News, Resources, and Events Tagged "I. Glenn Cohen"
Medicare Advantage: Growth Amidst Mounting Scrutiny,
The Medicare Advantage Program, home to nearly half of the eligible Medicare population, has recently come under increased scrutiny. The Government Accountability Office called on the Centers for Medicare &…
Malfunction, Malpractice
Who Is Liable When AI Injures a Patient? Medical errors happen; doctors are only human. And when doctors make mistakes, the law pertaining to who is liable is usually clear-cut.…
What rights do and should stakeholders have for medical data? A survey of patients, physicians, and hospital administrators,
We examine perceived and idea ownership of US patient medical data as governed by HIPPA in a survey of three stakeholder groups: patients, primary care physicians, and medical administrators. Current…
Cigna Accused of using AI, not Doctors to Deny Claims: Lawsuit
Glenn Cohen, JD, deputy dean and professor at Harvard Law School, told Medscape Medical News that this is the first lawsuit he's aware of in which AI…
The FDA Declares Levonorgestrel a Nonabortifacient—A 50-Year Saga Takes a Decisive Turn
Levonorgestrel (Plan B), also known as the morning-after pill, was the brainchild of Yuzpe and colleagues nearly 50 years ago. The drug has been available over the counter since 2006. Even…
Assisted Reproduction Post-Dobbsthe Prospect of Legislative Protection
Dobbs v. Jackson opened up the possibility of more state restrictions that may not only restrict abortion but also restrict assisted reproductive technologies (ARTs) such as in …
Hospital at Home Receives a New Lease on Life: A Promising if Uncertain Future
Though destined to sunset on May 11, 2023 at the conclusion of the 40 months-long federal Public Health Emergency (PHE), the Acute Hospital Care at Home (AHCaH) program was recently extended through December 31, 2024…
Patient-Assistance Programs, Kickbacks, and the Courts
Pharmaceutical companies have sought to reduce cost sharing by means of patient-assistance programs. Some such programs have been under scrutiny because of questions about whether they violate federal law.
Observational Studies Must be Reformed Before the Next Pandemic
Observational studies provide crucial information early during epidemics and pandemics, but they often suffer from methodological shortcomings, which can be resolved.
The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Model
The introduction of artificial intelligence (AI) into medical devices, decision support, and clinical practice is not new, with a particular uptick in investment and deployment within the past decade. What…
The New Threat to Abortion Access in the United States—The Comstock Act
In this Viewpoint we discuss an issue that is being litigated in several courts—the Comstock Act. This statute, named after US Postal Service agent and antivice crusader…
Inquiring Mind: His Path to Bioethics was Firmly Rooted in the Love of Learning
I. Glenn Cohen ’03 has always been fascinated with how things and people work, and with parsing thorny ethical dilemmas. He loves science and the law, and he’s…
To Protect Patients And Spark Innovation, Codify The FDA’s Oversight Of Laboratory-Developed Tests
The Food and Drug Administration (FDA) has long viewed the oversight of the safety and effectiveness of laboratory-developed tests as part of its regulatory mission. However, the scope of…
Hospitals are Testing AI to Communicate with Patients. They Still Don’t Know How to Talk to Them About It
Health systems across the country are exploring blending artificial intelligence into their communication with patients, from billing to after-hours messages about medication or symptoms. But how best to actually …
Abortion Miscoding—Legal Risks for Clinicians and Hospital Systems
With the expanded legal risks for clinicians and patients seeking abortion care after Dobbs v Jackson Women’s Health Organization, the prevalence of abortion miscoding—coding…
HIPPA is Misunderstood and Inadequate Tool for Protecting Medical Data
Patients, physicians, and hospital administrators in the USA are often unaware of how legislation governs medical data—but agree that rights over such data should be expanded for patients…
Order now! COVID-19 and the Law: Disruption, Impact and Legacy
This edited volume is based on the Petrie-Flom Center’s 2021 annual conference, which, in partnership with the Solomon Center for Health Law and Policy at Yale Law School,…
The abortion pill lawsuit that could change how the FDA approves drugs,
