What kinds of digital tools can help states implement disability exemptions for Medicaid recipients?

This year, several states applied for and received permission from the federal government to implement work requirements in their Medicaid programs. Policy designs vary by state, but all states build in considerations for people with disabilities. These considerations include exemptions and exceptions from work requirements for individuals unable to work due to a disability.

But how can states implement these policies in a way that is accurate, efficient, and fair?

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Join Us For A Special Evening with Author John Carreyrou

Please join us for a conversation with John Carreyrou, Investigative reporter for the Wall Street Journal and author of the New York Times bestseller “Bad Blood: Secrets and Lies in a Silicon Valley Startup.”

Carreyrou will discuss his book about the rise and fall of Silicon Valley darling, the blood testing company Theranos, and its charismatic, Stanford drop-out CEO, Elizabeth Holmes.

In recent weeks, news has emerged that the company will in fact cease operations, despite a short-lived attempt to survive after removing Holmes.

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Health care, disease care, or killing care?

By Hugo Caicedo

Traditional medical practice is rooted in advanced knowledge of diseases, their most appropriate treatment, and adequate proficiency in its applied practice. Notably, today, medical treatment does not typically occur until disease symptoms have manifested. While we now have ways to develop therapies that can halt the progression of some symptomatic diseases, symptomatic solutions are not meant to serve as a cure of disease but palliative treatment of late-stage chronic diseases.

The reactive approach in most medical interventions is magnified in that medicine is prone to errors. In November of 1999, the U.S. National Academy of Science, an organization representing the most highly regarded scientists and physician researchers in the U.S., published the report To Err is Human.

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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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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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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 Institute 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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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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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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‘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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Running healthcare, research and public trust up the flag pole

By Paul C. McLean

While I was aghast earlier this week that the White House struggled over whether to fly the flag at half-mast or full for the death of John McCain, and relieved that it was still the American flag, I distracted myself from the drama in Washington with other news:

Item: In Europe, there were 5,000 cases of the measles in all of 2016, 24,000 in 2017, and already 41,000 halfway through 2018, including 37 deaths, according to the World Health Organization. Globally, measles remains a leading cause of death among young children even though a safe and cost-effective vaccine is available.

Item: In the bizarre case of a convicted murdered claiming his victim wouldn’t have died had he stayed on life support, the Georgia Supreme Court rejected that argument because the patient “was basically brain dead.” [PDF]

Item: Twenty-five years later, gene therapy finally got a common-sense definition: “the intentional, expected permanent, and specific alteration of the DNA sequence of the cellular genome, for a clinical purpose.”

Bioethicists, policymakers, and clinicians tend not to lump brain death, gene therapy and the anti-vaccine movement together. And why should they? Though fate management is central to each, they are perplexing enough to the public (i.e. me) when considered separately.

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Can a national conscience be gene edited?

By Paul C. McLean

Gene editing is at once promising and perilous. Or, as John Oliver said in a recent episode of his news show, it is ”either going to kill all disease or kill every last one of us.”

The Nuffield Council on Bioethics is not as amusing as John Oliver, and unlike the summer film “Rampage,” its new gene editing report features neither The Rock nor a genetically modified, 30-foot wolf.

But if you want to understand what we may actually be getting ourselves into, England’s de facto national bioethics commission has produced a useful roadmap for educating the public and addressing concerns. It may the summer read you’ve been looking for.

And if there’s a gene splicer for envy, I’m ready to be CRISPR’d.

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Recreational Genetics or Research Enterprise? Cloudy Consent Issues Arising from Direct-to-Consumer Genetic Testing

23andme genetic testing kit

23andMe has partnered with GlaxoSmithKline, creating a flurry of questions around customer consent to how their data is used in research. (Phobo via imran/Flickr)

By Valerie Gutmann Koch

23andMe announced its $300 million partnership with GlaxoSmithKline late last month, a move that will allow the drug behemoth to develop drugs based on “deidentified” DNA and other information collected from the direct-to-consumer (DTC) genetic testing company’s five million customers.

Over the last decade, 23andMe has confrontedand survived – various challenges and existential threats to its existence. However, this announcement, while representing an incredible success for 23andMe’s business, presents potential obstacles for informed consent and the research enterprise.

It may also undermine public trust in the company.

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US Legislators Take a Scattered Approach to Neonatal Abstinence Syndrome

 woman holding newborn

By J. Alexander Short

Pennsylvania is the latest state to enact legislation in reaction to the growing impact the opioid epidemic has on infants. Governor Tom Wolf signed H.B. 1232 in June, effectively requiring hospital officials to notify child protective services when children are born affected by the mother’s substance abuse or affected by withdrawal symptoms as a result of prenatal drug exposure.

Such outcomes generally fall within the parameters of neonatal abstinence syndrome (“NAS”), a group of health problems that occur in newborns who were exposed to drugs while in the mother’s womb.  This legislation brings Pennsylvania into full compliance with the 2003 Federal Child Abuse Prevention and Treatment Act.

This legislative response makes sense.

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California Court of Appeal Rejects Challenge to Vaccine Law

Vaccines are now mandatory for school age children in California.

By Dorit Reiss

The Second Appellate District’s Court of Appeal upheld the California law that removed California’s Personal Belief Exemption (PBE) from school immunization requirements earlier this month.

The decision is a strong endorsement of immunization mandates and is binding on all state courts until another appellate decision is handed down, or the Supreme Court of California addresses the question.

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