POLAND Trends and Developments Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
their tasks, digital health authorities should co-operate in particular with the supervisory authorities estab - lished under Regulation (EU) 2016/679 and with the supervisory authorities established under Regulation (EU) 910/2014. Digital health authorities may also co- operate with the European Artificial Intelligence Board established by the AI Act, the Medical Device Coor - dination Group established by the MDR and IVDR, the European Data Innovation Board established in accordance with Regulation (EU) 2022/868, and com - petent authorities under Regulation (EU) 2023/2854. Member States should enable the participation of national entities in EU-level co-operation, so they can provide expertise and advice on the design of solu - tions necessary to achieve the objectives of the EHDS. Therefore, at both the EU and national levels, Member States, including Poland, must adapt existing insti - tutions or create new ones that will help implement the precepts arising from the above-mentioned legal acts. Article 65 of the AI Act established the European Artificial Intelligence Board, a key advisory body com - posed of representatives from each Member State, supported by the AI Office. The Board’s primary role is to ensure the effective implementation of the AI Act across the EU by co-ordinating the activities of national authorities, sharing technical and regulatory expertise, and advising on AI policy, innovation and international partnerships. Its goal is to foster a coher - ent and forward-looking AI policy framework that ben - efits all EU citizens while maintaining high standards of safety and ethics. The Medical Device Coordination Group was intro - duced under the MDR and IVDR, and its purpose is to co-ordinate the implementation of these regulations. Furthermore, a European Data Innovation Board will be established to support the European Commission in implementing existing EU legislation, programmes and policies. At the national level, the Ministry of Health is support - ed by the e-Health Centre, which manages healthcare organisation and protection and supports the man - agement decisions of the Minister of Health based on analyses that have been conducted. The Centre is also responsible for monitoring the planning, construction
and operation of IT systems at the central and regional levels. Additionally, a Polish draft bill on AI systems is currently being developed, which aims to introduce the AI Act into the national legal system. In Poland, the authority responsible for market surveillance will most likely be a Commission for the Development and Security of Artificial Intelligence. It is also proposed to designate the Minister of Digital Affairs as the authority responsible for the notification of conformity assess - ment bodies and the notifying authority – that is, the authority responsible for developing and applying the procedures necessary for assessing, designating and notifying bodies that assess the conformity of AI sys - tems, as well as for monitoring them. Matters related to accreditation will be entrusted to the Polish Centre for Accreditation based on the provisions of the Act of 13 April 2016 on conformity assessment and market surveillance systems. AI Models in Healthcare AI is one of the most important trends driving change in the healthcare sector. AI systems are presently used primarily in diagnostics, personalising treatment and organising healthcare. The largest percentage of healthcare providers say they use AI in diagnostics, for example, diagnostic imaging to detect pathologi - cal changes. Telemedicine solutions and chatbots are also gaining in popularity. Furthermore, AI systems are being used in surgical robotics, for example, da Vinci robots assist surgeons through advanced AI sys - tems that provide automatic support and feedback. In the context of medical administration, AI supports the automation of processes for healthcare organisa - tions. Data organisation through AI systems also facili - tates personalised medicine, where genetic data and patients’ medical histories are subject to computer- aided analysis. AI is also finding its way into home use, for example, in watches, rings and smart endoscopic capsule mechanisms. Although these offer health monitoring functions, they are not considered medi - cal devices in Poland. In the EU, AI is seen as a tool that supports humans, not replaces them. The goal is to build a world of aug - mented human intelligence, where humans remain at the helm. The EU’s approach is based on supporting research and industrial development while protecting
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