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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Outbreak Week: Harvard-wide Events will Focus on Epidemic Preparedness

Join the Harvard Global Health Initiative and the Petrie-Flom Center for a week of events focused on discussing epidemic and pandemic preparedness, in commemoration of the 1918 influenza pandemic that took 50 million lives.

Panels, art installations, symposia, and a film screen will be held University-wide throughout the week.

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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

Photos: Petrie-Flom Welcomes HLS Community at Annual Open House

At this reception, faculty, colleagues, and students with shared interests in health law policy, biotechnology, and bioethics gathered to learn about what the Petrie-Flom Center does and how to get involved.

Faculty Director I. Glenn Cohen and Executive Director Carmel Shachar reviewed our sponsored research portfolio, introduced our staff and fellows, and described various opportunities for students and others. We also discussed our work with partners around Harvard University, including the Center for Bioethics at Harvard Medical School. And of course we ate, drank, and made merry!

This event was free and open to the public.

Teaching Critical Thinking as a Public Health Initiative

Professor Tim Caulfield

Professor Tim Caulfield lectured at Harvard Law School.

By Mark Satta

Tim Caulfield—a Law Professor at the University of Alberta and the author of Is Gwyneth Paltrow Wrong About Everything?—wants to help us get better at fighting misinformation about health.

This past Monday, Caulfield came to the Petrie-Flom Center’s Health Policy Workshop and spoke to an audience of Harvard Law students, affiliates from throughout Harvard University, and academics and community members from the Boston area.

During his fascinating and dynamic presentation, Caulfield covered a lot of ground. He discussed political polarization on Twitter, the profit-maximizing machinations (or self-delusion) of celebrities pedaling bunk health products, and evidence that false claims spread faster than true ones. All that may leave one feeling pessimistic and Caulfield would likely sympathize with your pessimism. Yet, the presentation also contained reasons to have hope.

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Step therapy explained: An increasingly popular tool for cost control

By Rahul Nayak

News that the Centers for Medicare and Medicaid Services will allow Medicare Advantage programs to enact “step therapy” programs for drugs under Part B as part of an effort to combat rising drug prices has been making rounds in the health policy world recently.

Step therapy is used by all major private insurers and is aimed at curbing expenditures on expensive drugs. It requires that a patient to try a less expensive alternative treatment. Those who fail treatment with the less expensive drug would then be eligible for coverage of the more expensive treatment. Note that it is very similar to prior authorization, a ubiquitous policy tool in which a drug is approved for coverage only after ensuring certain clinical criteria are met.

What was once a relatively rare tool is now commonly used. I examined UnitedHealthcare’s list of step therapy drugs and there are now over 100 listings. This is an order of magnitude increase from the number of drugs listed just four years ago, when I first got interested in this issue.

Drugs listed for step therapy tend to be either new, extremely expensive therapies (e.g., 3rd-line biologics for rheumatoid arthritis, sofosbuvir for hepatitis C) or more expensive formulations of common drugs (e.g., extended release formulation of quetiapine).

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The cost of drug monopolies in the United States

By James Love

The United States, like other countries, uses the grant of legal monopolies as the incentive to reward successful R&D investments. The legal mechanisms are varied, and include most importantly patents on medical inventions, but also a variety of regulatory exclusivities in a patchwork of programs that address (for example) delays in regulatory approval, testing for pediatric patients, development of treatments for rare diseases, rights in test data used to provide new drugs and vaccines, and the development of new antibiotic drugs.

Each of these legal mechanisms that are used to block competition can be evaluated separately, but it is also useful to look at the big picture, and ask – what is the cost of the drug monopolies in the United States?

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Why We Need to Understand the Perspectives of Seniors on Dementia and Decisionmaking

elderly woman's hand in young woman's hand

By James Toomey

After his wife died, Tom, 83, lived with a caretaker. His daughter was worried. Tom wasn’t his old self. He was getting slower, repeated himself, didn’t seem to remember things that mattered. But when Adult Protective Services interviewed him, they thought he seemed fine. Later, when his daughter finally managed to get him into court to appoint a guardian, they discovered that the caretaker had made off with most of his savings.

Meanwhile, Patricia, 85, lived alone. She had some mild cognitive impairment, that was obvious. She didn’t get jokes the way she used to, seemed withdrawn, and her memory wasn’t as sharp. But she could get around on her own. She managed her finances and made her own decisions. A nephew disagreed. He referred her case to a doctor who found that her impairment had progressed to mild dementia, and a court declared the nephew her temporary guardian. If she hadn’t by chance run into an old friend who was an elder law attorney, the nephew would have stolen the tens of thousands of dollars he planned to.

