News, Resources, and Events Tagged "Bioethics"
Apply now! Call for Applications: Petrie-Flom Student Fellowship 2023-2024, Petrie-Flom Center at Harvard Law School
The Center and Student Fellowship The Center and Student Fellowship. The Petrie-Flom Center Student Fellowship Program is designed to mentor students seeking to become thought leaders in health law policy…
Call for Applications: Petrie-Flom Student Fellowship 2022-2023, Petrie-Flom Center at Harvard Law School
The Center and Student Fellowship The Center and Student Fellowship. The Petrie-Flom Center Student Fellowship Program is designed to mentor students seeking to become thought leaders in health law policy…
Call for Applications: Petrie-Flom Student Fellowship 2021-2022, Petrie-Flom Center at Harvard Law School
The Center and Student Fellowship The Center and Student Fellowship. The Petrie-Flom Center Student Fellowship Program is designed to mentor students seeking to become thought leaders in health law policy…
Call for Applications: Petrie-Flom Student Fellowship 2020-2021, Petrie-Flom Center at Harvard Law School
The Center and Student Fellowship The Petrie-Flom Center Student Fellowship Program is designed to mentor students seeking to become thought leaders in health law policy and bioethics. The fellowship supports…
Preimplantation sex selection via in vitro fertilization: time for a reappraisal
In recent years, there has been rapid increase in the availability of elective sex selection via genetic testing of preimplantation embryoscreated through in vitro fertilization. We explore the…
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…
The Unsettled Debate at the Heart of the Henrietta Lacks Case
“People think that because they have autonomy over their physical body, that means they have a, quote, property interest in it. That is just bluntly wrong,” Jacob Sherkow,…
Responding to the Call to Meaningfully Assess Institutional Review Board Effectiveness
Independent review and oversight have long been recognized as requirements for ethical research involving human participants, leading institutional review boards (IRBs) to become deeply entrenched in the research enterprise. Against…
2023 Petrie-Flom Center Annual Conference: Health Law as Private Law
Conference Description The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2023 annual conference: “Health Law as Private…
Call for submissions! Call For Submissions – Symposium on Disability and Climate Change
CALL FOR SUBMISSIONS – SYMPOSIUM ON DISABILITY AND CLIMATE CHANGE The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the Harvard Law School Project on…
Video now available! Abortion Rights and Reproductive Justice in Latin America: Recent Landmark Decisions from Mexico and Colombia
Viewing Options Watch the fully captioned event recording. Read the event coverage: Liz Mineo, "Lesson from Latin America for U.S. abortion rights movement," The Harvard Gazette (October 26, 2022). …
Video now available! FDA and Emergency Response
Learn more about the FDA’s emergency response to issues such as COVID-19, monkeypox, and infant formula. On September 20th, we hosted a discussion of these topics and more…
Video now available! Creating Sustainable Infrastructure for Pandemic Preparedness and Response
Online Viewing View the conversation on Twitter @PetrieFlom using #PandemicPreparedness. Watch the fully captioned event recording. Event Description The COVID-19 pandemic has reinvigorated the national and global…
Video now available! Dobbs v. Jackson: Understanding the Post-Roe Landscape
Online Viewing Watch the fully captioned event video. Read the event coverage: Brett Milano, "'A seismic moment in Constitutional history:' Experts in law and medicine examine the…
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…
Smarter health: The ethics of AI in health care
Smarter health: The ethics of AI in health care
The Role of Health as a Human Right in Universal Health Coverage
The Role of Health as a Human Right in Universal Health Coverage
Videos now available! 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Diagnostics and Therapeutics Outside of Traditional Clinical Settings
Even prior to the COVID-19 pandemic, health care delivery was already shifting away from the clinic and into the home, utilizing telehealth, wearable sensors, ambient surveillance, and other products. The…
Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations
Patients with rare diseases often have limited or no options for approved treatments or participation in clinical trials. In such cases, expanded access (or “compassionate use”) provides a…
Buffalo shooting ignites a debate over the role of genetics researchers in white supremacist ideology
The 18-year-old gunman suspected of carrying out a racist attack that killed 10 and injured three people in Buffalo, N.Y., last weekend left no questions about why he drove 200 miles…
Video now availble! Considering the Needs of the Vulnerable in the Next Stage of the Pandemic
Online Viewing View the conversation on Twitter @PetrieFlom using #COVID22. Watch the fully captioned event recording. Event Description After two years of the COVID-19 pandemic, there is flagging…
An obscure law could jeopardize profits for startups racing to get in on the first legal magic-mushroom market in the US
An obscure law could jeopardize profits for startups racing to get in on the first legal magic-mushroom market in the US.
