News, Resources, and Events Tagged "Biotechnology"
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…
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 …
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…
After Roe: The uncertain future of fertility treatment
Roughly 2 percent of children born in the U.S. are conceived by in vitro fertilization, according to the CDC. The process involves combining sperm and eggs to create…
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…
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…
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…
How a court decision overturning abortion could affect IVF
How a court decision overturning abortion could affect IVF
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
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…
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…
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…
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.
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…
After falling behind gene-editing rivals, Editas just got a much-needed win in the courtroom. Here’s how it could shake up the CRISPR landscape.
After falling behind gene-editing rivals, Editas just got a much-needed win in the courtroom. Here's how it could shake up the CRISPR landscape.
Public Policy Fellowship, Gingko Bioworks
At Ginkgo, we know that making GMO’s you can love requires more than just science and engineering. The products we make and the systems we participate in have…
Automating the Administrative State: 52nd Annual Administrative Law Symposium
Agenda 11:00 - 11:05 ET/8:00 - 8:05 PT, Welcome 11:05 - 11:35 ET/8:05 – 8:35 PT, Introductory Keynote Cass R. Sunstein Robert Walmsley University Professor, Harvard Law School Symposium Article: Governing by Algorithm? No Noise and …
Some Dana-Farber Cancer Institute trustees stood to profit from their philanthropic role
Boston’s top cancer center has long supported its trustees who invest in, and run, its startup companies. But after questions brought to them by the Globe Spotlight Team,…
Patient data ownership: who owns your health?
This article answers two questions from the perspective of United Kingdom law and policy: (i) is health information property? and (ii) should it be? We argue that special features of…
Labor Department Officials Frustrated With White House Over COVID-19 Vaccine and Testing Mandate
When President Joe Biden directed the Occupational Safety and Health Administration (OSHA) on Sept. 9 to impose strict COVID-19 vaccination and testing protocols on large businesses, the OSHA employees were ready.…
FTC resurrects a decade-old rule as a guardrail on the health app explosion
Health apps have to tell their users about any data breaches or risk a hefty fine, the Federal Trade Commission clarified in a policy statement last week. The rule that…
A Snapshot of U.S. IRB Review of COVID-19 Research in the Early Pandemic
Background/Objective: Along with the greater research enterprise, Institutional Review Boards (IRBs) had to quickly adapt to the COVID-19 pandemic. IRBs had to review and oversee COVID-related research, while navigating…
Mitochondrial disease: Replace or edit?
Maternal transmission of a wide spectrum of mutant alleles of mitochondrial DNA (mtDNA) gives rise to metabolic diseases of differing penetrance, presentation, and prognosis to offspring. Only a proportion of…
Pandemic has created unprecedented constitutional challenges - analysis
Traditional notions of civil liberties quickly become subjective in times of tension – no more so than in today’s era of uncertainty and pervasive political unrest. On Sunday,…
Health record company pays hospitals that use its algorithms
The electronic health record company Epic offers financial incentives to healthcare systems that use its proprietary algorithms — and those algorithms can deliver inaccurate predictions, a Stat News investigation found. …
Explaining medical AI is easier said than done
The growing use of artificial intelligence in medicine is paralleled by growing concern among many policymakers, patients, and physicians about the use of black-box algorithms. In a nutshell, it&rsquo…
Apply now! Call for Applications: Research Fellow for the Project on Psychedelics Law and Regulation (POPLAR), Petrie-Flom Center, Harvard Law School
Overview The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is hiring a full-time postdoctoral fellow to support its newly launched Project on Psychedelics Law…
Petrie-Flom Welcomes New Research Fellow in Digital Home Health!
