HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Friday, July 31, 2020

Accessibility and Open GLAM, Int’l Perspectives on Disability Exceptions in Copyright and the Visual Arts: Feeling Art

Andrea Wallace (University of Exeter), Accessibility and Open GLAM, Int’l Perspectives on Disability Exceptions in Copyright and the Visual Arts: Feeling Art, Eur. Law Blog (2020):

This chapter is approached from a community of practice perspective and explores accessibility projects for audiences with visual impairments undertaken by the GLAM sector, both online and onsite. Although the core of this activity is primarily approached through contract law and institutional policymaking, rather than IP law, an institution likely enjoys IP in the new works generated for audiences with visual impairments during reproduction. This chapter considers how new works might be subject to the same legal exceptions that apply to the in-copyright works in heritage collections, as well as the meaning of access in an age of inclusivity and equity.

July 31, 2020 | Permalink | Comments (0)

Protecting Our Health Care Providers from Liability in a Pandemic

Posted by Professor Sharona Hoffman, Contributing Editor

Cross-posted from NULR of Note

While COVID-19 creates profound medical concerns for health care providers, it also creates fear of potential lawsuits. Clinicians are forced to ration scarce resources, such as ventilators, when there is an inadequate supply. Medical professionals describe chaos in hospitals that makes it extremely difficult to treat all patients appropriately. Patients have had elective surgeries postponed indefinitely. Worse yet, some, including cancer patients, have had essential operations cancelled. All of these circumstances could lead to serious patient harm and subsequent litigation.

Medical professionals are worried, and rightly so. At this critical time, however, clinicians should be able to focus entirely on saving lives rather than on concerns about potential lawsuits.

These legal concerns are not new. In 2007, I spent a sabbatical semester at the Centers for Disease Control and Prevention (CDC) and worked on public health emergency preparedness in the aftermath of Hurricane Katrina. I wrote an article calling for comprehensive immunity protections for health care emergency responders. Such protection is more important than ever in the current pandemic.

United States law already provides immunity for some emergency responders. For example, some Good Samaritan laws protect volunteer responders from liability for negligent acts, while the Public Readiness and Emergency Preparedness Act provides immunity for the manufacture, testing, and administration of “countermeasures” in pandemics. Countermeasures are products such as drugs and devices that are authorized for emergency use. Federal and state government officials are also protected through qualified immunity, which covers those acting in their official capacities.

But existing emergency response provisions leave a startling gap. Paid health care providers may find themselves without immunity protection for much of the pandemic response work they do. Many providers work at hospitals that are overcrowded and short on supplies. What if they have to choose among desperately ill patients and deny some of them ventilators? What if a patient dies because her surgery was cancelled?  What if a doctor misclassifies someone’s surgery as elective rather than essential? What if doctors are called upon to work outside their areas of specialty or outside of state-of-the art hospital settings?  Available protections for these scenarios depend on state law, which are highly variable and inconsistent.

A few governors have heeded medical professionals’ calls for relief. The governors of New YorkNew Jersey, and Illinois recently issued executive orders with generous immunity provisions.

But this matter is too important to be left up to the discretion of busy governors in the midst of a pandemic. The public health emergency laws of all states should feature comprehensive immunity protections.

The statutes should provide that:

  1. Health care providers will not be liable for harm caused by good-faith activities in response to public health emergencies.

  2. Health care providers are covered whether they are volunteers or paid workers.

  3. Health care providers will remain liable for willful misconduct or gross negligence.

  4. Protections will be triggered by a state government’s declaration of a public health emergency.

This approach is balanced and would both encourage emergency response work and deter intentional misconduct. Immunity would provide much needed assurance to our overwhelmed and dedicated medical professionals, freeing them to concentrate on their life-saving work without worrying about the legal consequences of their good faith efforts.

