On September 11th, we had the pleasure of participating in an event organized by LifeScience Cluster on the application of artificial intelligence in healthcare. The webinar began with an explanation of the very concept of AI, which is controversial and riddled with myths. A key element of AI is machine learning. It involves creating predictions based on previous data. Within machine learning, deep learning, a model based on neural networks, was developed. The difference between traditional machine learning and deep learning lies primarily in the number of neural network layers. These enable the recognition of increasingly complex relationships. The concept of data science, which lies between artificial intelligence and data analysis, was also mentioned. It is the art of combining data with practice. This allows for the automation of many processes and better decision-making.

The discussion focused on generative AI – a class of AI systems that can create new content, data, or results that are not specifically programmed into them. These systems use techniques to generate realistic and contextually relevant information, often mimicking human creativity in tasks such as creating images, generating text, or even composing music.

An interesting question has been posed: “Will we ever run out of data?” While this seems impossible, it is a real problem. Using synthetic data could be a solution, but it is not only complicated but also often inefficient.

Modern healthcare utilizes NLP—a field of artificial intelligence that enables computers to understand and analyze human language. This technology allows programs to interpret text, recognize intentions, and conduct conversations with users. This technology has the potential to create assistants not only for patients, who could consult with them, especially for conditions with specific and recurring symptoms, but also for doctors, thus streamlining healthcare operations. This groundbreaking solution may soon become the answer to today’s problems of an overloaded system.

Artificial intelligence is also used to analyze test results and monitor patient health, thanks to the potential of not only computing power but also modern devices. An example presented during the webinar was devices used to treat neurodegenerative diseases. AI also participates in the development of new drugs – by analyzing a vast number of scientific articles, it checks the occurrence of specific chemical compounds in relation to their uses, then creates mind maps of how a given compound might affect patients based on empirical research.

Undeniably, AI is making increasingly bold inroads into the world of medicine, offering new diagnostic, therapeutic, and organizational capabilities. Machine learning algorithms can analyze medical images with accuracy comparable to, and sometimes even greater than, experienced specialists. In an age of aging populations and overburdened healthcare systems, AI could become a tool that reduces the workload of physicians and accelerates the diagnosis process.

On the other hand, however, many questions arise regarding the legal implications of using such technologies. The Polish legal system, like the laws of many other countries, has not kept pace with the development of artificial intelligence. As a result, a dangerous regulatory gap has emerged, where patient safety and liability for potential errors remain unclear.

Traditionally, liability for medical errors rests with the physician or healthcare facility. Physicians are held professionally, civilly, and in extreme cases, criminally liable. However, the situation becomes more complicated when an artificial intelligence system enters the treatment process. If an algorithm misinterprets an X-ray or CT scan, and the physician bases their decision on this analysis, the question arises: who is actually at fault? Is it the physician who trusted the technology, the software manufacturer who created the flawed system, or perhaps the institution itself that decided to implement it?

An even greater problem is that artificial intelligence is not a static tool. Unlike traditional medical devices, which retain their properties once approved for use, algorithms often learn continuously, modifying their performance based on incoming data. This creates enormous difficulties in the certification and oversight processes. How can a system be verified if it functions completely differently after a month of operation than it did when it was first approved for use?

The discussion about AI in medicine cannot ignore the issue of patient rights. Under data protection regulations in force in Poland and the European Union, health information is considered particularly sensitive. However, to be effective, AI requires vast data sets that allow for learning and algorithm improvement.

The biggest problem, however, lies in the liability of artificial intelligence itself. In the Polish legal system, AI does not and cannot currently have legal personality. It is treated merely as a tool, similar to a stethoscope or ultrasound machine. Meanwhile, its actions increasingly go beyond simple physician support and take the form of autonomous decisions. In practice, this creates a certain “liability vacuum”. Affected patients may have great difficulty determining who to direct their claims to – the doctor, the facility, or perhaps the system manufacturer.

On June 13, 2024, a Regulation of the European Parliament and of the Council, known as the AI Act, was issued, aimed at regulating issues related to the use of artificial intelligence, including in the area of healthcare. The regulation introduces a number of key requirements for AI-based systems. One of these is the obligation to implement a quality management system to ensure that the technology operates in accordance with the highest standards of safety and reliability. The Artificial Intelligence Act adopts a risk-based approach: the higher the risk, the more stringent the regulations. Another crucial element is the requirement for human oversight – AI systems cannot operate fully autonomously but must remain under the control of specialists who can evaluate and verify their decisions.

The AI Act also imposes transparency and disclosure requirements regarding the use of artificial intelligence. This requires the implementation of appropriate technical and organizational measures to ensure that the system operates as intended and that users understand when they are interacting with AI technology.

The regulation also mandates the maintenance of detailed technical documentation regarding AI systems and the reporting of any incidents related to their operation. This will enable ongoing monitoring of the safety and effectiveness of these solutions, which is particularly important in the medical sector, where errors can lead to serious health consequences.