At the Cutting Edge
Delivered talk for “At the Cutting Edge,” the Regulation and Innovation in the Biosciences Junior Scholars Workshop at the University of Iowa College of Law.
At the Cutting Edge
Delivered talk for “At the Cutting Edge,” the Regulation and Innovation in the Biosciences Junior Scholars Workshop at the University of Iowa College of Law.
At the Cutting Edge
Delivered talk for “At the Cutting Edge,” the Regulation and Innovation in the Biosciences Junior Scholars Workshop at the University of Iowa College of Law.
Harvard Law School professors call potential abortion rights rollback ‘unprecedented’
It is “close to unprecedented or unprecedented” for the Supreme Court of the United States to “undo[…] rights that were viewed as constitutionally central for half…
Why a growing number of Latin American countries are legalizing abortion
As Americans contemplate living in a country where Roe versus Wade is overturned, a very different story is playing out in many parts of Latin America. In recent years, countries…
Video now available! Roe in Limbo: A Townhall on the Leaked Dobbs Opinion
Online Viewing View the conversation on Twitter @PetrieFlom using #RoeInLimbo. View the fully captioned event recording. Event Description The leak of a draft opinion for Dobbs…
Better fat bubbles could power a new generation of mRNA vaccines
As any dietician will tell you, some fats are good—and that is surely true of the little fatty balls found in two of the world’s most…
When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research
Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when…
Video now available! Allocating Scarce Medical Resources: Equity and Justice Concerns
Online Viewing View the conversation at Twitter @PetrieFlom using #CrisStanCare. Watch the fully captioned recording. Event Description Crisis standards of care are guidelines that inform health care systems…
Video now available! Medical Justice and the Carceral State, Part 3: The Doctor's White Coat vs. The Officer's Uniform: Who Calls the Shots?
Online Viewing View the conversation on Twitter @PetrieFlom using #MedicalJustice. Watch the fully captioned event recording. Event Description Who decides when people in prison will receive…
National Academies of Sciences, Engineering, and Medicine: Using Innovative Data Science Approaches to Identify Individuals, Populations, and Communities at High Risk for Suicide
National Academies of Sciences, Engineering, and Medicine: Using Innovative Data Science Approaches to Identify Individuals, Populations, and Communities at High Risk for Suicide
Legal experts express shock at rare Supreme Court leak on major abortion rights case: ‘Highly disturbing’
Legal experts expressed shock and concern on Monday evening after Politico released what it says is a draft opinion on a major abortion rights case that's still…
Former nurse speaks out after sentencing in fatal drug error
Former nurse speaks out after sentencing in fatal drug error.
The Ethics and Laws of Medical Big Data
Debates on the human-rights implications of new and emerging technologies have been hampered by the lack of a comprehensive theoretical framework for the complex issues involved. This volume provides that…
Health AI for Good Rather Than Evil? The Need for a New Regulatory Framework for AI-Based Medical Devices
Artificial intelligence (AI), especially its subset machine learning, has tremendous potential to improve health care. However, health AI also raises new regulatory challenges. In this Article, I argue that there…
The Inexorable Logic of Priority-Setting: Just Four Choices for Courts?
Can public health care rights be reduced to just four choices? Even in countries with different cultures and resources, do “access” rights always depend on blending: (1) individual and…
Australia Moves Ahead Cautiously With ‘3-Parent IVF’
“There was a lot of excitement when the UK first legalized this several years ago, so it's surprising that there haven't been reports of failures or successes…
Handle with Care: The WHO Report on Human Genome Editing
The World Health Organization’s recent Report on Human Genome Editing departs from similar reports from other institutions in that it recognizes that ethical assessments of the technology are…
Stamping Out the Medicaid Coverage Gap: An ACA Imperative
In one of its most striking features, the Patient Protection and Affordable Care Act (ACA) expanded Medicaid eligibility for nearly all U.S. citizens and legal resident adults between the…
Patent battles
What counts as an original invention? What does it mean to be an inventor? If a data-crunching, machine-learning artificial intelligence system generates something that its human programmer never conceived,…
When it comes to removing mask mandates, who should decide — the law, or public health?
