3d rendering of a robot working with virtual display.

Artificial Intelligence and Health Law: Updates from England

By John Tingle

Artificial intelligence (AI) is making an impact on health law in England.

The growing presence of AI in law has been chronicled by organizations such as the Law Society, which published a forward-thinking, horizon-scanning paper on artificial intelligence and the legal profession back in 2018.

The report identifies several key emerging strands of AI development and use, including Q&A chatbots, document analysis, document delivery, legal adviser support, case outcome prediction, and clinical negligence analysis. These applications of AI already show promise: one algorithm developed by researchers at University College London, the University of Sheffield, and the University of Pennsylvania was able to predict case outcomes with 79% accuracy.

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doctor holding clipboard.

The Latest on Never Events in the NHS in England

By John Tingle

Never Events” — medical errors that should never occur — are a major and recurring problem in health care in England.

When they do occur, they sap confidence and trust in the health care system, and can result in significant injury or death to the patient. They can result in expensive litigation. There is also a significant financial cost to the NHS, which is always short of financial resources. The patient, their relatives, and all those involved in the incident bear emotional costs, too.

In the National Health Service (NHS), Never Events are defined and listed. The list includes such incidents as a foreign body being left in a patient, wrong implant/prosthesis, and wrong site surgery, among others. Sadly, the incidence of Never Events in the NHS is still too high.

Never Events are also a major patient safety metric that helps regulators such as the Care Quality Commission (CQC) and the public judge the safety of a hospital or other health care facility.

Recent publications highlight that Never Events remain a critical and a stubbornly persistent problem for the NHS to address.

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NHS building

When Will the NHS Get Its Complaints System Right?

By John Tingle

The National Health Service (NHS) in England has been trying to get an effective, fit-for-purpose complaints system for at least 28 years, and it has still not succeeded.

This has been one of the NHS’s perpetual and intractable problems. History has not served the NHS well here, despite the publication of countless reports on patient safety and NHS complaint handling, and several major crises happening, such as Mid Staffordshire.

More often than not, the reports into patient safety crises and NHS complaints system reform all say the same (or similar) thing, and point to the same issues.

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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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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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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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