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REGULATIONS ON THE USE OF ARTIFICIAL INTELLIGENCE IN DRUG PRODUCTION IN THE UNITED STATES AND THE EUROPEAN UNION – Practical comments on current and expected legal acts, including AI Act and AI Liability Directive

Publication date: November 29, 2024

The importance of artificial intelligence in creating new drugs

Artificial intelligence is increasingly used in research on the search for new drugs. Pharmaceutical companies are investing in AI programs that will allow for the production and introduction of new drugs to the market more efficiently. Studies show that the market for artificial intelligence in the process of discovering new drugs will increase fivefold in 5 years [1]. The efficiency of this technology should also be addressed. Boston Consulting Group has prepared a report on the issue of the number of active molecules discovered by AI [2]. The authors of the review confirmed that thanks to artificial intelligence, a doubling of the overall productivity of pharmaceutical research and development can be expected. It should be remembered, however, that the molecules discovered by AI are still in the testing phase, but the results are satisfactory so far. Due to the growing popularity of using AI in this way, legislators must regulate these issues in generally applicable laws. Lawmakers in the United States and the European Union are introducing new regulations regarding the regulation of AI systems. This may have a significant impact on the production of medical devices and their admission to trade.

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IP Box in Poland: opportunities, controversies and planned changes in tax regulations

Publication date: November 28, 2024

Introduction

The IP Box (Innovation Box) relief is one of the tools introduced to the Polish tax system to support research, development and innovation activities. Since 2019, Polish entrepreneurs, including individuals conducting business activities, can benefit from a preferential tax rate of 5% for income obtained from qualified intellectual property rights. This solution is of particular importance for the dynamically developing IT industry, in which the work of programmers often generates qualified income, for example from copyrights to software.

However, the IP Box relief raises many interpretation controversies, especially in relation to the definition of qualified intellectual property rights and documentation obligations. In practice, taxpayers often encounter difficulties in separating income covered by the relief and meeting the requirements for maintaining detailed records. An additional challenge is the application of the relief in the context of international cooperation, especially in the case of Polish programmers implementing contracts with foreign companies.

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Adequate countries and the processing of sensitive data

Publication date: November 13, 2024

The European Union, issuing Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ EU. L. of 2016, No. 119, p. 1, as amended), commonly known as the GDPR Regulation, had to face the threats resulting from the effects of globalism. It could not limit the processing of personal data only to the borders of Europe, where the GDPR guaranteed strong protection. It had to create a system that could also provide this protection in third countries outside the old continent.

It did so in Chapter V of the regulation, where a number of solutions were found to facilitate the processing of data in third countries and, on the other hand, ensure a high level of protection. The essence of this solution is the institution of “adequate countries”, i.e. those in which the European Commission has found an adequate level of personal data protection. However, the regulation also contains other solutions for situations when we will not be dealing with an adequate country.

European Data Protection Board

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Legal requirements for fintechs dealing with cross-border payments – EU and Polish perspective

Publication date: November 13, 2024

by Łukasz Ruman, KIELTYKA GLADKOWSKI KG LEGAL

Electronic money institution, Payment institution, Small payment institution, Payment services office

In today’s world, conducting financial activities electronically is becoming increasingly popular. Banks are focusing on conducting their activities via the Internet and electronic payments. Companies that conduct their accounting remotely and freely make payments using intangible money do the same.

Technical and IT support for such a large financial industry requires specialized entities. For this purpose, numerous companies have been established that are called “fintech”. The abbreviation comes from the English phrase financial technology. It is used to collectively name programs used to handle finances electronically, but also companies involved in the production and maintenance of such programs.

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Computerization of Legal Work with AI and New Technologies

Publication date: November 04, 2024, by Łukasz Chwałkowski

In the face of dynamic technological development, the legal profession is encountering new opportunities that could significantly alter the way legal services are provided. The computerization of legal work, using artificial intelligence (AI) and new technologies, not only increases efficiency but can also contribute to a more transparent and fairer justice system. Implementing AI in legal practice can offer various benefits:

Monitoring Case Law

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