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Privacy as the Price of Drug Access 隐私是获取药物的代价
Pub Date : 2022-03-07 DOI: 10.52214/stlr.v23i1.9390
Laura Karas
In response to the recent increase in FDA-approved specialty drugs and escalating specialty drug prices, drug companies now offer patient support programs (“PSPs”) for eligible patients prescribed a particular pharmaceutical drug. Such programs encompass both financial assistance for the purchase of a specialty drug and behavioral services, including nursing support and injection training, intended to improve drug adherence. Although ostensibly gratuitous, these programs have a steep and underappreciated cost: disclosure of protected health information. In effect, patient support programs compel patients to trade protected health information for drug access. This Article provides the first in- depth examination of the legal and ethical concerns associated with patient support programs. Enrollment in a drug company’s patient support program furnishes the company with linked patient- and prescriber- identifying information for each enrollee, data which may enable drug companies to target marketing to patients and healthcare providers with an otherwise unattainable degree of precision. Moreover, once a drug company acquires an enrollee’s protected health information pursuant to a valid Health Insurance Portability and Accountability Act (HIPAA) authorization, a drug company faces few limits on downstream uses of those data. This Article illuminates a possible role for patient support program-mediated data collection in two unlawful drug company practices: (1) kickback schemes in coordination with foundations that cover pharmaceutical drug copays, and (2) “product hopping” to a new brand-name drug formulation after patent expiration of an older formulation. The current regime for health data privacy in the United States lacks adequate safeguards to prevent drug companies from exploiting patient support program-derived data to the detriment of patients. The Article ends by proposing practical modifications to the HIPAA Privacy Rule to modernize HIPAA’s protections vis-à-vis health data transferred from covered entities to noncovered entities such as drug companies.
为了应对最近fda批准的特殊药物的增加和不断上涨的特殊药物价格,制药公司现在为处方特定药物的合格患者提供患者支持计划(“psp”)。这些计划既包括购买特殊药物的财政援助,也包括旨在提高药物依从性的行为服务,包括护理支持和注射培训。虽然这些项目表面上是无偿的,但却有一个高昂而未被重视的代价:泄露受保护的健康信息。实际上,患者支持计划迫使患者以受保护的健康信息换取药物获取。这篇文章提供了与病人支持计划相关的法律和伦理问题的第一次深入检查。在制药公司的患者支持计划中注册,为公司提供了每个注册者的相关患者和处方者识别信息,这些数据可以使制药公司以其他方式无法达到的精确程度对患者和医疗保健提供者进行目标营销。此外,一旦制药公司根据有效的《健康保险流通与责任法案》(health Insurance Portability and Accountability Act, HIPAA)授权获得了参保人受保护的健康信息,制药公司对这些数据的下游使用几乎没有限制。本文阐明了患者支持计划介导的数据收集在两种非法制药公司实践中的可能作用:(1)与涵盖药品共同支付的基金会协调的回扣计划,以及(2)在旧配方专利到期后“产品跳转”到新的品牌药物配方。美国目前的健康数据隐私制度缺乏足够的保障措施,无法防止制药公司利用患者支持方案衍生的数据损害患者的利益。文章最后提出了对HIPAA隐私规则的实际修改,以使HIPAA对-à-vis健康数据从覆盖实体转移到非覆盖实体(如制药公司)的保护现代化。
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引用次数: 0
Approaches to Assess Market Power in the Online Networking Market 在线网络市场中市场力量的评估方法
Pub Date : 2021-09-01 DOI: 10.52214/STLR.V22I2.8664
Shin-Ru Cheng
Facebook, the world’s largest online networking platform, is the subject of multiple antitrust investigations by various state and federal regulators. Yet scholars and practitioners remain divided on how to measure Facebook’s market power. Some argue that conventional approaches for identifying market power are suitable for the online networking market. This Article argues such conventional approaches are inadequate for assessing market power in online networking markets.This Article begins by introducing the traditional approaches that courts have employed to assess market power: the direct effects approach, the Lerner Index approach, and the market share approach. It next describes Facebook’s business model and shows that, because Facebook is a two-sided market, these traditional approaches should not be applied to Facebook.Instead, the Article proposes that the information gaps, switching costs, and entry barriers approaches are better suited for assessing the market power of online networking platforms. The Article thus concludes by proposing a legal framework for assessing market power in online networking platforms which employs such non-traditional approaches. While this Article uses Facebook as the main case study, this paper’s findings are equally applicable to similar online networking platforms.
