POLAND Law and Practice Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
7.4 Licensing and Commercialisation Among the many licensing and commissioning mod - els within the meaning of the AI Act – for example, in connection with the introduction of a specific medi - cal device to the market – the focus should be on Software as a Service (SaaS), on-premise and open- source licence models. It can be concluded that, in practice, medical facilities are more likely to operate under licences based on on-premise software models than SaaS, and other healthcare entities may be more inclined to use cloud solutions. 8. Specific Applications of Healthcare AI 8.1 Clinical Decision Support AI-supported clinical decisions include the obligation to provide the system with patient health data; there - fore, the EHDS Regulation applies. Article 3 stipulates that individuals have the right to access, at a mini - mum, their electronic personal health data processed through electronic data access services. Users of health data must also use data based on and in accordance with appropriate authorisation and co-operate with authorities regarding access to health data (Article 61). The GDPR also applies. Articles 35 and 36 stipulate that if a type of data processing is likely to pose a risk to the rights and freedoms of natu - ral persons, an impact assessment must be carried out. If such an assessment indicates a high risk to these rights, consultation with the relevant supervisory authority is required. AI systems are subject to the following requirements: • maintaining and retaining for the competent nation - al authorities for ten years technical documentation and documentation relating to the quality manage - ment system and the EU declaration of conformity; • registration (Article 49); • CE marking (Article 48); • submitting the system to a compliance procedure (Article 43); and • designing and developing the system in a manner that ensures operational transparency (Article 13).
8.2 Diagnostic Applications Article 12 of the Polish Code of Medical Ethics addresses the use of AI systems in treatment. A phy - sician may use such models in therapeutic, diagnostic or preventive procedures if four conditions are met: • the patient has been informed that AI will be used in the diagnosis or therapeutic process; • he patient has given informed consent to the use of AI; • the AI algorithms have been approved for medical use and have the appropriate certificates; and • the final diagnostic or therapeutic decision has been made by the physician. Apart from the issue of the use of a product approved for marketing in Poland and patient awareness, it should be noted that the medical device will be clas - sified separately depending on whether it is used for conventional diagnosis or for in vitro diagnostic pro - cedures, the regulations regarding which in the latter case will have their source in the IVDR. From a regulatory perspective, marketing such a device before notification requires first meeting standard operational regulatory requirements which are crucial for the entity introducing the device. Con - firmation of compliance with the relevant safety and performance requirements is crucial for the AI algo - rithm. From the perspective of AI algorithm opera - tion, it is crucial that these are normal conditions of intended use of the device and the assessment of adverse events. The most challenging task for AI systems in healthcare is creatively presenting a model at the regulatory level of acceptability of adverse events in the relationship between the benefit of the medical procedure and the risk to the patient within the meaning of Article 61 of the MDR. This is achieved through the so-called complex procedure and documentation of the clinical evaluation of the device. In the case of such devices, the marketing authorisation holder should co-operate with a notified body, which prepares a clinical follow- up plan.
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