TODAY, 10/16 at 5 PM: Health Law Workshop with I. Glenn Cohen

October 16, 2017 5:00 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Cops, Docs, and Code: A Dialogue Between Big Data in Health Care and Predictive Policing” by I. Glenn Cohen & Harry S. Graver

This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich at law.harvard.edu.

I. Glenn Cohen is Professor of Law and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Glenn’s current research projects relate to health information technologies, mobile health, reproduction/reproductive technology, research ethics, rationing in law and medicine, health policy, FDA law and to medical tourism – the travel of patients who are residents of one country, the “home country,” to another country, the “destination country,” for medical treatment. His past work has included projects on end of life decision-making, FDA regulation and commodification.

 

Michelle Mello on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week’s guest is Michelle M. Mello, Professor of Law and of Health Research & Policy at Stanford University. She is the author of more than 150 articles and book chapters on the medical malpractice system, medical errors and patient safety, research ethics, regulation of pharmaceuticals, legal interventions to combat obesity and noncommunicable disease, and other topics.

Our conversation focused on her recent work on medical apologiescommunication-and-resolution programsoverlapping surgery (which refers to operations performed by the same primary surgeon such that the start of one surgery overlaps with the end of another), reconciliation after medical injury, and the influence of the malpractice environment on care patterns.

The lightning round featured a tour of the many facets of synthetic ACA repeal: CHIP delay, health budget slashing, zombie reconciliation, marketing budget cuts, inexplicable “maintenance” efforts that bring down HealthCare.gov for 12 hours a day at peak sign up periods, the Trump EO on association health plans, and the suspension of CSR payments. As Nancy LeTourneau reports, “synthetic repeal won’t be scored by CBO and has tossed aside any attempt to replace the law. That means that the results could be even more disastrous for the American people.”

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Religion, Health, and Medicine: the Dialectic of Embedded Social Systems

The philosopher in me understands that there are universal principles in logic, mathematics, and in basic scientific tenets such as the law of gravity. Be that as it may, the historian in me recognizes that we inherit epistemologies and ways of thinking from those before us, and from our own historical and cultural contexts. Certain ideas dominate the world; and, while some are indeed universal, especially those based on science, the fact remains that a number of other concepts are only seemingly universal. The concepts of personhood, divinity, self, and even society as we tend to understand them today are largely inherited from a Western, Christian worldview. As these ideas have wrestled with philosophical inquiry throughout history, they have either been decoupled from their origins in religious thought, or they have been secularized and rationalized a la Kantian categorical imperatives or the like—and then disseminated in universities, institutions, cultures, and literatures.

On one level, to speak of the Western world as “secular” is, as the philosopher Charles Taylor notes, to say that “belief in God, or in the transcendent in any form, is contested; it is an option among many; it is therefore fragile; for some people in some milieus, it is very difficult, even ‘weird’” (Taylor: 2011, 49). But on another and much deeper level, this very possibility was only ever tenable on account of two major factors: “First, there had to develop a culture that marks a clear division between the ‘natural’ and the ‘supernatural,’ and second, it had to come to seem possible to live entirely within the natural” (Taylor, 50). This was only possible because of a unique philosophical climate that actively sought to dislodge the old form of moral order and social “embeddedness” in an attempt to establish a “purely immanent order.” Taylor’s groundbreaking work, A Secular Age argues that secularism is part of a grand narrative in the West and shows that its historical and cultural foundations are in fact thoroughly Christian and European. He pushes back against Max Weber’s secularization thesis that religion diminishes in the modern world and in the wake of increasing developments in science and technology—and instead gives a different account of what secularism might mean: one that has deep implications for morality, politics, and philosophy.

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“Siri, Should Robots Give Care?”

By Gali Katznelson

Having finally watched the movie Her, I may very well be committing the “Hollywood Scenarios” deadly sin by embarking on this post. This is one of the seven deadly sins of people who sensationalize artificial intelligence (AI), proposed by Rodney Brooks, former director of the Computer Science and Artificial Intelligence Laboratory at MIT. Alas, without spoiling the movie Her (you should watch it), it’s easy for me to conceptualize a world in which machines can be trained to mimic a caring relationship and provide emotional support. This is because, in some ways, it’s already happening.

