Liability for Mobile Health and Wearable Technologies
25 Annals of Health Law, 62 (2016)
Indiana University Robert H. McKinney School of Law Research Paper No. 2016-6
36 Pages Posted: 2 Feb 2016 Last revised: 8 Oct 2016
Date Written: January 31, 2016
Most of the legal commentary regarding mobile health has focused on direct regulation leveraging existing laws and regulators such as HIPAA privacy through HHS-OCR or device regulation by the FDA. However, much of the mobile health revolution likely will play out in lightly regulated spaces bereft of most of the privacy, security, and safety rules associated with traditional health care. This article examines the potential for common law liability models to bridge these gaps (even on a temporary basis). Part II of this paper provides an introduction to the terminology used, and presents a brief typology of the apps appearing in the health care space. Part III discusses the potential liability of physicians and other health care professionals. Part IV discusses the potential liability of institutional health care providers such as hospitals (that, in many cases is dependent upon the finding of fault in an individual professional). Part V discusses the applicability of product liability to mobile health developers and vendors. Part VI explains some of the issues that may arise when patients or consumers seek damages following privacy or security breaches. The survey concludes by noting that regulation by litigation may be a significant force in the app and wearable space during a period of light regulation by traditional regulators. This is a conclusion that is unlikely to cheer either health care providers or app developers; given that the indeterminacy associated with common law litigation is only exacerbated when applied to novel or emerging technologies.
Keywords: Health Law, Health Policy, Health Information Technology, Mobile Health, Digital Health, Products Liability, Medical Malpractice
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