-          Sharona Hoffman

July 31, 2020 | Permalink | Comments (0)

Who Knows Best (Interests)? The Case of Charlie Gard

Emma Cave (Durham University), Emma Nottingham (University of Winchester), Who Knows Best (Interests)? The Case of Charlie Gard, 16(3) Med. Law Rev. 500 (2020):

When baby Charlie Gard was diagnosed with a rare mitochondrial disease, his parents located a Professor of Neurology in the USA willing to provide nucleoside therapy which offered a theoretical chance of improvement and successfully raised £1.3 million through crowd funding. The decision that unproven therapy was contrary to Charlie Gard’s best interests and that life-sustaining treatment should be withdrawn was devastating for his parents and difficult for their supporters to comprehend. The decision was upheld at three levels of appeal and Charlie died in July 2017 aged 11 months. This commentary provides a critical analysis of the legal principles surrounding unproven treatment and application of the best interests test in the different contexts of hospital and court. It draws attention to conflicting guidance and explores differences in approach in relation to unproven treatment for adults lacking capacity and children.

July 31, 2020 | Permalink | Comments (0)

The SAMs Report ‘Towards a Sustainable Food System’ Bites the Hand That Feeds Us!

Kai P. Purnhagen (University of Bayreuth), Justus Wesseler (Wageningen University), The SAMs Report ‘Towards a Sustainable Food System’ Bites the Hand That Feeds Us! Eur. L. Blog (2020):

The Commission’s recently launched its new “farm to fork” strategy. An important input to the formulation of such kind of strategies are the reports of the scientific advisors. One of such preparatory reports for the “farm to fork” strategy is the Group of Chief Scientific Advisors’ report “Towards a sustainable food system”. We carefully evaluate its underlying assumptions, potential impact on the food system and its possibility for implementation. Unfortunately, we argue, the report falls short on each of these aspects. We will first summarize what we consider to be the content and main take-away from the report. We will then assess the report’s proposals. Finally, we will argue for a more nuanced approach to the existing governance of food systems, as the proposals from the SAM’s report metaphorically and literally risk to bite the hand that feed us.

July 31, 2020 | Permalink | Comments (0)

Healthcare Reform and Gender Specific Child Investment in Developing Countries

Juergen Jung (Townson University), Vinish Shrestha (Emory University), Healthcare Reform and Gender Specific Child Investment in Developing Countries, SSRN (2020):

We estimate whether a large scale health care reform benefits young boys more than young girls in terms of health and cognitive outcomes in the context of a developing country with labor market bias and cultural preferences favoring sons. We use exogenous variation of a health care reform, the National Health Policy, which was implemented in Nepal in 1991 along with data from the Nepal Living Standard Survey 1996. By using healthcare quality measures of health posts that provide primary healthcare as well as a constructed cost measure for accessing hospitals that provide tertiary (curative) care, we evaluate the effects of the health care reform on infant and child mortality by gender. Our results suggest that improvements in primary health care quality and cost reductions in tertiary care reduces the mortality rates of boys but does not affect the mortality rate of girls. Additionally, the findings provide suggestive evidence that differences in child health investments affect educational outcomes. We highlight the household's innate gender preference for sons, neglect of daughters' health, and differences in borrowing patterns across households with sons and daughters as potential drivers of some of the observed differences in the human capital investments of parents into boys vs. girls. Our research highlights the importance of cultural norms in the overall success of health reforms.

July 31, 2020 | Permalink | Comments (0)

Emotional Distress Claims, Dignitary Torts, and the Plaintiff-Friendly Fiction of Reasonable Sensitivity

Alessandra Suuberg, Emotional Distress Claims, Dignitary Torts, and the Plaintiff-Friendly Fiction of Reasonable Sensitivity, SSRN:

In 2019, an article in the University of Memphis Law Review considered whether individuals with a highly sensitive temperament are able to recover for intentional infliction of emotional distress (IIED), given the tort’s ‘reasonable person’ standard. The author argued that this standard discriminates against plaintiffs who are more susceptible to emotional harm than average. How has the law of IIED historically accounted for plaintiffs with underlying conditions? Here this question is addressed with respect to diagnosed and undiagnosed psychiatric vulnerabilities, including suspected or confirmed genetic predispositions, in light of continued research interest in the field of psychiatric genetics. Although scientific advances could allow plaintiffs to assert harm in new ways, alternatively shifting the focus of IIED away from the plaintiff’s vulnerabilities and toward the defendant’s conduct could return IIED to its roots as a dignitary tort and better serve the interest of individual corrective justice.