"I think from a social point of view, it's a really unsatisfying answer to say 'okay, well, people should just decide," said Carmel Shachar, executive director of Harvard Petrie-Flom…
The CMS Vaccine Mandate at the Supreme Court: A Hippocratic Imperative
On January 13, 2022, in a 5-4 decision in Biden v. Missouri, the U.S. Supreme Court stayed 2 lower court decisions enjoining the Centers for Medicare and Medicaid Services (CMS) vaccine mandate.…
Neuroscience and Law Experts Discuss Cannabis and Public Policy at Harvard Law School Panel
Experts in neuroscience and law discussed the legalization of cannabis and highlighted its implications for public policy at a virtual panel hosted by Harvard Law School’s Petrie-Flom Center…
It’s Almost Impossible to Find Out Which Covid Variant You Got
Last month, shortly after returning home from a bachelorette party, I tested positive for Covid. Twelve of us spent a weekend packed together in carefree revelry, including a night of…
Presentación del segundo tomo del Tratado Ecofeminista de Derechos Humanos
El pasado 21 de abril, en el Salón Verde, tuvo lugar la presentación del libro Tratado Ecofeminista de Derechos Humanos. Derechos Humanos para el Buen Vivir.…
Immaculate Conception? Priority and Invention in the CRISPR Patent Dispute
The U.S. Patent Trial and Appeal Board (PTAB), in an interference proceeding decided in February 2022, concluded that researchers at the Broad Institute (Cambridge, MA) were the first to &ldquo…
Focusing on well-being
In addition to its student members, the working group also includes Glenn Cohen ’03, James A. Attwood and Leslie Williams Professor of Law; Michael Gregory ’04, clinical…
Think Pragmatically: Investigators’ Obligations to Patient-Subjects When Research is Embedded in Care
Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and…
Will mRNA Technology Companies Spawn Innovation Ecosystems?
The mRNA technologies that helped rapidly create effective Covid-19 vaccines could become technology platform businesses, which has tremendous implications for players the world of drug development. These platforms could attract…
FDA’s breakthrough device program, meant to benefit patients, is delivering the biggest gains for companies
Five years ago, the Food and Drug Administration launched a new program with the best of intentions: to speed the development and review of cutting-edge and potentially lifesaving medical devices,…
European patent protection for medical uses of known products and drug repurposing
Drug repurposing is a strategy for identifying new uses of approved or investigational drugs that are outside the scope of the original medical indications1. Finding new therapeutic uses for existing…
Open-Source Clinical Machine Learning Models: Critical Appraisal of Feasibility, Advantages, and Challenges
Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used…
Incremental benefits of novel pharmaceuticals in the UK: a cross-sectional analysis of NICE technology appraisals from 2010 to 2020
Objectives: To evaluate the incremental value of new drugs across disease areas receiving favourable coverage decisions by the UK's National Institute for Health and Care Excellence (NICE) over…
COVID-19 Vaccine Refusal and Fair Allocation of Scarce Medical Resources
When hospitals face surges of patients with COVID-19, fair allocation of scarce medical resources remains a challenge. Scarcity has at times encompassed not only hospital and intensive care unit beds…
Legal Experts Discuss Health Care Inequity in Latin America at Harvard Law School Panel
The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School hosted a virtual panel Tuesday discussing the impact of the Inter-American Court of Human Rights in…
Can the Clever Use of Old Legal Strategies Thwart Psychedelic Monopolies?
The patent office may have examiners who lack knowledge in psychedelics. This has happened before with software patents, as I. Glenn Cohen and Mason Marks recently wrote in an…
The Broad won the biggest CRISPR patent fight yet, but the rivalry over gene editing is still simmering
The Broad won the biggest CRISPR patent fight yet, but the rivalry over gene editing is still simmering.
The Case for Regulatory Sandboxes
In a December interview, Elon Musk challenged government leaders to take out the regulatory trash. Outdated rules and regulations strip society of its dynamism and “harden the arteries…
Who will oversee the ethical limits of human embryo research?
To the Editor — A 1965 trans-Atlantic collaboration first accomplished the fertilization of in vitro-matured human oocytes1, with human embryo cultures becoming a reality shortly thereafter2. The application of these…
Interview with Prof. Christopher Robertson on the outcomes and implications of cases in which patients sued hospitals for access to ivermectin.
Christopher Robertson is a professor at the Boston University School of Law. Stephen Morrissey, the interviewer, is the Executive Managing Editor of the New England Journal of Medicine.
