“THE MOST EXPENSIVE PREVENTION IS ALSO CHEAPER THAN THE CHEAPEST TREATMENT” – LEGAL REGULATIONS FOR REPORTING PERFORMANCE TESTS OF A MEDICAL DEVICE FOR IN VITRO DIAGNOSTICS
Publication date: April 17, 2024
Medical devices for in vitro diagnostics.
In vitro diagnostic medical devices are intended for testing samples taken from the human body. This test is carried out outside the human body (in vitro) in laboratory conditions, as well as at home, in the case of products intended for self-testing. In accordance with the definition contained in Art. 2 point 2 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ EU, L. of 2017, No. 117, p. 176, as amended) (hereinafter: IVDR) medical device is a device that is a reagent, reagent product, calibrator, control material, kit, tool, instrument, hardware, software or system, whether used individually or in combination, intended by the manufacturer to be used in vitro for the examination of samples obtained from the human body, including blood and tissue obtained from donors, solely or principally for the purpose of providing information:
- about a process, physiological or disease state;
- congenital physical or mental developmental defect;
- predisposition to disease or illness;
- to determine safety and compatibility with potential recipients;
- to predict response or responses to treatment;
- to determine or monitor therapeutic activities.
ARTIFICIAL INTELLIGENCE IN CLINICAL TRIALS – PRACTICAL AND LEGAL ASPECTS
Publication date: April 16, 2024
Artificial intelligence (AI) is a field of science that deals with the creation and use of computer systems that can simulate human cognitive processes, such as learning, reasoning, decision-making and problem solving. AI has an increasing impact on various aspects of our lives, including medicine and health. This article will discuss how AI changes clinical trials, i.e. the process of testing new drugs and therapies on humans before they are approved for marketing and use.
Application of AI in clinical trials
Few comments on Pseudo-anonymisation: secret key encryption, hash function, hash function with key, deterministic encryption and tokenization
Publication date: April 16, 2024
In the light of the GDPR, the principles of data protection do not apply to data whose links between personal data and the persons concerned have been irreversibly removed. Consequently, anonymization is not subject to the provisions of the GDPR Regulation. However, the measure that the GDPR directly indicates as a method of data protection is pseudo-anonymization. In this case, personal data is replaced in such a way that with the use of appropriate information it is possible to identify the persons to whom data relates.
Next Generation virtual worlds – what opportunities may they bring? Human-Machine Interaction, Extended reality, digital twinning.
Publication date: April 16, 2024
For now, it is quite obvious, that advanced technology such as virtual worlds and metaverses is bringing a lot of opportunities in various fields. Education, health, manufacturing are only a few examples, where the technology of virtual worlds may be applied. To understand better the deeper meaning within these opportunities, it is worth to get to know how these developments will affect human-machine and human-human interactions.
Human-machine interaction
Next generation virtual worlds will connect various types of technologies – augmented and extended reality (VR, AR and XR) with digital twin and blockchain. These connections will formulate new types for the development of immersive environments interconnected with the real world. In this context, things such as Human-Machine Interaction (HMI), cognitive psychology and brain sciences are trying to understand how humans interact with and within the immersive environments and how those interactions impact human behaviour in both virtual and real worlds. Existing research indicates that virtual worlds have ability to change the way we connect, perceive and experience the world around us. Research in HMI includes two aspects: the interaction of the user with the interface and the impact of this process on the user’s behaviour. When it comes to virtual worlds, this process becomes more complex. The human experience associates not only with the virtual, real-time, multisensory interactions in realistic immersive simulations of the environment but also with the hybrid social environments such as AI-powered human-likes avatars.