July 31, 2020 | Permalink | Comments (0)

The Paradox of Inclusion: Applying Olmstead’s Integration Mandate in Prisons

Jamelia Morgan (University of Connecticut), The Paradox of Inclusion: Applying Olmstead’s Integration Mandate in Prisons, 26(2) Geo. J Poverty Law Pol’y (2020):

In this essay, I discuss Olmstead and some potential opportunities and barriers to implementing Olmstead’s integration mandate in prisons. In particular, I address what I term the paradox of inclusion with respect to applying the integration mandate in prison. Recognizing that the central features and function of prisons conflict with the animating spirit of Olmstead, I discuss what is at stake in legal advocacy aimed at providing greater access and inclusion for people with disabilities in these carceral spaces. I contend that precisely because Olmstead conflicts with some of the central features and functions of the American punishment system, the Olmstead decision possesses properties that may allow for a more transformative reimagining of the rights of all incarcerated people, in addition to incarcerated people with disabilities.

 

July 31, 2020 | Permalink | Comments (0)

The Internal Market, Incomplete: EU, Dutch and Belgian Legislation on Maximum Food Fortification with Micronutrients

Lisa van der Meer, Hanna Schebesta (Wageningen University), The Internal Market, Incomplete: EU, Dutch and Belgian Legislation on Maximum Food Fortification with Micronutrients, Wageningen Law Series (2020):

The article shows that food fortification legislation at the EU level leaves the achievement of the internal market incomplete. Regulation (EC) No 1925/2006 on the addition of vitamins, minerals and certain other substances to foods regulates the addition of micronutrients to food. A regulatory check of two markets in the European Union (EU) shows that EU countries at national level take diverging approaches to food fortification. In the Netherlands, food fortification with vitamin A (in the form of retinoid), selenium, copper and zinc is prohibited if it concerns food fortification in the strict sense. This regime is subject to an exemption authorisation scheme. The main reason why food fortification with some substances is not allowed in the Netherlands is because the range between the Recommended Daily Average (RDA) and the maximum Tolerable Upper Intake Level (UL) is too small. A safe level of intake would then not be much higher than the RDA. In this article, the different ranges between the RDA’s and the UL in the Netherlands, Belgium and the EU have been compared. Following the results of this report, these ranges do not seem to differ substantially and therefore, a priori do not seem to be a convincing scientific argument for divergent legislation on whether or not to prohibit food fortification with specific micronutrients. The results are discussed in light of EU regulation of on the addition of vitamins and minerals and the free movement of goods.

 

July 31, 2020 | Permalink | Comments (0)

Thursday, July 30, 2020

Resolving Tensions Between Disability Rights Law and COVID-19 Mask Policies

Elizabeth Pendo (St. Louis University), Robert Gatter (St. Louis University), Seema Mohapatra (Indiana University), Resolving Tensions Between Disability Rights Law and COVID-19 Mask Policies, St. Louis U. Legal Stud. Research Paper No. 2020-10:

As states reopen, an increasing number of state and local officials are requiring people to wear face masks while out of the home. Grocery stores, retail outlets, restaurants and other businesses are also announcing their own mask policies, which may differ from public policies. Public health measures to stop the spread of the coronavirus such as wearing masks have the potential to greatly benefit millions of Americans with disabilities, who are particularly vulnerable to the impact of COVID-19. But certain disabilities may make it difficult or inadvisable to wear a mask.

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July 30, 2020 | Permalink | Comments (0)

Can Faculty Be Forced Back to Campus?

