Field hospital in NY during COVID-19 pandemic.

Systemic Failures Need Systemic Solutions: COVID-19 and Macromedical Regulation

By Barak D. Richman and Steven L. Schwarcz

Among the many failures to mitigate the harm from COVID-19 in the U.S. has been the failure to meet surging demand for inpatient care. Hospital bed shortages, overwhelmed intensive care nurses, and scarcities of needed medical equipment have been embarrassing but constant features of the American health care landscape. A nation that spends nearly one out of every six dollars on health care should get much, much more for its money.

Though there is much blame to go around — and many insightful commentators have already allocated culpability — we observe that a significant regulatory deficiency has contributed to the nation’s failure to meet population health needs. This is the failure to regulate our hospitals holistically, as part of a comprehensive health care system.

Existing health care regulation focuses almost exclusively on regulating individual components of the health care industry. This existing regulation lacks the capacity to address how those components work together as a system — a system in which deficiencies in one component adversely impact the performance of the other components. We should not view hospitals as individual providers that treat individual patients. Instead, they are part of a larger safety net that needs to expand capacity when emergencies arise. Today’s pandemic destabilized hospital care because hospitals were neither coordinated nor managed systemically in order to meet population demands.

In Macromedical Regulation, 82 Ohio State Law Journal 727 (2021), we address the nation’s systemic failure to contain an infectious contagion, and we offer solutions by deriving lessons from the 2008 financial contagion. We contend that health care regulation must also include what we call “macromedical” regulation: regulation that focuses on protecting the stability of the health care sector as a system of interconnected parts.

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Person filling syringe from vial.

The Beginning of the End of Federalism As We Know It Here on Earth One and Earth 616?

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

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U.S. Supreme Court

Major Questions about Vaccine Mandates, the Supreme Court, and the Major Questions Doctrine

By Wendy Parmet and Dorit Reiss

This Friday, the Supreme Court will hear arguments about two federal vaccine mandates: the Centers for Medicare and Medicaid Services’ (CMS) mandate for health care workers, and the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate for employers with over 100 workers. In each case, a key question will be whether the Court should apply the so-called “major questions doctrine.” The Court’s adoption of this approach in the mandate cases would not only remove an important tool for combating the pandemic; it also would severely limit the federal government’s capacity to address many other health threats, while expanding the Court’s ability to substitute its judgment for Congress’.

Although not fully defined or delineated, the major questions doctrine bars administrative agencies from using broad grants of statutory authorities in new and “major” ways. A type of clear statement rule, it requires courts to presume that in the absence of specific Congressional authorization, agencies lack the power to issue new regulations that could be seen as “major.”

In theory, the rule allows courts to avoid federalism and separation of powers concerns. In practice, it empowers courts to resurrect long-discarded approaches to federalism and separation of powers without saying so. It also enables courts to disregard explicit grants of statutory authority (so much for textualism!).

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Phone with social media icons - instagram, facebook, and twitter.

Regulating Out of the Social Media Health Crisis

By Bailey Kennedy

If something changes the pathways in our brains and damages our health — and if it does so to Americans on a vast scale — it should be regulated as a threat to public health.

It’s time for our regulators to acknowledge that social media fits this description.

Social media poses an active health threat to many of its users, in a way that is akin to other regulated substances: it has been tied to a variety of harmful health outcomes, including depression. It has also become increasingly clear that social media can be addictive.

Even if it is a behavioral rather than a substantive addiction, with only indirect links to physical health, the high number of Americans who exhibit some degree of social media addiction is concerning.

Inasmuch as social media presents us with a public health crisis, the American government should consider potential regulatory steps to address it.

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Close up of a Doctor making a vaccination in the shoulder of patient.

The CMS Vaccine Mandate: The Nationwide Injunction and What It Means

By Kaitlynn Milvert

On November 30, 2021, a federal district court issued a nationwide preliminary injunction to block the Centers for Medicare and Medicaid Services (CMS) vaccine requirements for health care workers.

This ruling comes mere days before the December 6 deadline for employees of CMS-funded facilities to receive their first dose of a COVID-19 vaccine, and it casts uncertainty over upcoming deadlines for vaccination compliance.

