Mobile health applications: the patchwork of legal and liability issues suggests strategies to improve oversight.
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.
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Yang
Ross D
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Silverman
D016494:Computer Security / Q000331:legislation & jurisprudence*; D005260:Female; D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D033181:Information Dissemination / Q000331:legislation & jurisprudence; D008004:Licensure / Q000331:legislation & jurisprudence; D008297:Male; D008318:Malpractice / Q000331:legislation & jurisprudence*; D063731:Mobile Applications / Q000331:legislation & jurisprudence*; D018907:Privacy / Q000331:legislation & jurisprudence; D011786:Quality Control; D012306:Risk; D017216:Telemedicine / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
Legal/Regulatory Issues; Medical technology