This article offers another ‘take’ on the lively and current discussions beingheld on the outline of bioethical principles and legal regulation of artificialintelligence technologies, in the areas of medicine and health. It examines towhat extent women’s interests and feminist agendas are taken into account inthese discussions. For this purpose, the article focuses on the FemTech industry.It is specifically interested in AI-based technologies in the area of medicine andhealth that targets women and is focused on female issues. By doing so, thearticle studies the crossroads between AI-based technologies’ regulation,devices in favor of medicine and health, and technologies targeted for women.Based on empirical illustrations, and in light of the current positive law, thearticle explores the bioethical and legal dilemmas in the FemTech Industry froma feminist perspective. It specifically asks whether the use of AI in the FemTechindustry can be considered feminist. In other words, it explores whether thetechnologies that aim to treat women’s health, address new challenges facingfeminist ethics or social philosophy, or if they simply raise old bioethicalquestions in relation to new technologies. The article looks at the advantages,alongside the challenges, of AI-based FemTech devices from a feministperspective. Additionally, it sets the grounds for a feminist regulatory andethical policy, with respect to AI-based medical devices.
This article is a comparative study of the U.S. Drug Supply Chain SecurityAct, the EU Falsified Medicines Directive, and Taiwan’s pharmaceutical trackand trace system. This comparative approach will highlight the commonalitiesand differences in these various frameworks as they relate to pharmaceuticaltrack and trace and assess how these systems can learn from each other. Thearticle will provide a springboard for discussing an international framework forpharmaceutical track and trace, focusing on legal and operationalinteroperability. The core of the article will revolve around the need for nationalpharmaceutical track and trace systems to be interoperable with other nationalor regional systems. It will further emphasize how a collaborative internationalapproach is necessary to ensure the full effectiveness of the pharmaceuticalsupply chain. This article will give special attention to Taiwan’s pharmaceuticaltrack and trace system, providing a description of Taiwan’s pharmaceuticaltrack and trace regime and the elements necessary for its success, itsweaknesses, and opportunities for growth in a global track and trace system. Byintegrating the provisions of Taiwan’s Pharmaceutical Affairs Act, associatedregulations, and data from various sources, the Taiwanese government hassuccessfully created a comprehensive track and trace system for pharmaceuticalproducts. Integration among government systems in Taiwan further enhancesthe track and trace ecosystem’s comprehensiveness, enabling data to undergovarious verification and auditing processes. Finally, this article will argue thatnational track and trace systems should be interoperable with other national andregional systems to guarantee complete protection of the pharmaceutical supplychain. Therefore, this article will conclude with a proposal for a worldwideunified, interoperable, and digital platform for pharmaceutical track and trace.
For three decades, the federal agency charged with administrative oversightof the Federal Health Care Programs Anti-kickback statute, the Office of theInspector General of the Department of Health and Human Services, has advisedthat paying for marketing and advertising of covered health care items andservices should be treated as “at most a technical violation” of the law. OIG hasnoted that enforcement should be limited to cases where certain “suspectcharacteristics” are present and has issued several advisory opinions decliningenforcement in the case of commission-type payments to independent salesagents. In contrast, in the last twenty years, obiter dicta in a number of judicialdecisions upholding criminal convictions have described such commissions asa per se violation of the law. Left unchallenged, this rhetorical inflation presentsunjustified risks of enforcement to medical device makers for nothing morenefarious than selling their products in accordance with widespread industrynorms that do not implicate any of the purposes underlying the Anti-kickbackstatute. More important, these decisions have the potential to distort the healthcare economy through economically disadvantageous allocations of resources:the wastefulness of unwarranted enforcement on the one hand, and on the other,discouraging innovation by imposing additional costs on medical productmakers, especially the often small, entrepreneurial, one-product companies thatdominate the medical device industry, and do not have the resources to use afully-employed sales force. This article attempts to remedy these risks byshowing that, dicta in the opinions notwithstanding, the facts in those cases trackthe agency’s guidance, upholding convictions only when suspectcharacteristics—chiefly that the sales personnel are not truly independent salesrepresentatives but are in a position to exercise undue influence over referraldecisions—have been present. Presenting an independent but parallel argument,the article also examines a recent Supreme Court case narrowing the meaningof the term “induce” in an analogous criminal statute, and shows how this newauthority also (perhaps even more strongly) supports the conclusion that theAnti-kickback law may not be used to prosecute ordinary commissions. In thehope that it also will influence courts and lead to a more fair, accurate andpragmatic Anti-kickback law jurisprudence, the article concludes with anAppendix containing recommendations for joint OIG/Department of Justiceguidance that aligns the rules for enforcement discretion with this reality,instructing the bringing, or joining, of enforcement cases only when thepresence of suspect characteristics creates a genuine risk of the fraud and abuse evils that the statute was designed to prohibit.