There are the familiar voice assistants, such as Apple’s Siri, to which people may be turning for health support. A study published in JAMA Internal Medicine in 2016 found that that the responses of smartphone assistants such as Apple’s Siri or Samsung’s S Voice to mental and physical health concerns were often inadequate. Telling Siri about sexual abuse elicited the response, “I don’t know what you mean by ‘I was raped.’” Telling Samsung’s S Voice you wanted to commit suicide led to the perhaps not-so-sensitive response, “Don’t you dare hurt yourself.” This technology proved far from perfect in providing salient guidance. However, since this study came out over a year ago, programmers behind Siri and S Voice have remedied these issues by providing more appropriate responses, such as counseling hotline information.

An AI specifically trained to provide helpful responses to mental health issues is Tess, “a psychological AI that administers highly personalized psychotherapy, psycho-education, and health-related reminders, on-demand, when and where the mental health professional isn’t.” X2AI, the company behind Tess, is in the process of finalizing an official Board of Ethics, and for good reason. The ethical considerations of an artificially intelligent therapist are rampant, from privacy and security issues to the potential for delivering misguided information that could cost lives. Continue reading

Emergent Medical Data

By Mason Marks

In this brief essay, I describe a new type of medical information that is not protected by existing privacy laws. I call it Emergent Medical Data (EMD) because at first glance, it has no relationship to your health. Companies can derive EMD from your seemingly benign Facebook posts, a list of videos you watched on YouTube, a credit card purchase, or the contents of your e-mail. A person reading the raw data would be unaware that it conveys any health information. Machine learning algorithms must first massage the data before its health-related properties emerge.

Unlike medical information obtained by healthcare providers, which is protected by the Health Information Portability and Accountability Act (HIPAA), EMD receives little to no legal protection. A common rationale for maintaining health data privacy is that it promotes full transparency between patients and physicians. HIPAA assures patients that the sensitive conversations they have with their doctors will remain confidential. The penalties for breaching confidentiality can be steep. In 2016, the Department of Health and Human Services recorded over $20 million in fines resulting from HIPAA violations. When companies mine for EMD, they are not bound by HIPAA or subject to these penalties.

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Introducing New Blogger Mason Marks 

Mason Marks is joining Bill of Health as a regular contributor.

Mason is a Visiting Fellow at Yale Law School’s Information Society Project. His research focuses on the application of artificial intelligence to clinical decision making in healthcare. He is particularly interested in the regulation of machine learning and obstacles to its adoption by the medical community. His secondary interests include data privacy and the regulation of emerging technologies such as 3D-bioprinting, surgical robotics, and genome editing.

Mason received his J.D. from Vanderbilt Law School. He is a member of the California Bar and practices intellectual property law in the San Francisco Bay Area. He has represented clients in the biotechnology, pharmaceutical, and medical device industries. Prior to law school, he received his M.D. from Tufts University and his B.A. in biology from Amherst College.

Representative Publications:  Continue reading

Opportunity: Faculty Fellow in Health Law and Intellectual Property

The Jaharis Health Law Institute is now accepting applications for a Faculty Fellow in Health Law and Intellectual Property!

Established in 1984 and supported by the Mary and Michael Jaharis Health Law Institute (JHLI), DePaul’s health law program has consistently ranked among the top in the nation. JHLI offers students coursework that reflects the diversity of health law from community health to high-tech health care, making DePaul a leader in the education of future generations of health law partners, policy makers and critical thinkers.

About the Fellowship:
An endowment at the DePaul University College of Law funds a faculty fellowship program for scholars to create and disseminate scholarship and teach courses where two dynamic legal fields are increasingly intersecting—intellectual property and health law. The fellowship is designed to encourage scholars interested in entering a career in legal academia in these fields. The Jaharis Faculty Fellow will work with and be mentored by faculty from DePaul’s nationally-ranked Mary and Michael Jaharis Health Law Institute (JHLI) and Center for Intellectual Property Law & Information Technology (CIPLIT®). Continue reading

Call For Abstracts, Due 10/15! Beyond Disadvantage: Disability, Law, and Bioethics – PFC’s 2018 Annual Conference

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

disability-law-bioethics_slideHistorically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading

An Analysis of Five Years of Cerebral Palsy Claims in the UK

By John Tingle

NHS Resolution, an arm’s length body of the Department of Health that manages clinical negligence and other claims brought against the NHS in England, have just published a report on cerebral palsy legal claims. These claims are complex and result in large awards of compensation. In 2016-17, whilst the obstetrics specialty accounted for only 10% of the 10,686 claims received, they represented 50% of the £4,370 Million value of claims received.

