Doctor, DNA, microscope concept illustration.

Reclassification of Genetic Test Results: Potential Time Bombs in the Medical Record? 

By Ellen Wright Clayton

Findings from genetic tests are not static; as knowledge advances, our understanding of the implications of these results evolves.

But what this means for physicians and their duties to patients is unresolved, as I explain with co-authors in a new article in Genetics in Medicine, the official journal of the ACMG.

There is an increasing drumbeat of support for an ethical and legal duty for physicians to reinterpret genetic test results and re-contact patients about these new understandings to improve their care.

Currently, reviewing prior medical records is by no means routine. Clinicians may review past records if they suspect that they have missed something as symptoms evolve, or that the significance of a symptom or biomarker may have changed because of new research.

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Person in nursing home.

Long-Term Care After COVID: A Roadmap for Law Reform

By Nina A. Kohn

Between May 2020 and January 2021, 94 percent of U.S. nursing homes experienced at least one COVID-19 outbreak. And nursing home residents — isolated from family and friends, dependent on staff often tasked with providing care to far more residents than feasible, and sometimes crowded into rooms with three or more people — succumbed the virus at record rates. By March 2021, nursing home residents accounted for a quarter of all U.S. COVID-19-related deaths.

The poor conditions in nursing homes that have been exposed by the pandemic are symptomatic of long-standing problems in the industry.

Fortunately, as I discuss in-depth in a new essay in the Georgetown Law Journal Online, there are a series of practical reforms that could readily improve the quality of nursing home care, in large part by changing the incentives for nursing home providers.

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Herndon, USA - April 27, 2020: Virginia Fairfax County building exterior sign entrance to Mom's Organic Market store with request to wear face mask due to covid-19 pandemic.

Are Employers That Ditch Mask Mandates Liable for COVID-19 Infections at Work?

By Chloe Reichel

Last week, in response to U.S. Centers for Disease Control and Prevention (CDC) guidance indicating that vaccinated individuals need not wear face coverings indoors, a number of states and businesses swiftly did away with indoor mask mandates.

Widespread criticism followed, focusing on the dangerous policy vacuum that now exists. The CDC has suggested unvaccinated individuals follow an honor system and continue masking — but such an honor system is difficult, if not impossible, to enforce.

In the absence of indoor mask policies, individuals face increased risk of exposure to the virus. And some groups are particularly at risk of contracting the virus now, including immunocompromised individuals, for whom vaccines may not confer protection, and children under the age of 12, for whom a vaccine has not yet been authorized.

To better understand the new guidance and its implications for workers who are no longer protected by mask mandates, I spoke with Sharona Hoffman, an expert in health and employment law. Hoffman is the Edgar A. Hahn Professor of Law, a professor of bioethics, and Co-Director of Law-Medicine Center at Case Western Reserve University School of Law. In our interview, Hoffman explained whether an employer may be held liable if an employee contracts COVID-19 after an occupational exposure, and highlighted other key issues to anticipate regarding COVID-19 and the workplace.

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Field hospital in NY during COVID-19 pandemic.

Ethical and Legal Challenges Faced by Hospitals in New York’s First COVID-19 Surge

By Zachary E. Shapiro

After COVID-19 reached the United States, New York City quickly became the epicenter of the pandemic. Clinicians at New York Presbyterian Hospital-Weill Cornell Medical Center turned to the Clinical Ethics Consultation Service to help meet the ethical challenges that arose. During the surge, the Ethics Team saw a marked increase in the volume of consultations for individual patients in the hospital, and took part in over 2,500 informal consultations with caregivers. Discussions centered around a wide range of ethical issues distinct from those that come up in routine practice. As one of the only lawyers in the Division of Medical Ethics at Weill Cornell Medical College, I encountered a myriad of legal concerns presented by the pandemic.

During the height of the surge in New York, there was no formal legal guidance available to clinicians concerning medical practice during a pandemic. Questions about legal immunity abounded, as unclear state and federal guidance left many doctors worried that they were taking personal and professional risks by providing care to COVID-19 patients.

The pandemic forced doctors to shift away from traditional standards of care in terms of resuscitation, patient care, and surrogate decision-making. The ethics team had to take new dynamics into account, such as the risk of infection to doctors and staff, and balance these factors in the risk/benefit calculations for treatments and interventions. Undertaking these shifts without federal or state guidance caused significant distress and concern. It often seemed that the law was not only not helpful, but an active hindrance to medical practice, as many health care workers were consumed by worry about the prospect of future liability. This concern persisted, even though the deviations in the standard of practice were necessitated by the realities of the pandemic overwhelming our health care system.

