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.
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New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical Research
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 Area for scientific research purposes under the GDPR. These guidelines may be of particular relevance for pharmaceutical, medical device, and other life sciences companies that conduct clinical research.
Continue Reading New German Guidelines on GDPR Requirements for International Transfers of Health Data in Medical ResearchGerman Supervisory Authorities Publish Paper on Scientific Research and Data Protection
The German Conference of Independent Supervisory Authorities (“DSK”) published on March 23, 2022 a statement on scientific research and data protection (see here, in German). The DSK published the statement in response to the German Government’s initiative on a general law on research data as part of
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