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Artificial Intelligence Channeling the Power of Generative Health AI: Implications for Health Care, Research, and Governance (Part I) Medicine is one of humanitys greatest information-processing challenges. Understanding and repairing the human body requires synthesizing vast amounts of interconnected knowledge and information while making high-stakes decisions.
Addiction Marching Toward Gambling Madness (Pt. 1) Its time to fill your bracket and brush up on your ball-knowledge: March Madness is here. The iconic college basketball tournament has been a staple of the sports calendar for nearly a century, but the stakes of this year’s tournament are higher than ever before. Published March 20, 2025 Author Spencer Andrews Share Share on LinkedIn Share on X Share on Bluesky Share on Facebook Its time to fill your bracket and brush up on your ball-knowl
Government Regulation Hims? Hers? Its Novo Nordisks Semaglutide Market Now Between Feb. 19-26, shares for the telehealth company Hims & Hers Health, Inc. plummeted. The reason for the sudden drop in its stock price? An FDA announcement that semaglutide injection products, the GLP-1 medication in the blockbuster drugs Wegovy and Ozempic, are no longer in shortage.
Artificial Intelligence When Clinical Trials Meet Patents: Finding Balance in Law Transparency rules in clinical trials attempt to strike a balancebetween ensuring essential safety and efficacy data reaches the public, and preservingtruly proprietary informationthat fosters innovation. Published March 13, 2025 Author Gabriela Lenarczyk Share Share on LinkedIn Share on X Share on Bluesky Share on Facebook Transparency rules in clinical trials attempt to strike a balance between ensuring essential
Innovation, Law, and Ethics in International Bioscience Edited by Timo Minssen and Marcelo Corrales Compagnucci , the symposium convenes leading researchers from the International Collaborative Bioscience Innovation & Law Program ( Inter-CeBIL ), which is supported by a generous scientifically independent grant from the Novo Nordisk Foundation (NNF).
Artificial Intelligence Mind over Machine: Navigating the Legal and Ethical Frontier of Neurotech Picture a world where a patient suffering from a debilitating neurological disorder receives not only a diagnosis but also a bespoke brain implant designed to restore lost function. Published February 27, 2025 Author Abeer Malik Share Share on LinkedIn Share on X Share on Bluesky Share on Facebook Picture a world where a patient suffering from a debilitating neurological disorder receives not only a
Artificial Intelligence Europe Tightens Data Protection Rules for AI ModelsAnd Its a Big Deal for Healthcare and Life Sciences Imagine youre a researcher developing an AI model, such as an algorithm or other computer process, that can predict early-stage cancer using data from thousands of patient records. Youve been careful anonymizing datasets, following ethical guidelines, and ensuring patient confidentiality.
Artificial Intelligence Actionable Insights from the International Collaborative Research Program in Bioscience Innovation & Law Edited by Timo Minssen and Marcelo Corrales Compagnucci, the symposium convenes leading researchers from the International Collaborative Bioscience Innovation & Law Program, which is supported by a generous scientifically independent grant from the Novo Nordisk Foundation (NNF).
Food Safety Red Dye No. 3 and the Delaney Clause: A Relic of the Past or a Necessary Safety Measure? Its time to stock up on maraschino cherriesRed Dye No. 3 is officially off the market (sorry, Peter Barton Hutt, cherry enthusiast and leading food and drug lawyer). On Jan. 15, 2025, the U.S. Food and Drug Administration (FDA) banned the use of Red Dye No. 3 in food, drinks, and drugs.
by Mauritz Kop , Suzan Slijpen , Katie Liu , Jin-Hee Lee , Constanze Albrecht & I. Glenn Cohen I. Introduction: Harnessing Quantum and AI in Precision Medicine The convergence of artificial intelligence (AI) and quantum technology (QT) in precision medicine promises to revolutionize healthcare by enabling hyper-personalized treatment. Fundamentally, for our purposes, quantum technology leverages unique properties of quantum physicssuch as superposition and entanglementto solve problems beyon
artwork by Daiara Tukano by Daiara Tukano and Maria Fernanda Gebara Last June, we had the honor of speaking at Law and Policy of Psychedelic Medicine, the 2024 Annual Conference hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. You can watch our panel here. Speakers from around the world discussed the legal and ethical aspects of psychedelic use.
