Articles for the ‘Healthcare’ Category

Significant Turnaround in Russian Antitrust Practice of Protecting the Exclusivity of Drugs

Published 01 November 2024 by Boris Malakhov Lidings, Russia

Despite the fact that the issue of intellectual property rights turnover is included in the perimeter of antimonopoly regulation, until recently the Russian Antitrust Agency took rather an observant position.

The regulator’s position was that the issue of patent infringement is a private legal dispute between original and generic manufacturers, which should not affect the turnover of drugs, particularly the execution of contracts based on the results of public procurement. Only in isolated cases the Russian Antitrust Agency has established the fact of patent infringement and issued a corresponding order on the inadmissibility of anti-competitive practices.

Now the reverse trend has clearly emerged.

More in our update.

... Read more

AI in Health Care

Published 04 June 2024 by Maarten SchutMaarten Schut Kennedy van der Laan Kennedy Van der Laan, The Netherlands

We cannot imagine life without AI anymore. The health care world too makes increasing use of AI. In this fact sheet we will describe in broad outline what care providers should pay attention to when purchasing and using AI from a health care law perspective. We will also give tips and recommendations for good use.

... Read more

Webinar: The interplay of the Medical Device Regulation, AI and data protection in medical technology

Published 28 May 2024 by Dr. Oliver Stöckel SKW Schwarz, Germany

In the dynamic world of medical technology, it is essential to always be aware of the latest regulatory requirements. The introduction of the AI Act poses new legal challenges for medtech companies when using AI.

In addition, the requirements of the MDR and data protection must still be complied with, particularly with regard to the handling of sensitive health data. But how exactly does the “magic triangle” of MDR, AI Act and data protection work in medical technology?

Using practical examples we will answer this question and would like to invite you to our free webinar (in German language):

“The interplay of the Medical Device Regulation, AI and data protection in medical technology”
on Thursday, June 13, 2024
from 12:30 – 13:30
via MS Teams

Register for free today and benefit from our in-depth knowledge and expertise in the field of digital health: to the registration

... Read more

The advertising of medical devices in Austria

Published 05 February 2024 by Francine Brogyányi DORDA Rechtsanwälte GmbH, Austria

In every jurisdiction the advertising of medical devices comes with certain national peculiarities. The following article explains in more detail what needs to be considered if you intend to market medical devices to the Austrian market

... Read more

EU Court of Justice: Parallel importer may not remove PPP batch number

Published 22 January 2024 by Philippe de Jong ALTIUS Lawyers, Belgium

This blog post mainly focuses on the CJEU’s findings regarding the responsibility of parallel importers for ensuring the display of the original batch number on the product packaging.

... Read more