Facebook是全球最大的在线社交平台,目前正受到多个州和联邦监管机构的多起反垄断调查。然而,学者和实践者在如何衡量Facebook的市场力量方面仍存在分歧。一些人认为,传统的识别市场力量的方法适用于在线网络市场。本文认为,这种传统方法不足以评估在线网络市场中的市场力量。本文首先介绍了法院用来评估市场力量的传统方法:直接效应法、勒纳指数法和市场份额法。接下来,它描述了Facebook的商业模式,并表明,因为Facebook是一个双边市场,这些传统的方法不应该适用于Facebook。相反,本文提出信息差距、转换成本和进入壁垒方法更适合于评估在线网络平台的市场力量。因此,本文最后提出了一个评估采用这种非传统方法的在线网络平台市场力量的法律框架。虽然本文使用Facebook作为主要案例研究,但本文的研究结果同样适用于类似的在线网络平台。
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引用次数: 0
Calculated Discrimination: Exposing Racial Gerrymandering Using Computational Methods 计算歧视:用计算方法揭露种族不公正划分
Pub Date : 2021-09-01 DOI: 10.52214/stlr.v22i2.8669
Aviel Menter
In Rucho v. Common Cause, the Supreme Court held that challenges to partisan gerrymanders presented a nonjusticiable political question. This decision threatened to discard decades of work by political scientists and other experts, who had developed a myriad of techniques designed to help the courts objectively and unambiguously identify excessively partisan district maps. Simulated redistricting promised to be one of the most effective of these techniques. Simulated redistricting algorithms are computer programs capable of generating thousands of election-district maps, each of which conforms to a set of permissible criteria determined by the relevant state legislature. By measuring the partisan lean of both the automatically generated maps and the map put forth by the state legislature, a court could determine how much of this partisan bias was attributable to the deliberate actions of the legislature, rather than the natural distribution of the state’s population.Rucho ended partisan gerrymandering challenges brought under the U.S. Constitution—but it need not close the book on simulated redistricting. Although originally developed to combat partisan gerrymanders, simulated redistricting algorithms can be repurposed to help courts identify intentional racial gerrymanders. Instead of measuring the partisan bias of automatically generated maps, these programs can gauge improper racial considerations evident in the legislature’s plan and demonstrate the discriminatory intent that produced such an outcome. As long as the redistricting process remains in the hands of state legislatures, there is a threat that constitutionally impermissible considerations will be employed when drawing district plans. Simulated redistricting provides a powerful tool with which courts can detect a hidden unconstitutional motive in the redistricting process.
