Surgical ‘Never Events’ in the NHS

By John Tingle

NHS Improvement has just published a report on Surgical ‘Never Events’.The report presents an analysis of the local investigation reports into 38 surgical, ‘Never Events’ from across England that occurred between April 2016 and March 2017 (the last full year with data available).

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bioIP Faculty Workshop Call for Abstracts

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the 4th annual bioIP Faculty Workshop on Friday April 26, 2019, at Boston University.

The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

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Many Families with Down syndrome Children Would Consider Gene Modification, but with Serious Concerns

Photo by Andreas-photography/Flickr

By Marsha Michie, PhD and Megan Allyse, PhD

Scientists and bioethicists have been talking a lot recently about CRISPR/Cas9 and related technologies to alter genomes. But the voices of patients and families, especially those with genetic conditions, haven’t been nearly as audible in these conversations about so-called “gene editing”—despite calls for these voices from the National Academies and others.

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Now published: Consensus-based guidelines for the ethical oversight of Patient-Centered Outcomes Research

By Avni Gupta

Patient-Centered Outcomes Research (PCOR) is characterized by patients participating in various research roles other than merely the subjects. The Patient-Centered Outcomes Research Institute (PCORI), a major funder of PCOR research, defines patient engagement as including patients in all stages of research, “from topic selection through design and conduct of research to dissemination of results.”

However, while the concept of patient engagement in research and its potential for benefitting science are increasingly recognized by funders and investigators, IRBs’ comfort with patients in non-traditional roles in research protocols lags behind.

IRBs’ familiarity with patients in research has traditionally been with patients who are study participants or subjects, and are considered “vulnerable.” Therefore, many IRBs’ review process focuses on ensuring that adequate protective measures are in place to “protect” the patients, including measures such as a detailed written informed consent, continuing review, confidentiality measures, and so on.

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Why we need to “care” about healthcare

By Robert G. Urban

Humans often proclaim that “intelligence” is what sets our species apart – the ability to analyze, to imagine, to organize, to then cooperate and execute. A unique gift that enables us to be remarkable.

Monuments to humanity’s capability are sprinkled all across the world — early works are colossal demonstrations of ingenuity coupled to brute strength. Consider the statues of Easter Island, Rome’s colosseum, Egyptian and early American pyramids, or the Great Wall of China as examples, each demonstrating a singularly human ability (and need) to reshape our world and leave evidence of our presence.

And as time and talent has unfolded, the complexities of our contributions have advanced as well.

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‘Dignity’ and Biotechnology: Switzerland’s Sanctification of Nature

By James Toomey

Many countries are skeptical of biotechnology. Restrictions on cloning, in vitro fertilization, surrogacy, and genetic modification in agriculture are common. But perhaps no country goes quite as far as Switzerland.

In the early 1990s, Switzerland added to its constitution by popular referendum two articles that restrict the use of biological technologies in its Confederation. Article 119 bans the traditional bugaboos of human bio-conservatives (cloning, surrogacy, human genetic intervention, etc.), and further stipulates that legislation on any new technologies must “ensure[] the protection of human dignity.” Article 120 mandates that legislation related to biological technologies in other organisms must “take into account . . . the dignity of living beings . . .” What?

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Don’t miss today’s Health Law Workshop with Zack Buck

September 24, 2018 5:00 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “The Price of Universality: Sustainable Access and the Twilight of the ACA”

Zack Buck specializes in health law, and his scholarship examines governmental enforcement of laws affecting health and health care in the United States. Most recently, his writing has sought to evaluate how the enforcement of health care fraud and abuse laws impacts American quality of care, with a particular focus on the legal regulation of overtreatment. Over the last five years, his work has been published in the California Law Review, Boston College Law Review, Ohio State Law Journal, Maryland Law Review, Florida State Law Review, and U.C. Davis Law Review, among others.

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In a Shift, Healthcare Dominates Midterm Election Campaign Ads

hand holding remote pointed at many tv screens

By Rebecca Friedman

As the November midterm elections approach, healthcare is a top focus in campaign advertising.

According to a study by the Wesleyan Media Project, which tracks television advertisements for House and Senate races by state and topic, references to healthcare increased in August. The study found that 37 percent of all ads in August for federal races mentioned healthcare,  including references to both “ACA/health reform” and the more general “healthcare,” compared to 32 percent in the period between January 1, 2017 and July 31, 2018.

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Call for Abstracts now Open for 2019 Petrie-Flom Center Annual Conference

Breakthroughs in genetics have often raised complex ethical and legal questions. Many regard their genetic testing and sequencing as revealing something intensely personal and private. The questions raised by these technologies loom even larger as genetic testing is becoming more commonplace, affordable, and comprehensive. At the same time, advances in CRISPR and other related technologies raise anxieties about the implications of editing our own DNA. One can imagine a future when gene editing may become as widespread as genetic testing is today. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing. This conference will examine some of these issues.

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Stopping Nibbles around the ACA: Advocacy Organizations File Suit

mouse nibbles cheese block

By Carmel Shachar

Once it became clear that Congress did not have the appetite to repeal the Affordable Care Act (ACA), the Trump administration has pursued a strategy of “nibbling” around the edges of the ACA through regulations and rule making.

One of these nibbles included an expansion of short-term limited duration insurance (STLDI) plans, insurance schemes which a group of representatives called “junk plans” in an open letter to the National Association of Insurance Commissioners last month and which California may soon ban altogether by the end of September.

