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

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.

Artificial intelligence (AI) is no longer just a dream of distant future. As a recently published national survey by the Ministry of Health has shown, modern algorithms are gradually becoming a common feature in Czech hospitals and outpatient clinics. Practical experience clearly demonstrates enormous potential for streamlining care; however, experts also caution against blind enthusiasm. The use of uncertified generative models can pose safety risks to both patients and the

The EU has adopted Regulation (EU) 2023/2854 on data (Data Act). The aim is to create a uniform framework for fair and secure sharing of data from connected devices and digital services, strengthen user rights, and promote innovation across sectors. The Data Act will also have a significant impact on healthcare, particularly on medical devices that collect and transmit data on their use or on the patient's health status.