priva - cy-preserving manner, with appropriate institutional governance. 3.3 Post-Market Surveillance The AI Act focuses on key obligations regarding AI systems, including in relation to: • post-market monitoring; • information exchange and sharing; and • market surveillance. Under the MDR, all medical device manufacturers are required to conduct post-market surveillance. This includes establishing a risk management system and a system for reporting incidents and field safety cor - rective actions. AI systems used in healthcare, as high-risk systems, are subject to mandatory post-market surveillance (Article 72 (2)). Active collection and analysis of real- world data is required, including – where relevant – the system’s interactions with other AI systems. Addition - ally, monitoring should ensure ongoing assessment of the system’s compliance with regulations. All activi -
3. Regulatory Oversight of Healthcare AI 3.1 Regulatory Authorities Under current Polish law, no dedicated institution has been established to oversee the use of AI in Poland. However, the Polish state intends to adopt legislation that will implement the AI Act by regulating more gen - eral issues related to the AI market itself. According to the draft Polish law on AI systems, the AI market oversight body will be an entirely new entity called the Commission for the Development and Security of Artificial Intelligence, which will also address health - care AI. A certain safety brake in the context of supervision is introduced by the Polish Code of Medical Ethics, which in Article 12 provides that a physician may use AI algorithms in diagnostic, therapeutic or preventive procedures, but, among other things, on condition of informing the patient that AI will be used in the diagno - sis or therapeutic process and ensuring that the final diagnostic and therapeutic decision is always made by the physician. The President of the Personal Data Protection Office will also be responsible for overseeing the AI market. Their responsibilities will include overseeing high-risk artificial intelligence systems (listed in Annex III to the AI systems related to healthcare are classified as high-risk AI systems in the AI Act. This classification is important for manufacturers, importers and distribu - tors of, and entities using, AI systems. This triggers obligations under both the AI Act and the MDR: • Record keeping – Providers must ensure high-risk AI systems have automated logging throughout their lifecycle, capturing events for system trace - ability, risk identification and post-market moni - AI Act), including in healthcare. 3.2 Pre-Market Requirements
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