"To the extent that all of these things become a political question or a judicial question rather than a question of science and medicine, we're in a very dangerous…
Artificial Intelligence in Mental Health: Strategies for avoiding potential data harms
Event Description Applications of algorithmic and data-driven technologies in mental health care settings are rapidly expanding. While well-designed digital technologies may be used to promote effective…
Video now available! Achieving Telehealth’s Potential: The State Policy Landscape for Interstate Telehealth Practices
Event Description Telehealth has been an invaluable tool for preserving health care access during the pandemic. Early in the pandemic, policymakers on the federal and state level moved with remarkable…
Video now available! Achieving Telehealth’s Potential: The Federal Policy Landscape for Interstate Telehealth Practices
Event Description Telehealth has been an invaluable tool for preserving health care access during the pandemic. Early in the pandemic, policymakers on the federal and state level moved with remarkable…
Video now available! Achieving Telehealth’s Potential: The Policy Landscape’s Impact on Specialty Care
Event Description Telehealth has been an invaluable tool for preserving health care access during the pandemic. Early in the pandemic, policymakers on the federal and state level moved with remarkable…
Video now available! Climate Change and Health: A Health Policy and Bioethics Consortium
Event Description As one of the largest economic sectors globally, health care represents nearly 10% of GDP spending across O.E.C.D. countries. This significant activity produces an estimated 5-10%…
Video now available! What Magic Can Teach Us About Misinformation
Event Description This panel joined together the fields of medicine, magic, and ethics. We explored how misinformation and disinformation about health is created and spread, and how expectation violation…
EMTALA After Dobbs: Emergency Reproductive Health Care in the Balance
In Dobbs v Jackson Women's Health Organization, the U.S. Supreme Court decided that “the Constitution does not confer a right to abortion” and that the &ldquo…
What States Can and Can’t Do When Banning Abortion: Changes to laws are putting physicians in a difficult position when treating pregnant patients and figuring out whether performing an abortion might be legal.
Whether someone can get an abortion or related medical procedure mostly hinges on which state they live in after the Supreme Court overturned Roe v. Wade last month…
After Roe, Pregnant Women With Cancer Diagnoses May Face Wrenching Choices
In April of last year, Rachel Brown’s oncologist called with bad news — at age 36, she had an aggressive form of breast cancer. The very next day, she…
Hallucinate, Medicate, and Regulate
In this week’s Saturday Seminar, experts discuss ways to regulate psychedelics for medicinal use. Kenny Stills, Aaron Rodgers, and numerous other professional athletes reportedly describe significant…
Mounting Violence in Health Care: Is It Time to Harden the Sanctuary?
On June 1, 2022, an active shooter incident left 5 people dead at the Saint Francis Hospital in Tulsa, Okla. 1 The perpetrator, a disgruntled patient armed with an AR-15-style rifle purchased…
Legislation Restricting Gender-Affirming Care for Transgender Youth: Politics eclipse healthcare
In the past two years, in 25 US states, bills have been introduced to restrict access to gender-affirming medical care for minors. Some have already become law. We show how…
Genomic Politics and Equality
Professor Jennifer Hochschild’s Genomic Politics: How the Revolution in Genomic Science Is Shaping Society is a must-read for anyone interested in where our politics about genetics…
Whether Hospital Care at Home Continues When Pandemic Emergency Ends Is Up to Congress
When the pandemic public health emergency eventually ends, so will the various waivers and regulatory flexibilities enacted by HHS during the COVID-19 pandemic, including the ability to provide acute hospital…
Acute Hospital Care at Home in Medicare—Will a Pandemic Policy Be Sustained?
Faced with ever-diminishing nationwide inpatient hospital capacity wrought by the COVID-19 pandemic, in March 2020 the Centers for Medicare & Medicaid Services (CMS) announced the Hospitals Without Walls program to allow …
Report, Roberts Tried to Persuade Rest of Supreme Court to Keep Roe v. Wade in Place: The chief justice can try to persuade his Supreme Court colleagues to change the outcome of a case but has no direct power over their votes.