These anecdotes were recently related to me by Professor Peter Lichtenberg of Wayne State University, a clinical psychologist and national expert on the financial exploitation of seniors. We met at last April’s conference “Our Aging Brains” at Harvard Law School, where panelists demonstrated the challenges—and profound stakes measured in human suffering—involved in a legal ruling that an individual with dementia either has or lacks legal capacity.

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TOMORROW! Book Launch: Big Data, Health Law, and Bioethics

Book Launch: Big Data, Health Law, and Bioethics
September 5, 2018 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In March 2018, Cambridge University Press will publish Big Data, Health Law, and BioethicsThis volume, edited by I. Glenn Cohen, Holly Fernandez Lynch, Urs Gasser, and Effy Vayena, stems from the Petrie-Flom Center’s 2016 annual conference, which brought together leading experts to identify the various ways in which law and ethics intersect with the use of big data in health care and health research, particularly in the United States; understand the way U.S. law (and potentially other legal systems) currently promotes or stands as an obstacle to these potential uses; determine what might be learned from the legal and ethical treatment of uses of big data in other sectors and countries; and examine potential solutions (industry best practices, common law, legislative, executive, domestic, and international) for better use of big data in health care and health research in the U.S.

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Petrie-Flom Welcomes 2018-2019 Student Fellows

We are so excited to welcome a new crop of Student Fellows to the Petrie-Flom Center family. These six students are a fantastic cohort of health law policy, biotechnology, and bioethics scholars who join us from Harvard Law School, the Harvard T.H. Chan School of Public Health, Harvard Medical School, and the HMS Center for Bioethics.

They will each undertake a year-long research project with mentorship from Center faculty and affiliates, and will also regularly be blogging here at Bill of Health. Keep an eye out for their bylines!

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The Cry Over Fake Milk

two glasses of milk

By Rebecca Friedman

A debate has been brewing between the cattle milk industry and the plant-based milk industry (producing drinks made from ingredients such as almonds, soy, and rice), regarding what products can actually be labeled “milk.”

This has motivated the Federal Drug Administration to review how milk is defined under federal regulations, in order to protect public health and ensure that consumers are purchasing what they expect based on a product’s label.

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The Need for an Economic Bioethics

abstract visuals of economics

By Mark Robinson

As the animations of markets increasingly shape the timbre and character of medicine, scholars studying ethical issues in health and medicine must be increasingly attentive to the role of market forces as they shape modern health care.

For those interested in the social, ethical, and conceptual dimensions of contemporary health and medicine, there has been a sustained focus on a key set of important challenges; how do we ensure adequate access to health for marginalized and global populations? What are the social and ethical implications of emergent technologies? How are issues of consent articulated in the everyday interactions of the clinic? What are our obligations to persons in terms of end-of-life care? These longstanding concerns regarding access, new technologies and the rights of patients comprise the major thrusts and foci of bioethics, health care ethics, and associated areas of inquiry.

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‘Big Data, Health Law, and Bioethics’ Examines the Intersection of Major Issues in Health Care

When data from all aspects of our lives can be relevant to our health – from our habits at the grocery store and our Google searches to our FitBit data and our medical records – can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? A new timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors.

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Call for Authors-Feminist Judgments: Rewritten Health Law Opinions

By Nicolas Terry

(Posted for Seema Mohapatra and Lindsay Wiley)

Seema Mohapatra and Lindsay Wiley are pleased to announce a Call for Authors for Feminist Judgments: Rewritten Health Law Opinions. Authors interested in contributing a rewritten opinion or commentary should respond by Sept. 22 via the form found here: https://docs.google.com/forms/d/19fz5PYWMtrhJc1qgrs1gMSmEblhrD-z8hjMbNZI_Gxs/edit.

Prospective authors are asked to indicate which of 15 health law opinions – selected with the advice of our advisory committee – they would be interested in rewriting or commenting on and provide a description of why their top-choice case is a good candidate for a feminist rewrite. For more information, please see the full text of the Call for Authors that follows. Continue reading

Seeking out global patient safety research

By John Tingle

Unsafe health care is a problem of global proportions .The remedies and solutions to many patient safety problems are unlikely to be found in just one countries health care system. Health is one of the world’s great generics, it transcends countries borders, we are all dealing with the health of human beings which is the common denominator. Whilst country contexts may change the subject matter, the patient, remains constant. WHO state:

“Ensuring the safety of patients is a high visibility issue for those delivering health care – not just in any single country, but worldwide. The safety of health care is now a major global concern. Services that are unsafe and of low quality lead to diminished health outcomes and even to harm. The experience of countries that are heavily engaged in national efforts clearly demonstrates that, although health systems differ from country to country, many threats to patient safety have similar causes and often similar solutions (p.1).

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