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. Raimondo overruling decades of precedent under which courts gave deference to agency interpretation of federal statutes the agency was charged with enforcing. The case is already reverberating in the ..read more

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.  Pfizer/BioNTech responded that Moderna’s pledge authorized them to practice the asserted patents, at least until the end of the World Health Organization (WHO)-declared pandemic, which occurred in May 2023 ..read more

by Daniela Cepeda Cuadrado There is a wealth of research demonstrating that corruption — the abuse of entrusted power for private gain — has contributed to weakening health systems and worsening public health globally. Corruption is associated with a higher infant mortality rate, the rise of antimicrobial resistance, and the diversion of key resources to invest in strengthening health systems. Corruption’s impact on health systems is well documented – that is if we see health systems only as the structures in place to cater to people’s physical health needs. But the discussion on corruption an ..read more

by Leslie P. Francis That’s correct: unless your prescription for misoprostol meets strict new conditions, possession of the drug is now illegal in Louisiana.  In late May 2024, Louisiana governor Jeff Landry signed a bill making misoprostol and mifepristone schedule IV drugs, the most highly regulated controlled substances.  Violating the law may result in jail sentences or fines. These Louisiana laws, and laws in other states making medication abortion illegal or restricting access to the method, were not addressed by the Supreme Court’s rejection in June of the Alliance for Hippoc ..read more

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 ago. As Price and Cohen have pointed out, entities subject to federal Health Insurance Portability and ..read more

by Barbara Pfeffer Billauer Legal pundits are predicting the imminent demise (or at least substantial enfeeblement) of the Chevron doctrine. Until recently, that case afforded substantial judicial deference to decisions made by administrative agencies if a statutory provision under its purview was ambiguous. Now two cases are before the Supreme Court challenging an agency interpretation regarding funding of statutorily required monitors on fishing boats. This development signals a “sea-change” is in sight for agency autonomy, as deference to agency decisions is being threatened. Chevron holds ..read more

Interviewed by William Leonard Pickard George Church, PhD, is the Robert Winthrop Professor of Genetics at Harvard Medical School, Professor of Health Sciences and Technology at Harvard University and the Massachusetts Institute of Technology. He is a founding member of the Wyss Institute for Biologically Inspired Engineering at Harvard. His research efforts include the first direct genome sequencing method, collaborating in initiating the Human Genome Project, and creating the Personal Genome Project. He co-founded over 50 biotechnology companies as spin-offs from the ..read more

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 ..read more

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

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