Tag: health law policy

Cape Town, South Africa - 6 April 2020 : Empty streets and stay home sign in Cape Town during the Coronavirus lockdown.

One Year Later: COVID-19, Human Rights, and the Rule of Law in South Africa

Chloe Reichel Leave a comment

By Chloe Reichel

South Africa has faced a devastating national COVID-19 epidemic, with over 1.5 million confirmed cases, and over 50,000 confirmed deaths.

The true toll, in terms of cases and deaths, is likely much higher. Research shows the country has recorded 150,000 excess deaths since May 2020.

The pandemic has also profoundly affected South Africans’ constitutionally recognized rights.

Since the start of the pandemic, the country has experienced varying degrees of lockdown, which, at different points, included a curfew, bans on the sale of alcohol and tobacco, and the closure of most businesses. The lockdown has been enforced strictly, resulting in hundreds of thousands of arrests for violations.

Mark Heywood highlighted some of these rights concerns last June in “Human Rights, the Rule of Law, and COVID-19 in South Africa,” a contribution to Bill of Health‘s digital symposium on global responses to COVID-19.

I spoke with Heywood in late March 2021 to get an update on the state of human rights and the rule of law in South Africa one year into the COVID-19 pandemic. Our conversation, which has been edited and condensed, follows.

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empty hospital bed

Regulatory Gap in Health Tech: Resource Allocation Algorithms

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By Jenna Becker

Hospitals use artificial intelligence and machine learning (AI/ML) not only in clinical decision-making, but also to allocate scarce resources.

These resource allocation algorithms have received less regulatory attention than clinical decision-making algorithms, but nevertheless pose similar concerns, particularly with respect to their potential for bias.

Without regulatory oversight, the risks associated with resource allocation algorithms are significant. Health systems must take particular care when implementing these solutions.

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NHS building

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

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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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Code on computer.

Building Trust Through Transparency? FDA Regulation of AI/ML-Based Software

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By Jenna Becker

To generate trust in artificial intelligence and machine learning (AI/ML)-based software used in health care, the U.S. Food and Drug Administration (FDA) intends to regulate this technology with an eye toward user transparency. 

But will transparency in health care AI actually build trust among users? Or will algorithm explanations go ignored? I argue that individual algorithm explanations will likely do little to build trust among health care AI users.

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Photo of person with gloved hand holding flask at lab bench.

Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported?

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By Laura Karas

Are manufacturing method patents — patents not on a pharmaceutical drug itself, but on a method of production of a drug — warranted intellectual property protections, or groundless obstacles to competition?

Patents protect and reward innovation by permitting the patent-holder the exclusive right to make, use, and sell the invention for a twenty-year period. Pharmaceutical companies have attracted scrutiny, criticism, and legal challenges for amassing large numbers of patents on pharmaceutical drugs, especially high-priced and high revenue-earning drugs.

Here I explore the topic of pharmaceutical patents on methods of production and translate into layman’s terms some thought-provoking recent scholarship by innovation scholars W. Nicholson Price and Arti Rai.

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Busy Nurse's Station In Modern Hospital

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

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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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WASHINGTON, DC - OCT. 8, 2019: Rally for LGBTQ rights outside Supreme Court as Justices hear oral arguments in three cases dealing with discrimination in the workplace because of sexual orientation.

It’s Time to Update the ACA’s Anti-Discrimination Protections

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By Jenna Becker

Assuming that the Affordable Care Act (ACA) withstands its most recent challenge in California v. Texas, the Biden administration should prioritize as a future reform the codification of clearer nondiscrimination standards.

The ACA’s Section 1557, which provides anti-discrimination protections, has been fraught with challenges. Section 1557 incorporates nondiscrimination protections from four separate civil rights statutes. This vague language allows administrations to offer widely differing interpretations of healthcare anti-discrimination protections.

In a 2016 rule, the Obama administration interpreted Section 1557 broadly, including protections based on gender identity and sexual orientation, as well as specific language access requirements. Many of these protections were eliminated in a 2020 rule promulgated by the Trump administration.

It’s time to end these fluctuating standards. The Biden administration should work with Congress to add clearer nondiscrimination protections to the ACA.

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U.S. Capitol Building at Night

Advantages of Using the Congressional Review Act to Revoke Health Care Waivers

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By Matthew B. Lawrence

The Trump Administration has granted health care waivers that the Biden Administration will surely look to end, including work requirement waivers that the Supreme Court is going to consider in Azar v. Gresham. How the Biden Administration approaches this task may set precedents that last far into the future, which is one argument in favor of considering the Congressional Review Act as a potential path forward.

Waivers are a huge part of health policy. They entail a state seeking approval from the federal government to make various changes to ACA or Medicaid programs. Waivers are normally approved for several years at a time, and routinely renewed. They foster experimentation, and are also (or especially) a tool the federal government uses to steer national health policy by pushing states to adopt some reforms and not others, as I explain in a forthcoming article.

Over at the Yale Journal of Regulation blog, I describe how the Congressional Review Act (CRA) could potentially be used to revoke health care waivers (like community engagement, aka work requirement, waivers).

In brief, the CRA is a way Congress can change the law to revoke agency actions without the votes necessary to override a filibuster. The CRA might be a cleaner alternative for revoking health care waivers than administrative revocation by the Biden Administration. One big policy advantage of this route is that it wouldn’t come back to haunt health policy. Revocations through the administrative process would set a precedent that could undermine the stability of all waivers, but revocations through the CRA would not.

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