在鲁乔诉共同事业案(Rucho v. Common Cause)中,最高法院认为,对党派不公正划分选区的挑战提出了一个不可审理的政治问题。这一决定有可能使政治学家和其他专家几十年的工作成果夭折,他们开发了无数的技术,旨在帮助法院客观、明确地识别过于党派化的选区地图。模拟重划被认为是这些技术中最有效的一种。模拟选区重新划分算法是一种计算机程序,能够生成数千张选区地图,每一张地图都符合相关州立法机构确定的一套允许的标准。通过测量自动生成的地图和州议会绘制的地图的党派倾向,法院可以确定这种党派偏见在多大程度上归因于立法机构的故意行为,而不是该州人口的自然分布。鲁乔结束了根据美国宪法提出的党派不公正划分选区的挑战,但它不需要结束模拟重新划分的书。虽然最初是为了对抗党派的不公正划分而开发的,但模拟重新划分算法可以重新用于帮助法院识别故意的种族不公正划分。这些程序不是衡量自动生成地图的党派偏见,而是可以衡量立法机构计划中明显存在的不当种族考虑,并证明产生这种结果的歧视意图。只要重新划分选区的过程仍然掌握在州立法机构手中,就有可能在绘制地区规划时考虑到宪法不允许的因素。模拟选区重新划分提供了一个强大的工具,法院可以通过它来发现选区重新划分过程中隐藏的违宪动机。
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引用次数: 1
Ground-Level Pressing Issues at the Intersection of AI and IP 人工智能和知识产权交叉领域的底层紧迫问题
Pub Date : 2021-09-01 DOI: 10.52214/STLR.V22I2.8665
David Kappos, Åsa Kling
Humankind has always sought to solve problems. This impetus has transformed hunters and gatherers into a society beginning to enjoy the fruits of the fourth industrial revolution. As part of the fourth industrial revolution, and the increased computing power accompanying it, the long-theorized concept of artificial intelligence (“AI”) is finally becoming a reality. This raises new issues in myriad fields—from the moral and ethical implications of replacing human activity with machines to who will own inventions created by AI. While these questions are worth exploring, they have already received a fair amount of coverage in popular and theoretical writing. This paper will take a different direction, focusing on the current and near-future issues arising on the ground at the intersection of AI and intellectual property (“IP”). After providing a brief overview of AI, we will analyze legal issues unique to AI, including access to data, patent requirements, open source licenses and trade secrecy. We will then suggest best practices for obtaining and preserving IP protection for AI-related innovations through the United States and European Union IP systems. By addressing these issues, the intellectual property system will be better positioned to do its part in unlocking AI’s immense potential.
人类一直在寻求解决问题。这一推动力已经将猎人和采集者转变为一个开始享受第四次工业革命成果的社会。作为第四次工业革命的一部分,以及随之而来的计算能力的增强,长期理论化的人工智能(“AI”)概念终于成为现实。这在许多领域引发了新的问题——从用机器取代人类活动的道德和伦理影响,到谁将拥有人工智能创造的发明。虽然这些问题值得探索,但它们已经在流行和理论写作中得到了相当多的报道。本文将采取不同的方向,重点关注人工智能和知识产权(“IP”)交叉领域当前和不久的将来出现的问题。在简要介绍了人工智能之后,我们将分析人工智能特有的法律问题,包括数据访问、专利要求、开源许可和商业保密。然后,我们将建议通过美国和欧盟知识产权制度为人工智能相关创新获得和保留知识产权保护的最佳做法。通过解决这些问题,知识产权制度将更好地发挥其作用,释放人工智能的巨大潜力。
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引用次数: 0
How the Poor Data Privacy Regime Contributes to Misinformation Spread and Democratic Erosion 糟糕的数据隐私制度如何导致错误信息的传播和民主的侵蚀
Pub Date : 2021-09-01 DOI: 10.52214/STLR.V22I2.8668
Wayne Unger
Disinformation campaigns reduce trust in democracy, harm democratic institutions, and endanger public health and safety. While disinformation and misinformation are not new, their rapid and widespread dissemination has only recently been made possible by technological developments that enable never-before-seen levels of mass communication and persuasion.Today, a mix of social media, algorithms, personal profiling, and psychology enable a new dimension of political messaging—a dimension that disinformers exploit for their political gain. These enablers share a root cause—the poor data privacy and security regime in the U.S.At its core, democracy requires independent thought, personal autonomy, and trust in democratic institutions. A public that thinks critically and acts independently can check the government’s power and authority. However, when the public is misinformed, it lacks the autonomy to freely elect and check its representatives and the fundamental basis for democracy erodes. This Article addresses a root cause of misinformation dissemination —the absence of strong data privacy protections in the U.S.—and its effects on democracy. This Article explains, from a technological perspective, how personal information is used for personal profiling, and how personal profiling contributes to the mass interpersonal persuasion that disinformation campaigns exploit to advance their political goals.
