Black-Box Medicine: Legal and Ethical Issues

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Black-box medicine—the use of opaque computational models to make care decisions—has the potential to shape health care by improving and aiding many medical tasks. For example, IBM Watson for Oncology is a machine-learning system that intends to help clinicians quickly identify essential information in patients’ medical records and explore treatment options for 13 cancers. However, it has only recently emerged that the recommendations Watson for Oncology gave for cancer treatments were “often incorrect” and that IBM kept this defect secret for over a year. What are the ethical and legal issues of black-box medicine? When do algorithms operate like a “black box“? How can we ensure that artificial intelligence technologies deliver what they promise? Read More

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Baby Not on Board: Must Children Born Through Illicit Insemination Be Barred From Recovery?

By Jody Lyneé Madeira

A new reproductive technology case type is forcing state and federal courts to answer a difficult question: can a fertility doctor be sued for medical malpractice by a biological child whom he conceives in secret through artificial insemination, substituting his sperm for an anonymous donor’s without consent?

Shockingly, one court has now answered this question in the negative, finding that the donor-conceived child couldn’t have been the physician’s “patient” prior to conception.

This gravely unjust ruling allows doctors to deny responsibilities to the very children they were paid to help create. But there are ways to avoid these outcomes, both in existing case law and legislative remedies. Read More

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Ethical Concerns of DNA Databases used for Crime Control

By Aziza Ahmed

Genetic databases for crime control have become a national topic for debate after the arrest of the Golden State Killer, also known by his real name, Joseph James DeAngelo.

At the time of his arrest, DeAngelo was 72 years old and had committed more than 50 rapes and 12 murders. While his arrest was celebrated as a law enforcement victory, a host of questions emerged because of the way law enforcement officials eventually found DeAngelo: through a combination of traditional detective work and utilization of data from a crowd-sourced genetic database. In this case, police searched GED-Match, a website created by the Mormon church where users can share genealogical information and find “familial” DNA matches

The Golden State Killer case reignited numerous debates on the issue of DNA searches and the use of DNA evidence, but with a twist. The big question is, should investigators utilize genetic databases, whether run by the government or by private agencies and individuals, to identify the families of suspects, if doing so will lead them to the culprit?

Though the opportunities for crime-solving by utilizing DNA database searches may be vast, new technologies and innovative uses of them do not occur in a vacuum. Instead, novel uses of technology demand consideration of a vast number of ethical issues, and mandate careful interrogation of the potential impact of DNA databases on crime control. Read More

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Measuring the Opioid Crisis: The Need for Standardized Cause-of-Death Reporting

By J. Alexander Short

All too often, the modern opioid epidemic is reduced to numbers. Over 70,000 drug overdose deaths occurred in the United States in 2017. This marked a substantial increase from the more than 63,000 deaths reported in 2016. So many news articles, books, and even policymakers depend on these numbers as an accurate measure of the opioid crisis. However, can we rely on their accuracy?

Unfortunately, there are surprising inconsistencies in the reporting of drug overdose deaths that warrants further investigation. Read More

3 Things You Should Know About the Petrie-Flom Center’s 2019 Annual Conference

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive, and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

We are excited, therefore, to have many major thought leaders in this space discuss these issues at the Petrie-Flom Annual Conference, “Consuming Genetics: Ethical and Legal Considerations of New Technologies,” which will take place at Harvard Law School in May. Read More

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The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More

Climate Change is Harming Health and the Treatment is Medicine, Law, and Bioethics

By Renee N. Salas

The flurry of media around recent climate change reports may have left your head spinning. These were all released in anticipation of the United Nation’s 24th Convention of the Party (COP24), in follow-up to the Paris Agreement, where the actual nuts and bolts of achieving this historic public health commitment was to be ironed out.

There are two key messages from these reports for the United States. First, climate change is human caused, happening today, and is worse than predicted. Second, climate change is harming the health of Americans now.

As an emergency medicine doctor, telling a patient a diagnosis is something I do frequently. Thus, if America were my patient, I would say that while the health diagnosis of climate change is grave, there is reason to be optimistic — because treatment exists. That treatment is the reduction of greenhouse gas emissions and switching from fossil fuels to solar and wind.

To achieve this treatment in our current political environment, we need historic teamwork that involves every discipline. This includes medicine, law, and bioethics joining together in novel collaborations that work to improve health and save lives.

Read More

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Administration’s Guidance on State Innovation Waivers under the ACA Violates the Act’s Statutory Guardrails

By Joel McElvain

This post was originally published on Take Care. 

The Affordable Care Act reformed the individual health insurance market to protect persons with pre-existing conditions. Insurers who participate in this market must sell plans with a standard set of comprehensive benefits, and may not deny coverage to, or impose higher premiums on, persons with pre-existing conditions.

Through legislative, regulatory, and litigation efforts, the Trump Administration has sought to depart from the ACA’s regime to allow the sale of plans that are medically-underwritten, offer more limited health benefits, or both.

The Administration’s latest such effort comes in the form of guidance by the Departments of Treasury and Health and Human Services that adopts a broader reading of the Act’s provision for state innovation waivers. Read More

Ebola… again: What have we learned?

By Alicia Ely Yamin

As Susan Sontag eloquently noted decades ago, illness conjures metaphors that reveal a great deal about how we think about, and, in turn, address them. None more so than the lethal Ebola, which monstrously disfigures bodies before killing the infected person and spreading rapidly through the routines of everyday life.

In the West, Ebola evokes images of illness as a deadly foreign invasion, while in the West African pandemic we know that first those who were afflicted—and later those who survived—were stigmatized as possessing demons.

The growing outbreak in the DRC has produced calls for greater physical and financial involvement from the US government by a number of health law scholars, citing the potential for exponential spread if it reaches highly populated areas, and underscoring it as a global health security issue.  Thus far, WHO’s Director General has not declared it a “Public Health Emergency of International Concern” (PHEIC), which triggers consideration of both trade and travel restrictions, as well as international assistance and under the International Health Regulations. Read More