WASHINGTON – One of the more interesting power dynamics from the Supreme Court's historic term that ended in June was the sidelining of Chief Justice John…
‘Life of the mother’ is suddenly vulnerable
The Gazette asked two experts in reproductive law about the Texas lawsuit and how we define a health emergency. I. Glenn Cohen is the James A. Attwood…
Should Alexa Diagnose Alzheimer’s?: Legal and ethical issues with at-home consumer devices
Voice-based AI-powered digital assistants, such as Alexa, Siri, and Google Assistant, present an exciting opportunity to translate healthcare from the hospital to the home. But building a digital, medical panopticon…
Embryonic Research Could Be the Next Target After Roe
The majority opinion written by Justice Samuel Alito doesn’t single out IVF or human embryonic research, but his choice of words to describe abortion could be seen as…
Reproductive Technologies and the Law Third Edition
Reproductive Technologies and the Law is designed to introduce our students to the essentials in science, medicine, law and ethics that underpin and shape each of the topics that…
The End of Roe v Wade and New Legal Frontiers on the Constitutional Right to Abortion
n June 24, 2002, the US Supreme Court ended the constitutional right to abortion in Dobbs v Jackson Women’s Health Organization.1 The Court’s majority decision authored…
HIPAA won’t protect you if prosecutors want your reproductive health records
Justice Brett Kavanaugh’s concurring opinion suggested that crossing state lines should not be prohibited. “He believes there is a constitutional right to interstate travel for abortion,”…
“This is not about protecting life”: Supreme Court overturn of Roe v. Wade threatens lives of cancer patients, doctors
“If your state prohibits abortion, can they also prohibit you to travel out of the state? No state, as far as I know, has passed a law to that…
Roe v. Wade’s fall is a ‘turning point’ for Chief Justice John Roberts’ control over the Supreme Court, court watchers say
"[Roberts]'s moved from being a necessary vote for the conservative bloc to being basically not necessary," I. Glenn Cohen, a professor at Harvard Law School, told Insider. "He'…
‘A seismic moment in Constitutional history’: Experts in law and medicine examine the Supreme Court’s decision overturning the right to abortion
According to Harvard Law School Professor I. Glenn Cohen ’03, the ruling represented “a seismic moment in Constitutional history, indeed in American history … I can’t…
What the Supreme Court’s abortion reversal means for in vitro fertilization
The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization will upend the lives of pregnant persons across the United States seeking abortions…
How the Supreme Court Ruling Clouds Future for IVF Treatments
The main concern is not that state lawmakers will target IVF, says I. Glenn Cohen, a Harvard Law School professor who specializes in bioethics, but that “the…
The 50-year history of abortion and oncology in The Cancer Letter archives
“This research has been a political football over the course of the last 30 years, with different administrations of the federal government taking different positions on it,” I. Glenn…
Harvard Law’s I. Glenn Cohen: To provide good care, doctors will run afoul of criminal law in some states as Roe v. Wade ends
Physicians and pregnant women alike have no choice but to navigate the labyrinthine complexities generated by the Dobbs v. Jackson decision—including the risk of being accused…
Skating the line between general wellness products and regulated devices: strategies and implications
Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets. Federal regulators have responded to these changes with a…
Ethics-by-design: efficient, fair and inclusive resource allocation using machine learning
The distribution of crucial medical goods and services in conditions of scarcity is among the most important, albeit contested, areas of public policy development. Policymakers must strike a balance between…
What Overturning Roe v Wade May Mean for Assisted Reproductive Technologies in the US
The Supreme Court's overturning of Roe v. Wade may affect the regulation of reproductive technologies like in-vitro fertilization (IVF). Justice Alito's leaked opinion in Dobbes…
Facebook Is Receiving Sensitive Medical Information from Hospital Websites
Facebook Is Receiving Sensitive Medical Information from Hospital Websites
How a court decision overturning abortion could affect IVF
How a court decision overturning abortion could affect IVF
Harris to convene privacy experts to talk stakes of Roe v. Wade
Harris to convene privacy experts to talk stakes of Roe v. Wade
Smarter health: The ethics of AI in health care
Smarter health: The ethics of AI in health care
If Roe is overturned, the ripples could affect IVF and genetic testing of embryos, experts warn
If Roe is overturned, the ripples could affect IVF and genetic testing of embryos, experts warn
Readout from Vice President Harris’s Meeting with Constitutional Law, Privacy, and Technology Experts on Reproductive Rights
Readout from Vice President Harris’s Meeting with Constitutional Law, Privacy, and Technology Experts on Reproductive Rights
Order now! The Future of Medical Device Regulation: Innovation and Protection