虚假信息运动降低了人们对民主的信任,损害了民主制度,危害了公众健康和安全。虽然虚假信息和错误信息并不新鲜,但它们的迅速和广泛传播直到最近才成为可能,因为技术发展使大众传播和说服达到了前所未有的水平。今天,社交媒体、算法、个人特征分析和心理学的结合使政治信息的一个新维度成为可能——一个被造谣者利用来获取政治利益的维度。这些促成因素有一个共同的根本原因——美国糟糕的数据隐私和安全制度。民主的核心要求独立思考、个人自治和对民主机构的信任。一个具有批判性思维和独立行动的公众可以制衡政府的权力和权威。但是,如果国民被误导,就会失去自由选举和监督代表的自主权,民主主义的根本基础就会受到侵蚀。本文解决了错误信息传播的根本原因——美国缺乏强有力的数据隐私保护——及其对民主的影响。本文从技术角度解释了个人信息如何用于个人分析,以及个人分析如何有助于虚假信息运动利用大众人际说服来推进其政治目标。
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引用次数: 1
Burning Bridges: The Automated Facial Recognition Technology and Public Space Surveillance in the Modern State 燃烧的桥梁:现代国家的自动面部识别技术与公共空间监控
Pub Date : 2021-09-01 DOI: 10.52214/STLR.V22I2.8666
Monika Zalnieriute
Live automated facial recognition technology, rolled out in public spaces and cities across the world, is transforming the nature of modern policing.  R (on the application of Bridges) v Chief Constable of South Wales Police, decided in August 2020, is the first successful legal challenge to automated facial recognition technology in the world. In Bridges, the United Kingdom’s Court of Appeal held that the South Wales Police force’s use of automated facial recognition technology was unlawful. This landmark ruling could influence future policy on facial recognition in many countries. The Bridges decision imposes some limits on the police’s previously unconstrained discretion to decide whom to target and where to deploy the technology. Yet, while the decision requires that the police adopt a clearer legal framework to limit this discretion, it does not, in principle, prevent the use of facial recognition technology for mass-surveillance in public places, nor for monitoring political protests. On the contrary, the Court held that the use of automated facial recognition in public spaces – even to identify and track the movement of very large numbers of people – was an acceptable means for achieving law enforcement goals. Thus, the Court dismissed the wider impact and significant risks posed by using facial recognition technology in public spaces. It underplayed the heavy burden this technology can place on democratic participation and freedoms of expression and association, which require collective action in public spaces. The Court neither demanded transparency about the technologies used by the police force, which is often shielded behind the “trade secrets” of the corporations who produce them, nor did it act to prevent inconsistency between local police forces’ rules and regulations on automated facial recognition technology. Thus, while the Bridges decision is reassuring and demands change in the discretionary approaches of U.K. police in the short term, its long-term impact in burning the “bridges” between the expanding public space surveillance infrastructure and the modern state is unlikely. In fact, the decision legitimizes such an expansion. 
