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.
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Publication date: April 15, 2024
15 new medical professions in Poland – the new act of law entered into force on March 26, 2024. Importantly, work is still underway on the regulation specifying professional activities for individual medical professions, and this is important in the context of employers entrusting the scope of responsibilities to persons performing these new medical professions, such as also the need to ensure the health safety of patients.
New medical professions in Poland – from March 26, 2024.
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Publication date: April 15, 2024
The issue of the right to abortion in Poland is currently a lively topic of political discussions aimed at changing existing regulations in a way that gives women the right to decide about their own body. Currently, attention is focused on four projects (drafts) bringing changes in the analyzed topics:
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Publication date: April 05, 2024
Conversational AI and AI powered video bots for health education
On March 19th 2024 the lawyers of KIELTYKA GLADKOWSKI took part in the workshop devoted to the use of AI in patient engagement.
The workshop focused on the utilization of artificial intelligence (AI) in patient care and was led by Lawrence Byrd, Senior Director of Communications APIs at Vonage. The Vonage company is a global cloud communication leader providing Apps and APIs (such as AI, Video, Voice, SMS, UC, and more) and is a prominent supplier of embedded video for hundreds of global Telehealth innovators. Vonage also assists businesses in stimulating their digital transformation.
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Publication date: April 03, 2024
The sale of a new drug or medical device and clinical trials is a process between two opposing interest groups. On the one hand, it is about patient protection and the safety of the pharmaceutical market. On the other hand, it is about creating a legal environment that will accelerate the creation of new drugs.
Both goals are important. It is important to create the right legal balance. The balance between patient protection and facilitation of modern medicines and medical devices makes Europe attractive for locating new innovations in technology and creating new medicines and medical devices.
Placing legal priorities in creating law is a political compromise between the speed of producing a new drug and blocking innovation justified by patient safety.
The attractiveness of Europe for the pharmaceutical business compared to other global markets depends on the proper placement of priorities.
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