美国食品和药物管理局现在允许在医疗设备审查中使用匿名真实数据, FDA now allows anonymized real-world data in medical device reviews to speed up approvals.

美国食品和药物管理局更新了指导方针,允许在医疗器械应用中使用未被识别的真实世界证据,从而消除了对可识别患者数据的需求. The FDA has updated its guidance to allow the use of de-identified real-world evidence in medical device applications, removing the need for identifiable patient data. 这一变化使审查人员能够使用来自癌症登记、保险索赔和电子健康记录等来源的匿名数据,加快评价,扩大获得宝贵见解的机会。 This change enables reviewers to use anonymized data from sources like cancer registries, insurance claims, and electronic health records, accelerating evaluations and expanding access to valuable insights. 此举旨在通过解开庞大的、受隐私保护的数据集,加快患者获得改变生活疗法的速度。 The move aims to speed up patient access to life-changing therapies by unlocking vast, privacy-protected datasets. 美国食品和药物管理局可能在未来将类似的变化扩展到药物和生物应用. The FDA may extend similar changes to drug and biologic applications in the future.