News, Resources, and Events Tagged "Regulation"
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…
The New European Medical Device Regulation: Balancing Innovation and Patient Safety
The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they…
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…
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…
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…
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…
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…
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.
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…
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,…
Video now available! A Macro View of Microdosing
View the conversationon Twitter @PetrieFlom using #POPLAR. Watch the fully captioned event recording. Event Description Microdosing psychedelics involves consuming doses that are one-twentieth to one-tenth the size of standard…
Lucky IP
A person naturally owns the fruits of their intellectual labour; so goes the labour argument for intellectual property (IP). But what should happen when a creator gets ‘lucky’…
Video now available! Setting a National Psychedelic Policy Agenda
View the conversation on Twitter @PetrieFlom using #POPLAR. View the fully captioned event video. Event Description As the psychedelic renaissance unfolds, groups are forming to identify national policy…
Controversial Alzheimer’s drug approval ignites FDA reform debate
The FDA's conditional approval of a controversial Alzheimer's drug last year has sparked heightened scrutiny and an attempted overhaul of a popular regulatory pathway used to fast-track…
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…
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…
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…
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?
Video now available! Reporting on the Psychedelic Legal Renaissance
Join the conversation and submit questions on Twitter @PetrieFlom using #POPLAR. View the fully captioned event video. Event Description The psychedelic renaissance is characterized by growing interest in researching, commercializing,…
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…
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…
How can the government successfully engage the private sector in health for equitable distribution of COVID-19 vaccines?
Alicia Ely Yamin teaches courses related to global health and human rights at Harvard Law School and Harvard TH Chan School of Public Health. She is also Senior Advisor on…
CRISPR’s Nobel Prize winners defeated in key patent claim for genome editor
According to a ruling by an appeal board of the U.S. Patent and Trademark Office (USPTO), a different group, led by the Broad Institute of MIT and Harvard, made…
CRISPR Ruling Invalidates Some Biotech Company Patents
The Broad Institute was the first to invent CRISPR-Cas9 technology for use in animal cells, the U.S. Patent and Trademark Office said, siding against two Nobel laureates in a…
Episode 22: The Decriminalization of Abortion in Colombia
Abortion is no longer a crime in Colombia. Alicia Yamin, who heads up Harvard’s Global Health and Rights Project, discusses the hemispheric impact of the recent Colombian Constitutional…
UC Berkeley loses CRISPR gene editing patent case
It’s a major blow for UC, representing a potential loss of $100 million to $10 billion in U.S. licensing revenues, according to Jacob Sherkow, a professor at the University…
UC Berkeley loses CRISPR patent case, invalidating patent rights it granted gene-editing companies developing human therapies
Ending the latest chapter in a years-long legal battle over who invented CRISPR, the U.S. Patent and Trademark Office ruled on Monday that the revolutionary genome editing technology belongs…
Broad prevails in crucial ruling over CRISPR licensing
Ending the latest chapter in a years-long legal battle over who invented CRISPR, the US Patent and Trademark Office ruled on Monday that the revolutionary genome editing technology belongs to…
The ‘Green Wave’ fighting to legalise abortion across Latin America
Colombia has decriminalised abortion in the first 24 weeks of pregnancy after a 5-4 majority ruling by the nation’s constitutional court. It’s the latest victory of the '…
Video now available! Psychedelics and Trauma
View the conversation on Twitter @PetrieFlom using #POPLAR. Watch the fully captioned event video. Event Description Psychedelic substances such as psilocybin, MDMA, and ketamine are being used increasingly in research…
Earth BioGenome Project plans to sequence genome of every known eukaryotic organism
Jacob Sherkow, a professor of law at the University of Illinois, is the lead author of a paper for the special feature that detailed ethical, legal and social issues…
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.
