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The Evolving Law and Ethics of Digital Health

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Digital Health

Part of the book series: Health Informatics ((HI))

Abstract

Given the novelty of digital health technologies, there remains significant confusion over which laws and regulations might apply to these technologies, and how. This chapter describes the major bodies of state and federal law that can apply, including medical device regulation by the FDA, state and federal consumer protection laws, data privacy and security laws, and potential legal liability for physicians, hospitals, manufacturers, and developers. The chapter examines how awkwardly these laws have adapted to the novel features of digital health, and vice versa. It concludes by detailing how, in the absence of quality screening by the FDA, four alternative methods of quality screening have emerged, including (1) due diligence by venture capital firms, (2) hospital guidelines for users and developers, (3) review by third-parties, such as app review web sites, and (4) coverage policies by health insurers. I call these “surrogate” or “proxy” regulation.

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Notes

  1. 1.

    I use “digital health” loosely to include mobile health, telemedicine, “big data” analytics, wearables, ingestible sensors, 3D printing, virtual reality, and related health technologies.

  2. 2.

    Moreover, due to space constraints, I omit discussion of important legal issues like patents, intellectual property, clinical research, discrimination, and cybersecurity that affect the industry.

  3. 3.

    Among the requirements include annual registration of manufacturing facilities and listing of device made, labeling rules, quality standards for design and manufacturing, and submission of necessary adverse event reports and corrections.

  4. 4.

    Brickman v. FitBit, Inc., 2016 WL 3844327 (N.D. Cal. 2016).

  5. 5.

    State licensure is extensive. The state of Texas, for example, applies specific legal requirements on well over two dozen different “health professions,” including physicians, nurses, surgical assistants, dentists, and the like. See Texas Occupations Code, Title 3 (Health Professions).

  6. 6.

    Note, however, that the company might still be subject to product liability, as discussed in Sect. 18.2.5 below.

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Authors and Affiliations

  1. Dedman School of Law, Southern Methodist University, Dallas, TX, USA

    Nathan Cortez

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  1. Nathan Cortez
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Correspondence to Nathan Cortez .

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Editors and Affiliations

  1. Stanford University School of Medicine, Stanford, California, USA

    Homero Rivas

  2. University of Copenhagen, Copenhagen, Denmark

    Katarzyna Wac

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Cortez, N. (2018). The Evolving Law and Ethics of Digital Health. In: Rivas, H., Wac, K. (eds) Digital Health. Health Informatics. Springer, Cham. https://doi.org/10.1007/978-3-319-61446-5_18

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  • DOI: https://doi.org/10.1007/978-3-319-61446-5_18

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