在世界各地的公共场所和城市推出的实时自动面部识别技术正在改变现代警务的性质。2020年8月决定的R(关于Bridges的应用)诉南威尔士警察局局长一案,是世界上第一个成功的对自动面部识别技术的法律挑战。在Bridges一案中,英国上诉法院认为南威尔士警方使用自动面部识别技术是非法的。这一具有里程碑意义的裁决可能会影响许多国家未来的面部识别政策。布里奇斯案的裁决对警方以前不受约束的自由裁量权施加了一些限制,警方可以决定针对谁以及在哪里部署这项技术。然而,尽管该决定要求警方采用更清晰的法律框架来限制这种自由裁量权,但原则上,它并未阻止将面部识别技术用于公共场所的大规模监控,也没有阻止其用于监控政治抗议活动。相反,法院认为,在公共场所使用自动面部识别- -即使是为了识别和跟踪大量人员的移动- -是实现执法目标的一种可接受的手段。因此,法院驳回了在公共场所使用面部识别技术所带来的更广泛影响和重大风险。它低估了这项技术可能给民主参与、言论自由和结社自由带来的沉重负担,这需要在公共空间采取集体行动。法院既没有要求警察使用的技术透明化,因为这些技术往往隐藏在生产这些技术的公司的“商业秘密”背后,也没有采取行动防止地方警察在自动面部识别技术方面的规则和规定不一致。因此,虽然布里奇斯案的决定令人放心,并要求在短期内改变英国警方的自由裁量方式,但它在烧毁不断扩大的公共空间监控基础设施与现代国家之间的“桥梁”方面的长期影响是不太可能的。事实上,这一决定使这种扩张合法化。
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引用次数: 3
Big Data’s Exploitation of Social Determinants of Health: Human Rights Implications 大数据对健康社会决定因素的利用:人权影响
Pub Date : 2021-03-22 DOI: 10.52214/STLR.V22I1.8054
S. Wood
This Article acknowledges the necessity of including social determinants of health (SDH) data in healthcare planning and treatment but highlights the lack of regulation around the collection of SDH data and potential for violating consumers’ basic rights to be treated equally, protected from discrimination, and to have their privacy respected. The Article analyzes different approaches from the U.S. and EU and proffers the global application of the GDPR plus data human rights provisions as the most sustainable option in a world where technology is ever-changing.
本文承认在医疗保健计划和治疗中纳入健康社会决定因素(SDH)数据的必要性,但强调缺乏对SDH数据收集的监管,并且可能侵犯消费者获得平等对待、免受歧视保护和尊重其隐私的基本权利。本文分析了美国和欧盟的不同做法,并提出在技术不断变化的世界中,GDPR加上数据人权规定的全球应用是最可持续的选择。
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引用次数: 1
Safeguarding Civilian Internet Access During Armed Conflict: Protecting Humanity’s Most Important Resource in War 武装冲突期间保护民用互联网接入:保护战争中人类最重要的资源
Pub Date : 2021-03-22 DOI: 10.52214/STLR.V22I1.8056
T. E. Hutchins
A recent spate of governmental shutdowns of the civilian internet in a broad range of violent contexts, from uprisings in Hong Kong and Iraq to armed conflicts in Ethiopia, Kashmir, Myanmar, and Yemen, suggests civilian internet blackouts are the ‘new normal.’ Given the vital and expanding role of internet connectivity in modern society, and the emergence of artificial intelligence, internet shutdowns raise important questions regarding their legality under intentional law. This article considers whether the existing international humanitarian law provides adequate protection for civilian internet connectivity and infrastructure during armed conflicts. Concluding that current safeguards are insufficient, this article proposes a new legal paradigm with special protections for physical internet infrastructure and the right of civilian access, while advocating the adoption of emblems (such as the Red Cross or Blue Shield) in the digital world to protect vital humanitarian communications.
