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.

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.

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.