Partners of KIELTYKA GLADKOWSKI KG LEGAL are honoured to be appointed as speakers at the annual Conference of the American Bar Association International Law Section that will take place in Washington DC, USA between MAY 7–10, 2024.

The panel discussion is devoted to Developing & Delivering A Cure: Legal and Regulatory Opportunities & Obstacles For Global New Life Sciences & Health Care Products.

Malgorzata Kieltyka and Jakub Gladkowski as panelist covering the EU area will analyze legal, regulatory and practical problems and new opportunities for legal development and delivery of modern life science products to global markets.

The lawyers of KIELTYKA GLADKOWSKI KG LEGAL will focus on new technologies in medicinal products and medical devices, large language models, machine learning, artificial intelligence, generative intelligence, more efficient chemical synthesis routes, selection of molecules and isolation of entities with the greatest potential, teams of advanced algorithms, and cheminformatics libraries.

The aim of our lawyers is to point at legal challenges of this area, like liability for data, algorithms as medical devices, data hallucination, biased algorithms, pre-trained data models.

The program will analyze an interdisciplinary legal problem at the intersection of pharmaceutical and medical law as well as technological and data protection law solutions complementing the practical approach of modern materials, polymer and software engineering procedures.

When modern functionality lies on the border between diagnostics and the treatment process, the legal trade in medical equipment, as in the case of medicines, requires the design of product documentation and testing through a formalized clinical trials process in terms of both medical and ethical properties.

The legal introduction of a modern AI devices to the market for medical procedures that predicts future disease in a healthy patient in a probable time horizon depends, among other things, on the answer to the question whether, on legal grounds, predicting disease in healthy patients is still a diagnosis or perhaps conservative treatment? It is also an interdisciplinary legal problem at the intersection of pharmaceutical and medical law, as well as technological and data protection law solutions, complementing the practical approach of modern materials, polymer and software engineering procedures. The "life of the product" is followed by legal responsibility for the effect of operation of the device, and this legal effect applies to all jurisdictions.

For panelists from European Union destinations, the point of reference for the discussion is the legal assessment and legal status of modern technologies in medicine, the modern functionality of which lies on the border between diagnosis and the treatment process. Legal trade in medical equipment, as in the case of medicines, requires the design of product documentation and testing through a formalized clinical examination process in terms of both medical and ethical properties. In the case of additional product elements in the form of software and AI, there are also problems with the protection of data processed during procedures.

The progression of disease predictability in a healthy person over a long time horizon is a phenomenon possible thanks to the most modern medical devices using AI and processing large amounts of data. When predicting a disease with a high degree of probability, we are not dealing with a classic patient. This is not a case of pure diagnosis, i.e. an assessment of whether the patient is healthy, cured or sick. In such a case, we are dealing with a special type of prevention, which in a broader context should be confronted with the treatment process.

The medical market in the European Union is subject to strict regulation because it is required by the particular rationality of the safety of the object of protection - human health. This has a direct impact on the shape of the regulatory environment, the architecture of which focuses on the main axis of division:

1/ medical devices for diagnostics

2/ medical devices for treatment

3/ medicinal products.

Therefore, it is important to locate new medical devices within the current legal status and to properly assess the status of such devices so that they can be properly included in the appropriate framework for the legalization of a medical device.

Our lawyers aim in the presentation to answer the question of how competitive the European jurisdiction is for conducting clinical trials on diagnostic medical devices by recapitulating the basic assumptions of conducting clinical trials.

The panel discussion will also cover aspects of:

•  use of AI to improve R&D productivity;
• use of AI and gen AI to predict the 3-D structure of molecules;
• liability for AI and data;
• Real-World Evidence (RWE) - defined as clinical evidence regarding the use and potential benefits or risks of a medical product derived from the analysis of real-world data;
• Good clinical practice;
• supplemental new drug applications (sNDA);
• legal aspects of use of AI in clinical trials;
• specific challenges (obstacles) and selected incentives and simplifications in clinical trials in Europe.
• interplay between the Clinical Trials Regulation and the General Data Protection Regulation.
• Adapting to the new EU Data Act: implications for medical devices and other health devices.