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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Vial and syringe.

Challenges in COVID-19 Vaccine Rollout: Lessons from the UK

By Sravya Chary

Just over a week after the United Kingdom became the first Western country to authorize the COVID-19 vaccine developed by Pfizer and BioNTech for emergency use, the U.S. Food and Drug Administration (FDA) followed suit on December 11, 2020.

This lag may prove beneficial. The United States can and should cautiously assess the United Kingdom’s vaccination strategy to avoid challenges that may impede its ability to control the virus.

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Vaccine.

Benefits and Drawbacks of Emergency Use Authorizations for COVID Vaccines

By Sravya Chary

Two COVID-19 vaccine manufacturers recently submitted Emergency Use Authorization (EUA) requests to the Food and Drug Administration (FDA) for their candidates.

While the need for a safe and efficacious COVID-19 vaccine is dire and immediate, an EUA may not be the best regulatory method to provide access. Experts warn that the EUA pathway may impede vital scientific progress needed to establish the long term safety and efficacy of investigational COVID-19 vaccines.

According to the FDA, an Emergency Use Authorization is a tool that allows an unapproved medical product to be released to the public in a health crisis given that the medical product meets statutory criteria outlined in Section 564 of the Federal Food, Drug, and Cosmetic Act.

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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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NHS building

Update on Developing a Culture of Patient Safety in the NHS

By John Tingle

There are no quick fixes to developing an ingrained patient safety culture in health systems — change will not happen overnight. Nevertheless, the National Health Service (NHS) and the government in the U.K. are committed to continuing to improve patient safety.

In 2019, NHS England and NHS Improvement laid down an NHS Patient Safety Strategy roadmap, which continues to hold potential one year later.

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NHS building

The Enormity of the Patient Safety Challenges Facing the NHS in England

By John Tingle

Adding to the enormity of the challenges facing the NHS in developing a patient safety-focused culture, NHS Resolution and the Care Quality Commission (CQC) have recently produced important reports on NHS litigation and poor care. The analysis of these reports will help to reveal the full nature and extent of the NHS’s patient safety problems.

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Photograph of a gavel in front of a British flag

A New Litigation Crisis on the Horizon: Negligent Delays for Non-COVID-19 Patients

By John Tingle

As the dust begins to settle around the COVID-19 pandemic, a clearer picture is beginning to emerge of possible litigation trends against the United Kingdom’s NHS (National Health Service) for actions taken during the crisis.

Many NHS services have been reduced or suspended during the crisis. Negligent delays in treatment are a common cause of action in clinical negligence and medical malpractice cases. Legal claims could be made by patients who argue that they have suffered, and continue to suffer, because of lack of access to care and treatment due to COVID-19 NHS emergency restrictions. These claims raise tort, public law and human rights concerns, and some law firms have already been approached by patients asking for advice in this area.

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WHO flag.

WHO and Global Patient Safety: A View from Across the Pond

By John Tingle

After months of heavy criticism of the World Health Organization, President Donald Trump announced on Friday that the United States would end its relationship with the WHO.

As the organization shoulders sustained disparagement from President Trump, it is worth highlighting the critical work the WHO has done over the years. This post will focus on the role the WHO has played in promoting patient safety around the world and in the United Kingdom National Health Service (NHS) through useful materials and key initiatives.

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