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NHS building

Health Care Providers’ Legal Duty to Be Open and Honest with Patients

By John Tingle

Last September, the first ever prosecution of a National Health Service (NHS) trust for failure to comply with the regulation concerning duty of candor was adjudicated.

University Hospitals Plymouth NHS Trust was ordered to pay a total of £12,565 after admitting it failed to disclose details relating to a surgical procedure and to apologize following the death of a 91-year-old woman.

Duties of candor require that patients be informed of adverse events as soon as possible after they occur. These duties serve as mechanisms to help balance power dynamics in health care and to advance patient rights. In England, duties of candor are contained in the professional codes of ethics of doctors and nurses, and in statutory regulations.

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Empty hospital bed.

New Data Reignites Concerns over COVID-19 and Nursing Homes in New York State

By James W. Lytle 

Concerns over New York State’s response to the COVID-19 pandemic, particularly with respect to its treatment of nursing homes, have recently re-emerged in light of a new report and court ruling related to the matter.

Almost from the outset of the pandemic, the State faced scrutiny as to whether it was accurately reporting deaths of nursing home patients.

After nursing homes complained in April about the lack of PPE and other resources to combat the pandemic, Governor Andrew Cuomo responded that it was not the state’s responsibility, and asked the Department of Health and the Attorney General to launch investigations into nursing homes’ response to the pandemic.

Nine months later, in late January 2021, the report by New York State Attorney General Letitia James of the nursing home investigation was released.

Among the report’s headlines, the Attorney General’s preliminary analysis found that the Department of Health had undercounted deaths of nursing home residents due to COVID-19 by about 50%, largely because of the failure of the State to count the deaths of those residents who were transferred to hospitals immediately prior to their deaths. No other state excluded patients who had been transferred before death to hospitals from their nursing home fatality reports.

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2020 with second zero filled in with virion.

Bill of Health’s Top 10 Posts of 2020

By Chloe Reichel

In 2020, topics relating to bioethics, health law policy, and biotechnology took center stage in the collective national and global consciousness.

The COVID-19 pandemic has, unfortunately, posed countless urgent bioethical and health law policy questions. The police killing of George Floyd in May 2020 sparked wider awareness of the systemic racial injustice in the U.S., which permeates all aspects of society and has profound detrimental effects on health.

Our contributors have grappled with these issues on the pages of this blog

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Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

HHS Recognizes Key Role of Telehealth in Amended PREP Act Declaration

By Vrushab Gowda

On December 3rd, the Department of Health and Human Services (HHS) extended its provisions to cover telehealth services in amending its Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID–19.

This represents the first time HHS has covered telehealth services under the authority of the PREP Act. Telehealth providers are now permitted to deliver a range of COVID-related care across the country, including states in which they do not hold professional licenses. The Declaration, moreover, offers them expansive liability protection, effectively immunizing them against a host of claims in connection to their administration of designated countermeasures.

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NHS building

COVID-19 and the State of Health and Social Care in England

By John Tingle

The COVID-19 pandemic has exacerbated challenges facing the provision of health and social care in England, a recent report from the Care Quality Commission (CQC) finds.

The CQC is the independent regulator of health and social care in England. Every year they produce an assessment of the state of the country’s health and social care. The yearly lookbacks include information on trends, challenges, successes, failures and opportunities.

The most recent report analyzes service provision both pre- and post COVID-19, and draws key conclusions from this information. From a patient safety perspective, the report contains important lessons about issues the COVID-19 pandemic has brought into sharp focus. The report also highlights trailing patient safety problems that existed before the pandemic, and are still present as England grapples with the pandemic’s second wave.

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Empty gym.

Are COVID Waivers Enforceable? Look to Gym Waivers for Insights

By Sunnie Ning

Salons, movie theaters, gyms, churches — if you have been somewhere recently that is indoors or requires close personal contact, chances are, you have encountered a COVID liability waiver. But how enforceable are they?

Liability waivers, which stand at the intersection of torts and contract law, are a matter of state law. They have been on the rise as a contractual solution to tort problems since the 1980s, and are now common for recreational and sporting activities with higher-than-normal risks. However, no court has adjudicated on the enforceability of a COVID liability waiver yet, and the unique nature of the pandemic makes it difficult to predict how courts will rule.

Standard gym and health club waivers, operating outside the context of a pandemic, may provide insights into the enforceability of COVID waivers.

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