Passport in suitcase.

Ethical, Legal, and Scientific Challenges for COVID-19 Vaccine Passports

By Chloe Reichel

As COVID-19 vaccines become more widespread, passports that certify immunization status may facilitate a return to normalcy, write Lawrence O. Gostin, I. Glenn Cohen, and Jana Shaw in a viewpoint published today in JAMA.

But these vaccine passports, or digital health passes, are not without scientific, legal, and ethical challenges.

I asked Gostin, Faculty Director of the O’Neill Institute for National and Global Health Law at Georgetown University Law Center, Cohen, Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and Shaw, a professor of pediatrics at Upstate Medical University, about the key areas of concern and promise for vaccine passports. Our conversation, which has been edited and condensed, follows.

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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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Disability with technology line icon set.

Reflecting on the Struggle for Disability Rights a Year into the Pandemic

By Amalia Sweet

On March 9, the Petrie-Flom Center and Harvard Law School Project on Disability gathered a panel to discuss the extent to which the pandemic has set back progress toward ensuring the rights of persons with disabilities.

Though calls for solidarity in March 2020 declared the emerging pandemic to be a “great equalizer,” the past 12 months have demonstrated how the pandemic has exacerbated existing social inequalities, disproportionately impacting the already marginalized.

The panel discussion, hosted by Petrie-Flom Center Senior Fellow in Global Health and Rights Alicia Ely Yamin and moderated by Harvard Law School Project on Disability Executive Director Michael Ashley Stein, provided voice to the uniquely and acutely devastating impacts of the pandemic on persons with disabilities, who are still struggling to secure protection of their basic rights.

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green, red, and yellow qr codes on phones.

The Promise and Pitfalls of China’s QR Codes as Health Certificates

This article is adapted from a longer paper published in the Harvard Journal of Law and Technology (JOLT)’s Digest section. To access the original paper, please visit JOLT.

By April Xiaoyi Xu

At this point in the COVID-19 pandemic, China has successfully managed to contain the spread of the virus, due in large part to its technological strategy, which uses QR codes as a kind of health certificate.

These color-coded QR codes are automatically generated using cell phone data. Green indicates that an individual is healthy and can move freely, yellow signals that the user must quarantine for up to seven days, and red for fourteen days. The basis for these determinations, as well as the extent of the data collected in order to make them, remains opaque.

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Busy Nurse's Station In Modern Hospital

What’s in a Name? The Value of the Term ‘Never Events’

By John Tingle 

The Healthcare Safety Inspection Branch (HSIB) in England, which conducts independent investigations of patient safety concerns relating to the country’s National Health Service (NHS), has just published a learning report that examines the findings of investigations they have carried out on incidents classified as “Never Events.”

England’s NHS defines Never Events as “patient safety incidents that are wholly preventable,” in accordance with the implementation of “guidance or safety recommendations that provide strong systemic protective barriers.”

In the National Health Service’s policy and framework, Never Events are listed under the following headings: surgical, medication, mental health, and general. These headings include incidents such as overdose of certain medications, failure to remove a foreign object used during a procedure, and transfusion of incompatible blood.

The investigations for the HSIB report cover seven of the 15 types of Never Events listed in the National Health Service (NHS) Never Events policy and framework published in 2018. These seven categories account for over 96% of the total Never Events recorded in 2018 – 2019.

Controversially, the HSIB report recommends that NHS England and NHS Improvement revise the Never Events list to remove several which don’t have “strong and systemic safety barriers.” “These events,” the report states, “are therefore not wholly preventable and do not fit the current definition of Never Events.”

This suggestion is, arguably, not in the spirit of advancing the patient safety agenda in the NHS in England.

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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

doctor holding clipboard.

The Inherent Value of Patient Safety Reports as Key Educational Tools

By John Tingle

Many patient safety adverse events across the National Health Service (NHS) in England have common causes, which exist regardless of clinical specialty, such as failures in communication, poor record keeping, and poor staffing levels.

This commonality of cause means that patient reports emanating from various clinical areas can have general, health system-wide value, relevance, and application. From these reports, it is possible to extrapolate generally applicable patient safety themes that can apply in a wide range of health care settings.

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Empty hospital bed.

The Inevitability of Error in Health Care

By John Tingle

A recent publication by the World Health Organization (WHO), a first draft of a global patient safety action plan 2021-2030, seems to have rekindled conversations about the “inevitability of error” in the field of patient safety.

The “inevitability of error” argument indicates that mistakes in health care do inevitably happen; that they are the consequences of the complex nature of health care treatment. Nursing and medicine depend on people, and nobody is infallible — we all make mistakes.

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