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 Medicare Advantage: Growth Amidst Mounting Scrutiny, image

Medicare Advantage: Growth Amidst Mounting Scrutiny,

Eli Y. Adashi, Daniel P. O'Mahony, and I. Glenn Cohen.
The Journal of the American Board of Family Medicine.

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 image

Malfunction, Malpractice

Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics with Glenn Cohen

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, image

What rights do and should stakeholders have for medical data? A survey of patients, physicians, and hospital administrators,

Romain Cadario, Carmel Shachar, I. Glenn Cohen, and Carey K. Morewedge
medRxiv preprint

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…

Navigating a Path Toward Routine Recording in the Operating Room image

Navigating a Path Toward Routine Recording in the Operating Room

Alexander Langerman, Catherine Hammack-Aviran, I Glenn Cohen, et al.
Annals of Surgery

Cigna Accused of using AI, not Doctors to Deny Claims image

Cigna Accused of using AI, not Doctors to Deny Claims: Lawsuit

Steph Weber, featuring I. Glenn Cohen
Medscape Medical News

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 image

The FDA Declares Levonorgestrel a Nonabortifacient—A 50-Year Saga Takes a Decisive Turn

Eli Y. Adashi, I. Glenn Cohen, and Allen J. Wilcox
JAMA Health Forum

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 image

Assisted Reproduction Post-Dobbsthe Prospect of Legislative Protection

Eli Y. Adashi, Daniel P. O’Mahony, and I. Glenn Cohen
Fertility and Sterility Reports

 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 image

Hospital at Home Receives a New Lease on Life: A Promising if Uncertain Future

Eli Y. Adashi, Daniel P. O'Mahony, and I. Glenn Cohen
The American Journal of Medicine

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 image

Patient-Assistance Programs, Kickbacks, and the Courts

Jacob T. Elberg, Eli Y. Adashi, and Glenn Cohen
New England Journal of Medicine

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 image

Observational Studies Must be Reformed Before the Next Pandemic

Emily E. Ricotta, Annette Rid, Glenn Cohen, et al.
Nature Medicine

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 image

The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Model

Timo Minssen, Effa Vayena, and I. Glenn Cohen
JAMA

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 image

The New Threat to Abortion Access in the United States—The Comstock Act

I. Glenn Cohen, et al.
JAMA

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 image

Inquiring Mind: His Path to Bioethics was Firmly Rooted in the Love of Learning

Colleen Walsh, featuring I. Glenn Cohen
Harvard Law Bulletin

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 image

To Protect Patients And Spark Innovation, Codify The FDA’s Oversight Of Laboratory-Developed Tests

Eli Y. Adashi, Daniel P. O’Mahony, and Glenn Cohen
Health Affairs Forefront

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 image

Hospitals are Testing AI to Communicate with Patients. They Still Don’t Know How to Talk to Them About It

Mohana Ravindranath, quoting Glenn Cohen
STAT

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 image

Abortion Miscoding—Legal Risks for Clinicians and Hospital Systems

Sravya Chary, Danielle Pacia, and Carmel Shachar
JAMA

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 image

HIPPA is Misunderstood and Inadequate Tool for Protecting Medical Data

Charmel Shachar, Romain Cadario, I. Glenn Cohen, and Carey K. Morewedge
Nature Medicine

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…

COVID-19 and the Law image

Order now! COVID-19 and the Law: Disruption, Impact and Legacy

I. Glenn Cohen, Abbe R. Gluck, Katherine Kraschel, Carmel Shachar
Cambridge University Press

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, image

The abortion pill lawsuit that could change how the FDA approves drugs,

by Paige Sutherland and Meghna Chakrabarti, featuring I. Glenn Cohen
WBUR On Point

"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 image

Artificial Intelligence in Mental Health: Strategies for avoiding potential data harms

March 22, 2023

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…

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Video now available! Achieving Telehealth’s Potential: The State Policy Landscape for Interstate Telehealth Practices

March 13, 2023
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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…

Achieving Telehealth’s Potential image

Video now available! Achieving Telehealth’s Potential: The Federal Policy Landscape for Interstate Telehealth Practices

March 09, 2023
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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…

Achieving Telehealth’s Potential image

Video now available! Achieving Telehealth’s Potential: The Policy Landscape’s Impact on Specialty Care

February 23, 2023
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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…

Climate Change and Health image

Video now available! Climate Change and Health: A Health Policy and Bioethics Consortium

February 10, 2023
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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%…

What Magic Can Teach Us About Misinformation image

Video now available! What Magic Can Teach Us About Misinformation

January 13, 2023
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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 image

