Scientist analyzes DNA gel used in genetics, forensics, drug discovery, biology and medicine

Transplant Genomics: Ethical, Legal, and Social Implications

By Tamar Schiff

The appeal of precision medicine is of particular significance in transplantation. Treatment options are already integrally dependent on genetic factors – the donor-recipient match – and the demand for transplantable tissues far outstrips the available supply.

And the potential is only growing. Advances in genetic and genomic studies have identified an increasing number of novel biomarkers of potential use in transplant-related care. These include predictors of disease course, graft survival, response to immunosuppression, and likelihood of disease recurrence or other complications.

With wider availability of sequencing technologies and innovations in databanking, future clinical applications in transplant care may require ever-growing considerations of the significance of genetic variants, fair access to precision medicine therapeutics and participation in research, ethical approaches to data aggregation, and social determinants of health.

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USB drive

The False Dilemmas of the Fifth Circuit’s HIPAA Ruling

By Leslie Francis

In a caustic opinion issued on January 14, the Fifth Circuit vacated penalties assessed by the U.S. Department of Health and Human Services (HHS) against the University of Texas M.D. Anderson Cancer Center for HIPAA security breaches.

As has happened to many other health care entities, M.D. Anderson had employees who were not careful with their laptops and thumb drives (and the data therein). A laptop with the unencrypted protected health care information of nearly 30,000 patients was stolen. Unencrypted thumb drives with information on another almost 6,000 patients were lost. M.D. Anderson disclosed the security breaches to HHS, which assessed civil monetary penalties for violation of HIPAA’s encryption and disclosure rules. M.D. Anderson then filed a petition for review, which resulted in the Fifth Circuit holding that the agency action was arbitrary and capricious for failure to consider an important aspect of the problem.

Commentators have already pointed out that this decision will reverberate throughout the HIPAA enforcement world. As it does, I hope it is met with scorn, for it trades on the informal logical fallacy of the false dilemma in two noteworthy ways.

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Gavel and a house on a white background. Concept art for eviction.

Why Biden’s Extension of the Eviction Moratorium Isn’t Enough

By Molly Prothero

On President Joe Biden’s first day in office, he signed an executive order calling on the U.S. Centers for Disease Control and Prevention (CDC) to extend its federal eviction moratorium through March 2021.

But this action protects only a subset of tenants who meet specific qualifications and, crucially, know to fill out a CDC Affidavit and submit it to their landlords. And despite skyrocketing COVID-19 case counts, most state eviction moratoriums have now lifted, leaving tenants vulnerable to displacement and homelessness.

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Doctor or surgeon with organ transport after organ donation for surgery in front of the clinic in protective clothing.

How to Encourage Organ Donation

By James W. Lytle

Last week, Bill of Health published a Q&A with Phil Walton, the Project Lead for Deemed Consent Legislation with the National Health Service Blood and Transplant Division, and Alexandra Glazier, the President/CEO of the New England Donor Services.

In the first part of this conversation, Walton and Glazier described the various frameworks undergirding organ donor registries in their home countries. Walton detailed the “deemed consent” or “opt-out” registry employed by Wales and England, while Glazier detailed the opt-in, prompted choice framework in the U.S.

In this second installment, Walton and Glazier discuss strategies to encourage organ donation, regardless of the opt-in or opt-out framework. The conversation also touched on health disparities and strategies to address them.

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COVID-19 fake news concept illustration.

COVID-19 Vaccine Misinformation and the Anti-Vaccine Movement

By Dorit Rubinstein Reiss

The anti-vaccine movement is aggressively working to promote misinformation about COVID-19 vaccines, up to and including promoting fake claims of deaths from vaccines. We need to be aware of its efforts, and be prepared to respond.

It’s worth emphasizing that this blog post is focused on the anti-vaccine movement, not people with concerns about vaccines (the “vaccine hesitant”).

In relation to COVID-19, anti-vaccine activists have aggressively promoted misinformation from the start of the pandemic.

In March 2020, anti-vaccine activists incorrectly alleged – by misrepresenting a study – that flu vaccines increase COVID-19 risks. In June, anti-vaccine activist Del Bigtree described COVID-19 as a “cold,” blamed those who died for their own deaths, and called on his followers to “catch that cold.”

And from the beginning, anti-vaccine activists were committed to the ideas that COVID-19 vaccines would not work, would be dangerous, and would be promoted by a nefarious global conspiracy. They continue to spread these allegations, for example, using the fact that there are liability protections for COVID-19 vaccines to imply the vaccines are dangerous. Liability protections for COVID-19 vaccine manufacturers are real; but they are not evidence that the vaccines are unsafe.

This post will focus on one type of misinformation: alleged deaths from COVID-19 vaccines.

