From Regulation to Innovation: The Impact of the EU AI Act on XR and AI in Healthcare
Bill of Health
by Marcelo Corrales
5d ago
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 A ..read more
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Stephanie Tabashneck: An “Interpreter” Between Two Fields
Bill of Health
by The Petrie-Flom Center Staff
1w ago
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. Your training and your career ha ..read more
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Routing Back to Roe in Light of Adverse State Supreme Court Abortion Decisions
Bill of Health
by The Petrie-Flom Center Staff
1M ago
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 a ..read more
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Two Years On From A “Landmark” Abortion Decision in Kenya
Bill of Health
by Joelle Boxer
1M ago
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 P ..read more
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Salus Populi: Training the Judiciary in the Social Drivers of Health
Bill of Health
by The Petrie-Flom Center Staff
1M ago
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 als ..read more
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Cell Therapies and their Legal Discontents
Bill of Health
by Adithi Iyer
1M ago
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 patient ..read more
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Protecting Health Privacy is a Royal Pain
Bill of Health
by Bobby Stroup
1M ago
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 co ..read more
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EU and US Regulatory Challenges Facing AI Health Care Innovator Firms
Bill of Health
by The Petrie-Flom Center Staff
1M ago
      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 clinical ..read more
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Insurance Coverage for Psychedelic Therapy
Bill of Health
by Vincent Joralemon
2M ago
By Vincent Joralemon As therapies using drugs like MDMA, psilocybin, and LSD advance through the FDA research and approval pipeline, patients should be prepared for steep price tags attached to these procedures. For example, experts estimate MDMA-assisted therapy for PTSD will cost upwards of $12,000 per patient. These high costs highlight the need for comprehensive insurance coverage because many of those experiencing symptoms of conditions like PTSD also frequently lack the resources to pay for such treatments. Looking at how the current system works, including presently available psychedeli ..read more
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The FDA Backdoor to MDMA Rescheduling
Bill of Health
by Vincent Joralemon
2M ago
By Vincent Joralemon MDMA (also known as the club drug “molly” or “ecstasy”) is a Schedule I controlled substance — the most restrictive drug class with the most severe criminal consequences linked to it. But, perhaps not for long. A recent effort to get MDMA approved by the U.S. Food and Drug Administration (FDA) for post-traumatic stress disorder (PTSD) means the drug may be rescheduled, which will lead to substantially decreased regulations attached to it. This provides a compelling model for efforts to decriminalize and destigmatize other substances moving forward. How Scheduling Works In ..read more
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