Arlene S. Kanter (Syracuse University), Can Faculty Be Forced Back to Campus? Chron. Higher Educ. (2020):

This essay discusses the right of faculty to work from home during this COVID-19 pandemic. Various laws, including the Americans with Disabilities Act, provide protections for faculty who do not feel safe returning to campus.

 

July 30, 2020 | Permalink | Comments (0)

Screens, Teens, and Porn Scenes: Legislative approaches to protecting youth from exposure to pornography

Byrin Romney, Screens, Teens, and Porn Scenes: Legislative approaches to protecting youth from exposure to pornography, 45 Vt. L. Rev. (2020):

Internet access is an essential part of daily life for most children. Due to the lack of online protections, American children have unrestricted access to the largest and most extreme adult video library in the history of the world. Consequently, children are being exposed to pornography at unprecedented rates.

A child's first exposure to pornographic material is generally around 11 years old. Some seek it intentionally while others stumble upon it by accident. Adolescents are more susceptible to being influenced by pornography because of the significant physical, emotional, cognitive, and sexual changes associated with adolescent development.

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July 30, 2020 | Permalink | Comments (0)

GMO Corn, Mexico, and Coloniality

Ernesto Hernandez Lopez (Chapman University), GMO Corn, Mexico, and Coloniality, 22(4) Vand. J. Ent. Tech. L 725 (2020):

Genetically modified (“GMO”) corn germinates legal controversies in México. Since 2013, Mexican courts have temporarily suspended GMO corn because it threatens biodiversity. In the Colectividad del Maíz lawsuit, courts have prohibited México from issuing commercial GMO permits while the litigation continues. Companies like Monsanto need these permits to sell GMO seeds. Corn is the most essential food item for millions of Mexicans and is central to Mexican culture. Mexicans wait for Colectividad del Maíz’s resolution, siding with biodiversity or GMOs. This Article describes scientific GMO controversies and analyzes biosecurity, class-action, and international environmental law. It argues that this corn fight feeds larger moral questions about biotechnology and México’s sovereignty. Courts and policy makers respond to these controversies with their sovereign powers. Decolonial theory shows how assumptions about economics, law, and ideology rooted in historical colonial structures—“coloniality”—shape these responses. This Article illustrates the significance of coloniality to how the government responds to GMOs, at a time when GMO safety is increasingly questioned in México and elsewhere.

 

July 30, 2020 | Permalink | Comments (0)

Race Selective Abortion Bans: A New Way to Prevent the Elimination of Minority Groups in the United States

Tysharah Jones (Regent University), Race Selective Abortion Bans: A New Way to Prevent the Elimination of Minority Groups in the United States, SSRN:

This article will address whether race selective abortion bans infringe on a women’s right to obtain an abortion when the state has a compelling interest in protecting against the elimination of a race through modern day eugenics. Section I discusses how abortion jurisprudence has developed over time. Section II discusses race selective abortion bans. Section III examines and analyzes selective - abortion bans, specifically race-selective abortion bans. Section IV presents numerous solutions for addressing the high abortion rate in different community settings and the prevention of abortion being used as a form of modern-day eugenics. The objective of this article is to educate on the current status of race selective abortion laws in the United States, and to place that knowledge in the context of the history of the eugenics movement.

July 30, 2020 | Permalink | Comments (0)

Comments on the EU White Paper on AI: A Regulatory Framework for High-Risk Healthcare AI Applications

Anastasiya Kiseleva (Vrije Universiteit Brussel), Comments on the EU White Paper on AI: A Regulatory Framework for High-Risk Healthcare AI Applications, SSRN:

The EU White Paper on AI mentions healthcare as one of the sectors where AI applications might pose high risks. These comments provide the vision on the regulatory framework for high-risk healthcare AI applications. The key takeaways concern transparency, preventing bias, safety and quality of AI applications used for medical purposes. I suggest that the transparency of AI shall not be equated to its explainability. To increase transparency and ensure the safety of AI healthcare applications, cooperation between manufacturers and users of AI (healthcare providers) shall be improved. I highlight that biased AI decisions alert on the inaccuracy of algorithms. While discrimination and stigmatization are difficult to identify and prove, especially for AI and especially for healthcare, controlling of AI’s accuracy is an efficient tool to prevent and mitigate biases in AI systems. Finally, I briefly compare the two regulations that might apply to AI tools in healthcare - the Medical Devices Regulation (EU) 2017/745 (MDR) and the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). I conclude that the IVDR is more tailored to AI characteristics while it is more detailed and more focused on data quality and relevance. Thus, the IVDR rules can be a good starting point for clarifying and implementing a regulatory framework for high-risk AI healthcare applications.

July 30, 2020 | Permalink | Comments (0)

Wednesday, July 29, 2020

Drowsy Driving Considerations in Non-Commercial Drivers for the Sleep Physician

Ann Marie Marciarille (University of Missouri at Kansas City), Anand Bhat, David Ingram (Children’s Mercy Hospital), Damien Stevens (University of Kansas), Drowsy Driving Considerations in Non-Commercial Drivers for the Sleep Physician, J. Clinical Sleep Med. (2019):

The sleep physician faces many challenges in the assessment of drowsy driving. The following article reviews current clinical evaluation methods and legal considerations at the state level in the United States.

July 29, 2020 | Permalink | Comments (0)

The Walmart Effect: Testing Private Interventions to Reduce Gun Suicide

Ian Ayres (Yale University), Zachary Shelley (Yale Law School), Fredrick E. Vars (University of Alabama), The Walmart Effect: Testing Private Interventions to Reduce Gun Suicide, SSRN:

This article tests the impact of Walmart’s corporate decisions to end the sale of handguns at its stores in 1994 and to discontinue the sale of all firearms at approximately 59% of its stores in 2006 before resuming firearms sales at some of those stores in 2011. Using a difference-in-differences framework, we find that that from 1994 to 2005 counties with Walmarts robustly experienced a reduction in the suicide rate and experienced no change in the homicide rate. These models, which control for a variety of legal, social and demographic variables, as well as county and time fixed effects, suggest that Walmart’s policy change caused a 3.3 to 7.5% reduction in the suicide rate within affected counties – which represents an estimated 5,104 to 11,970 lives saved over the studied period (425-998 per year). These reductions were particularly pronounced in counties in large metropolitan areas, with lower indicia of social capital, and with weaker gun control laws. We also find a separate, statistically significant (though only corollary) impact of gun control laws – with a one standard deviation increase in the number of gun laws correlated with a 0.2 to 14.4% decrease in suicide rate. In contrast, Walmart’s 2006 and 2011 decisions to discontinue and subsequently resume the sale of rifles and shotguns in many of its stores was not associated with a robustly measured effect on homicide or suicide rates. We do find evidence that Walmart’s 2006 decision to reduce the number of its stores that sold firearms caused a statistically significant reduction in the suicide rate for counties in which Walmart did not subsequently resume firearms sales.

July 29, 2020 | Permalink | Comments (0)

Summoning a New Artificial Intelligence Patent Model: In the Age of Pandemic

Shlomit Yanisky-Ravid (Yale Law School), Regina Jin, Summoning a New Artificial Intelligence Patent Model: In the Age of Pandemic, SSRN:

To combat the fast-moving spread of the pandemic we need an equally speedy and powerful tool. On the forefront against COVID-19, for example, AI technology has become a digital armament in the development of new drugs, vaccines, diagnostic methods, and forecasting programs. Patenting these new, nonobvious, and efficient technological solutions is a critical step in fostering the research and development, the huge investments as well as the commercial processes. This article considers the challenges of the current patent law as they apply to AI inventions in general and especially in the age of a global pandemic. The article proposes a novel solution to the hurdles of patenting AI technology by establishing a new patent track model for AI inventions (including the inventions that are made by AI systems and creative AI systems themselves). Unlike other publications promoting either complete abandonment of AI related patents, or advocating to maintain current patent laws, or recommending minor adjustment to patent laws, this article suggests a novel model of separate patent venue solely targeting AI inventions. The argument of this article is based on four pillars: the difficulty of having a patent-eligible subject matter, the hurdle of the “blackbox” conundrum, the confusion of who is “a person of ordinary skills in the art” (“POSITA"), and the criticality of establishing a new AI patent track model, a crucial step, especially during a global epidemic.