route of administration (e.g., oral, topical, injectable) as the brand-name. 1 The innovator/brand-name and generic sectors are differentiated less by the substance of their drugs and more by their business models, strategies, operations, goals, and challenges.Innovators invent and patent medicines, which are marketed exclusively by the patent holder during the patent(s) life.Generic firms target weak patents or off-patent drugs, copy the formula, and sell a "generic" form of the innovator's medicine at a discount.Thus, patent expiration or invalidation results in competition, lower prices, and higher access as generics and innovators market interchangeable products to the same patients.Although generics rely on innovators to invent the next product, short-term success can be mutually exclusive when the two share a market.As innovators' patents age, generic suitor(s) prepare to launch-which may be done "at-risk" (i.e., before the innovator's patent expires) if the generic firm believes a patent is invalid-a discounted, interchangeable version of the original drug.At this stage, the Hatch-Waxman process (to be discussed) for generic entry draws the parties into negotiations.Sometimes, and particularly beneficial to patients struggling with affordability, the parties enter a settlement to allow generic entry prior to patent expiration.In its study of generic entry prior to patent expiration, the Federal Trade Commission ("FTC") identified that "in 7 of the 20 final settlements, the brandname company granted a license to the generic applicant to use the patents that cover the brand-name drug product prior to patent expiration so that the generic applicant could market under its [abbreviated new drug application]" ("ANDA"). 2Another FTC study showed opposite outcomes, where among 218 settlement agreements, "66 final agreements involved some form of compensation from the brand to the generic combined with a delay in generic entry." 3 While not in the majority, these 66 agreements represent "pay-for-delay"-a concerning tactic leveraged by some patent holders to delay generic competition and prop up monopolies. 4As a result, patients "miss out on generic prices that can be as much as 90% less than brand prices.For example, brand-name medication that costs $300 per month might be sold as a generic for as little as $30 per month." 5 Regardless of who (e.g., patient, insurer, taxpayer, public program) pays what "price" (e.g., copays, insurance premiums, list price), the difference between brand and generic price is not small.6. KAISER FAM.FOUND., Poll: Nearly 1 in 4 Americans Taking Prescription Drugs Say It's Difficult to Afford Their Medicines, including Larger Shares Among Those with Health Issues, with Low Incomes and Nearing Medicare Age (Mar.2019), https://www.kff.org/health-costs/pressrelease/poll-nearly-1-in-4-americans-taking-prescription-drugs-say-its-difficult-to-affordmedicines-including-larger-shares-with-low-incomes/[https://perma.cc/BSU2-A3RB].7. Id.
