Healthcare AI 2025

POLAND Law and Practice Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal

2.3 Approval and Certification Processes In the commercial healthcare market, developers of AI systems in healthcare will primarily need to adhere to the regulatory approval and certification requirements for medical device marketing procedures. These apply when an AI system is introduced into the Polish mar - ket with a declared intended use as a medical device. Because an item of medical software can belong to various classes of medical device depending on its function and the risk it poses to the patient, the developer, as the responsible entity, will be subject to the relevant conformity assessment rules of the MDR, depending on the declared classification of the AI Software as a Medical Device (SaMD) into Class I, IIa, IIb or III. This will be the case when the AI system is intended for use in a medical device as a treatment or standard diagnostic tool. In the case of in vitro diagnostics, the classification path indicated in the IVDR will apply. In the context of requirements for evidence of safety and effectiveness, an item of software, including an AI system, must obtain a CE mark before being placed on the market, and the product must be marked with it by the manufacturer alone or with the involvement of a notified body. Therefore, the speed of the path for certain AI applications will depend on the need for a notified body to participate in the certification process. 2.4 Software as a Medical Device (SaMD) The source of regulation for AI-based software depends on the declared intended use of the device: • For SaMD intended for treatment or diagnosis without in vitro procedures, the source of regula - tory obligations is the MDR and Polish acts sup - plementing the functioning of the healthcare sector administration (for example, the Polish act supple - menting the clinical trials procedure, if the clinical evaluation requires such supplementary action for a specific SaMD before market introduction, as not every clinical evaluation of a SaMD requires such action). • The IVDR is a specific regulation for SaMD intend - ed for in vitro diagnostic procedures.

MDR The MDR contains a definition of a medical device that confirms that software can also be a medical device. It also contains rules for the marketing of medical devices and identifies the authorities responsible for overseeing the compliance of medical devices with the MDR. According to the MDR, a medical device may include software, provided that the manufacturer has intended the software for use with humans for at least one of the specific medical purposes indicated in the MDR. In Poland, the regulation is supplemented by the Act of 7 April 2022 on medical devices. The EHDS Regulation aims to establish a common framework for the use and exchange of electronic health data across the EU and sets forth rules for training, testing and evaluation of algorithms, includ - ing those used in medical devices. GDPR The GDPR regulates data processing, including the circumstances in which data can be used to train AI, and it contains a definition of sensitive data. Work on a draft Polish Act on Artificial Intelligence Systems is currently under way, the developer of which is the Polish Ministry of Digital Affairs. The 2025 amendment to the Polish Code of Medi - cal Ethics regulates issues related to the use of AI in medicine, stipulating the need to ensure that the algorithms used are approved for use and certified. It is essential to inform the patient about the possibility of AI being used and to obtain their informed consent. The Polish Act on Medical Activity of 15 April 2011 defines the legal framework for medical facilities and health service providers, including the principles underlying the use of information technology and AI to diagnose and treat patients. Soft law, for example, the Health Care Artificial Intel - ligence Code of Conduct of the National Academy of Medicine, can provide an element of guidance for healthcare professionals and AI systems developers.

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