AI-generated image of robot doctor with surgical mask on.

Who’s Liable for Bad Medical Advice in the Age of ChatGPT?

By Matthew Chun

By now, everyone’s heard of ChatGPT — an artificial intelligence (AI) system by OpenAI that has captivated the world with its ability to process and generate humanlike text in various domains. In the field of medicine, ChatGPT already has been reported to ace the U.S. medical licensing exam, diagnose illnesses, and even outshine human doctors on measures of perceived empathy, raising many questions about how AI will reshape health care as we know it.

But what happens when AI gets things wrong? What are the risks of using generative AI systems like ChatGPT in medical practice, and who is ultimately held responsible for patient harm? This blog post will examine the liability risks for health care providers and AI providers alike as ChatGPT and similar AI models increasingly are used for medical applications.

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Blood donor at donation with bouncy ball holding in hand.

Lift the Blood Ban, But Don’t Penalize PrEP Users 

By Doron Dorfman

On May 11, the U.S. Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban.

While this decision should be applauded as a step toward equality, the policy remains flawed and needlessly stigmatizing, as it excludes potential donors who use pre-exposure prophylaxis (PrEP), an antiviral regimen that prevents HIV infection from sex.

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Narcan Naloxone nasal spray opioid drug overdose prevention medication.

Public Health Product Hops

By Michael S. Sinha, Edna Besic, and Melissa Mann

Members of Congress have been focused on drug pricing for the last several years, culminating recently in new drug pricing provisions within the Inflation Reduction Act of 2022. One reason for our drug pricing problem is that we allow manufacturers to charge whatever the market will bear for a new therapeutic. However, as we have also seen, manufacturers often engage in anticompetitive “games” aimed at extending market exclusivity and forestalling generic competition. One of these games is product hopping.

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Medical Development Laboratory: Caucasian Female Scientist Looking Under Microscope, Analyzes Petri Dish Sample. Specialists Working on Medicine, Biotechnology Research in Advanced Pharma Lab.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Alexander Egilman, andAaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of March. The selections feature topics ranging from an analysis of patent challenges by generic manufacturers on brand-name inhalers, a discussion of the Alliance for Hippocratic Medicine v. FDA lawsuit and its potential implications for pharmaceutical regulation, and an estimate of U.S. public investment in the development of mRNA COVID-19 vaccines. A full posting of abstracts/summaries of these articles may be found on our website.

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Supreme Court of the United States.

The Federal Judiciary Is Broken — But Not for the Reason You Think

By Jennifer Bard

Recent events, including the discovery that Justice Thomas has been accepting luxury vacations from and selling real estate to a billionaire, and the Fifth Circuit’s finding in Alliance for Hippocratic Medicine v. FDA that federal courts have the power to modify the conditions under which the FDA can approve a drug, may seem separate. But they’re not. Both involve a threat to our constitutional government and both highlight the need to shield all federal decision makers from entities with billions at stake and a fiduciary interest in increasing the value of their company for the benefit of shareholders. And while issues of influence affecting Supreme Court Justices attract the most attention, the factors that make Justices targets extend across the entire federal judiciary.

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Washington DC, USA - FEBRUARY 10 2021: President Joe Biden delivers remarks to Department of Defense personnel, with Vice President Kamala Harris and Secretary of Defense Lloyd J. Austin III.

4 Years into the COVID-19 Pandemic: Where We Stand

By Jennifer S. Bard

The White House is preparing to shut down their COVID Task Force this May, in conjunction with ending the public health emergency — the latest in a series of astounding and shortsighted decisions that put individual Americans at as great a risk from serious harm as a result of catching COVID-19 as at any stage in the pandemic.

By declaring the pandemic over by fiat, the government is giving up the fight when they should be redoubling their efforts. Not only is COVID still very much with us, but all existing methods of preventing infection have either been severely weakened by the virus’ mutations, or simply abandoned. Additionally, more is known of the harm COVID causes past the initial infection.

There is nothing vague or subtle about the “end” of a disease outbreak. Either cases actually disappear, as with seasonal influenza, or they are dramatically reduced through a vaccine that prevents further transmission, as happened with measles and polio. Neither event has happened here. Instead, like HIV, which continues to be an ongoing public health emergency, the virus continues to infect and mutate.

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Adderall bottle on shelf.

Losing Control of Controlled Substances? The Case of Telehealth Prescriptions 

By Minsoo Kwon

Telehealth services that specialize in the treatment of mental health concerns, such as Cerebral Inc., highlight the ongoing challenge of appropriately balancing accessibility of care with patient safety.

While increased accessibility of mental health care services through telehealth is a valuable goal, if our aim is the well-being of patients, safety must be paramount.

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