POLAND Law and Practice Contributed by: Barbara Kiełtyka, Jakub Gładkowski and Małgorzata Kiełtyka, Kieltyka Gladkowski KG Legal
in medical procedures of varying degrees of com - plexity. Therefore, intellectual property protection is a multi-layer issue, not an issue only in the context of industrial property law, including patent protection, because software, even in a trained model, is subject to copyright. Computer programs, are not considered inventions. Yet, the exclusion of a computer program from patent - ability applies only to the extent that the European patent application or European patent concerns the computer program itself. A computer program is not technical in nature, and therefore is not unpatented technical knowledge and does not merit patenting. Therefore, the so-called technical test can be applied: where the invention (and thus grounds for patentabil - ity) manifests itself in the use. This is so-called protection based on the principle of producing a further technical effect and applies to computer-implemented inventions. Therefore, each case should be approached individually, an example being the European patent for an innovative method of predicting the growth of microorganisms using AI. 7.2 Copyright and Trade Secrets Applications of healthcare AI systems rely on software and trained computational operations performed on data. Therefore, in addition to the traditional under - standing of invention as a patentable subject, AI sys - tems are protected as software, for which copyright law in Poland has special provisions similar to those in force. This concerns a specific chapter in Polish copyright law dedicated to the legal status of soft - ware. These provisions apply the same legal principles to software as they do to artistic works. Legal struc - tures designed to protect authors of artistic works also apply to software code. The problem is that machine learning and AI are not a closed system of codes (AI is not a closed, complete binary system). Legislators and lawyers therefore assume that a dedicated IP pro - tection law for AI will be created in a few years.. Protection can be granted to both the computer pro - gram itself and its source code and algorithms, pro - vided they do not constitute merely an idea and are not excluded from protection based on exceptions.
The definition of a trade secret is provided in the Polish Act on Combating Unfair Competition and is understood to include technical, technological and organisational information about a company, or other information of economic value. Potentially, the out - puts generated by an AI system could also be covered by trade secrets law, thus protecting something that otherwise could be copied or distributed as it is not covered by copyright under a separate regime. 7.3 Ownership of AI Outputs The results of AI systems based on software and computational operations on data using algorithms to process them are assessed first from the level of copyright protection, and only then from the level of invention and patent protection as computer-imple - mented inventions in class C2 according to the Euro - pean Patent Office. Only a human can be considered a creator under cop - yright law. This means that the outputs generated by an AI system based on collected data, training on that data, and queries entered into the system are likely not subject to copyright protection because they are not the result of creative, intellectual human work, even though human work occurred in earlier stages and may even have been predominant. A trained AI system used for a specific medical pro - cedure, such as cancer diagnosis, is a medical device whose outputs are an element of the execution of a specific medical procedure. The status of such data is therefore identical to the ownership of operational data belonging to a medical institution and covered by patient data protection regulations. The status of such data, therefore, clearly differs, in being data produced by the practical operation of a device within a medical institution and used for specific medical procedures, from the status of the AI system when it is made avail - able for medical purposes. Therefore, this fact cre - ates the need for IP clauses in contracts to cover this issue with a mutual obligation relationship between the entity using the high-risk AI system and the entity marketing or commissioning such an AI system, for example, within the framework of a specific medical device and end-user licence.
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