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ARIHQ v. Santé Québec: Québec Cour Supérieure hebt Schiedsspruch wegen halluzinierender KI auf
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
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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.
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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.
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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.
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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
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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.
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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.
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Haftung: Gesamtschuld vs. Teilschuld | Folge 10
BIS-Regeln für Connected Vehicles Technologien in den USA – Herausforderung für global agierende Automotive-Unternehmen mit China-Nexus
Restriktionen für „chinesische“ Fahrzeugtechnologien in den USA – Worum geht’s?
#9: Tokenisation Unlocked: A Glimpse into the Future of Financial Markets
EHDS implementation: preparing for health data access and reuse
EHDS implementation has begun. For life sciences companies, the key issue is how controlled access to health data, secondary use, AI training and data protection governance will work in practice – and what should be prepared before 2029.
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