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July 29, 2020 | Permalink | Comments (0)

Vaccine Hesitancy: Experimentalism as Regulatory Opportunity

Ana Santos Rutschman (Saint Louis University), Timothy L. Wiemken (Saint Louis University), Vaccine Hesitancy: Experimentalism as Regulatory Opportunity, St. Louis U. Legal Stud. Research Paper No. 2020-13:

This symposium on patient innovation has prompted us to explore problems related to departures from official vaccination schedules. At a time in which vaccine confidence has been plummeting across the world, we argue that a more granular understanding—and ultimately a more finely tuned regulatory framework—is needed to reflect the current behavioral heterogeneity among indicated patients who choose to forego or delay administration of recommended vaccines. In particular, we focus on a phenomenon we term “vaccine staggering:” a departure from vaccination schedules in the form of delays in receiving one or more vaccines, which is motivated by the desire to boost the efficacy of each vaccine received by a child or adult.

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July 29, 2020 | Permalink | Comments (0)

Tort of Medical Negligence in Pro Bono Cases

Shivansh Shukla (NALSAR University of Law), Tort of Medical Negligence in Pro Bono Cases, SSRN:

Indians, of late, have risen to the challenge of healthcare and increased their efforts to provide healthcare facilities to their underprivileged compatriots. This is primarily being done through NGOs and other organizations many of which are funded by the Government. One of the most popular ways to do so have been establishment of health centers which provide the poor with free of cost health services. As we know, instances of malpractice and negligence, unfortunately, have penetrated into every known field and medical field is no exception to this. The usual legal cases of medical negligence are usually covered under the Consumer Protection Act, 1986 but not the cases of negligence and malpractice in the above mentioned health camps because the poor beneficiaries don’t qualify as “consumers” since they haven’t paid any sort of consideration for the services they availed. This research paper seeks to bring to light the role of NGOs and social activists as primary and secondary health care providers in India, unearth their underlying issues but at the same time, lends a special eye to the instances of medical negligence in their camps. The paper in its quest to do so, tries to answer few questions like whether those poor people have any remedy and if yes, then how can they avail it? And whether there is need for procedural guidelines and policy considerations to safeguard the rights of poor and save them from the vicious legal cycle of this country?

 

July 29, 2020 | Permalink | Comments (0)

Does Precise Case Information Limit Precautionary Behavior? Evidence from COVID-19 in Singapore

Aljoscha Janssen, Matthew H. Shapiro, Does Precise Case Information Limit Precautionary Behavior? Evidence from COVID-19 in Singapore, SSRN:

Limiting the spread of contagious diseases can involve both government-managed and voluntary efforts. Governments have a number of policy options beyond direct intervention that can shape individuals’ responses to a pandemic and its associated costs. During its first wave of COVID-19 cases, Singapore was among a few countries that attempted to adjust behavior through the public provision of detailed case information. Singapore's Ministry of Health maintained and shared precise, daily information detailing local travel behavior and residences of COVID-19 cases. We use this transparency policy along with device-level cellphone data to quantify how local and national COVID-19 case announcements trigger differential behavioral changes. We find evidence that individuals are three times more responsive to outbreaks in granularly defined locales. Conditional on keeping infection rates at a manageable level, the results suggest economic value in this type of transparency by mitigating precautionary activity reductions.

July 29, 2020 | Permalink | Comments (0)