EMTALA After Dobbs: Emergency Reproductive Health Care in the Balance

Eli Y. Adashi and I. Glenn Cohen
Annals of Internal Medicine

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…

The Family Glitch, Premium Stacking, And The Need to Revisit Health Care Reform image

The Family Glitch, Premium Stacking, And The Need to Revisit Health Care Reform

Carmel Shachar, James René Jolin, I. Glenn Cohen, and Eli Y. Adashi
Health Affairs Forefront

“For as we mark the turning of spring, we also mark a new season in America,” President Barack Obama famously remarked upon signing the Affordable Care…

What States Can and Can’t Do When Banning Abortion image

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.

Jessica Rendall, quoting I. Glenn Cohen (Faculty Director)
CNET

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 image

After Roe, Pregnant Women With Cancer Diagnoses May Face Wrenching Choices

Gina Kolata, quoting I. Glenn Cohen (Faculty Director)
The New York Times

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 image

Hallucinate, Medicate, and Regulate

Elizabeth Yin et al. quoting I. Glenn Cohen (Faculty Director)
The Regulatory Review

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 image

Mounting Violence in Health Care: Is It Time to Harden the Sanctuary?

Eli Y. Adashi, I. Glenn Cohen (Faculty Director)
The American Journal of Medicine

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 image

Legislation Restricting Gender-Affirming Care for Transgender Youth: Politics eclipse healthcare

Katherine L. Kraschel (Former Student Fellow), Alexander Chen, Jack L. Turban, I. Glenn Cohen (Faculty Director)
Cell Reports Medicine

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 image

Genomic Politics and Equality

I. Glenn Cohen (Faculty Director)
American Journal of Law 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 image

Whether Hospital Care at Home Continues When Pandemic Emergency Ends Is Up to Congress

Allison Inserro, quoting I. Glenn Cohen (Faculty Director)
American Journal of Managed Care

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? image

Acute Hospital Care at Home in Medicare—Will a Pandemic Policy Be Sustained?

Eli Y. Adashi, I. Glenn Cohen (Faculty Director)
JAMA Health Forum

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 image

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.

John Fritze, quoting I. Glenn Cohen (Faculty Director)
USA Today

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 image

‘Life of the mother’ is suddenly vulnerable

Christina Pazzanese, featuring I. Glenn Cohen (Faculty Director) and Alicia Ely Yamin (Senior Fellow)
The Harvard Gazette

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

David A. Simon (Research Fellow in Digital Home Health), Barbara J. Evans, Carmel Shachar (Executive Director), and I. Glenn Cohen (Faculty Director)
Cell Reports Medicine

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 image

Embryonic Research Could Be the Next Target After Roe

Matt Reynolds, quoting I. Glenn Cohen (Faculty Director)
Wired

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 image

Reproductive Technologies and the Law Third Edition

Judith Daar, I. Glenn Cohen (Faculty Director), et al.
Carolina Academic Press

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…

HIPAA won’t protect you if prosecutors want your reproductive health records image

HIPAA won’t protect you if prosecutors want your reproductive health records

Eric Boodman, Tara Bannow, Bob Herman, and Casey Ross, quoting I. Glenn Cohen (Faculty Director) and Carmel Shachar (Executive Director)
STAT

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 image

“This is not about protecting life”: Supreme Court overturn of Roe v. Wade threatens lives of cancer patients, doctors

By Alice Tracey and Alexandria Carolan, quoting I. Glenn Cohen (Faculty Director)
Cancer Letter

“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 image

Roe v. Wade’s fall is a ‘turning point’ for Chief Justice John Roberts’ control over the Supreme Court, court watchers say

Oma Seddiq, quoting I. Glenn Cohen (Faculty Director)
Business Insider

"[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’ image

‘A seismic moment in Constitutional history’: Experts in law and medicine examine the Supreme Court’s decision overturning the right to abortion

Brett Milano, quoting I. Glenn Cohen (Faculty Director)
Harvard Law Today

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 image

What the Supreme Court’s abortion reversal means for in vitro fertilization

I. Glenn Cohen (Faculty Director), Judith Daar, and Eli Y. Adashi
Boston Globe

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 image

How the Supreme Court Ruling Clouds Future for IVF Treatments

Carey Goldberg, quoting I. Glenn Cohen (Faculty Director)
Bloomberg

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 image

The 50-year history of abortion and oncology in The Cancer Letter archives

The Cancer History Project, quoting I. Glenn Cohen (Faculty Director)
Cancer Letter