By contrast, philosophers of medical ethics have wrestled with the complexity of determining medicine's proper scope for at least half a century. 8rawing on this more rigorous debate could help refine and clarify legal standards governing prescribing.However, such an effort would have to contend with the fact that the philosophical literature on this question is strikingly inconclusive.Some prominent bioethicists contend medicine is defined by an "internal morality" that defines its scope.For example, some claim the essence of medical practice is healing, so that actions taken for other purposes, such as enhancing one's physical appearance, do not qualify as medical in nature and are therefore improper for physicians to perform. 9Others deny medicine's scope is limited by any internal morality, instead insisting that judgments regarding the propriety of physicians' conduct must be governed by considerations external to the practice of medicine. 10In this view, as long as cosmetic surgery is ethical in general (e.g., under universal moral principles), it is ethical for physicians to engage in that practice.There is no essential nature of medicine that physicians would transgress in so doing.Happily, this debate need not be resolved in order for the law to benefit from it.Rather than seeking to determine what medicine's "true" nature is, it may be useful to examine the various conceptions offered by these observers and seek an account that is consonant with existing legal standards while also helping refine them.Not every account of medicine's proper scope is equally suitable for informing the legal standards governing prescribing."Internal" accounts that reject nontherapeutic practices as "non-medical" are flatly inconsistent with existing law, which countenances cosmetic surgery, vasectomies, and other nontherapeutic practices as within medicine's ambit.Conversely, external accounts that deny the existence of an internal morality of medicine without providing an alternative definition of medicine's scope are of little use when specifying which acts doctors can lawfully perform.What is needed is a standard that is broadly consistent with existing legal standards, but that helps clarify them.An account of medicine's scope offered by philosopher Christopher Boorse meets these criteria.Although Boorse takes no position regarding whether medicine is governed by an internal morality, he argues that if such a morality exists, it is a broad one. 11Rather than limiting the practice of medicine to treating illnesses, in this view doctors can provide a wide range of interventions as long as they are seeking to use their expertise and skill
The musical Annie Get Your Gun tells the story of real-life sharpshooter Annie Oakley, "[a] backwoods gal" who defied gender norms by using her marksmanship skill to support her family by selling game. 1 After she was persuaded to join a Wild West Show, she quickly eclipsed the show's leading man and star marksman, Frank Butler, thereby jeopardizing her chance at romance with him. 2 "Anything You Can Do" is a duet between the two characters in which both attempt to assert their superiority over the other before a competition.Annie is only able to ensure the future of their romance by pretending to lose to Frank during a shoot-out, 3 illustrating not only the historic fragility of the male ego, but also the requirement for many women to dim their lights for the love of men.Annie's story is not unique for the women of her time (the early 1900s), but today's girls and women often still must tiptoe around the egos of boys and men to receive their love and admiration-or to simply avoid their ire.Misogyny persists, and sometimes it shows its ugly head in the oddest of places-like a transgender girls sports ban.In recent years, several state legislatures have enacted legislation intended to prevent male-to-female transgender students from participating on the sports teams which affirm their gender identities. 4 Legislatures frame this legislation as protective in nature, the purported intention being to protect equality in women's and girls' sports by limiting access to biologically female student athletes.Idaho was the first state to enact such legislation with its 2020 Fairness in Women's Sports Act. 5 The Idaho law reaches collegiate athletes and purportedly tracks various biological, psychological, and judicial rationales which suggest that biologically male athletes possess inherently superior athletic ability due to their sex-based characteristics.Based on these purported justifications, the law requires designation of sports teams as only male, female, ----------------
Lead has an old and even ancient legacy of harm to humans. 1 Despite this history, lead was widely used in the development of consumer goods used for and around children in the United States during the industrial era. 2 The decision to use it in two widely distributed commercial products created a public health nightmare.Leaded gasoline and leaded paint robbed countless children and adults of opportunities for greater economic prosperity, educational achievement, and deeper social engagement. 3Moreover, death and disease have been visited upon millions of unsuspecting families and individuals around the world because of their exposure to lead. 4 In the United States alone, deaths attributable to lead exposure have been estimated at over four hundred thousand. 5 At the global level, the World Health Organization has made the following determinations:Lead exposure can have serious consequences for the health of children.At high levels of exposure to lead the brain and central nervous system can be severely damaged, which could result in a coma, convulsions, and even death.Children who survive severe lead poisoning may be left with permanent intellectual disability and behavioral disorders.At lower levels of exposure that cause no obvious symptoms, lead is now known to produce a spectrum of injury across multiple body systems.In particular, lead can affect children's brain development, resulting in reduced intelligence quotient (IQ), behavioral changes such as reduced --------------
