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EU | JRC Warns Biological AI Is Advancing Faster Than Its Real-World Readiness — Strong Performance Does Not Yet Mean Models Are Ready for Clinical Use

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EU | JRC Warns Biological AI Is Advancing Faster Than Its Real-World Readiness — Strong Performance Does Not Yet Mean Models Are Ready for Clinical Use2026-09-12T16:40:21+00:00

EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications

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EU | Article 50 AI Transparency Requirements Now Apply — Human Review Exception Important for RWR Publications2026-09-12T15:27:59+00:00

EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing

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EU | Digital Omnibus Resets High-Risk AI Timelines and Expands Rules for Bias and Real-World Testing2026-09-12T15:23:35+00:00

USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence

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USA | FDA Explores GenAI Medical Device Framework — RWD Could Shape Premarket and Postmarket Evidence2026-09-12T14:52:08+00:00

CANADA | CDA Sets Expectations for AI-Generated RWE — Human Oversight, Validation and Transparency Required

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CANADA | CDA Sets Expectations for AI-Generated RWE — Human Oversight, Validation and Transparency Required2026-09-12T11:47:27+00:00

EU | HTACG Sets AI Transparency Expectations for JCA Dossiers — Human Oversight, Tool Disclosure and Prompt Records Required

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EU | HTACG Sets AI Transparency Expectations for JCA Dossiers — Human Oversight, Tool Disclosure and Prompt Records Required2026-08-10T17:01:33+00:00

UK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme

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UK | MHRA Publishes National Commission Findings on Public and Stakeholder Views of AI in Healthcare — Safety, Trust, Transparency and Lifecycle Oversight Emerge as Central Theme2026-07-03T10:54:43+00:00

NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality

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NORWAY | Helsedirektoratet and Normen Publish Guidance on Safe Use of AI for Healthcare Documentation — Reinforcing Human Oversight, Information Security and Source Data Quality2026-07-03T10:48:13+00:00

EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle

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EU | EMA Publishes 2025 AI Observatory Report — AI Moves From Regulatory Concept to Practical Implementation Across the Medicines Lifecycle2026-07-03T10:10:25+00:00
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