We’re excited to announce our new Research Fellow in Digital Home Health, David Simon! Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital…
A U.S. court ruling may force biologics makers to review patent protections
In a decision with broad implications for the pharmaceutical industry, a U.S. appeals court recently restricted wide-ranging patent claims for antibody treatments, a ruling legal experts say may force…
Read more! The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Announces Advisory Board
February 11, 2021 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is excited to announce its new, interdisciplinary Advisory Board. The Advisory Board, which had…
Read more! The Petrie-Flom Center Launches New Project: Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health
Diagnosing in the Home will seek to examine the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions. …
F.D.A. Panel Endorses Moderna’s Covid-19 Vaccine
The coronavirus vaccine made by Moderna moved closer to authorization on Thursday, a significant step that would expand the reach of the nation’s vaccination campaign to rural areas…
Why Amazon’s ‘doctor Alexa’ may not be what the world ordered
You wake up at 7:29am and ask Amazon’s Alexa virtual assistant what the weather will be like. Within seconds, Amazon realises you sound unwell and offers you medicine…
Nanocourse Series: Governance and Ethics of Biotechnology, Scientific Citizenship Initiative at Harvard Medical School
The Governance & Ethics of Biotechnology is a 3-module nanocourse series that each center on an emerging biotechnology. STEM graduate students will…
Keeping the Patient at the Center of Machine Learning in Healthcare
Char et al. (2020) aspire to provide “a systematic approach to identifying … ethical concerns” around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their…
Congress must clarify limits of gene-editing technologies
Genome editing of human embryos represents one of the most contentious potential scientific applications today. But what if geneticists could sidestep the controversy by editing sperm and eggs instead? According…
Ethical and Legal Implications of Remote Monitoring of Medical Devices
Millions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer…
The two months in 1980 that shaped the future of biotech
Tuesday, December 2, marked the fourth, quietest, but not the least important of this string of biotech events. The U.S. Patent and Trademark Office granted U.S. Patent No. 4,237,224, &ldquo…
An Ethical Roadmap for Breakthrough MRI Technology
Imagine getting a brain scan without ever having to go to a lab. Michael Garwood, PhD, Malcolm B. Hanson Professor of Radiology, and his colleagues at the University of Minnesota…
AI Surveillance during Pandemics: Ethical Implementation Imperatives
From the article: “The health needs created by the pandemic put significant pressure on physicians, hospital leaders, public health officials, and other care providers to collaborate with developers to…
‘Immunity passports’ won’t reopen America
From the article: “The appeal is obvious for employers. They would have no outbreak in their workplace, and for the more public facing businesses, it can be a selling…
Podcasts now available! 2020 Petrie-Flom Center Annual Conference: Innovation and Protection: The Future of Medical Device Regulation
Notice of Revision In light of developments with COVID-19, we converted our annual conference into a series of podcasts interviewing our contributors.Check out the episodes on This Week in…
CANCELED The International Regulators’ Roundtable on Artificial Intelligence Technologies in Health Care
Notice of Cancelation In light of developments with COVID-19, we have made the decision to cancel the International Regulators' Roundtable on Artificial Intelligence Technologies in Health Care. Conference Description Join…
Welcoming Fellow-in-Residence Mason Marks
Along with our partners at the Edmond J. Safra Center for Ethics at Harvard University, the Petrie-Flom Center is thrilled to announce our new jointly hosted Fellow-in-Residence, Mason Marks. Dr.…
Call for Applications: Petrie-Flom Center Student Fellowship 2020-2021
What do a MacArthur Genius award winner, several health law professors at top schools, executive directors of leading health law centers, an associate chief counsel of the FDA, and partners…
The need for a system view to regulate artificial intelligence/machine learning-based software as medical device
Abstract Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized…
Editors’ Choice 2020: Journal of Law and the Biosciences
In this virtual issue from Journal of Law and the Biosciences, we present 17 informative articles, published in 2017-2019, hand-picked by the journal’s three Editors-in-Chief: Nita Farahany from Duke…
The Business of Biotechnology, RA Capital
From the course description: Who is this for and why should you take this course? So much of what’s important to success in the biotechnology sector is not…
Call for papers - Journal Special Issue on Advances and Current Trends in Sensing Physiological Parameters for Human Wellness and Patient Monitoring, IEEE Sensors Journal
Call for Papers IEEE Sensors Journal: Special Issue on Advances and Current Trends in Sensing Physiological Parameters for Human Wellness and Patient Monitoring Sensor technology and advanced sensing systems…
Eighth Annual Health Law Year in P/Review
At the Petrie-Flom Center's eighth annual Health Law Year in P/Review, leading experts discussed major developments in health law and policy during 2019 and what to watch out for…
Algorithms on regulatory lockdown in medicine
From the abstract: As use of artificial intelligence and machine learning (AI/ML) in medicine continues to grow, regulators face a fundamental problem: After evaluating a medical AI/ML technology…
This portable MRI developed by a Yale professor could make health care more affordable.