This edited volume is based on the Petrie-Flom Center’s 2020 annual conference, which brought together leading experts to explore the challenges medical device regulation might face …
Supplying International Aid Effectively: Ethics and Law
Confronting pandemics and improving health in low-income countries requires ambitious public health plans. Global health responses to HIV/AIDS and multidrug resistant tuberculosis can provide guidance on how to garner…
“I’d feel like someone was watchin’ me… watching for a good reason”: perceptions of data privacy, access, and sharing in the context of real-time PrEP adherence monitoring among HIV-negative MSM with
Once-daily oral tenofovir/emtricitabine is highly effective as pre-exposure prophylaxis (PrEP) against HIV but is dependent on adherence, which may be challenging for men who have sex with men (MSM)…
Health Care Fraud: The Leading Violation of the False Claims Act
It is a sign of the times when the lion's share of the schemes intent on defrauding the federal government are in the health care arena. Data reported by…
Article supports FDA review of lab-developed tests
This change drew "wide-ranging expressions of concern" about the future safety of LDTs, according to authors Dr. Eli Adashi of Brown University in Providence, RI, and I. Glenn Cohen of…
A Complex Patent & Pricing Picture: Regulating Psychedelics More of a Journey Than a Trip
Pharma and legal experts weigh in on the rush to secure intellectual property around psychedelic medicines, the value imperative that should govern pricing strategies, and the likely long-haul battle for…
SARS-CoV-2 Laboratory-Developed Tests: Integrity Restored
On November 15, 2021, the US Department of Health and Human Services (HHS) rescinded a Trump-era policy that had directed the US Food and Drug Administration (FDA) to discontinue the premarket reviews…
Mitigating Racial Bias in Machine Learning
When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or…
Transparency and the Doctor–Patient Relationship — Rethinking Conflict-of-Interest Disclosures
To reduce the harm associated with improper financial relationships between manufacturers and physicians, practitioners could be required to disclose such relationships directly to patients.
Patents on Psychedelics: The Next Legal Battlefront of Drug Development
In the past two decades, pioneering research has rekindled interest in the therapeutic use of psychedelic substances such as psilocybin, ibogaine, and dimethyltryptamine (DMT). Indigenous communities have used them for…
The hospital-at-home presents novel liabilities for physicians, hospitals, caregivers, and patients
Healthcare is increasingly provided in a patient’s home, with potential cost savings and clinical improvements. But the hospital-at-home also raises unique liability issues not only for physicians and…
Video now available! Should Alexa Diagnose Alzheimer’s?: A Health Policy and Bioethics Consortium
View the conversation on Twitter @PetrieFlom using #DiagnosingAtHome. Check out the event coverage: Paul E. Alexis and Krishi Kishore, "Bioethics Panel Discusses Smart Device Disease Diagnosis," The Harvard Crimson (February 14, 2022) …
Sharing Clinical Notes: Potential Medical-Legal Benefits and Risks
As of April 2021, a new federal rule mandated that US clinicians and health organizations make electronic health records much more accessible to patients without charge. Part of the bipartisan 21st…
NFTs offer new method to control personal health information
NFTs, or nonfungible tokens, created using blockchain technology, first made a splash in the art world as a platform to buy and sell digital art backed by a digital contract.…
How NFTs could transform health information exchange
Personal (sometimes called “protected”) health information (PHI) is highly valued (1) and will become centrally important as big data and machine learning move to the forefront of health care…
Reassessing Psychedelics: A new HLS initiative examines the legal and ethical aspects of therapeutic psychedelics
“When it comes to the interface with the law, the time could not be better for examining psychedelics,” says HLS Professor I. Glenn Cohen ’03, faculty director of…
Supreme Court Ruling on the Texas Abortion Law: Beginning to Unravel Roe v Wade
In 2021, Texas enacted an abortion statute, SB8, stating “a physician may not knowingly perform or induce an abortion on a pregnant woman if the physician detected a fetal heartbeat…
At-home Diagnostics and Diagnostic Excellence: Devices vs General Wellness Products
Patients increasingly use health-related products that straddle a regulatory line they never see and most do not know exists—the line between US Food and Drug Administration (FDA)&ndash…
Video now available! Challenges for Mobile Diagnostics: Mobile MRI as a Case Study
Watch the fully captioned event recording. View the conversation on Twitter @PetrieFlom using #PrivateMRIs. Event Description Developed in the 1970s and commercialized shortly thereafter, Magnetic Resonance Imaging (MRI) has since…
Fact check: False claim that Nuremberg Code prohibits mask mandates
“The claim that this violates the Nuremberg Code is 100% false," I. Glenn Cohen, deputy dean of the Harvard Law School, said in an email.
