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Upgraded diagnostic medical device with AI software module for prognostic purposes – legal status in the EU – is it still the same medical device?

Artificial intelligence (AI) used in medical devices

Artificial intelligence (AI) technologies are being used more and more boldly in areas that until now were reserved exclusively for humans. They are mainly used in decision-making, image analysis, speech, or natural languages analysis. These systems involve creating models of intelligent behaviour that can be used in computer programs and solve problems that cannot be solved using standard classical algorithms. This requires large amounts of data through which AI applications learn patterns and features that predict the output. This makes them different from classical algorithms, which have predefined rules and which AI creates on its own based on data provided to it. In medical devices AI causes operational speeding up of mechanisms and analysis of particular cases.

Artificial intelligence in medical diagnosis and prognosis

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KIELTYKA GLADKOWSKI KG LEGAL will participate in “Healthtronics EU-Israel bridge”

On 27 January 2022 there will take place the event “Healthtronics EU – Israel bridge”, organized by LifeScience Cluster Krakow, which will be attended by partners from KG LEGAL. The meeting is aimed at establishing cooperation between Polish, European and Israeli entities within the framework of a virtual business mission and their familiarisation with the health sector in the European Union countries and Israel. In addition, it aims to broaden the horizons of the high-tech industry, provide practical knowledge on the commercialisation of products and inspire projects in the field of health and biotechnology. The meeting will discuss topics related to value chains in the health sector, the e-health ecosystem in Israel and the Israeli medical device sector. During the meeting, a three-hour networking event is planned for representatives of companies from the European Union countries and Israel, who will have the opportunity to present themselves during the meeting and establish contacts between each other. Companies such as ARANET, BIO-T, BORN, PERCEPTUS, DARWIN BIOMEDICAL, TYTOCARE, VIRUSIGHT, VITALERTER, YSIUM MEDICAL, ZAYA ARTIFICIAL INTELLIGENCE will participate in the meeting.

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KIELTYKA GLADKOWSKI KG LEGAL ATTENDED THE LEGAL500 VIRTUAL ROUNDTABLE ON POST-MERGER INTEGRATION AFTER THE PANDEMIC

The event was attended by US-based general counsels, heads of legal and legal directors in the corporate/M&A field. Together with the Lex Mundi, the participants discussed how the emerging post-Covid regulatory landscape suggests that corporate legal teams will have more influence than ever over integration.

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THE PROCEDURES OF BIOBANKS WITH BIOLOGICAL MATERIAL (SERUM, BODY FLUIDS, FROZEN CELLS, DNA SAMPLES FROM DONORS)– POLISH LAW IN THE LIGHT OF INTERNATIONAL CASES

In the US, in the context of the case of donor 1558 a legislative initiative has been launched to protect the parents of children conceived using genetic material taken from a donor.

In the case widely discussed in the press, 27-year-old Steven Gunner died of a drug overdose. His biological father was sperm donor number 1558 who according to the biobank’s description, was a brown-eyed student who played guitar and hockey. After the tragedy, Steven’s parents learned that the sperm donor suffered from schizophrenia and died the same way as Steven – from a drug overdose. As a result of their actions, Republican Senator Gallivan introduced a draft legislation to waive the donor’s confidentiality for a period of five years back so their medical records could be checked.

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KIELTYKA GLADKOWSKI ATTENDED THE WEBINAR ORGANISED BY THE LEGAL 500 ON CHILE’S ENVIRONMENT FOR FINTECH STARTUPS

KIELTYKA GLADKOWSKI attended The Legal 500 and Apparcel Uriarte & Vassallo’s webinar ‘Chile: the to-go destination for international fintech startups’.

In this international webinar there were analysed the possibilities that Chile offers as a Latin American hub for international startups and fintechs.

The event explored the reasons that have led the country to become internationally renowned in the development of financial startups, as well as the promising future that lies ahead with the Fintech Bill that is being discussed in Congress. 

The webinar featured the presentation of legal experts from AUV and dLocal, Uruguay’s first unicorn. They presented key aspects such as startups’ softlanding, financial inclusion, open banking and regulation. On this last point, the legal director of the CMF shed light on the advantages that Chile offers for fintech companies, and what these companies should expect in order to successfully operate in Chile.

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