Incarceration and its Impact on Health: Equity and Social Justice Series & Medical Justice and the Carceral State Series Webinar
In light of the COVID-19 pandemic, this panel discussion will be held virtually, as an online webinar. To ensure that you will receive access to the livestream and be kept…
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 …
An Ethics Checklist for Digital Health Research in Psychiatry: Viewpoint
Background: Psychiatry has long needed a better and more scalable way to capture the dynamics of behavior and its disturbances, quantitatively across multiple data channels, at high temporal resolution in…
Fast Drug Approvals to Get Lawmaker Focus in FDA Fee Plan Review
User fees may “hide some of the federal government’s budget and shift the burden to other parties,” said Jonathan Darrow, an assistant professor of medicine at…
Coalition Building to Unlock the Therapeutic Effects of Psychedelics
Event Description The Solomon Center for Health Law and Policy welcomes you to join them for their first event of the year! This panel invited experts and change-makers from various…
Understanding Medicare’s Aduhelm Coverage Decision
Yesterday, the Centers for Medicare and Medicaid Services (CMS) issued a draft National Coverage Determination (NCD) proposing that monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s…
Direct participation of people with communication disabilities in research on poverty and disabilities in low and middle income countries: A critical review
An estimated 1 billion people with disabilities live in low and middle income countries, a population that includes people with communication disabilities (PwCD). PwCD are a heterogenous group with a wide…
Pharmacies shouldn’t be the only place to get Paxlovid, the new Covid pill
It’s easy to feel like we’re in a pandemic “Groundhog Day” loop as the U.S. faces yet another Covid-19 surge with overwhelmed hospitals,…
The Supreme Court and vaccine mandates: Three questions
“The court is not inherently opposed to vaccine mandates or requirements, but they want to see it very closely tied to a strong reasoning and to agencies that handle…
The controversial Alzheimer’s drug isn’t getting much love from Medicare
Access restricted: Medicare is proposing to only cover the new, pricey Alzheimer’s drug for patients enrolled in certain clinical trials, a condition that would severely limit its use. …
A new Alzheimer’s drug shows why the FDA’s speedy approval process is broken
Whether it’s covid or cancer, when you’re a patient facing a life-threatening disease without good treatment options, your risk tolerance is bound to be pretty high.…
Curbside Consults in Clinical Medicine: Empirical and Liability Challenges
Abstract In most U.S. jurisdictions, clinicians providing informal “curbside” consults are protected from medical malpractice liability due to the absence of a doctor-patient relationship. A recent Minnesota…
Make or break for Biogen: How the national coverage decision for amyloid-targeted Alzheimer’s drugs will shake out
Ever since Biogen’s controversial Alzheimer’s drug Aduhelm won an accelerated approval in June, despite scant evidence of clinical benefit, the country has turned its attention to…
A looming decision on Medicare coverage for Biogen’s Alzheimer’s drug could shock state Medicaid programs
Shortly after the controversial Biogen drug Alzheimer’s was approved in the U.S. last year, a pair of state Medicaid directors tried to ring alarm bells.
Medicare must soon say whether it will cover the pricey new Alzheimer’s drug
It’s a massive week for the pricey, new Alzheimer’s drug. Medicare officials are bumping up against a critical Wednesday deadline to issue a proposal on whether …
Podcast: Prescription Drug Policy, Drug Pricing & Aduhelm With Rachel Sachs
While COVID-19 shallowed many headlines in the health care space, a lot of movement was made in various health policy areas, including prescription drug pricing. On today's episode of…
The Right to Health: The Potential and Limits of Catalysing Systemic Change through the Courts
This chapter focuses on the judicialization of health rights in Latin America. It begins by outlining the constitutional provisions in relation to health rights in five countries: Argentina, Brazil, Colombia,…
PORTAL Fellowship, Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School
The Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital Department of Medicine and Harvard Medical School invites its 2022 round of applications for postdoctoral fellows in pharmaceutical…
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 …
Alzheimer’s experts call on FDA to pull Biogen’s Aduhelm
Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from…
Biogen Quickly Cuts Alzheimer’s Drug Cost After Payer Pushback
Biogen Inc. said it would cut the list price of its Alzheimer’s disease drug Aduhelm in half in the U.S., a move that comes after the treatment…
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…
Warning: Oregon Legalized Supported Adult Use of Psilocybin, Not Psychedelic Therapy
During the 2020 presidential election, over 55 percent of Oregon voters approved Measure 109, also called the Oregon Psilocybin Services Act. With this historic vote, Oregon became the first state to legalize the…
Every drug should be labelled to tell you how well it works
When buying over- the-counter drugs or being prescribed medication by your GP, what’s the one thing you want to know? The answer is obvious, of course: how well…
Changes in the Use of Hydroxyprogesterone Caproate Injection After Confirmatory Trial Failure
The US Food and Drug Administration (FDA) accelerated approval pathway allows new drugs with uncertain clinical benefits to be approved on the basis of clinical trials involving surrogate end points.…
Challenges in confirming drug effectiveness after early approval
It’s easy to understand the urge to make potentially beneficial drugs quickly available to patients in need. It’s also easy to go too far. Through its 2021…
Vaccines, Regulation, and Patents: A Conversation with Harvard Medical School Professor Dr. Jonathan J. Darrow
HHPR Senior Editor James Jolin interviewed Jonathan Darrow, S.J.D., LL.M., J.D., M.B.A, an Assistant Professor of Medicine at Harvard Medical School and a Faculty…
Hastings Center Welcomes 24 New Fellows
The Hastings Center is pleased to announce the election of 24 new fellows. Hastings Center fellows are a group of more than 200 individuals of outstanding accomplishment whose work has informed scholarship…
“We measure what we can measure”: Struggles in defining and evaluating institutional review board quality
There has been a persistent lack of clarity regarding how to define and measure the quality of Institutional Review Boards (IRBs). To address this challenge, we interviewed 43 individuals designated as…
Medicare Coverage of Aducanumab — Implications for State Budgets
CMS is considering whether and under what circumstances Medicare will pay for aducanumab for Alzheimer’s disease. A restrictive coverage determination could save the federal government money, but it…
Ecosystem effectuation: creating new value through open innovation during a pandemic
The severity of the COVID-19 pandemic confronts us with a global grand challenge representing an unprecedented crisis for health, economies, and societies. While digital champions are thriving, a large number…
Video now available! Ethics in Psychedelic Therapy and Research
Watch the fully captioned event recording. View the conversation on Twitter @PetrieFlom using #POPLAR. Event Description Psychedelic substances like psilocybin, MDMA, and ketamine are increasingly used in research and clinical…
Let’s Make a Deal…on Drug Prices
Democrats are on the brink of passing a historic set of drug price reforms. How will they impact patients, insurers and the drug industry?
