New Portable MRI Revolutionizing Brain Research Demands Ethical and Legal Innovation

by Francis X. Shen, Susan M. Wolf, and Frances Lawrenz

The advent of highly portable MRI will transform brain research, but urgently requires ethical and legal guidance.

Rather than participants traveling to the MRI scanner, now the scanner can travel to them. This advance could enable research with remote and marginalized communities that have not previously been able to participate, and in doing so address the lack of representativeness and diversity in human neuroscience research.

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What You Need to Know About Marijuana Rescheduling

by Victoria Litman, M.Div., J.D., LL.M.

On May 21, 2024, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) signed by Attorney General Merrick Garland in the Federal Register. This publication kicks off a 62-day comment period on a rule that would move marijuana to Schedule 3 of the Controlled Substances Act (CSA), classifying it as a substance with “a moderate to low potential for physical and psychological dependence.” The process of rescheduling may be long and is unlikely to create a pathway to federal compliance for state-legal marijuana businesses without further federal legislation. Ultimately, Congress likely will need to clarify the division of federal and state regulatory powers over cannabis.

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From Regulation to Innovation: The Impact of the EU AI Act on XR and AI in Healthcare

By Marcelo Corrales Compagnucci

Extended Reality (XR) technologies like Virtual Reality (VR), Augmented Reality (AR), and Mixed Reality (MR), are revolutionizing healthcare. These tools, powered by artificial intelligence (AI), are enhancing how medical professionals work across various specialties such as cardiology, pharmacy, and neuroscience, improving precision and efficiency in ways previously unimaginable. Tools like IBM Watson and DeepMind are already in use, with current applications in diagnosis, predictive analytics, and personalized treatment. Near-future advancements include AI in surgical robotics and real-time patient monitoring through wearables.

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Stephanie Tabashneck: An “Interpreter” Between Two Fields

Stephanie Tabashneck, PsyD, JD, is a Senior Fellow in Law and Applied Neuroscience at the Petrie-Flom Center and Center for Law, Brain and Behavior (CLBB) at Massachusetts General Hospital/Harvard Medical School. A forensic psychologist and an attorney, she focuses her research, practice, and teaching on neural development in children and adolescents, substance use issues, and providing forensic evaluations and expert testimony. This Q&A, which has been condensed and edited for clarity, offers a glimpse into Dr. Tabashneck’s wide-ranging and dynamic career.

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Routing Back to Roe in Light of Adverse State Supreme Court Abortion Decisions

By James G. Hodge, Jr. and Jennifer L. Piatt

Surrounding the U.S. Supreme Court’s withdrawal of the longstanding constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization on June 24, 2022, multiple state supreme courts have done their own “about face” on reproductive rights. Motivated perhaps by the infamous leaked decision in Dobbs, the Iowa Supreme Court reversed its 2018 decision finding abortion protections in the state constitution, concluding on June 17, 2022 that no such fundamental right exists. Following a January 2023 decision rejecting a 6-week statutory ban as violating the state’s constitution, a reconstituted South Carolina Supreme Court found the ban constitutional in August 2023. Florida’s Supreme Court protected abortion as a fundamental privacy right under the state constitution in 1989 only to reverse its view on April 1, 2024.

Most recently, on April 9, 2024 a majority of the Arizona Supreme Court resurrected an 1864 territorial law banning all abortions except to save the life of the pregnant woman in Planned Parenthood v. Hazelrigg. That decision thrust Arizona into the realm of 14 other states with the most stringent restrictions nationally – no abortions with virtually no exceptions.

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Two Years On From A “Landmark” Abortion Decision in Kenya

Two years ago, the Kenyan High Court in Malindi decided PAK and Salim Mohammed v. Attorney General et al., affirming that the constitutional right to abortion is “fundamental.”

Approximately 2,600 people lose their lives to unsafe abortion in Kenya each year, with an additional 21,000 people requiring hospitalization. While the Kenyan Constitution, adopted in 2010, allows for abortion when the pregnant person’s life or health is at risk under Article 26(4), the Kenyan Penal Code still criminalizes it—a legal grey area creating “ambiguity, confusion, and stigma.