Covid-19 pandemic isn’t over for Black Americans, report warns
Asearing report released Tuesday by the Black Coalition Against COVID details the immense toll the Covid-19 pandemic has taken — and continues to take — on Black communities,…
Writing Definitions in Rewriting Nature: Lessons from FDA Law
Paul Enríquez’ book Rewriting Nature fits neatly within what has become a cottage industry of legal takes on genome editing. It is also something that many…
Honoring the public trust: curbing the bane of physician sexual misconduct
The Federation of State Medical Boards defines physician sexual misconduct as any ‘behavior that exploits the physician-patient relationship in a sexual way.’ Although several attempts have been made…
Computational ethics
Technological advances are enabling roles for machines that present novel ethical challenges. The study of 'AI ethics' has emerged to confront these challenges, and connects perspectives from philosophy, computer science,…
Humans in the Loop
From lethal drones to cancer diagnostics, complex and artificially intelligent algorithms are increasingly integrated into decisionmaking that affects human lives, raising challenging questions about the proper allocation of decisional authority…
Health Worker Vaccine Mandate Stays Intact as Pandemic Recedes
But “the federal government is not a particularly nimble entity. It’s not designed to turn on a dime,” said Carmel Shachar, executive director of the Petrie-Flom…
“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…
Strategies to Manage Drugs and Devices Approved Based on Limited Evidence: Results of a Modified Delphi Panel
Prescription drugs and medical devices are increasingly coming to market through expedited US Food and Drug Administration (FDA) pathways that require only limited evidence of safety and efficacy, such as…
AI Insurance: How Liability Insurance Can Drive the Responsible Adoption of Artificial Intelligence in Health Care
Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors…
Where Democracy Falters, So Do Reproductive Rights
“It’s a slow, iterative process on the ground in building [reproductive rights] up,” said Alicia Ely Yamin, a senior fellow at the Petrie-Flom Center for Health…
Ethics and the 2018 Practice Guideline on Disorders of Consciousness
The 2018 practice guideline on disorders of consciousness marks an important turning point in the care of patients with severe brain injury. As clinicians and health systems implement the guideline in…
Step Therapy’s Balancing Act — Protecting Patients while Addressing High Drug Prices
The debate regarding step therapy reflects a tension between two important policy goals: safeguarding patients’ access to high-quality care and constraining spending on prescription drugs, including by limiting the…
A Physician’s Duty to Treat: Rethinking Medical Ethics in Carceral Spaces
Event Description Incarcerated people in the U.S. suffer disproportionately from chronic health conditions, their acute medical needs often go unmet, and the carceral healthcare system that serves them is…
Intellia Stock Has Tumbled. There Are Issues With Gene-Editing Patents.
Shares of gene-editing leader Intellia Therapeutics have dropped 35% since late February, when the U.S. Patent and Trademark Office decided it would not grant patents that Intellia relied on in…
When Desperate Patients Go to Court for Unproven Treatments — The Battle for Hospital Independence
During the Covid-19 pandemic, patients have asked courts to compel hospitals to administer unproven therapies, including ivermectin. These lawsuits have called into question the judiciary’s role in medical…
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…
It’s Time for American Feminists to Learn From Latin America’s Abortion-Rights Movement
“You guys left the streets,” Mexican feminist Verónica Cruz told me last September. We were speaking eight days after a law took effect in Texas that…
So, just how much are those CRISPR patents actually worth?
There was a single question conspicuously absent in all the discussion over last week’s CRISPR patent ruling (a single number, really): How much are the patents actually worth?
Distributed Governance of Medical AI
Artificial intelligence (AI) promises to bring substantial benefits to medicine. In addition to pushing the frontiers of what is humanly possible, like predicting kidney failure or sepsis before any human…
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…
Introduction: Health Law and Anti-Racism: Reckoning and Response
Law and racism are intertwined, with legal tools bearing the potential to serve as instruments of oppression or equity. This Special Issue explores this dual nature of health law, with…
Reflections on Paul Farmer’s legacy: a clarion call for transformative human rights praxis in global health
Paul Farmer’s far-too-early passing on February 21, 2022 is an incalculable loss to those of us who knew and loved him, to students and patients around the globe, to the…
How do we encourage innovation on “long COVID”?
Since the pandemic began, numerous recovered COVID-19 patients have reported having “long COVID”: COVID-19 symptoms persisting well beyond the underlying viral infection period. Whether such a condition is…
Crispr Patent Ruling Picks Winners in Dispute Over Gene-Editing Technology
In the latest twist in a long-running legal dispute over a popular gene-editing tool, U.S. patent authorities ruled that the Broad Institute deserves the credit for inventing a way…
Travel restrictions and variants of concern: global health laws need to reflect evidence
As the coronavirus disease 2019 (COVID-19) spread in the early days of the pandemic, governments neglected World Health Organization (WHO) guidance and imposed travel restrictions. These public health measures employed varied…