“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 image

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

Matthew Bin Han Ong, featuring I. Glenn Cohen (Faculty Director)
Cancer Letter

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

I. Glenn Cohen (Faculty Director), Carmel Shachar (Executive Director), and David Simon (Research Fellow)
Journal of Law and the Biosciences

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

Theodore P Papalexopoulos, Dimitris Bertsimas, I Glenn Cohen (Faculty Director), Rebecca R Goff, Darren E Stewart, and Nikolaos Trichakis
Journal of Law and the Biosciences

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 image

What Overturning Roe v Wade May Mean for Assisted Reproductive Technologies in the US

I. Glenn Cohen (Faculty Director), Judith Daar, and Eli Y. Adashi
JAMA

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 image

Facebook Is Receiving Sensitive Medical Information from Hospital Websites

Featuring I. Glenn Cohen (Faculty Director)
The Markup

Facebook Is Receiving Sensitive Medical Information from Hospital Websites

How a court decision overturning abortion could affect IVF image

How a court decision overturning abortion could affect IVF

Featuring I. Glenn Cohen (Faculty Director)
Reuters

How a court decision overturning abortion could affect IVF

Harris to convene privacy experts to talk stakes of Roe v. Wade image

Harris to convene privacy experts to talk stakes of Roe v. Wade

Featuring I. Glenn Cohen (Faculty Director)
The Hill

Harris to convene privacy experts to talk stakes of Roe v. Wade

Smarter health: The ethics of AI in health care

Featuring I. Glenn Cohen (Faculty Director)
WBUR

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 image

If Roe is overturned, the ripples could affect IVF and genetic testing of embryos, experts warn

Featuring I. Glenn Cohen (Faculty Director)
STAT+

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 image

Readout from Vice President Harris’s Meeting with Constitutional Law, Privacy, and Technology Experts on Reproductive Rights

Featuring I. Glenn Cohen (Faculty Director)
The White House

Readout from Vice President Harris’s Meeting with Constitutional Law, Privacy, and Technology Experts on Reproductive Rights

The Future of Medical Device Regulation image

Order now! The Future of Medical Device Regulation: Innovation and Protection

I. Glenn Cohen, Timo Minssen, W. Nicholson Price II, Christopher T. Robertson, and Carmel Shachar
Cambridge University Press

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 image

Supplying International Aid Effectively: Ethics and Law

April 08, 2022

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 image

“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

Georgia R. Goodman et al., including I. Glenn Cohen (Faculty Director)
AIDS and Behavior

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 image

Health Care Fraud: The Leading Violation of the False Claims Act

Eli Y. Adashi and I. Glenn Cohen (Faculty Director)
The American Journal of Medicine

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 image

Article supports FDA review of lab-developed tests

Kate Madden Yee, featuring I. Glenn Cohen (Faculty Director)
LabPulse.com

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 image

A Complex Patent & Pricing Picture: Regulating Psychedelics More of a Journey Than a Trip

William Borden, featuring I. Glenn Cohen (Faculty Director)
PharmExec.com

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 image

SARS-CoV-2 Laboratory-Developed Tests: Integrity Restored

Eli Y. Adashi and I. Glenn Cohen (Faculty Director)
JAMA

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 image

Mitigating Racial Bias in Machine Learning

by Kristin M. Kostick-Quenet, I. Glenn Cohen (Faculty Director), Sara Gerke, et al.
Journal of Law, Medicine and Ethics

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 image

Transparency and the Doctor–Patient Relationship — Rethinking Conflict-of-Interest Disclosures

Eli Y. Adashi, I. Glenn Cohen (Faculty Director), and Jacob T. Elberg
The New England Journal of Medicine

To reduce the harm associated with improper financial relationships between manufacturers and physicians, practitioners could be required to disclose such relationships directly to patients.

The hospital-at-home presents novel liabilities for physicians, hospitals, caregivers, and patients image

The hospital-at-home presents novel liabilities for physicians, hospitals, caregivers, and patients

David A. Simon (Research Fellow, Digital Home Health), I. Glenn Cohen (Faculty Director), Celynne Balatbat & Anaeze C. Offodile II
Nature Medicine

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…

Should Alexa Diagnose Alzheimer’s? image

Video now available! Should Alexa Diagnose Alzheimer’s?: A Health Policy and Bioethics Consortium

February 11, 2022
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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 image

