top of page
The EUDR Is Also Coming for Medical Devices
Regulation (EU) 2023/1115 (EUDR) has been in force since 2023. The obligations set out in the Regulation will begin to apply on December 30 of this year. The key is to determine whether a specific product is subject to the obligations under the EUDR—that is, whether the product is among the relevant products listed in Annex I. This assessment can be the most challenging part in practice. As in many other cases, there are numerous exceptions to consider here as well.

Markéta Hrubá
3 days ago


Telemedicine in the Czech Republic: Innovation at a Crossroads
Telemedicine and remote care are pilot projects no more. Instead they turned into themes, that could transform availability and organization of health services. Technologies evolved with the experience of providers and attempts at creating a stable framework for their usage. Nevertheless, a number of questions remain unresolved. Mainly legislative definition of telemedicine service, its funding, assessment of its health-economic benefits, and the status of software and other

Aleš Martinovský
4 days ago


Cybersecurity Regulation in Healthcare II
In the previous issue of the Newsletter, we described how digitalisation is transforming healthcare, the associated security risks, and how the CSA, the CRA and the new Cybersecurity Act differ from one another. It is now appropriate to examine their practical implications: the obligations they impose on MD manufacturers, suppliers of associated digital products and healthcare providers, and the rights or claims that healthcare facilities may, in turn, assert against manufact

Markéta Hrubá
Jul 31


"ZUM" Has Become the Prime Minister’s Top Priority in Healthcare
Throughout June, not only specialized healthcare media but also the mainstream media reported in detail that Prime Minister Andrej Babiš was sending letters to Health Minister Adam Vojtěch, in which he strongly urged the implementation of numerous legislative and executive measures intended to stabilize the situation in the healthcare sector. Somewhat surprisingly, this has brought into the spotlight the legislative framework for reimbursement regulation of separately billed

Jakub Král
Jul 22


Cybersecurity Regulations in Healthcare
Securing sensitive patient data and ensuring the reliability of life-saving equipment have become absolute priorities, as any vulnerability can have fatal consequences. The EU and the Czech Republic are therefore building a strong defensive shield through legislative measures: the Cybersecurity Act (CSA), the Cybersecurity Resilience Act (CRA), and the national Cybersecurity Act (ZoKB), which complement one another, despite having different objectives.

Markéta Hrubá
Jun 29


bottom of page