However, the Artificial Intelligence Act does not focus on the individual rights of people affected by AI – such as patients. For example, the right of patients to object to a healthcare professional using an AI system for diagnosis is not included in the regulation. However, Article 85 introduces the right for any natural or legal person—including patients—to file a complaint with a market surveillance authority if they suspect a violation of the AI Act. Furthermore, Article 86 introduces the right to an explanation of the individual decision-making process, which entails the right to obtain from the entity using it a clear and substantive explanation of the role of this AI system in the decision-making procedure and the main elements of the decision taken.

While the regulation does not solve all problems, it represents a significant step toward streamlining the use of AI and increasing patient safety. Will it prove sufficient to resolve the issue of AI liability in medicine? Only the future and practice will tell, once the act is fully implemented.

Artykuł Participation of KG Legal Kiełtyka Gładkowski Law Firm in the webinar ‘Artificial intelligence in medicine – practical applications and the future of healthcare’ pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

On October 28, 2021 KIELTYKA GLADKOWSKI participated in a webinar hosted by the IOE&IT and Digital Trader Services.

From the start of 2022, all British importers will need to complete declarations for imports from the EU. The deadline for transportation inspections, including sanitary inspections of food, animal products and plant-based goods, has been delayed until 2022. Despite this, importers must be prepared to fill out declarations from January 1, 2022.

The webinar therefore explained the new timeline for import controls and what this means for traders. Experts provided practical advice about what traders can do to prepare for these changes.

The webinar covered the following topics:

• The customs controls and checks that are being introduced on 1 January 2022
• The requirement to use the new Goods Vehicle Movement Service (GVMS) and how this works
• When pre-notification and health certification will be introduced for agri-foods and steps traders can take
• When physical checks will be introduced at Border Control Posts.

What is GVMS?

GVMS – Goods Vehicle Movement Service is a new IT platform established by HMRC. It is available at certain ports for faster clearance of goods with pre-lodged declarations. GVMS is used for the operation of digital transit offices. When a transit consignment enters a country, transit regulations require the goods to be presented at a customs office of transit at the border. GVMS-linked ports provide the Office of Transit function “digitally”. Thanks to this lorries do not have to physically pass through a transit office. The GVMS links the Movement Reference Numbers (MRNs) for all pre-submitted declarations in a consignment to a single Goods Movement Record (GMR) that identifies the truck/trailer license plates. Each GMR contains details of a single journey by a single vehicle and can be used only once. The transporter needs only to present the GMR to the carrier at the border to prove that all his goods have pre-declarations. From 2022 this system will be extended to movements between GB and EU on both imports and exports via certain GB RoRo port locations.

The system is estimated to need to process 400 million customs declarations per year.

Physical checks at Border Control Posts

The new requirements for Export Health Certificates, which were due to be introduced on 1 October 2021, will now be introduced on 1 July 2022. Requirements for pre-notification of agri-food imports will not be introduced until January 2022, while requirements for safety and security declarations, export health certificates, and physical checks on most agri-food goods will not be in place until July 2022. This is due to the pressures businesses face in dealing with the coronavirus pandemic and Brexit simultaneously, and because the UK government still has work to do in preparation for changes.

The topics discussed at the webinar will help our lawyers at KIELTYKA GLADKOWSKI to provide targeted and effective legal assistance in cross border commercial and transport cases.

Sources:

What you need to know about Goods Vehicle Movement Service (GVMS) (customs4trade.com)

Goods Vehicle Movement Service (GVMS) | Descartes

Registration (gotowebinar.com)

Government sets out pragmatic new timetable for introducing border controls – GOV.UK (www.gov.uk)

UK further delays border control checks on EU food imports – Food Safety News

The GB–EU border   | The Institute for Government

https://en.wikipedia.org/wiki/Goods_Vehicle_Movement_Service

Artykuł KIELTYKA GLADKOWSKI TOOK PART IN IOE&IT WEBINAR ABOUT KIELTYKA GLADKOWSKI TOOK PART IN IOE&IT WEBINAR ABOUT TRADING WITH POLAND AND THE UK UNDER THE UK-EU AGREEMENT – NEW CUSTOMS RULES UNDER THE UK-EU AGREEMENT – NEW CUSTOMS RULES pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Artykuł KG Legal participated in the webinar “European Funds for the cooperation of entrepreneurs and scientists” pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Moreover, the judgment and infringements of the intellectual property rights were discussed.

Artykuł KG Legal participated in the webinar “Intellectual Property Law” pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Artykuł “Company Law” – webinarium pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The webinar was prepared for in-house lawyers, law firm partners, investors and stakeholders in the legal, IP, tech and outsourcing industries.

The seminar involved the key issues of legal ethics, managing smart litigation budgets, big data and the digitized legal practice, global developments in cyber security and risk management, as well as competition law challenges and common challenges which GCs can face while managing small legal teams and lean budgets.

The organisers of the seminar drew attention to the fact that nowadays, GCs of global companies are required not only to provide day-to-day legal advice for businesses, but they are also helping executive and corporate boards with coming up with strategies for overall business stability and profitability. To achieve that goal they need to stay in touch with every new regulatory development and mitigate the emerging legal risks in diversified and changing jurisdictions. All that takes place while taking care of legal budgets management.

The speakers shared their personal experience on that matter and the insights on various problems that may occur in this area.

Artykuł KG Legal participated in an online seminar about multi-purpose legal departments and about effective navigation in an ever-changing business world pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.