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Open Source in Healthcare and Life Sciences – Legal Framework and Compliance Requirements
Open source in healthcare requires robust compliance and security standards.
Labeling AI-Generated Content – Implementing the Transparency Requirements of the AI Regulation in the Automotive Sector
The UPC’s first referral to the European Court of Justice: Cross-border preliminary injunctions against intermediaries and non-UPC defendants
Hungarian supreme court on legal standing to challenge generic marketing authorisations
Case law – Hungarian Supreme Court (Kúria), precedent-setting judgment of 7 May 2026 – Kfv.37.810/2025/27 – On legal standing to challenge generic marketing authorisations
8 / 9 观点
Case law – VfGH on the eImpfpass and central vaccination register
The Austrian Constitutional Court rejected challenges to the eImpfpass and central vaccination register on procedural grounds. The decision leaves the register in place, but highlights the role of data protection remedies in digital health infrastructure.
6 / 9 观点
The new Product Liability Directive: three life sciences priorities before the 2026 deadline
The new EU Product Liability Directive applies to products placed on the market after 9 December 2026. Three changes call for decisions by life sciences companies now: software and AI as products, an eased burden of proof, and disclosure of internal evidence.
3 / 9 观点
Update: AI-Enabled Medical Devices and IVDs Confirmed as “High-Risk”
Digital Omnibus Update. More time (up to August 2028) yet confirming that AI-enabled medical devices and IVDs stay subject to the AI Act.
4 / 9 观点
Poland’s new AI systems act: a regulator and practical tools
Poland’s new AI systems act builds the national framework for the EU AI Act. A new regulator is introduced, alongside two practical tools.
9 / 9 观点
Medical Cannabis Platforms Breach Advertising Ban
Case law – German Federal Court of Justice (Bundesgerichtshof) – Online platforms brokering medical cannabis treatments breach the prohibition of public advertising under the German Healthcare Advertising Act
7 / 9 观点
France renews its simplified anti-gift conventions – what life sciences companies operating in France need to know
France enforces one of Europe's strictest anti-gift regimes, broadly prohibiting any benefit to healthcare professionals, in particular. Within this framework, simplified conventions offer a practical derogation — allowing companies to bundle hospitality declarations into a single filing. These conventions have just been renewed for another two years, with notable developments: COMIDENT (dental sector) joins as a signatory and a new two-month deadline applies for participant list submissions for certain types of convention.
5 / 9 观点
ARIHQ v. Santé Québec: Québec Superior Court set aside an arbitral award due to hallucinating AI
Tightening of the “BIS Rules” for Connected Vehicle Technologies in the U.S. – Challenge for global Automotive Companies with China-Nexus
Restrictions on “Chinese” vehicle technologies in the U.S. – What’s it about?