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illustration of person tracking his health condition with smart bracelet, mobile application and cloud services.

Should We Regulate Direct-to-Consumer Health Apps?

By Sara Gerke and Chloe Reichel

According to one estimate, over 318,000 health apps are available in app stores, and over 200 health apps are added each day. Of these, only a fraction are regulated by the U.S. Food and Drug Administration (FDA); those classified as “medical devices,” which typically pose a moderate to high risk to user safety.

In this final installment of our In Focus Series on Direct-to-Consumer Health Apps, we asked our respondents to reflect on this largely unregulated space in health tech.

Specifically, we asked: How can/should regulators deal with the assessment of health apps? For apps not currently regulated by the FDA, should they undergo any kind of review, such as whether they are helpful for consumers?

Read their answers below, and explore the following links for their responses to other questions in the series.

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gavel.

Appeals Court Overturns FDA’s Partial Ban on Shock Devices: Analysis of Ruling

By David Orentlicher

In its regulation of medical devices, the U.S. Food and Drug Administration (FDA) may ban devices that pose “an unreasonable and substantial risk of illness or injury.” But earlier this month, the U.S. Court of Appeals for the D.C. Circuit decided that the FDA may not issue a partial ban of a medical device.

The case, Judge Rotenberg Educational Center v. FDA, addressed the use of electrical stimulation devices to treat self-injurious or aggressive behavior, as in patients with serious intellectual or developmental disabilities.

In March 2020, the FDA attempted to prohibit this use of electrical stimulation (or electrical shock) because of the risks it poses to patients. As the FDA observed, persons with self-injurious or aggressive behavior may have “difficulty communicating pain and other harms caused by” electrical stimulation, and consent to the use of electrical stimulation is typically made by a third party, limiting the patient’s control over use of the device.

In other settings, including smoking cessation treatment, or treatment of substance use disorder, the FDA permits the practice. Hence the partial, rather than total, ban of electrical stimulation devices.

But by a 2-1 vote, the Judge Rotenberg Educational Center court held that prohibiting electrical stimulation in some settings, but not others, runs afoul of a “practice of medicine” statutory provision. This provision precludes the FDA from limiting or interfering with a health care practitioner’s authority “to prescribe or administer any legally marketed device to a patient for any condition or disease.” In the majority’s view, once the FDA permits use of a medical device, it must defer to the states for regulation of decisions regarding which patients are appropriate candidates for the device.

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Illustration of multicolored profiles. An overlay of strings of ones and zeroes is visible

We Need to Do More with Hospitals’ Data, But There Are Better Ways

By Wendy Netter Epstein and Charlotte Tschider

This May, Google announced a new partnership with national hospital chain HCA Healthcare to consolidate HCA’s digital health data from electronic medical records and medical devices and store it in Google Cloud.

This move is the just the latest of a growing trend — in the first half of this year alone, there have been at least 38 partnerships announced between providers and big tech. Health systems are hoping to leverage the know-how of tech titans to unlock the potential of their treasure troves of data.

Health systems have faltered in achieving this on their own, facing, on the one hand, technical and practical challenges, and, on the other, political and ethical concerns.

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Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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Close up of a computer screen displaying code

Top Health Considerations in the European Commission’s ‘Harmonised Rules on Artificial Intelligence’

By Rachele Hendricks-Sturrup

On April 21, 2021, the European Commission released a “first-ever” legal framework on artificial intelligence (AI) in an attempt to address societal risks associated with AI implementation.

The EU has now effectively set a global stage for AI regulation, being the first nation of member states to create a legal framework with specific intent to address or mitigate potentially harmful effects of broad AI implementation.

Within the proposed framework, the Commission touched on a variety of considerations and  “high-risk” AI system scenarios. The Commission defined high-risk AI systems as those that pose significant (material or immaterial) risks to the health and safety or fundamental rights of persons.

This post outlines four key considerations in the proposal with regard to health: 1) prioritizing emergency health care; 2) law enforcement profiling as a social determinant of health; 3) immigrant health risk screening; and 4) AI regulatory sandboxes and a health data space to support AI product commercialization and public health innovation.

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