Health law in an incredibly broad and dynamic field centered around technology. The field is ever changing as health care law and technology advance. In some aspects, the field is advancing as medical technology improves. However, the COVID-19 pandemic produced significant questions and concerns regarding technology and health disparities.

Last week, the Jaharis Health Law Institute hosted a Spring Symposium addressing Health Disparities: Is Technology the Answer? Ana Santos Rutschman, Assistant Professor of Law, Center for Health Law Studies at Saint Louis University School of law, discussed the production and distribution of COVID-19 vaccines with respect to health law related issues. She highlighted that to some extent, the law and society treat vaccines and other life-saving goods as commodities.

How do we as society produce vaccines and allocate emerging health goods at such a rapid rate? Professor Rutschman explained that the production of COVID-19 vaccines are subject to contracts and reflect an intellectual property framework. Generally speaking, she noted that scientifically, the United States succeeds in producing critically needed health goods, vaccines in particular. For example, the United States controlled the Ebola virus outbreak, and in record timing, approved the Ebola vaccine.

Even with the ability to produce critical health goods at such a rapid pace, the United States struggles to distribute vaccines equally among minority racial and ethnic groups. Theories of inequalities in distribution and production of COVID-19 vaccines reflect under-enrollment of racial minorities in clinical medical trials. Professor Rutschman, quoting Dr. Anthony Fauci, mentioned that COVID-19 clinical trials failed to properly reflect the racial and ethnic makeup of the United States. The law requires some representation of minorities but this minimum is very low compared to actual numbers.

Vaccines in particular come with data and trust deficits which cause uncertainty among minority communities. Professor Rutschman believes minorities are systematically short changed within the field of health. In order to make a difference and combat health disparities, Professor Rutschman argues that meaningful changes are required. Vaccine distribution and contract law must work together. Systematic changes are needed. The government can correct some inefficiencies regarding vaccine production and distribution, however administrative changes are needed to do so.

COVID-19 has exposed the structural barriers at the root of health disparities in the United States. This year’s Jaharis Symposium focused on the premise that while technological advances have the potential to revolutionize the delivery of health care, they also raise significant questions about who has access to these innovations and whether they are advancing the interests of the populations with the greatest needs.

As part of this symposium, Valarie Blake, a Professor of Law at the University of West Virginia, presented her research on telehealth in rural America with a focus on the Appalachian region. Professor Blake explained that the health status of Appalachians is near the bottom of America when it comes to health outcomes, such as poisoning deaths, diabetes deaths, HIV prevalence, and more. This is due in part to the many tangible and intangible barriers that people living in rural Appalachia face when it comes to healthcare, such as a lack of sufficient healthcare force, travel barriers, low health literacy, the normalization of poor health, and a general mistrust of medical professionals. Telehealth could be a solution to some of these barriers, Professor Blake explained, but it cannot and should not be the only option. Telehealth has the potential to address problems with transportation and provider shortages, but poor internet speed and coverage can bring more issues. Furthermore, the advent of telehealth presents significant long-term challenges in areas such as quality of care, privacy, fraud, and equality. For example, safeguards are needed for long-term prescribing of controlled substances, many rural states lack sophisticated fraud detection forces, and the lifting of HIPAA enforcement, while meant to improve the speed of entry into telehealth, may be an unnecessary deregulation. For these reasons, Professor Blake argued that telehealth should be considered an additional service to in-person care, and not the sole tool in making healthcare services equally accessible.

Alex Pearlman, a science and technology journalist and bioethicist, presented at the Jaharis Health Law Institute’s Symposium on April 29, 2021. Pearlman’s background is reporting on emerging issues in research, health policy and biotechnology and her work has appeared in numerous leading national and international media outlets, including Stat, New Scientist, MIT Technology Review, The Boston Globe and Vice. Pearlman works as a digital ethnographer and researcher in the Wexler Lab at the University of Pennsylvania Department of Medical Ethics & Health Policy, where she is studying ethical issues in the Community Biology movement during the COVID-19 pandemic. Pearlman also is a research affiliate with the Community Biotechnology Initiative at the MIT Media Lab, where she studies the intersection of the Community Biology movement with issues in ethics and policy, and she is working on the creation of a research ethics framework for use by independent community labs. For the symposium, Pearlman presented on biohackers.

A biohacker is “a do-it-yourself tinkerer, [o]ften participating in self experimentation, gene editing interventions, and agitating against the patent system.” These biohackers, driven by altruistic motives, have “hacked” certain elements of healthcare to provide cheaper options for medication. Some examples of this are the one hour at-home COVID-19 test, open insulin, and the EpiPencil, which is an off-the-shelf answer to increase in price of the EpiPen. Pearlman focused much of the presentation on Glybera, a gene therapy for LPLD, and its pirated counterpart. When Glybera first came on the market, it was the most expensive gene therapy ever at $1 million. Biohackers reverse engineered Glybera using published studies and named the product “Slybera.” Slybera has never been tested as no one will touch the hacked therapy. While biohackers raise many questions of ethics and standards, Pearlman asks, “if there are low cost alternatives, isn’t it in everyone’s best interest to get them resources?”

Dr. Theodosia Stavroulaki is a Jaharis Faculty fellow at DePaul University College of Law. Dr. Stavroulaki teaches and researches topics in Health Law, Public Health, and Anti-Trust law, and has published work in World Competition, Law & Economics Review, Loyola Consumer Law Review, CPI Antitrust Chronicle and the American Journal of Law & Medicine. Her presentation focused on the major issues that arise when health insurance companies merge with powerful drug suppliers. Professor Stavroulaki mentioned that when insurance companies, like Aetna, merge with drug companies like CVS, they can then use big data analytics to identify the likelihood and risks of certain diseases, and design health plans that will discourage high risk patients from purchasing their programs. She further discussed a blind spot in antitrust law, which is that it does not distinguish between different socio-economic groups. This poses a problem because by placing all consumers into one unidentifiable group, antitrust law fails to consider the effects of certain conduct on different consumers.

Dr. Stavroulaki further discussed three ways in which antitrust enforcers should consider the harm these mergers may impose. She first mentioned how vulnerable, high-risk consumers constitute a separate relevant market. Further she discussed how this type of merger will make it difficult for insurance companies to enter the market in the future, seeing as acquiring a retail pharmacy would be a prerequisite. Second, Dr. Stavroulaki suggested that antitrust enforcers can consider how the merger’s negative impact on high-risk consumers should weigh more heavily than its positive impact on low-risk ones, notwithstanding that the net effect of the merger should be assessed. Finally, the proposed merger may facilitate health insurer’s efforts to violate the Affordable Care Act that prohibits discriminatory premium rates. On the other hand, she mentioned the merger might allow for the identification of patients who are not being properly treated in order to provide them with access to the care they require. Dr. Stavroulaki provided an insightful and interesting view into mergers that harm our health.