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 …

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 …

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 …

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, …

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 …

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 …