Armontrout James, Torous John, Fisher Matthew, Drogin Eric, Gutheil Thomas
University of California, San Francisco, 401 Parnassus Avenue Box PLP-0984, San Francisco, CA, 94143-0984, USA.
Beth Israel Deaconess Medical Center, 330 Brookline Ave E/Rabb 2, Boston, MA, 02115, USA.
Curr Psychiatry Rep. 2016 Oct;18(10):91. doi: 10.1007/s11920-016-0726-x.
Mobile health (mHealth) apps are becoming much more widely available. As more patients learn about and download apps, clinicians are sure to face more questions about the role these apps can play in treatment. Clinicians thus need to familiarize themselves with the clinical and legal risks that apps may introduce. Regulatory rules and organizations that oversee the safety and efficacy of mHealth apps are currently fragmentary in nature and clinicians should pay special attention to categories of apps which are currently exempt from significant regulation. Uniform HIPAA protection does not apply to personal health data that are shared with apps in many contexts which creates a number of clinically relevant privacy and security concerns. Clinicians should also consider several relatively novel potential adverse clinical outcomes and liability concerns that may be relevant to specific categories of apps, including apps that target (i) medication adherence, (ii) collection of self-reported data, (iii) collection of passive data, and (iv) generation of treatment recommendations for psychotherapeutic and behavioral interventions. Considering these potential pitfalls (and disclosing them to patients as a part of obtaining informed consent) is necessary as clinicians consider incorporating apps into treatment.
移动医疗（mHealth）应用程序正变得越来越普及。随着越来越多的患者了解并下载应用程序，临床医生肯定会面临更多关于这些应用程序在治疗中所起作用的问题。因此，临床医生需要熟悉应用程序可能带来的临床和法律风险。目前，监管移动医疗应用程序安全性和有效性的规则及组织本质上是零散的，临床医生应特别关注目前免于严格监管的应用程序类别。在许多情况下，统一的《健康保险流通与责任法案》（HIPAA）保护不适用于与应用程序共享的个人健康数据，这引发了一些与临床相关的隐私和安全问题。临床医生还应考虑一些相对新颖的潜在不良临床后果以及与特定类别应用程序相关的责任问题，这些应用程序包括针对（i）药物依从性、（ii）自我报告数据收集、（iii）被动数据收集以及（iv）心理治疗和行为干预治疗建议生成的应用程序。在临床医生考虑将应用程序纳入治疗时，考虑这些潜在的陷阱（并将其告知患者作为获得知情同意的一部分）是必要的。