artwork by Daiara Tukano by Daiara Tukano and Maria Fernanda Gebara Last June, we had the honor of speaking at Law and Policy of Psychedelic Medicine, the 2024 Annual Conference hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. You can watch our panel here. Part I of this post highlighted the ethical considerations surrounding the use of Indigenous medicines.
by Spencer Andrews Weve all had the experience: you receive a targeted ad on your phone or computer which mysteriously seems to read your mind. This happened to me recently when I, a busy law student, began receiving a wave of ads selling supplements which purport to improve brain focus, clarity, and memory. I had been thinking about ways to increase my productivity, and just in the nick of time, a miracle drug appeared to answer my need.
by Thalia Viveros Uehara and Alicia Ely Yamin Conclusion of the Digital Symposium Climate Change and Health: Mobilizing Public International Law into Action COP29 in Baku underscored what many had feared a summit defined by missed opportunities. Perhaps this was to be expected, given that it was the second COP in a row held in a petro-state, with more fossil fuel lobbyists in attendance than climate and environmental activists.
by Anna Aguilar and Sidney Lee In 1971, Congress tasked the U.S. Department of Housing and Urban Development (HUD) with establishing procedures to eliminate as far as practicable the dangers of lead poisoning. Yet, HUD has repeatedly fallen short of accomplishing this. More than 50 years later, for children in federally assisted housing in the United States, lead exposure is hardly a thing of the past.
by Anna Aguilar and Sidney Lee In 1971, Congress tasked the U.S. Department of Housing and Urban Development (HUD) with establishing procedures to eliminate as far as practicable the dangers of lead poisoning. Yet, HUD has repeatedly fallen short of accomplishing this. More than 50 years later, for children in federally assisted housing in the United States, lead exposure is hardly a thing of the past.
by Spencer Andrews Weve all had the experience: you receive a targeted ad on your phone or computer which mysteriously seems to read your mind. This happened to me recently when I, a busy law student, began receiving a wave of ads selling supplements which purport to improve brain focus, clarity, and memory. I had been thinking about ways to increase my productivity, and just in the nick of time, a miracle drug appeared to answer my need.
artwork by Daiara Tukano by Daiara Tukano and Maria Fernanda Gebara Last June, we had the honor of speaking at Law and Policy of Psychedelic Medicine, the 2024 Annual Conference hosted by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. You can watch our panel here. Part I of this post highlighted the ethical considerations surrounding the use of Indigenous medicines.
by Mauritz Kop, Suzan Slijpen, Katie Liu, Jin-Hee Lee, Constanze Albrecht & I. Glenn Cohen I. Introduction: Harnessing Quantum and AI in Precision Medicine The convergence of artificial intelligence (AI) and quantum technology (QT) in precision medicine promises to revolutionize healthcare by enabling hyper-personalized treatment. Fundamentally, for our purposes, quantum technology leverages unique properties of quantum physicssuch as superposition and entanglementto solve problems beyond cl
Photo credit: @wambuigichobi | SMA A Masai woman raises her fist as other women leaders look on at COP 27 in Sharm El Sheikh, Egypt during one of the debriefs by the Women and Gender Constituency. by Faith Lumonya , Esther Wambui , and Eunice Musiime As global temperatures rise and the frequency of extreme weather events — such as floods, droughts, and heat waves — increases, climate change poses a growing threat to the progress of women’s sexual and reproductive health and rights (SRHR).
by Cecile de Villiers South Africa is considered the most unequal country in the world, with stagnant economic growth and staggeringly high unemployment. More than five million or 31.2% of workers in South Africa find economic opportunities in the “ informal economy ,” often because there are fewer barriers (training, skills, regulation) to entering the sector.
