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When are medical apps medical? Off-label use and the Food and Drug Administration

机译：什么时候医疗应用程序医疗？标签外使用和食品药品监督管理局

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摘要

People have a love/hate relationship with rapidly changing healthcare technology. While consumer demand for medical apps continues to grow as rapidly as does supply (there are over 100,000 health, wellness and medical applications, or ‘apps’ on the market), healthcare professionals and safety experts worry about the impact of these apps on the health consumer. In response to the rapidly growing mobile healthcare sector, the Food and Drug Administration has put forth guidelines to regulate ‘mobile medical apps’ (MMAs), those health-related apps that are (self) designated as medical devices. In this article, I argue that this decision, to only regulate apps that bill themselves as medical devices, will create a market for ‘off-label’ app use. Further, I will talk about the oft used analogy between off-label apps and off-label pharmaceuticals, showing that off-labeling apps will provide patients none of the benefits that come with a physician prescribing a drug off-label, while exposing the mobile healthcare consumer to significant risks that go significantly beyond those that we know of (and must accept) from prescription drugs. Recognizing that the Food and Drug Administration is not going to be able to significantly change its policies on oversight, I will suggest specific actions to at least mitigate some of the risks associated with off-label app use.
机译：人们与快速变化的医疗技术之间存在着爱恨交织的关系。尽管消费者对医疗应用的需求与供应一样持续增长（市场上有超过100,000种健康，保健和医疗应用或“应用”），但医疗保健专业人员和安全专家担心这些应用对健康的影响消费者。为了响应快速增长的移动医疗保健行业，美国食品药品管理局（FDA）提出了规范“移动医疗应用程序”（MMA）的指南，这些应用程序被（自行）指定为医疗设备。在本文中，我认为，这一决定仅对自费为医疗设备的应用进行监管，将为“标签外”应用的使用创造一个市场。此外，我将讨论标签外应用程序和标签外药品之间经常使用的类比，这表明标签外应用程序将为患者提供处方药以外标签的医生所没有的任何好处，同时还暴露了移动设备。医疗保健消费者面临的重大风险远远超过了我们从处方药中知道（必须接受）的风险。认识到美国食品药品监督管理局（Food and Drug Administration）将无法显着改变其监督政策，因此，我建议采取具体措施，至少减轻与标签外应用程序使用相关的某些风险。

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