Omar Riyad A
J Law Health. 2020;34(1):30-105.
In light of the confusion invited by applying the label "de-identified" to information that can be used to identify patients, it is paramount that regulators, compliance professionals, patient advocates and the general public understand the significant differences between the standards applied by HIPAA and those applied by permissive "de-identification guidelines." This Article discusses those differences in detail. The discussion proceeds in four Parts. Part II (HIPAA's Heartbeat: Why HIPAA Protects Identifiable Patient Information) examines Congress's motivations for defining individually identifiable health information broadly, which included to stop the harms patients endured prior to 1996 arising from the commercial sale of their medical records. Part III (Taking the "I" Out of Identifiable Information: HIPAA's Requirements for De-Identified Health Information) discusses HIPAA's requirements for de-identification that were never intended to create a loophole for identifiable patient information to escape HIPAA's protections. Part IV (Anatomy of a Hack: Methods for Labeling Identifiable information "De-Identified") examines the goals, methods, and results of permissive "de-identification guidelines" and compares them to HIPAA's requirements. Part V (Protecting Un-Protected Health Information) evaluates the suitability of permissive "de-identification guidelines," concluding that the vulnerabilities inherent in their current articulation render them ineffective as a data protection standard. It also discusses ways in which compliance professionals, regulators, and advocates can foster accountability and transparency in the utilization of health information that can be used to identify patients.
鉴于将“去标识化”标签应用于可用于识别患者的信息所引发的混乱,监管机构、合规专业人员、患者权益倡导者和公众必须了解《健康保险流通与责任法案》(HIPAA)所适用的标准与宽松的“去标识化指南”所适用的标准之间的重大差异。本文将详细讨论这些差异。讨论分为四个部分。第二部分(HIPAA的核心:为何HIPAA保护可识别的患者信息)探讨了国会将可单独识别的健康信息进行宽泛定义的动机,其中包括制止患者在1996年之前因医疗记录的商业出售而遭受的伤害。第三部分(从可识别信息中去除“我”:HIPAA对去标识化健康信息的要求)讨论了HIPAA对去标识化的要求,这些要求从未打算为可识别的患者信息逃避HIPAA的保护创造漏洞。第四部分(黑客攻击剖析:将可识别信息标记为“去标识化”的方法)研究了宽松的“去标识化指南”的目标、方法和结果,并将它们与HIPAA的要求进行比较。第五部分(保护未受保护的健康信息)评估了宽松的“去标识化指南”的适用性,得出结论认为,其当前表述中固有的漏洞使其作为数据保护标准无效。它还讨论了合规专业人员、监管机构和倡导者可以促进在使用可用于识别患者的健康信息时的问责制和透明度的方法。