Health Aff (Millwood). 2014 Feb;33(2):222-7. doi: 10.1377/hlthaff.2013.0958.
Mobile health (mHealth) technology has facilitated the transition of care beyond the traditional hospital setting to the homes of patients. Yet few studies have evaluated the legal implications of the expansion of mHealth applications, or "apps." Such apps are affected by a patchwork of policies related to medical licensure, privacy and security protection, and malpractice liability. For example, the privacy protections of the Health Insurance Portability and Accountability Act (HIPAA) of 1996 may apply to only some uses of the apps. Similarly, it is not clear what a doctor's malpractice liability would be if he or she injured a patient as the result of inaccurate information supplied by the patient's self-monitoring health app. This article examines the legal issues related to the oversight of health apps, discusses current federal regulations, and suggests strategies to improve the oversight of these apps.
移动医疗(mHealth)技术使医疗护理超越了传统的医院环境,延伸到了患者的家庭中。然而,很少有研究评估移动医疗应用程序(即“应用”)扩展所带来的法律影响。这些应用受到与医疗许可、隐私和安全保护以及医疗事故责任相关的各种政策的影响。例如,1996 年《健康保险携带和责任法案》(HIPAA)的隐私保护可能仅适用于应用的某些用途。同样,医生的医疗事故责任是什么,如果他或她因为患者自我监测健康应用提供的不准确信息而伤害了患者,这也并不清楚。本文探讨了与健康应用程序监管相关的法律问题,讨论了当前的联邦法规,并提出了改进这些应用程序监管的策略。