I remember the heartbreak I felt when my best friend deserted me shortly after our wedding . . .I spiraled into an even deeper depression, leading to my resignation from Apple and eventual homelessness in North Carolina.Events turned even more harrowing when an unfortunate encounter with the police led to my hospitalization and official diagnoses of psychosis, schizophrenia, and bipolar disorder.All these experiences hammered home the true weight of loneliness. 1Although the study of America's homelessness epidemic has deepened in the past two decades, 2 public narratives about homelessness are misconceived and inconsistent.When we look beyond the numbers and delve into accounts of advocates like Jha'asryel-Akquil Bishop, whose lived expertise offers a heartbreaking perspective of homelessness, policing, and mental illness, we realize how increased access to voluntary, community-based mental health supports and decriminalization are necessary means to ending homelessness.Personal accounts also reinforce how conditions of homelessness are intrinsically intersectional.Predominantly Black and Brown racial and ethnic -----------------------------* Siya (she/her) is a civil and human rights lawyer at the National Homelessness Law Center (NHLC), based in New York City, where she is building strategic litigation and policy advocacy capacity in the movement to decriminalize homelessness and make housing a
Elder law and disability law have historically developed separately, with minimal interaction. However, there are many similarities and shared interests between both fields and both groups – older persons and persons with disabilities. This paper is the first attempt to comparatively analyze the legal academic publications that have addressed both disability and older persons’ rights in the last two decades. Using a systematic scoping review methodology, we quantitatively analyzed 180 articles published in the last two decades in legal journals and qualitatively analyzed seventeen of these articles that directly address the relationship between both fields. This systematic review yielded a comprehensive up-to-date quantitative and qualitative picture of the relationship between disability law and elder law. Our findings show that current comparative literature is one-directional, as it is ‘old-age-based’ and ‘disability-focused’. The analysis produced five elements characterizing the relationship between the two fields: similarities, differences, tension, separation efforts and bridging efforts. Discussing these findings, this paper suggests two different narratives to explain the revealed relationship. One emphasizes the subtle manifestations of ageism in disability studies and disability law and ableism in gerontology and elder law. The other highlights the different histories of both fields and the human rights movements they serve. More broadly, the paper demonstrates the benefits of a systematic scoping review as an empirical methodology for comparative research generally, and specifically, the opportunities that an open dialogue between elder law and disability law provides.
The United Nations General Assembly held the first-ever High-Level Meeting on Tuberculosis in 2018 (the TB UNLHM). In the Political Declaration that followed, Heads of State made ambitious pledges to end TB and drug resistant TB by 2030. Among these were pioneering legal and human rights commitments on the right to health, non-discrimination, and access to medicines. In 2020 and 2023, the UN Secretary-General and World Health Organization released reports examining countries’ progress toward the UN pledges. The reports discuss some human rights initiatives and contain data for key targets, such as reductions in TB incidence and deaths, but they do not empirically evaluate progress toward the legal and human rights commitments. This paper fills this gap by reviewing law and policy in ten countries with high burdens of drug-resistant TB. It develops the TB UNHLM Legal Rights Index modeled on the Human Development Index, comprising quantitative indicators for the legal and human rights pledges. Using this empirical framework, this paper evaluates over 150 legal instruments from the ten countries and finds that each has failed to meet all three commitments. The results nonetheless demonstrate significant variation among the countries and highlight challenges and opportunities as they work to fulfill their pledges in the new Political Declaration from the second TB UNHLM held in September 2023.
Under Indiana Code Section 20-35-4-1.5, schools have a duty to educate students with a disability. 1 However, due to ineffective disciplinary measures in schools, students with debilitating behavioral health disorders are not receiving the education they are due. This Note will explore why Indiana should adopt legislation like New York’s ‘Timothy’s Law’ to allow for insurance coverage of Multisystemic Therapy to be implemented in schools as an alternative to other disciplinary actions for students diagnosed with disruptive behavioral disorders, and in particular, Oppositional Defiant Disorder (ODD). Specifically, this Note will begin with a hypothetical scenario of a young child diagnosed with ODD who did not receive proper treatment of his disorder. This Note will then outline what ODD is, its history, and discuss how it is currently treated. Next, this Note will outline how schools are affected by Oppositional Defiant Disorder and how this directly contributes to juvenile incarceration rates. This Note will then propose a solution to juvenile incarceration rates of children with ODD by proposing that schools implement multisystemic therapy programs, modeled after a Californian logic model. During this proposal, this Note will discuss what Multisystemic Therapy is and how it would look in a school setting. This Note will further outline the cost of implementing the program and analyze how Indiana legislation currently has passed some legislation that can off-set the cost of the program. Finally, this Note will recommend further legislative changes like New York’s “Timothy Law” that will allow for insurance coverage of the therapy.