Regeneron, Janssen Drugs Fit Profile Targeted in Spending Bill
The idea that drugmakers get a government-backed monopoly for a period of time to recoup their investment in new drugs and then must face competition has long been the &ldquo…
Opinion: The drug pricing deal isn’t really a victory for Dems, or a loss for PhRMA. But it could be a harbinger of change
Rachel Sachs, a law professor at Washington University in St. Louis who studies drug pricing and innovation, said she didn’t think companies potentially bringing in more competition prior…
Simplify drug labelling to show benefits clearly
Aducanumab, an Alzheimer’s disease treatment, was approved by the US Food and Drug Administration (FDA) in June this year despite a lack of robust evidence that it actually…
Democrats are trying to cut drug costs for employers, too
By the numbers: Applying inflation caps to the commercial market would generate more than $150 billion in revenue for the federal government by 2030, according to an estimate by West Health. The…
Understanding The New Drug Price Reform Deal
Yesterday, the text of the Democratic deal on prescription drug pricing reform was released. These drug pricing reforms are intended to move forward as part of a broader reconciliation package…
Editorial: Can a Pandemic Law-Making Exercise Promote Global Health Justice?
Amid the unfolding "moral catastrophe" of COVID-19, and across the entries in this symposium, we see a clamor for any pandemic law-making exercise to promote more justice in global health. …
Advocates express tempered optimism for Dems’ drug pricing deal
But Rachel Sachs, a health policy expert at Washington University in St. Louis, argued that the industry would have a negative reaction regardless of the scale of the drug pricing…
Dems resurrect a scaled back plan for Medicare drug price negotiations
Only a few days after President Joe Biden seemed to signal that drug pricing reforms were left for dead, Democrats are already circulating plans for a scaled-back version of what…
Problematic Interactions Between AI and Health Privacy
The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens…
Pelosi working to gather support for last-minute, last-ditch drug pricing policy
WASHINGTON — House Speaker Nancy Pelosi’s office is working to gather support for a last-ditch proposal to lower prescription drug costs after the White House shunned the issue…
Cross-Border Transfers of Personal Data after Schrems II: Supplementary Measures and New Standard Contractual Clauses (SCCs)
This article analyses the legal challenges of international data transfers resulting from the recent Court of Justice of the European Union (CJEU) decision in Case C-311/18 Data Protection Commissioner v…
FDA Drug Approval and the Ethics of Desperation
In justifying the accelerated approval of aducanumab (Aduhelm; Biogen), US Food and Drug Administration (FDA) officials emphasized that many patients with Alzheimer disease and their families “made it clear…
Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use
Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision-making, problems that undermine both trust in their ability to protect human research participants and respect…
German Pharmaceutical Pricing: Lessons for the United States
To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell…
The obstacles to decriminalizing psychedelic drugs are political, not legal, say experts
Drug use should be treated as a health rather than a legal issue, says California State Senator Scott Wiener ’96, who has sponsored legislation to decriminalize the use and possession…
A Strategy for Rescheduling Psilocybin
Public and scientific interest in psychedelics such as psilocybin and MDMA is expanding. Once off-limits because of federal prohibition, a trickle of research from the 1990s has grown into a…
Collaboration in times of crisis: A study on COVID-19 vaccine R&D partnerships
Collaboration is central for initiatives and efforts in the race to fight COVID-19, with particular focus on fostering rapid development of safe and effective COVID-19 vaccines. We investigated the types…
Beyond Security Patches—Fundamental Incentive Problems in Health Care Cybersecurity
With ransomware attacks now targeting critical US infrastructure, hospitals and health systems are under serious threat. In May 2021, at least 1 US health system and multiple hospitals overseas were victims of…
Health experts discuss high drug prices and potential for reform at virtual Penn event
Penn’s Leonard Davis Institute of Health Economics hosted a virtual seminar in which panelists discussed high drug prices and possibilities for reform in the present political climate. The…
Picking Embryos With Best Health Odds Sparks New DNA Debate
Rafal Smigrodzki won’t make a big deal of it, but someday, when his toddler daughter Aurea is old enough to understand, he plans to explain that she likely…
Tracking the FDA advisory panel meeting on Covid-19 booster shots
Do most Americans already need Covid-19 booster shots, or at least will they soon? Those questions have been hotly debated in the public square over the past few weeks. But…