Once case may cost £20 Million or more for one child. The report shows that the same errors are often being repeated and that key patient safety lessons go unlearned. The report analyses the data held by NHS Resolution on its claims management system on compensation claims for cerebral palsy that occurred between 2012-2016.There were 50 claims between this period that were suitable for review with a potential financial liability greater than £390 Million. This figure excludes the costs of defending the claim and the wider cost impact on the NHS as a whole. The results of the report are split into two parts. Part one looks at the quality of the serious incident (SI) investigation reports and part two looks at arising clinical themes. Continue reading

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 September. The selections feature topics ranging from changes in misuse and abuse of prescription opioids following implementation of REMS programs, to the determinants of market exclusivity for prescription drugs, to the fate of FDA post-approval studies. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bucher Bartelson B, Le Lait MC, Green JL, Cepeda MS, Coplan PM, Maziere JY, Wedin GP, Dart RC. Changes in misuse and abuse of prescription opioids following implementation of Extended-Release and Long-Acting Opioid Analgesic Risk Evaluation and Mitigation Strategy. Pharmacoepidemiol Drug Saf. 2017;26(9):1061-1070.
  2. Hey SP, Cohen IG, Adashi EY, Kesselheim AS. Influence, integrity, and the FDA: An ethical framework. Science. 2017;357(6354):876-877.
  3. Kashoki M, Lee C, Stein P. FDA Oversight of Postmarketing Studies. N Engl J Med. 2017;377(12):1201-1202.
  4. Kesselheim AS, Sinha MS, Avorn J. Determinants of Market Exclusivity for Prescription Drugs in the United States. JAMA Intern Med. 2017 Sep 11. [Epub ahead of print]
  5. Mostaghim SR, Gagne JJ, Kesselheim AS. Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study. BMJ. 2017;358:j3837.
  6. Woloshin S, Schwartz LM, White B, Moore TJ. The Fate of FDA Postapproval Studies. N Engl J Med. 2017;377(12):1114-1117.
  7. Zeitoun JD, Baron G, Vivot A, Atal I, Downing NS, Ross JS, Ravaud P. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study. Int J Cancer. 2017 Sep 20. [Epub ahead of print]

From Westworld to U.S. Prisons: Reframing the Debate on the Right to Health

Is there a “Right to Health?” For many countries in the world, including Latin American countries like Brazil, the answer is easily in the affirmative. Similarly, in the hit HBO show Westworld, the “hosts” (androids on the verge of discovering consciousness) also possess a right to health. How so? Despite atrocious cruelty the human “guests” constantly inflict upon them, the company that runs Westworld maintains a highly extensive, functional “universal health care system” that employs the latest medical technologies for androids to take care of any health problems of all damaged hosts. The efficiency of the system is breathtaking: a cowboy host with 20 bullet wounds and a broken arm could be fully restored overnight; when the sun rises the next morning, the host returns to the simulated reality as if nothing happened.

Of course, the right to health in Westworld is not a result of democratic deliberations or judicial activism that invokes the UDHR or related treaty obligations. Instead, it originates in the sheer necessity of running a seamless alternate reality that requires good maintenance of the hosts, whom the Board depend on to please the guests and maximize the company’s profits. In other words, the physical wellbeing of the hosts is intrinsically tied to the functioning of the entire Westworld machinery and its profitability. Fixing them quickly and adequately allows them to return to their respective, pre-determined roles in a complex narrative with countless plots and subplot twists meticulously designed by their human masters. Continue reading

Ireland’s Abortion Referendum and Medical Care in Pregnancy

By Clíodhna Ní Chéileachair

This week, Ireland made international headlines as the governing political party announced a date-range for a referendum on the Eighth Amendment to the Irish Constitution, the provision which recognizes a fetal right to life, and places it on an equal footing to the right to life of the woman carrying the fetus. The move wasn’t a surprise to Irish voters – the referendum had been promised by Taoiseach Leo Varadkar since his election last June, and comes after decades of protest and organization by a multitude of activist groups, protesting what they view as an archaic, unworkable and agency-destroying constitutional provision that has led to the exporting of abortion care for Irish woman to the UK and Netherlands, and the deaths of women in Ireland. The implications of the Eighth Amendment for access to abortion care are obvious enough – it is illegal in almost all cases. Less prominent has been the pronounced effect that this constitutional ban on abortion has had for medical treatment and care in pregnancy, where the doctor involved is, constitutionally speaking, treating two patients with equal rights to life.