These patterns suggest that the consolidation concerns initially raised regarding ACOs were warranted and that gains from care coordination facilitated by ACOs will have to be balanced against higher prices and possibly lower-quality care that could result from consolidation.").4.
On June 12, 2016, a man walked into a popular gay dance club in Orlando, FL and opened fire. 1 At the time, the Pulse shooting was called the deadliest mass shooting in United States history, with at least forty-nine dead and dozens more injured. 2This horrific hate crime targeted directly at the LGBTQ community during Pride festivities came after the Supreme Court handed down its landmark marriage equality decision in Obergefell v. Hodges, 3 increasing queer visibility throughout the country. 4Large swaths of the country came together to support the victims of the Pulse nightclub shooting, with local and national government officials issuing statements, vigils across the country, and the President and Vice President of the United States meeting with survivors and victims' families. 5This outpouring of support after Pulse was in stark contrast to the complete lack of response from government or public officials after the 1973 arson attack on the UpStairs Lounge in New Orleans, the previously most deadly incident targeting the LGBTQ community. 6 After thirty-two people, among them pro-LGBTQ church-goers, were killed in the fire, local and state officials almost entirely ignored the event. 7 Local churches even refused to host funerals for the victims of this arson. 8While both tragedies showcase clear targeting of the LGBTQ community, the government's response after the Pulse shooting showed a shifting of the tides toward acceptance, understanding, and recognition.Federally, it appeared that the United States was making positive progress for the queer
We shape our buildings; thereafter our buildings shape us."-Winston Churchill 1As our climate changes, our building practices must also change.Conventionally built infrastructure will deteriorate as natural disasters become more prevalent and severe.Additionally, built environments contribute to the worsening effects of climate change by generating over 40% of annual global carbon dioxide emissions. 2Implementation of green building codes, which consider durability and sustainability in the materials, design, and components of construction, can lower the environmental impact from conventional buildings while creating resilience and protection from the effects of climate change.In 2021, the Indiana General Assembly added Public Law 180 (PL 180) to Indiana's Home Rule statute, historically a statute which grants broad power for self-government to local communities.Instead, PL 180 preempts local Indiana governments at the state level, prohibiting them from requiring that their built environments be constructed with any energy-saving or -producing designs, components, or materials. 3 Additionally, PL 180 reinforces Indiana's dependence on fossil fuel powered energy sources and delays our inevitable shift to renewable energy production, causing higher utility bills for Hoosiers and maintaining vulnerability to power outages.Rumored to be enacted for the benefit of gas and construction companies, PL 180 unnecessarily takes power from local Indiana governments to protect residents from the effects of climate change that are forecasted to become severely destructive in our near future.
descent. 2 SCD is also the most common genetic disease in the US, as 1 in 12 African Americans carry the autosomal recessive mutation on one allele, and 1 in 500 African Americans are born with the disease due to inheritance of two mutated alleles. 3 The sickle cell mutation causes red blood cells to "sickle" and clump when partially depleted of oxygen causing the clots and subsequent ischemia that instigate the various SCD syndromes. 4 The numerous SCD syndromes include ischemic (venous stasis) leg ulcers, avascular necrosis of the hip, shoulder, or knee, cholecystitis or gallbladder colic, priapism, headache, and gout. 5However, the lifelong and unpredictable vaso-occlusive crisis pain which most necessitates consistent management, also makes SCD treatment so problematic. 6 Opioid analgesics are the well-established treatment for SCD, and there is no ethical controversy in administering opioids to SCD patients experiencing acute pain. 7 Early intervention with fluids and opioids is very important, because aborting VOC pain can prevent extensive tissue damage. 8 Nevertheless, despite all the evidence supporting treatment with opioids, SCD patients are often refused long-term pain management or are prescribed medications with lower efficacy than opioids. 9Unfortunately, there is no quick fix to this problem because SCD patients not receiving the care they need due to numerous impeding factors.Section 1 of this paper discusses the issues driving health care disparities and inequities in patients with SCD, including issues of past and present racial bias along with the deficient evidence driving health policy.Section 2 discusses the potential legal remedies SCD patients can seek when failed by the health care though Mediterranean populations are now more likely to inherit Thalassemia than Sickle Cell Disease.See