Recently, several organizations, including the Association for Community Affiliated Plans (ACAP), National Alliance on Mental Illness (NAMI), Mental Health America, American Psychiatric Association (APA), AIDS United, National Partnership for Women & Families, and Little Lobbyists, filed a suit to block the implementation of STLDI plan expansion and mitigate the impact it will have on the health insurance marketplaces.

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Health Law Scholar Citation Rankings: A Better Picture This Year

By Scott Burris

Glenn and Mark have done their bit for benchmarking our field with another round of health law professor rankings. It is a largely thankless task, so thank you professors.  Last year, I responded to their list with the observation that any count based on law review publication alone was problematic in assessing the contributions of those in our field whose scholarship is primarily empirical or aimed at the health world.  I offered a suggestive “top scholars list” based on Google Scholar profiles.  Using Google Scholar, which captures articles in all fields, plus books and gray literature, brought a number of different names into the top 20.  Since Google Scholar depends on individuals to create and clean their profiles, my list missed a lot of top scholars without profiles (I am talking about you, Michelle Mello and George Annas,  etc. etc.), but it was enough to suggest that some very productive and much-cited scholars were missed in the Hall-Cohen list.

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Patient Safety in Mental Health Care

By John Tingle

Mental health care is a high government NHS priority. There is a real drive to rob this care area of its Cinderella image. Mental health care should not now be seen as the poor relation of acute physical care in terms of resource allocation as it has been seen in the past. However, a recent report by the Health and Social Care Regulator of England, the Care Quality Commission (CQC) seems to push this care area back into the Cinderella limelight again with the finding that sexual incidents appear commonplace on mental health wards in the NHS. The CQC is a very important health and social care regulator in England and it produces excellent reports on health care quality and patient safety. The organisation makes sure health, social care services provide people with safe, effective, compassionate, high-quality care, and they encourage care services to improve.

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You Received Genetic Test Results from Direct to Consumer Companies or from Research – Will Your Doctor Be Happy to See You?

23andme boxes

By Ellen W. Clayton

You recently responded to a TV advertisement by a direct to consumer (DTC) genetic testing company because you wanted to find more of your relatives. The company also offered to send you your genomic data.  Although not what you originally had in mind, you decided to send the data to another DTC company for interpretation to learn more about your health. Unfortunately, you were told that you are at risk for a condition you had never heard of.  Even though the company sent some educational information, you quickly decided to call your doctor for more information and to start prevention or treatment.

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Most-Cited Health Law Scholars in WestLaw, 2013-2017

By Mark A. Hall and I. Glenn Cohen

This post updates the ranking of health law scholars we posted last year (using 2010-2014 data), based on the latest law faculty citation analysis done by Greg Sisk (which covers 2013-2017). As before, we are following the steps Brian Leiter uses to compile “most-cited” rankings of tenured law faculty in a number of other subject areas.

Health law (as many people conceive it) is a broad field that includes bioethics, biotechnology, medical malpractice, health care finance and regulation, health policy, and public health.  Therefore, to supplement the Sisk data, we include health law scholars beyond those based at law schools.

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Most-Cited Health Law Scholars in Web of Science, 2013-2017

By I. Glenn Cohen, Mark A. Hall, David M. Studdert

This is a companion post to Most-Cited Health Law Scholars in WestLaw, 2013-2017. As noted there, health law is a broad and fundamentally interdisciplinary field that spans bioethics, biotechnology, medical malpractice, health care finance and regulation, health policy, and public health.  The Westlaw citation search partially accounted for this breadth by including leading health law scholars in schools of public health and medicine.  However, two major limitations remain—both especially important in our field—which prompted this additional citation analysis.

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Don’t miss today’s Health Law Workshop with Matthew Lawrence

Matthew J. B. Lawrence is Assistant Professor of Law at Penn State Dickinson Law. From 2013 to 2015 he was an Academic Fellow at the Petrie-Flom Center, where his research focused on civil procedure, health law, and administrative law. His scholarship has been published in the New York University Law Review, the University of Cincinnati Law Review, the Fordham Law Review, and the Indiana Law Journal. During his fellowship Matt also designed and taught a class at Harvard Law School entitled “Law and Medicine: The Affordable Care Act,” and spoke widely at conferences and events on health law issues.

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Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of August. The selections feature topics ranging from promoting patient interests in implementing the federal right to try act; to the percentage of US patients with cancer who benefit from genome-driven oncology, to Medicare spending on brand-name combination medications and their generic constituents. A full posting of abstracts/summaries of these articles may be found on our website.

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A status update on the Medicaid work requirement landscape

People standing in a line

By Alexandra Slessarev

Earlier this week, Michigan submitted a proposal to the Trump administration requesting approval to impose work requirements on Medicaid expansion beneficiaries. Michigan’s proposal was submitted through the Medicaid Act’s section 1115 waiver program, which allows states to introduce experimental projects that “further the objectives” of the Act. (For a more in-depth discussion of the function of section 1115 waivers in the Medicaid scheme, see Carmel Shachar’s Bill of Health post from earlier this summer.)

Work requirement waivers garnered a rush of attention after the Trump administration issued guidance indicating that it would begin approving such requests. Michigan is now one of twelve states that have submitted a work requirement proposal, with four of those states having successfully received approval from HHS.

This recent development in Michigan provides an opportunity to take stock of the Medicaid work requirement landscape since the Trump administration began approving the waivers. Continue reading