从香港和伊拉克的暴动到埃塞俄比亚、克什米尔、缅甸和也门的武装冲突,最近政府在广泛的暴力背景下关闭了民用互联网,这表明民用互联网关闭是“新常态”。“鉴于互联网连接在现代社会中至关重要且不断扩大的作用,以及人工智能的出现,互联网关闭引发了有关其在故意法下合法性的重要问题。”本文考虑现有的国际人道法是否为武装冲突期间的民用互联网连接和基础设施提供了足够的保护。鉴于目前的保障措施不足,本文提出了一种新的法律范式,对实体互联网基础设施和平民访问权提供特殊保护,同时提倡在数字世界中采用标志(如红十字会或蓝盾)来保护重要的人道主义通信。
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引用次数: 0
WHY WE FEAR GENETIC INFORMANTS: USING GENETIC GENEALOGY TO CATCH SERIAL KILLERS. 为什么我们害怕基因线人:利用基因谱系来抓连环杀手。
Pub Date : 2020-03-06 DOI: 10.7916/STLR.V21I1.5765
Teneille R. Brown
Consumer genetics has exploded, driven by the second-most popular hobby in the United States: genealogy. This hobby has been co-opted by law enforcement to solve cold cases, by linking crime-scene DNA with the DNA of a suspect's relative, which is contained in a direct-to-consumer (DTC) genetic database. The relative’s genetic data acts as a silent witness, or genetic informant, wordlessly guiding law enforcement to a handful of potential suspects. At least thirty murderers and rapists have been arrested in this way, a process which I describe in careful detail in this article. Legal scholars have sounded many alarms, and have called for immediate bans on this methodology, which is referred to as long- range familial searching (or "LRFS"). The opponents’ concerns are many, but generally boil down to fears that LRFS will invade the privacy and autonomy of presumptively innocent individuals. These concerns, I argue, are considerably overblown. Indeed, many aspects of the methodology implicate nothing new, legally or ethically, and might even better protect privacy while exonerating the innocent. Law enforcement’s use of LRFS to solve cold cases is a bogeyman. The real threat to genetic privacy comes from shoddy consumer consent procedures, poor data security standards, and user agreements that permit rampant secondary uses of data. So why do so many legal scholars fear a world where law enforcement uses this methodology? I surmise that our fear of so-called genetic informants stems from the sticky and long-standing traps of genetic essentialism and genetic determinism, where we incorrectly attribute intentional action to our genes and fear a world where humans are controlled by our biology. Rather than banning the use of genetic genealogy to catch serial killers and rapists, I call for improved direct-to-consumer consent processes, and more transparent privacy and security measures. This will better protect genetic privacy in line with consumer expectations, while still permitting the use of LRFS to deliver justice to victims and punish those who commit society's most heinous acts.
在美国第二受欢迎的爱好——家谱的推动下,消费者遗传学出现了爆炸式增长。这一爱好已经被执法部门用来解决悬案,通过将犯罪现场的DNA与嫌疑人亲属的DNA联系起来,这些DNA包含在直接面向消费者(DTC)的基因数据库中。亲属的基因数据充当了沉默的证人或基因信息提供者,无声地指导执法部门找到少数潜在的嫌疑人。至少有30名杀人犯和强奸犯以这种方式被捕,我将在本文中详细描述这一过程。法律学者已经敲响了许多警钟,并呼吁立即禁止这种被称为“长期家族搜索”(LRFS)的方法。反对者的担忧有很多,但通常归结为担心LRFS会侵犯假定无辜的个人的隐私和自主权。我认为,这些担忧相当夸张。事实上,这种方法的许多方面在法律上或道德上都没有什么新意,甚至可能在为无辜者开脱的同时更好地保护隐私。执法部门使用LRFS来解决悬案是一种邪恶的行为。对基因隐私的真正威胁来自劣质的消费者同意程序、糟糕的数据安全标准,以及允许猖獗的数据二次使用的用户协议。那么,为什么这么多法律学者害怕执法部门使用这种方法呢?我推测,我们对所谓的基因线人的恐惧源于基因本质主义和基因决定论的顽固和长期陷阱,在这些陷阱中,我们错误地将有意的行为归因于我们的基因,并害怕一个人类被我们的生物学控制的世界。与其禁止使用基因谱系来抓捕连环杀手和强奸犯,我呼吁改进直接面向消费者的同意程序,并采取更透明的隐私和安全措施。这将更好地保护基因隐私,符合消费者的期望,同时仍然允许使用LRFS为受害者伸张正义,惩罚那些犯下社会最令人发指行为的人。
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引用次数: 5
WHY WE FEAR GENETIC INFORMANTS: USING GENETIC GENEALOGY TO CATCH SERIAL KILLERS. 为什么我们害怕基因线人?利用基因谱系捕获连环杀手。
Teneille R Brown
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引用次数: 0
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