Germany

On 5 December 2025, the Act Transposing the NIS 2 Directive and Regulating Key Aspects of Information Security Management in the Federal Administration (Gesetz zur Umsetzung der NIS-2-Richtlinie und zur Regelung wesentlicher Grundzüge des Informationssicherheitsmanagements in der Bundesverwaltung (“NIS2UmsG”) (see here, in German only) became binding in Germany. According to the Federal Office for Information Security (Bundesamt für Sicherheit in der Informationstechnik (“BSI”) (see here, in German only), roughly 29,500 companies will have to comply with the increased cybersecurity requirements adopted by the NIS2UmsG.Continue Reading Germany Transposes NIS 2 Directive – Increased Cybersecurity Requirements for Businesses

On December 4, 2025, the German Federal Government published its Federal Modernization Agenda, setting out a series of suggested amendments to the GDPR and the Federal Data Protection Act (Bundesdatenschutzgesetz). Among the key measures, Germany seeks to shift certain responsibilities from users to manufacturers and providers of standard IT products—following the model of the Cyber Resilience Act (CRA) and the AI Act—so that organizations can deploy standard solutions more easily and in compliance with the law.

The German Data Protection Conference (Datenschutzkonferenz, DSK)—the body of federal and state data protection authorities—has adopted a resolution strongly supporting this approach. The resolution builds on recommendations the DSK first made in its 2019 evaluation of the GDPR.Continue Reading German Government Proposes GDPR Reform to Shift Responsibility to Manufacturers

By December 9, 2026, all EU Member States must update their product liability laws to align with the (new) Product Liability Directive (EU) 2024/2853 (“PLD”). The PLD imposes liability on manufacturers of products (and other relevant parties) for harm caused by defective products, regardless of fault. The PLD modernizes the current EU product liability framework and renders the framework more claimant-friendly (see our previous blog post). It is expected to lead to an increase in claims, primarily as a result of the following changes:Continue Reading EU Member States Begin Rolling Out New Product Liability Rules

On September 17, 2025, the German Supervisory Authorities (Konferenz der unabhängigen Datenschutzaufsichtsbehörden des Bundes und der Länder, DSK) published new guidelines and recommendations addressing the complex requirements for transferring personal data, particularly health data (including health data contained in biomaterials), to countries outside of the European Economic…

Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research

On 31 July 2024, the German Higher Regional Court of Munich (OLG München) delivered a judgment providing key insights into the repercussions board members may encounter for violating the General Data Protection Regulation (GDPR). Although the primary legal question centered around the legality of an executive’s dismissal under German corporate and employment law, the court’s decision was heavily influenced by its determination that the executive had prompted the company to engage in unlawful data processing, thereby breaching the GDPR. This blog post highlights the essential facts of the case and the court’s findings regarding the data protection issues involved.Continue Reading German Court Upholds Board Member’s Dismissal For GDPR Breach

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog…

Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

On February 7, 2024, the German Federal Cabinet approved a draft law (“the Draft Law”) amending the Federal Data Protection Act (“BDSG”).  The Draft Law will now go to the Bundesrat (the legislative body that represents the sixteen Länder (federated states) of Germany at the federal level ) for its opinion and then to the Bundestag (the federal parliament) for discussion and, potentially, adoption.Continue Reading German Government Proposes to Amend Federal Data Protection Act

Digital health apps are increasingly used in practice. They raise various questions under regulatory and data protection and data security laws. On November 6, 2023, the German Conference of the Independent Data Protection Supervisory Authorities (Datenschutzkonferenz, DSK), a national body which brings together Germany’s federal and regional data protection authorities, issued a paper about the GDPR’s application to cloud-based digital health applications (“health apps”) that are not subject to the German Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung, the “DiGA Regulation”).Continue Reading German Data Protection Authorities Publish Paper on Cloud-Based Digital Health Applications

On April 27, 2023, the Advocate General (“AG”) of the Court of Justice of the European Union (“CJEU”) issued its opinion in the case C-807/21 on the conditions for imposing GDPR fines on legal persons (e.g., companies).  He opined that Member States’ law may not stipulate conditions going beyond those set out in the GDPR that make it more difficult to impute GDPR infringements to companies.  In addition, he is of the opinion that the GDPR penalties may only be imposed on intentional or negligent conducts, since the GDPR does not provide for a strict liability (no fault) system.Continue Reading CJEU’s Advocate General Issues Opinion on GDPR Fines Against Companies