迈向移动健康安全和隐私法规的自动计算审计

B. Tung, Zhiyuan Yu, Ning Zhang
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引用次数: 1

摘要

日益复杂的监管环境向我们提出了一个难题:我们如何确定自己是否符合不断增长的监管体系?计算法律审计可能会有所帮助,因为计算工具非常善于理解大量数据。在本研究中,我们探讨了创建一个计算审计员的可能性,该审计员检查移动健康(mHealth)应用程序是否满足联邦安全和隐私法规。在这样做的过程中,我们发现,虽然将开放式的、普遍适用的、复杂的法律转化为计算原则具有挑战性,但使用非法律的、权威的、解释性文件允许计算操作化,同时保留法律的开放式性质。我们在182个FDA/ ce批准的移动健康应用程序上测试了我们的审核员。我们的研究表明,使用非法律的、权威的指导性文件可能有助于创建计算审计员,这是一种很有前途的工具,可以帮助我们管理日益增长的监管责任。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Towards Automated Computational Auditing of mHealth Security and Privacy Regulations
The growing complexity of our regulatory environment presents us with a hard problem: how can we determine if we are compliant with an ever-growing body of regulations? Computational legal auditing may help, as computational tools are exceptionally good at making sense of large amounts of data. In this research, we explore the possibility of creating a computational auditor that checks if mobile health (mHealth) apps satisfy federal security and privacy regulations. In doing so, we find that while it is challenging to convert open-ended, generally applicable, complicated laws into computational principles, the use of non-legal, authoritative, explanatory documents allows for computational operationalization while preserving the open-ended nature of the law. We test our auditor on 182 FDA/CE-approved mHealth apps. Our research suggests that the use of non-legal, authoritative, guidance documents may help with the creation of computational auditors, a promising tool to help us manage our ever-growing regulatory responsibilities.
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