Code on computer.

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

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?

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’

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

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

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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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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AI concept art.

Health Care AI in Pandemic Times

By Jenna Becker

The early days of the COVID-19 pandemic was met by the rapid rollout of artificial intelligence tools to diagnose the disease and identify patients at risk of worsening illness in health care settings.

Understandably, these tools generally were released without regulatory oversight, and some models were deployed prior to peer review. However, even after several months of ongoing use, several AI developers still have not shared their testing results for external review. 

This precedent set by the pandemic may have a lasting — and potentially harmful — impact on the oversight of health care AI.

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abortion protest outside supreme court.

The COVID-19 Pandemic Reveals the Stakes of the Campaign Against Abortion

By Mary Ziegler

Once again, we’re talking about whether abortion counts as health care. The COVID-19 pandemic has sparked new efforts to limit access, from the government’s unwillingness to lift in-person requirements for medication abortion to the introduction of stay-at-home orders blocking access altogether. The campaign to frame abortion as a moral, not medical, issue began decades ago. The pandemic has revealed the broader stakes of this campaign — and what it might mean for access to care well after the worst of the pandemic is behind us.

For antiabortion leaders, there are obvious strategic reasons to insist that abortion is not health care. The stigma surrounding abortion is real and durable. Notwithstanding recent increases, many obstetric programs do not provide comprehensive abortion training (if they provide any training at all). A 2020 study in Plos One found that a majority of patients believed that they would be looked down upon “at least a little” for having had an abortion. This perceived stigma affects those refused abortions — and causes longer-term adverse mental health outcomes. Stigma has long been an effective tool for the antiabortion movement. The pandemic has done nothing to change that.

But, put in historical context, today’s effort to treat reproductive services as unessential means much more. That campaign is part of a broader agenda to undermine the idea of an autonomy-rooted abortion rights — and lay the groundwork for overturning Roe v. Wade.

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