Sharing Clinical Notes: Potential Medical-Legal Benefits and Risks

Charlotte Blease, I. Glenn Cohen (Faculty Director), and Sharona Hoffman
JAMA

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 image

NFTs offer new method to control personal health information

Molly Chiu, featuring I. Glenn Cohen (Faculty Director)
Baylor College of Medicine News

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 image

How NFTs could transform health information exchange

Kristin Kostick-Quenet, Kenneth D. Mandl, Timo Minssen, I. Glenn Cohen (Faculty Director), Urs Gasser, Isaac Kohane, and Amy L. McGuire
Science

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 image

Reassessing Psychedelics: A new HLS initiative examines the legal and ethical aspects of therapeutic psychedelics

Elaine McArdle, featuring I. Glenn Cohen (Faculty Director)
Harvard Law Today

“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 image

Supreme Court Ruling on the Texas Abortion Law: Beginning to Unravel Roe v Wade

I. Glenn Cohen (Faculty Director), Rebecca B. Reingold, and Lawrence O. Gostin
JAMA

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 image

At-home Diagnostics and Diagnostic Excellence: Devices vs General Wellness Products

David A. Simon (Research Fellow, Digital Home Health), Carmel Shachar (Executive Director), and I. Glenn Cohen (Faculty Director)
JAMA

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…

Challenges for Mobile Diagnostics image

Video now available! Challenges for Mobile Diagnostics: Mobile MRI as a Case Study

January 19, 2022
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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 image

Fact check: False claim that Nuremberg Code prohibits mask mandates

Daniel Funke, featuring I. Glenn Cohen (Faculty Director)
USA Today

“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 image

The Danger of the Supreme Court Undercutting Biden’s Vaccination Rules

Carmel Shachar (Executive Director) and I. Glenn Cohen (Faculty Director)
TIME

“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 image

Weighing President Biden’s first year: Health care and the pandemic

Rachel Reed, featuring Carmel Shachar (Executive Director) and I. Glenn Cohen (Faculty Director)
Harvard Law Today

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 image

The Pandemic Preparedness Program: Reimagining Public Health

Eli Y. Adashi and I. Glenn Cohen (Faculty Director)
JAMA

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 image

A Divisive Ruling on Devices — Genus Medical Technologies v. FDA

Patricia J. Zettler, Eli Y. Adashi, and I. Glenn Cohen (Faculty Director)
The New England Journal of Medicine

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 image

Deadly Legacy—The 510(k) Path to Medical Device Clearance

Eli Y. Adashi, Katina M. Robison, I. Glenn Cohen (Faculty Director)
JAMA Surgery

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…

SCOTUS Revisits Abortion image

Video now available! SCOTUS Revisits Abortion: Legal Strategies in Dobbs Oral Arguments

December 06, 2021
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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 image

Fate of Roe v. Wade Will Depend on 3 Justices

Rob Quinn, featuring I. Glenn Cohen (Faculty Director)
Newser

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 image

Trump’s Supreme Court picks Amy Coney Barrett and Brett Kavanaugh could decide the fate of Roe v. Wade

Oma Seddiq, featuring I. Glenn Cohen (Faculty Director)
Insider

"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 image

Biden Vaccine-or-Test Rule’s Future at Stake in Court Lottery

Robert Iafolla, featuring I. Glenn Cohen (Faculty Director)
Bloomberg Law

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 image

Legal and Bioethics Experts Discuss Future of Abortion at Law School Panel

Alexander I. Fung and Waseem S. Nabulsi, featuring I. Glenn Cohen (Faculty Director)
The Harvard Crimson

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…

The Future of Abortion in America image

Video now available! The Future of Abortion in America: A Virtual Townhall Discussion for Students

November 10, 2021
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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 image

SYMPOSIUM SPEAKER SERIES: International Pandemic Lawmaking: Can a 'Pandemic Treaty' Promote Global Health Justice?

November 04, 2021

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…

Book Launch: Consumer Genetic Technologies image

Video now available! Book Launch: Consumer Genetic Technologies: Ethical and Legal Considerations

November 02, 2021
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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 image

Court’s interest in Texas could signal end of Roe

Todd J. Gilman, featuring I. Glenn Cohen (Faculty Director)
Pittsburgh Post-Gazette

“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,”…

Book Talk: The Genome Defense image

Video now available! Book Talk: The Genome Defense: Inside the Epic Legal Battle to Determine Who Owns Your DNA

October 20, 2021
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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 image

Pharmaceutical Companies, Human Rights, and the Alien Tort Statute

I. Glenn Cohen (Faculty Director), Tyler Giannini, and Eli Y. Adashi
Journal of Law, Medicine & Ethics

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…