This article will describe the PAK decision and analyze it in line with trends in transnational abortion law.

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Salus Populi: Training the Judiciary in the Social Drivers of Health

By Elaine Marshall, Isabel Geisler, L. Virginia Martinez, Krystal Abbott, and Katherine Hazen

Social drivers of health (SDOH), sometimes known as the social determinants of health, are factors in the social environment that shape individual and population health, including poverty, racism, housing, education, and employment. When judges decide cases that impact these social factors, their rulings can have important health implications. While cases impacting the SDOH can be landmark Supreme Court cases, such as the ruling on the CDC’s eviction moratorium during the COVID-19 pandemic, judges also make decisions on a daily basis that can affect the SDOH and thereby health. Take, for example, a child welfare case out of New York, In re Brittany T, 852 N.Y.S.2d 475 (N.Y. App. Div. 2008), where the issue before the judge was whether a family willfully and without just cause violated orders meant to support their child’s health through diet and exercise. The order required the family to use all resources available to ensure the well-being of the child, enroll the child at their own cost in a local gym and attend it at least 2-3 times a week, and actively and honestly participate in a nutrition program.

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Cell Therapies and their Legal Discontents

In February, the news broke that the Food and Drug Administration (FDA) had approved a “first of its kind” new cancer therapy. Iovance’s AMTAGVITM, the subject of the approval, is a personalized immunotherapy for advanced melanoma. To be treated, adult patients who are ineligible for surgery or have metastatic disease provide their tumor cells to their medical team. Tumor-attacking T-cells are isolated from the sample, grown and multiplied in-lab, and re-infused into the patients for a turbo-charged immune response that, according to clinical trial data, have shown promise in shrinking patients’ tumors. This drug joins a list of others that work something like this: Patients provide cell samples, which are then isolated and modified or expanded in-lab, and then eventually infused back into their bodies. This general patient experience, though, indicates a different model from what we have seen before. These “living drugs” use your own cells, but better, to fight these daunting battles.

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Protecting Health Privacy is a Royal Pain

Heightened Scrutiny of Your Royal Highness

On Sunday, March 10, tabloids were in quite a frenzy when the British royal family published a photoshopped picture of Catherine, princess of Wales. The hubbub was extra hubbubbly, because this was the first official photo after the princess had abdominal surgery this past January. The order of events caused some people to speculate the edits indicated there was something to hide about the princess’s health status.

Shortly after the public reaction, the princess issued an apology for the edits. Sadly, less than two weeks later, the rumors were confirmed to be true: Princess Catherine did have a health problem. She had been diagnosed with cancer and had commenced preventative chemotherapy. As part of this announcement, Princess Catherine bravely encouraged the public, “For everyone facing this disease in whatever form, please do not lose faith or hope. You are not alone.” Read More

EU and US Regulatory Challenges Facing AI Health Care Innovator Firms

 

 

 

By Suzan Slijpen, Mauritz Kop & I. Glenn Cohen

 

 

 

1. Introduction: A Fragmented AI in Healthcare Regulatory Landscape

In the past few years, we have witnessed a surge in artificial intelligence-related research and diagnostics in the medical field. It is possible that in some fields of medicine in the future AI tools used in diagnostics will generally perform far better than a human clinician. Prime examples of this can be found in radiology, particularly in the detection -and even the prediction- of malignant tumors.

Although the actual development of a clinically usable, deployable deep-learning algorithm is a challenge in and of itself, we have moved from an early period where there was not enough guidance as to ethical and other issues to an era where many guidelines have proliferated. While one might ordinarily say “let a thousand flowers bloom,” the fact that they partially overlap, sometimes diverge, and are often written at different levels of generality make it difficult for well-meaning companies to keep up. This is specifically the case for innovative firms who aim to bring their product into the European market.

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