The Danger of the Supreme Court Undercutting Biden’s Vaccination Rules
“There are three quarters of a million new [COVID] cases yesterday. . . [t]hat is 10 times as many as when OSHA put in this ruling. The hospitals are today, yesterday,…
Weighing President Biden’s first year: Health care and the pandemic
As part of a series examining the first year of the Biden presidency, Harvard Law Today asked two experts in health care law and policy, I. Glenn Cohen ’03, James…
The Pandemic Preparedness Program: Reimagining Public Health
On September 2, 2021, the White House released its long-awaited pandemic preparedness proposal titled American Pandemic Preparedness: Transforming Our Capabilities. Called for by presidential executive order 13987 and National Security Memorandum 1, the proposal, 8…
A Divisive Ruling on Devices — Genus Medical Technologies v. FDA
The FDA has long taken the legal position that regulated devices could also be categorized as drugs. But according to a recent case, products meeting the definition of a device …
Deadly Legacy—The 510(k) Path to Medical Device Clearance
On December 29, 2020, the US Food and Drug Administration (FDA) issued final guidance to the effect that laparoscopic power morcellators (LPMs) should be used “only with a tissue containment system…
Video now available! SCOTUS Revisits Abortion: Legal Strategies in Dobbs Oral Arguments
Watch the fully captioned event recording. View the conversation on Twitter @PetrieFlom using #Dobbs. Event Description On December 1, the U.S. Supreme Court heard oral argument in Dobbs v. Jackson…
Fate of Roe v. Wade Will Depend on 3 Justices
After Supreme Court arguments Wednesday, the future of abortion rights in America will now likely be decided by three justices, including the second two of Donald Trump's three nominees…
Trump’s Supreme Court picks Amy Coney Barrett and Brett Kavanaugh could decide the fate of Roe v. Wade
"It's very clear where Justice Kagan, Justice Sotomayor, and Justice Breyer are," I. Glenn Cohen, a professor at Harvard Law School, told Insider. "They are going to vote to…
Biden Vaccine-or-Test Rule’s Future at Stake in Court Lottery
The Fifth Circuit panel incorrectly stated that the rule requires workers to choose “between their job(s) and their jab(s)” because it has an option for testing,…
Legal and Bioethics Experts Discuss Future of Abortion at Law School Panel
Legal and bioethics experts convened to discuss the future of abortion amid efforts to overturn Roe v. Wade at a virtual panel held by the Petrie-Flom Center for Health Law…
Video now available! The Future of Abortion in America: A Virtual Townhall Discussion for Students
View the conversation @PetrieFlom using #AbortionTownhall. View the fully captioned event video. Event Description The future of abortion access in America is not secure, as recent developments have shown. In…
SYMPOSIUM SPEAKER SERIES: International Pandemic Lawmaking: Can a 'Pandemic Treaty' Promote Global Health Justice?
In light of the COVID-19 pandemic, this panel discussion was held virtually, as an online webinar. Event Description Amid contention that global governance was unprepared and incapacitated in its response…
Video now available! Book Launch: Consumer Genetic Technologies: Ethical and Legal Considerations
View the conversation at @PetrieFlom using #ConsumerGenetics. We will share the fully captioned event recording within 1-2 weeks. Event Description In September 2021, Cambridge University Press published Consumer Genetic Technologies: Ethical…
Court’s interest in Texas could signal end of Roe
“We may get some tea leaves from [Monday’s] argument, but I would be very surprised if there were major changes that come directly out of it,”…
Video now available! Book Talk: The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA
View the conversation on Twitter @PetrieFlom using #GenomeDefense. Watch the fully captioned event video. Event Description When Chris Hansen, an ACLU lawyer, learned that the U.S. government was issuing…
Pharmaceutical Companies, Human Rights, and the Alien Tort Statute
On January 3, 2019, U.S. District Judge Theodore D. Chuang of the U.S. District Court of the District of Maryland took a crucial first step in redressing one of the…