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22 Yale J. Health Pol'y L. & Ethics 1 (2023-2024)

handle is hein.journals/yjhple22 and id is 1 raw text is: The Patient's Voice: Legal Implications of Patient-Reported Outcome Measures Sharona Hoffman* and Andy Podgurski** Abstract: In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field. Patient-reported outcome measures (PROMs) are reports of patients' symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic questionnaires. In this era of growing efforts to control health care costs, improve care delivery, and combat physician burnout, patients' own input can be invaluable for clinicians as well as researchers, regulators, and insurers. At the same time, however, PROMs have several pitfalls, and the implementation of PROM programs is challenging and complex. The article argues that health care providers should be keenly aware of potential medical malpractice risks associated with PROMs. In addition, because PROMs collect a plethora of sensitive information about pain, sexual function, anxiety, and other matters, the HIPAA Privacy Rule should be revised to address PROMs specifically. The Article further posits that it would be premature for regulatory agencies or private insurers to require PROM submission at this time. It also details strategies, such as use of artificial intelligence, to strengthen PROMs and facilitate their integration into clinical practice and other arenas. * Edgar A. Hahn Professor of Law, Professor of Bioethics, and Co-Director of Law-Medicine Center, Case Western Reserve University School of Law. B.A., Wellesley College; J.D., Harvard Law School; LL.M. in Health Law, University of Houston; S.J.D. in Health Law, Case Western Reserve University. Author of ELECTRONIC HEALTH RECORDS AND MEDICAL BIG DATA: LAW AND POLICY (Cambridge University Press 2016). For more information see https://sharona hoffman.com/. Work on this article was supported in part by a grant: NSF CCF 2200255. ** Professor of Computer and Data Sciences, Case Western Reserve University, B.S., M.S., Ph.D., University of Massachusetts. The authors thank Jessie Hill, Max Mehlman, Jaymie Shanker, Katharine Van Tassel, and all attendees of the Case Western Reserve School of Law summer workshop for their thoughtful comments on prior drafts. We also thank Rebecca Smith for her invaluable research assistance. 1

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