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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 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

GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data

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GLOBAL | ICH E6(R3) Annex 2 Reaches Step 4 — Final GCP Guidance Adopted for Trials Using Decentralised Elements, Pragmatic Approaches and Real-World Data2026-07-03T10:42:54+00:00

EU | First Public JCA Outputs Show How the HTA Regulation Is Changing Evidence Expectations for Oncology Medicines

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EU | First Public JCA Outputs Show How the HTA Regulation Is Changing Evidence Expectations for Oncology Medicines2026-07-03T10:08:49+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

UK | HRA Publishes Two-Year Plan to Support Safe AI-Powered Innovation in Health and Social Care Research

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UK | HRA Publishes Two-Year Plan to Support Safe AI-Powered Innovation in Health and Social Care Research2026-06-12T11:37:14+00:00

UK | NICE Reports Major Shift Away From SABA-Only Asthma Treatment — More Than One Million People Now Using AIR or MART Combination Inhalers

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UK | NICE Reports Major Shift Away From SABA-Only Asthma Treatment — More Than One Million People Now Using AIR or MART Combination Inhalers2026-06-12T11:30:22+00:00

EU | MDR/IVDR Simplification Proposal Moves into Active Scrutiny — Lifecycle Evidence Trade-Offs Under Debate

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EU | MDR/IVDR Simplification Proposal Moves into Active Scrutiny — Lifecycle Evidence Trade-Offs Under Debate2026-06-12T11:07:33+00:00

EU | TEHDAS2 Launches New Public Consultations to Support Implementation of the European Health Data Space

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EU | TEHDAS2 Launches New Public Consultations to Support Implementation of the European Health Data Space2026-05-14T14:09:14+00:00

USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making

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USA | FDA Highlights Expanding Role of Real-World Evidence in Medical Device Decision-Making2026-04-12T13:13:11+00:00
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