From the article: More data and greater accessibility have led to “serious ethical concerns,” said Francis Shen, a professor at the University of Minnesota Law School. He and…
Health Law Workshop: Jacob S. Sherkow: Adaptive Intellectual Property
Presentation This presentation is not available for download. About the Presenter Jacob S. Sherkow is the 2019-2020 Edmond J. Safra Center and Petrie-Flom Center Fellow in Ethics of Technological and…
Health Law Workshop: Insoo Hyun: Towards a New Bioengineering Ethics
Presentation Topic: "Towards a New Bioengineering Ethics" The readings for this presentation are not available for download. About the Presenter Insoo Hyun is Professor of Bioethics and Philosophy at Case…
Health Law Workshop: Alex John London: Is There a Moral Dilemma at the Heart of Research with Humans?
Presentation Topic: “Is There a Moral Dilemma at the Heart of Research with Humans?” This paper is not available for download. About the Presenter Alex John London is…
Fellows-in-Residence: Edmond J. Safra Center for Ethics, Harvard University
The 2019 call for applications is now closed. From the posting: Application deadline: November 15, 2019 The Edmond J. Safra Center for Ethics at Harvard University invites applications from a broad range…
2019 Petrie-Flom Center Open House
Description At this reception, we welcomed faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics, and discussed what the Petrie-Flom Center does and how to…
Biohackers are pirating a cheap version of a million-dollar gene therapy
From the article: Experts briefed on the biohacking project were divided, with some calling it misguided and unlikely to work. Others say the excessive cost of genetic treatments has left…
Ethics & the Law – I. Glenn Cohen, Professor of Law at Harvard University: Technology, Law, Ethics
From the show notes: In this thoroughly interesting and informative podcast, I. Glenn Cohen, James A. Attwood and Leslie Williams Professor of Law at Harvard Law School, provides an overview…
Call for Abstracts: 2020 bioIP Faculty Workshop, ASLME, Loyola University Chicago School of Law
Full call for abstracts: The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the 5th annual bioIP Faculty Workshop on Friday May 1, 2020, at Loyola University of…
Ethical and legal issues of ingestible electronic sensors
From the abstract: Ingestible electronic sensors are a promising technology for improving health outcomes that may, for example, be useful in monitoring and promoting the taking of medication. However, these…
Call for Applications: Petrie-Flom Student Fellowship 2019-2020, Petrie-Flom Center at Harvard Law School
The call for applications for the 2019-2020 Student Fellowship is now closed. Sign up for our newsletter to receive updates on future fellowships and other opportunities at the…
Petrie-Flom Center Student Internship, Petrie-Flom Center at Harvard Law School
The Petrie-Flom Center has filled all internship positions at the Center for the Fall 2019 semester. To stay on top of upcoming opportunities at the Center, subscribe to our newsletter! …
Biosimilar Approvals And The BPCIA: Too Soon To Give Up
From the article: The Biologics Price Competition and Innovation Act (BPCIA), part of the 2010 Affordable Care Act, sought to drive down prices for biologics, much as the 1984 Hatch-Waxman Act did…
There Is No Single, Best Policy for Drug Prices
From the article: Since its approval by the Food and Drug Administration in 2002, Humira has been protected from direct competition by patents and F.D.A.-provided market exclusivity. This…
A Question of Prevention: I. Glenn Cohen on a procedure to avoid passing on genetic mutations, and the push to legalize it
From the article: Calls are growing for the U.S. to lift a ban on mitochondrial replacement therapy, or MRT, a procedure developed to enable women who are at risk…
Creating eggs and sperm from stem cells: the next big thing in assisted reproduction?
[...] We are already in an age of disruptive reproductive technologies. Babies have been born using mitochondrial replacement techniques, often known as three-parent babies. News of mice born to same-sex parents…
In support of mitochondrial replacement therapy
From the correspondence: To the Editor — A US law aimed at preventing the gene editing of human embryos has had the broader effect of banning an intervention that seeks…
No one can be truly anonymous ever again thanks to genetic sequencing
This article is behind a paywall. Harvard affiliates can access the full text via Hollis. A battle between billionaires over the control of country club tennis courts six years ago…
The Second Reproductive Revolution: Glenn Cohen delivers chair lecture
From the article: Technology is changing reproduction, says Professor I. Glenn Cohen ’03, one of the world’s leading experts on the intersection of bioethics and the law. In…
How bans on germline editing deprive patients with mitochondrial disease
From the article: "To the Editor — In 2015, the UK parliament voted to empower its Human Fertilization and Embryo Authority (HFEA) to approve the use of mitochondrial replacement therapy (MRT)1…
2019 Petrie-Flom Center Annual Conference: Consuming Genetics: Ethical and Legal Considerations of New Technologies
Couldn't join us for the conference? Join the conversation on Twitter with #DTCgenome! And check out many of our speakers' slide presentations and our "Consuming Genetics" blog symposium! The…
Ethical and Legal Challenges of Artificial Intelligence in Cardiology
From the article: Artificial intelligence (AI) offers new opportunities to improve diagnosis and treatment across a wide spectrum of cardiovascular conditions. In theory, algorithms driven by AI can interpret the…
Germline editing: could ban encourage medical tourism?
