Informed Consent and Medical Artificial Intelligence: What to Tell the Patient?
Informed Consent and Medical Artificial Intelligence: What to Tell the Patient?
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知情同意和医疗人工智能：该告诉患者什么？
DOI：
10.2139/ssrn.3529576
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发表时间：
2020
期刊：
影响因子：
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通讯作者：
I. Cohen
中科院分区：
文献类型：
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作者：
I. Cohen
想象一下，您是一名被诊断出患有前列腺癌的患者。在美国，治疗它的两种主要方法是积极监测和根治性膀胱切除术的手术选择。您的医生建议手术选择，并花费大量时间解释手术步骤，消除肿瘤的好处（除其他外）以及手术后勃起功能障碍和尿失禁的风险（除其他外）。你的医生没有告诉你的是，她已经根据人工智能（AI）/机器学习（ML）系统的分析，在主动监测的基础上提出了直肠癌切除术的建议，该系统根据对你的年龄，肿瘤大小和电子健康记录中发现的其他个人特征的分析推荐了这个治疗计划。医生是否从法律的角度获得了知情同意？从伦理角度？如果医生实际上选择"否决"人工智能系统，而医生没有告诉你，她是否侵犯了你的法律的或道德的知情同意权？如果你发现AI/ML系统被用来对你的护理提出建议，但没有人告诉你，你会有什么感觉？好吧，想想看，你知道你上次看医生时是否使用了AI/ML系统吗？
这篇文章是乔治城法律杂志研讨会的一部分，是第一篇深入研究医疗AI/ML如何与我们的知情同意概念相结合的文章。第一部分简要介绍了医学人工智能和机器学习。第二部分阐述了美国知情同意法的核心和半影，然后试图确定在当前的原则下，AI/ML在多大程度上参与患者的健康应该被披露。第三部分审查了目前的学说是否"有它的权利"，审查更公开的经验和规范的方法来解决这个问题。
我的结论是：虽然在关节中有一些作用，但我对现有法律的学说的最佳阅读是，一般来说，没有告知患者使用医疗AI/ML来帮助制定治疗建议的责任不会存在。有几种情况下，该原则可能更宽泛，我试图从中得出（例如当患者询问时，当医疗AI/ML更不透明时，当它在最终决策中被赋予过大的角色时，或者当AI/ML用于降低成本而不是改善患者健康时），尽管即使在这里扩展它也不确定。我还对这个问题提出了一些想法：如果该原则有空间（无论是通过普通法还是立法行动），那么当涉及到医疗AI/ML时，该原则应该是什么样子？我还简要地谈到了知情同意原则应该如何与AI/ML的偏见训练数据的担忧相互作用的问题。
Imagine you are a patient who has been diagnosed with prostate cancer. The two main approaches to treating it in the United States are active surveillance versus the surgical option of radical prostatectomy. Your physician recommends the surgical option, and spends considerable time explaining the steps in the surgery, the benefits of (among other things) eliminating the tumor and the risks of (among other things) erectile dysfunction and urinary incontinence after the surgery. What your physician does not tell you is that she has arrived at her recommendation of prostatectomy over active surveillance based on the analysis of an Artificial Intelligence (AI)/Machine Learning (ML) system, which recommended this treatment plan based on analysis of your age, tumor size, and other personal characteristics found in your electronic health record. Has the doctor secured informed consent from a legal perspective? From an ethical perspective? If the doctor actually chose to “overrule” the AI system, and the doctor fails to tell you that, has she violated your legal or ethical right to informed consent? If you were to find out that the AI/ML system was used to make recommendations on your care and no one told you, how would you feel? Well, come to think of it, do you know whether an AI/ML system was used the last time you saw a physician?
This Article, part of a Symposium in the Georgetown Law Journal, is the first to examine in depth how medical AI/ML interfaces with our concept of informed consent. Part I provides a brief primer on medical Artificial Intelligence and Machine Learning. Part II sets out the core and penumbra of U.S. informed consent law and then seeks to determine to what extent AI/ML involvement in a patient’s health should be disclosed under the current doctrine. Part III examines whether the current doctrine “has it right,” examining more openly empirical and normative approaches to the question.
To forefront my conclusions: while there is some play in the joints, my best reading of the existing legal doctrine is that in general, liability will not lie for failing to inform patients about the use of medical AI/ML to help formulate treatment recommendations. There are a few situations where the doctrine may be more capacious, which I try to draw out (such as when patients inquire, when the medical AI/ML is more opaque, when it is given an outsized role in the final decision-making, or when the AI/ML is used to reduce costs rather than improve patient health), though extending it even here is not certain. I also offer some thoughts on the question: if there is room in the doctrine (either via common law or legislative action), what would it be desirable for the doctrine to look like when it comes to medical AI/ML? I also briefly touch on the question of how the doctrine of informed consent should interact with concerns about biased training data for AI/ML.