EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research GalleryEU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research
2025, AI, Cvbersecurity, Data Privacy and Data Protection, EHDS, EU, Expert Insights, Members-Only, Minor Update, October 2025
EU | Cybersecurity and Medical Device Rules Converge — What NIS2 Means for MDR, IVDR, AI Act, EHDS, and Real-World Research
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UK | MHRA Selects Next-Phase AI Tools with Potential to Detect Diseases Earlier
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EU | TEHDAS2 Opens Public Consultation on Health Data Access Guidelines — Paving the Way for EHDS Implementation
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EU | European Commission Issues Draft Guidance on Serious AI Incidents — Implications for Real-World Research
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GLOBAL | ICH Adopts Revised Guideline on Post-Approval Safety Data – ICH E2D(R1)
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EU | EMA Proposes New Standards for Patient Experience Data Across the Medicine Lifecycle
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BRAZIL | Decree No. 12,651 (2025) Establishes the National System of Ethics in Research with Human Beings
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EU | European Medicines Agencies Network Data Strategy Prioritises Real-World Data Integration
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CANADA | Health Canada Update Guidance on Expanded Access Clinical Trials
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