Health Data and the GDPR in Workplace Chats: When a Diagnosis Becomes “Information for Everyone”

A WhatsApp group for scheduling shifts, an annoyed comment about covering someone’s shift, and, right in the middle of it all, the diagnosis of a sick coworker: The Siegburg Labor Court views this as a violation of the GDPR that justifies an injunction and damages. The defendant must personally pay 1,000 euros, because a chat group does not become private simply because it was created as a private group.

Health Data and the GDPR in Workplace Chats: When a Diagnosis Becomes “Information for Everyone”2026-08-24T10:21:46+02:00

Product Liability for Medical Devices: An Overview of the New Law

The new Product Liability Act tightens product liability requirements for software used in medical devices. The more digital systems continue to learn or receive updates after they are placed on the market, the more important the question becomes: development risk or manufacturer control? It is precisely this distinction that will determine liability for medical devices in the future.

Product Liability for Medical Devices: An Overview of the New Law2026-08-24T10:36:01+02:00

The End of Article 82 of the MDR? Why AI and Software Are Now Taking Center Stage

The planned deletion of Article 82 of the MDR could have far-reaching consequences for software and AI in drug trials. The more digital systems evaluate clinical endpoints or generate evidence, the more important the question becomes: Is it an investigational device or an investigational product? It is precisely this distinction that could become the central regulatory challenge in the future.

The End of Article 82 of the MDR? Why AI and Software Are Now Taking Center Stage2026-08-31T17:24:42+02:00

The right to treatment with artificial intelligence and access to smart medical devices – potential challenges

The rapid advances in artificial intelligence and the entry into force of the DigiG are promoting the integration of intelligent medical devices into healthcare by making diagnostics, therapy and assistance systems more efficient and at the same time improving access and reimbursement of digital applications.

The right to treatment with artificial intelligence and access to smart medical devices – potential challenges2026-04-17T14:08:18+02:00

Cyber Resilience Act, medical devices and the AI Act – An integrated perspective on cybersecurity and AI in the healthcare industry

With the Cyber Resilience Act (CRA) and the upcoming AI Act, the EU is setting new requirements for IT security and the use of artificial intelligence (AI). These regulations play a central role, particularly in the area of digital healthcare products, which include connected medical devices. The new regulations set standards that require an integrated safety strategy in order to make innovations such as AI in medicine safe and compliant.

Cyber Resilience Act, medical devices and the AI Act – An integrated perspective on cybersecurity and AI in the healthcare industry2026-08-31T17:46:20+02:00

Artificial intelligence and cybersecurity in the light of MDR

The European legal framework, including the Medical Device Regulation ("MDR") and the soon to come into force AI Regulation ("AI Regulation"), places strict requirements on the safety and performance of AI-based medical devices. The relationship between the Medical Device Regulation and the AI Regulation is characterized by supplementary certification requirements: While the MDR regulates the safety and performance of physical medical devices, the AI Regulation addresses specific risks and the data integrity of AI systems. Products that fall under both sets of regulations must meet the requirements of both regulations in order to be certified, which provides a double safety guarantee for both physical and software-related safety.

Artificial intelligence and cybersecurity in the light of MDR2026-08-31T17:33:59+02:00
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