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Picture of doctor neck down using an ipad with digital health graphics superimposed

Symposium Introduction: Ethical, Legal, and Social Implications of Deep Phenotyping

This post is the introduction to our Ethical, Legal, and Social Implications of Deep Phenotyping symposium. All contributions to the symposium will be available here.

By Francis X. Shen

This digital symposium explores the ethical, legal, and social implications of advances in deep phenotyping in psychiatry research.

Deep phenotyping in psychiatric research and practice is a term used to describe the collection and analysis of multiple streams of behavioral and biological data, some of this data collected around the clock, to identify and intervene in critical health events.

By combining 24/7 data — on location, movement, email and text communications, and social media — with brain scans, genetics/genomics, neuropsychological batteries, and clinical interviews, researchers will have an unprecedented amount of objective, individual-level data. Analyzing this data with ever-evolving artificial intelligence (AI) offers the possibility of intervening early with precision and could even prevent the most critical sentinel events.

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Empty classroom.

Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts

By Emily Caputo and Blake N. Shultz

As school systems consider policy options for the spring semester, both vaccination requirements and proposals to address inequities in access to education may be top of mind. However, policymakers should be aware of the possible legal challenges they may face.

The COVID-19 pandemic has created an educational crisis in the United States by disrupting the learning of millions of students across the country. School closures, remote learning, and generalized societal stress have all raised serious concerns about persistent harm to adolescent learning and development — particularly among low-income and minority students.

While the pandemic has exposed widespread inequities in educational opportunity, it has also revealed the relative inability of the courts to promote access to education. A recent California lawsuit illustrates the manner in which students must rely on state-level, rather than federal, protections to ensure equal access to education. And COVID-19 vaccination requirements, which could facilitate a return to in-person education, are likely to result in lawsuits, and may be struck down by a skeptical and conservative Supreme Court.

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hospital equipment

Balancing Health Care Rationing and Disability Rights in a Pandemic

By Yolanda Bustillo and Rachel Perler

Amid the present surge of the coronavirus pandemic, it is crucial that disability rights are a factor in the development of triage protocols.

During the last week of December, the CDC recorded a record of 225,269 new coronavirus cases and 118,948 total hospitalizations. Health care systems across the country have predicted that they soon may face shortages of ventilators, personal protective equipment (PPE), and other limited resources.

In Utah, for example, hospital administrators have implemented informal triage protocols that prioritize patients based on health status, clinical factors, and the time sensitivity of their needed procedures. Hospitals in California have similarly begun rationing care.

If these dire circumstances worsen, hospital systems may apply triage protocols that deviate from best practices and impermissibly discriminate against people with disabilities.

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Person typing on computer.

Online Terms of Use for Genealogy Websites – What’s in the Fine Print?

By Jorge L. Contreras

Since genealogy websites first went online, researchers have been using the data that they contain in large-scale epidemiological and population health studies. In many cases, data is collected using automated tools and analyzed using sophisticated algorithms.

These techniques have supported a growing number of discoveries and scientific papers. For example, researchers have used this data to identify genetic markers for Alzheimer’s Disease, to trace an inherited cancer syndrome back to a single German couple born in the 1700s, and to gain a better understanding of longevity and family dispersion.  In the last of these studies, researchers analyzed family trees from 86 million individual genealogy website profiles.

Despite the scientific value of publicly-available genealogy website information, and its free accessibility via the Internet, it is not always the case that this data can be used for research without the permission of the site operator or the individual data subjects.

In fact, the online terms of use (TOU) for genealogy websites may restrict or prohibit the types of uses for data found on those sites.

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Close up of a mosquito sucking blood on human skin. This mosquito is a carrier of Malaria, Encephalitis, Dengue and Zika virus.

Responsibly Developing Gene Drives: The GeneConvene Global Collaborative

By James Toomey

Researchers believe that gene drives could eliminate vector-borne diseases such as malaria, by modifying mosquito species or eradicating those that carry disease, kill off invasive species, and combat the growing problem of pesticide resistance.

A gene drive is a technique for genetically modifying entire species of wild organisms. Genetically modified individuals of the species are released into the wild, so as to raise the probability that a particular gene will be passed onto the species’ progeny via reproduction.

Over the course of many generations, the gene — even if detrimental — can spread to an entire population.

But as of now, this is all hypothetical. No gene drive has been tested in the wild, and many people are skeptical that they should ever be used.

The GeneConvene Global Collaborative, a project of the Foundation for the National Institutes of Health, was started this past July to promote the responsible development and regulation of gene drive technologies. It brings together researchers, regulators and stakeholders around the world to develop best practices for gene drive research and implementation.

Because of my prior writing on this topic, I participated in GeneConvene’s fall webinar series and spoke with scientists there about the project. Read More