The Approval Illusion: When Regulatory Success Masks Commercial Collapse It all began with the reimbursement of Casgevy (exagamglogene autotemcel), which received FDA breakthrough therapy designation in 2023 and full approval …
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EU MDR Classification for Digital Health Software: Why “Not Intended for Medical Use” Fails and How Regulatory Debt Emerges “Not Intended for Medical Use” Executive Summary A persistent and dangerous …
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In September 2024, the Australian Government published the final report of the Health Technology Assessment (HTA) Policy and Methods Review. On the surface, it is a national reform document. In …
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The EU Artificial Intelligence Act: Why Understanding Europe’s New Framework for Medical AI is important
Governing the next generation of clinical intelligence Artificial intelligence is rapidly moving from research laboratories into everyday clinical practice. Algorithms now assist clinicians in interpreting radiological images, predicting patient deterioration, …
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The European Health Data Space: How EU Health Data Could Rewrite Evidence-Based Care A quiet revolution in European health data As Brussels debates Joint Clinical Assessments (JCAs) under the EU …
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The EU Health Technology Assessment Regulation (EU) 2021/2282 creates a common European-level clinical assessment, the Joint Clinical Assessment (JCA), that will sit on top of, rather than replace, national pricing …
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Point-of-Care in France: From Legal Access to Payment If you are a manufacturer of point-of-care testing systems seeking reimbursement in France, the 2026 reform changes the legal landscape but not …
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Spain has quietly recalibrated the rules of access. With Royal Decree 90/2026, the Spanish National Health System has modernised how certain non-hospital medical products enter public financing. What was once …
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Joint Clinical Assessment EU The introduction of the European Union (EU) Joint Clinical Assessment (JCA) under Regulation (EU) 2021/2282 marks a transformative step in harmonising health technology assessments (HTAs) across …
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The Reimbursement Sanity Check Most reimbursement advice encourages companies to push harder.The Reimbursement Sanity Check asks whether they are pushing in the right direction at all. Healthcare systems rarely fail …