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- UK regulator debates whether AI scribes count as medical devicesUK regulators are examining whether AI-driven clinical documentation tools, often called AI scribes, should be classified as medical devices under current law. The proposal has generated debate am…
- Analysis questions expanded orphan drug exemptions under recent legislationEd Silverman, a Pharmalot columnist, examined a provision in the One Big Beautiful Bill Act that keeps certain orphan drugs out of Medicare price negotiations. The Inflation Reduction Act, which b…