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The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues

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Handbook of Bioethical Decisions. Volume I

Part of the book series: Collaborative Bioethics ((CB,volume 2))

Abstract

Artificial Intelligence (AI), especially of the machine learning (ML) variety, is used by health care organizations to assist with a number of tasks, including diagnosing patients and optimizing operational workflows. AI products already proliferate the health care market, with usage increasing as the technology matures. Although AI may potentially revolutionize health care, the use of AI in health settings also leads to risks ranging from violating patient privacy to implementing a biased algorithm. This chapter begins with a broad overview of health care AI and how it is currently used. We then adopt a “lifecycle” approach to discussing issues with health care AI. We start by discussing the legal and ethical issues pertaining to how data to build AI are gathered in health care settings, focusing on privacy. Next, we turn to issues in algorithm development, especially algorithmic bias. We then discuss AI deployment to treat patients, focusing on informed consent. Finally, we will discuss existing oversight mechanisms for health AI in the United States: liability and regulation.

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Notes

  1. 1.

    By “meaningful” we intend to distinguish at the extreme what we might think of as pro forma consent. For example, where the first time a patient enters a health care facility, they sign a form they likely never read that they consent to future use of their data with the identifiers stripped; if they have read the form, chances are they really do not understand the risks and benefits, because how could they without being given specifics about intended uses, what other data sets are present that may be triangulated with this data set, the cybersecurity practices of various data holders, etc.?

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Acknowledgments

I.G.C. was supported by a grant from the Collaborative Research Program for Biomedical Innovation Law, a scientifically independent collaborative research program supported by a Novo Nordisk Foundation grant (NNF17SA0027784). I.G.C. was also supported by Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health, a grant from the Gordon and Betty Moore Foundation (grant agreement number 9974). S.G. reports grants from the European Union (Grant Agreement no. 101057321 and no. 101057099), the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health (Grant Agreement no. 3R01EB027650-03S1), and the Rock Ethics Institute at Penn State University.

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Correspondence to Jenna Becker .

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Becker, J., Gerke, S., Cohen, I.G. (2023). The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues. In: Valdés, E., Lecaros, J.A. (eds) Handbook of Bioethical Decisions. Volume I. Collaborative Bioethics, vol 2. Springer, Cham. https://doi.org/10.1007/978-3-031-29451-8_24

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