by Rebekah Ninan A recent lawsuit in the Southern District of New York has alleged that the health insurance company Anthem Blue and Cross Blue Shield violated state laws and committed fraud by maintaining “ghost networks” of mental health providers. Ghost networks are directories for insurance companies that contain outdated or inaccurate information about providers covered by the insurance plan.
by Jessica Samuels For 100 years, food fortification , the practice of deliberately increasing the content of vitamins and minerals in a food, has been essential to combating public health crises. However, these practices have continued into the modern era. Because overconsumption of nutrients has been linked to toxicity and diseases, public health officials should continue to reflect on the benefits and risks of food fortification today.
by Rupa Palanki The United States increasingly faces a crisis in maternal and infant health care. Over 2.3 million American women of reproductive age live in maternity care deserts — counties with little to no access to birthing centers and obstetric care. These deserts often result from rural hospital closures, health care provider shortages, and long-standing structural inequalities.
by Donrich Thaldar As the era of genomic medicine dawns, large-scale genomics projects are becoming increasingly central to health care advancements. Projects like FinnGen in Finland, the UK Biobank , and the All of Us initiative in the United States are charting new frontiers in precision medicine, enabling researchers to unlock the genetic codes underlying a wide array of diseases.
by Rebekah Ninan This summer, a startling study from researchers at University of California, Berkeley revealed tampons from several brands contain toxic heavy metals like lead, arsenic, and cadmium. This finding follows the 2023 discovery that many menstrual products contain per- and polyfluoroalkyl substances (PFAS), even those marketed as PFAS-free.
by Spencer Andrews What makes a city livable? The answer, some say, is more “ third places ,” spaces distinct from one’s home (the first place) and one’s workplace (the second place). A third place, like a café, park, or library, fosters the sense of community and connection that makes a neighborhood great to live in. This imprecise yet uncomplicated framing effectively refocuses a complex set of social, economic, and urban design issues on a simple solution to the “livability” problem.
by Rebekah Ninan This past month, California Governor Gavin Newsom signed a wave of artificial intelligence-related legislation into law. Much public debate has been focused on SB 1047, a proposal ultimately vetoed by Governor Newsom, which would have held AI companies liable for “ catastrophic harms ” from AI models. Comparatively little attention has been paid to three new laws aimed at health care-related AI and data privacy.
Come work with us! The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics (PFC) seeks an experienced, dynamic, passionate, and flexible Communications Manager to support, promote, and creatively amplify the work of PFC with the overall goal of raising its profile and advancing its mission. PFC is a highly collaborative and agile team that works together on all aspects of our work.
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is pleased to announce our 2025 annual conference: “Law, Healthcare, and the Aging Brain and Body.” This year’s conference is organized in collaboration with Nina A. Kohn , the David M. Levy Professor of Law at Syracuse University College of Law and the Solomon Center Distinguished Scholar in Elder Law with the Solomon Center for Health Law and Policy at Yale Law School and Francis X.
By Zack Buck Yet another case that examines the authority of administrative agencies to interpret health care laws will make its way to the Supreme Court next term. And the case could have major implications for hospital financing as well. In June 2024, the U.S. Supreme Court granted cert in Advocate Christ Medical, et al. v. Becerra , a case that centers on the appropriate calculation of so-called disproportionate share hospital (DSH) payments, which are made to hospitals that treat a high perc
by Nathan Cortez If you wanted quick medical advice, you’d ask your friend with an MD or BSN. Not a JD. Likewise, if you wanted to know how to regulate nitrogen oxide under the Clean Air Act, you’d probably trust the scientists at Environmental Protection Agency (EPA) over the judges on a court that referred to the gas as nitrous oxide (laughing gas).