From the article: "We question some aspects of Eric Lander and colleagues’ proposed moratorium, although — like most in the bioethics and science-policy communities — we are also deeply…
Call for Applications: Petrie-Flom Center Student Fellowship 2019-2020
What do a MacArthur Genius award winner, several health law professors at top schools, executive directors of leading health law centers, an associate chief counsel of the FDA, and partners…
Gene Editing of Babies and Universal Human Rights: Hot Topics in Health Law
At this event, Professor George Annas, beloved health law professor at Boston University, discussed gene editing of babies and the idea of health care as a human right. The event…
Mitochondrial Replacement Therapy: Considering the Future of U.S. Policy on "Three-Parent IVF"
Couldn't join us? Check out the conversation on Twitter: @PetrieFlom #MRTpanel and some of our speakers' slide presentations below! Learn more about the issues! Check out media coverage supporting…
Cheap, portable scanners could transform brain imaging: But how will scientists deliver the data?
From the article: "If such devices become widespread, they’ll raise new ethical questions, says Francis Shen, a law professor and neuroethicist at the University of Minnesota (UMN) in…
Patient advocates and scientists launch push to lift ban on ‘three-parent IVF’
From the article: In the U.S., the procedure is effectively banned because of a congressional amendment passed in 2015 that’s been renewed every year since. But now, a…
City Visions: How will artificial intelligence transform medicine?
From the introduction: Host Joseph Pace and guests explore the ways in which artificial intelligence (AI) will impact US healthcare. Will doctors become obsolete? Will existing biases in medicine worsen? …
Genome Editing: Rights and Wrongs: A Health Policy and Bioethics Consortium
Gene-editing technologies offer substantial promise in treating disease, but their use raises important ethical and public health questions about how these innovations should be applied and regulated. Different groups have…
Present-day posthumous reproduction and traditional levirate marriage: two types of interactions
From the article: "The paper studies the position of Jewish law on posthumous reproduction and its mutual interaction with the legal and bioethical discussion of this issue. It examines two…
What’s the future of human gene editing?: Balancing ethical and religious concerns with evidence-based uses of genetic technologies
From the article: "In the legislative realm, the US Congress is poised to renew its ban on creating CRISPR babies, as well as “three-parent babies” that are used…
Shadow health records meet new data privacy laws
From the article: "Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and…
Can You Sue An Algorithm For Malpractice?
From the article: "What’s in the box? The “black box,” that is. Increasingly, doctors are relying on sophisticated, and at times inscrutable, algorithms to make healthcare…
Black-Box Medicine: Legal and Ethical Issues: A Health Policy and Bioethics Consortium
Couldn't join us for the event? Check out some of the panelists' slide presentations below! Description Black-box medicine—the use of opaque computational models to make care decisions…
Infertile woman is pregnant with a ‘three-parent baby’ in first ever clinical trial
From the article: "I. Glenn Cohen, a Harvard health law professor, warned American parents may well seek the treatment elsewhere, and it won't be clear how many three-parent babies…
Pregnancy reported in the first known trial of ‘three-person IVF’ for infertility
From the article: "I. Glenn Cohen, a Harvard health law professor, said this new trial, as well as Zhang’s travel to Mexico for mitochondrial replacement therapy, may put…
Perspectives on Gene Editing
From the article: "Progress in this field has been so rapid that the dialogue around potential ethical, societal, and safety issues is scrambling to catch up. This disconnect was brought…
Privacy in the age of medical big data
From the article: "Big data has come to medicine. Its advocates promise increased accountability, quality, efficiency, and innovation. Most recently, the rapid development of machine-learning techniques and artificial intelligence (AI)…
When is a Medical Treatment Worth $850,000? The Value of Luxturna and Gene Therapy Treatments: A Health Policy and Bioethics Consortium
Luxturna, a gene therapy treatment for a rare form of inherited blindness, was recently approved and administered for the first time to a patient at Massachusetts Eye and Ear in…