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Browsing by Subject "health law"

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    Liability for Mobile Health and Wearable Technologies
    (2016) Terry, Nicolas P.; Wiley, Lindsay F.; Robert H. McKinney School of Law
    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.
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    Prescriptions Sans Frontieres (or How I Stopped Worrying About Viagra on the Web But Grew Concerned About the Future of Healthcare Delivery)
    (2004) Terry, Nicolas P.
    This Article argues that the threat posed by rogue Internet prescribing and dispensing does not justify the level, style, and mechanics of current regulation. Current and emerging regulation may chill the development of lawful, efficient, necessary, and patient-friendly services and recommends alternate approaches. Part I of the Article sets out the key distinguishing features of the aforementioned initiatives and suggests that simple confusion between different and emergent models seem to be misleading legislators and regulators and imperiling patient choice. Part II discusses current regulation of Internet prescribing and dispensing and addresses the areas that most concern regulators. In the process, it examines the regulation of Internet prescribing by state licensing boards and the controversy surrounding transnational prescription dispensing. Parts III and IV of the Article then look beyond the current forms of Internet prescribing and dispensing to identify the stakeholders and critically analyze the regulatory themes that populate the landscape. These themes, including those labeled as uneasy federalism, under-regulation, and over-regulation, help us better understand the ways our legal and regulatory systems create disincentives to the adoption of new technologies or business models. Part V of the Article describes the steps necessary to maintain rigorous control over healthcare quality while avoiding disincentives to the provision of the next generation of effective and efficient healthcare.
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    Regulating What Has Yet To Be Created: An Introduction
    (2019) Georgiadis, Millie M.; Ryznar, Margaret; Biochemistry and Molecular Biology, School of Medicine
    The emerging field of synthetic biology—with the potential for engineering life from scratch—has inherited the laws and regulations of its biotechnology precursor. Yet, synthetic biology allows scientists to do entirely new things. This Article considers the resulting legal and ethical issues after surveying the technological capabilities developed within the field of synthetic biology.
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