We are delighted to welcome a new group of Student Fellows to the Petrie-Flom Center family: Spencer Andrews, Zain Khalid, Abeer Malik, Rebekah Ninan, Rupa Palanki, and Jessica Samuels. These six students are a fantastic cohort of scholars who join us from Harvard Law School and Harvard Medical School. Each will undertake a year-long research project with mentorship from Center faculty and affiliates and will blog here at Bill of Health regularly.
by James Toomey If you are supposed to make a legally binding decision on behalf of someone incapacitated by dementia, chances are the law will tell you to apply the “substituted judgment” standard—you will be asked to make the decision the person for whom you are deciding would have made, if they had capacity. But why? You might think that the decision they would have made is a very bad one.
by James Toomey Imagine that you were to develop dementia and someone else had to make medical decisions on your behalf. How would you want them to decide? Then suppose that you had to make medical decisions on behalf of another person with dementia. Would you think about decision-making in the same way? A new study in AJOB Empirical Bioethics by myself, Jonathan Lewis, Ivar Hannikainen, and Brian Earp suggests that people may favor different decisions when deciding for others versus when decidi
by Tara Sklar Because I believe strongly in the benefits of telehealth, I have obtained licenses in six states through the Interstate Medical Licensure Compact. Doing this took months, cost thousands of dollars, and still leaves me unable to care virtually for patients in 43 states. The process is so cumbersome that less than 1% of physicians use it.
by Shannon M. MacDonald “M” was diagnosed with a rare skull-based cancer. A one-in-a-million diagnosis, he was given little information about his diagnosis and told he must seek care outside his home state. “M” worked full time, was the primary caretaker for two young kids, and could not fathom how he could travel to another state for treatment. He did not come to his scheduled out-of-state appointment.
By Helen Hughes and Mark Sulkowski As physicians who have dedicated our careers to clinical research and to the advancement of telemedicine respectively, we’ve witnessed first-hand the transformative power of technology in health care. However, despite our progress over the last four years, there remains a glaring barrier to the potential of telehealth in the United States: the complex, state-based system of health care licensure.
By Rebecca Canino , Anne R. Links, and Fawaz Al Ammary In the face of a growing organ donation crisis in the United States, characterized by a decline in donors and a surge in transplant waitlists, it has become increasingly clear that existing regulatory barriers impede access to critical transplant services. One solution lies in dismantling the artificial barrier of state-based medical licensure, a move that holds the potential to significantly enhance access for both donors and recipients of
This post launches a Digital Symposium on The Future of Telehealth Regulation, edited by Carmel Shachar, Assistant Clinical Professor of Law and Faculty Director of the Health Law and Policy Clinic at the Center for Health Law and Policy Innovation. The symposium continues the conversation from a working group held in June 2023 titled “Achieving Telehealth’s Potential”, out of which a Consensus Statement for two feasible policy paths forward emerged.
by Karina Bashir The law helps establish legitimacy and inform societal norms—a role that becomes particularly pronounced in the field of psychedelics. Lingering stigma from the War on Drugs , despite the promising scientific potential of psychedelics, hinders the growth of the psychedelic industry and its public acceptance.
This post originally appeared on Health Care in Motion , published by the Center for Health Law and Policy Innovation. The last days of the Supreme Court of the United States’ (SCOTUS) term brought some blockbuster decisions with far reaching implications for federal agencies charged with regulating health care. In an expected but still monumental move, SCOTUS issued a decision in Loper Bright vs.
By Jorge L. Contreras On July 2, 2024, the High Court of the United Kingdom issued a decision in Moderna’s mRNA vaccine patent litigation against Pfizer and BioNTech. As I previously discussed in October of 2020, Moderna pledged not to enforce its patents against makers of COVID-19 vaccines during the pandemic. Then, in 2022, Moderna sued competing vaccine makers Pfizer and BioNTech.
By Michael L. Millenson The latest draft government strategic plan for health information technology pledges to support health information sharing among individuals, health care providers and others “so that they can make informed decisions and create better health outcomes.” Those good intentions notwithstanding, the current health data landscape is dramatically different from when the organizational author of the plan, the Office of the National Coordinator for Health IT, formed two decades ag
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