The only scenario in which an abortion in Ireland is legally permissible is in cases where the woman’s life is at risk from the continuance of the pregnancy. In all other cases, including cases where the fetus is non-viable, where the pregnancy is a result of rape or incest, or where the fetus will risk the health of the woman, but not her life, abortion is illegal. Criminal punishment for illegally procuring an abortion runs to a prison term of 14 years, which includes doctors who provide illegal treatment. Women who can afford it travel to the United Kingdom to avail of abortion services there, but doctors in Ireland cannot legally refer their patients to clinics in the UK, even in cases where continuing the pregnancy risks the health of the woman. It is unknown how many women have ended a pregnancy with illegal, imported abortion pills.

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Book Review: “Into the Gray Zone” by Adrian Owen

By Leslie C. Griffin

I recommend neuroscientist Adrian Owen’s new book, Into the Gray Zone. The “gray zone” refers to patients who undergo such traumatic brain injury that they are diagnosed as vegetative, minimally conscious, comatose, or in other medical states where they aren’t fully present. Owen’s career has been devoted to getting full access to their brains through various forms of brain testing.

The author nimbly combines scientific, philosophical and personal approaches to brain injury. He repeatedly details the scientific means that allowed him to start and extend his career. We learn about his use of PET (positron-emission tomography) and then his move to fMRI (functional magnetic resonance imaging).

Kate was the first patient whose consciousness he recognized through PET scans. Kate—surprisingly—recovered, and later wrote to Owen, asking him to use her case to show others that they too could be discovered despite their illness. Owen “felt an enduring, close connection with Kate, something that had a profound influence on me and my work; she was always Patient #1, always the person I’d refer to when I gave lectures about how this journey began” (p. 37).  Continue reading

New York’s Highest Court Summarily Rejects a Constitutional Challenge to New York’s Ban on Physician-Assisted Suicide

By Norman L. Cantor

Justice Cardozo, the legendary jurist from New York, would turn over in his grave upon reading the New York Court of Appeals’ per curiam (unsigned) opinion in Myers v. Schneiderman, 2017 WL 3897181 (9/17/17).  The lawsuit was filed by several terminally ill patients (and physicians serving such patients) challenging New York’s ban on physician assistance to a competent, terminally ill medical patient seeking a lethal prescription.  The deficiency that would upset Cardozo was not so much the Court’s conclusion that application of assisted suicide laws to a dying patient does not violate constitutional rights of liberty and equal protection, but rather the Court’s perfunctory, over-simplified handling of the constitutional issues.

The most plausible constitutional challenge in this context is equal protection – a claim that states act arbitrarily in allowing terminal patients certain means of hastening a grueling dying process (rejection of life-sustaining medical intervention, use of risky analgesics or sedatives to relieve suffering, and voluntarily stopping of eating and drinking (VSED)) while banning a physician’s provision of a more expeditious means of hastening death – a lethal medication.   The per curiam opinion’s dismissive response to this equal protection claim was that New York’s laws don’t differentiate among persons.   From the Court’s perspective, every competent patient is entitled to reject medical intervention and every person is forbidden to assist a suicide.  There are no invidious “discriminations” present.  This myopic formulation of the equal protection issue ducks the complex distinctions made by state laws in the context of dying medical patients.

The issue of controlling the time and manner of death derives from medical science’s newfound (mid-20th century) capacity to prolong a fatally stricken patient’s dying process – sometimes beyond the patient’s tolerance for suffering or indignity.  Patient choice and some medical management of the dying process became an accepted norm in confronting irremediably fatal pathology.   The initial accepted means of controlling the timing of unavoidable death was through patients’ control of life-sustaining medical intervention  (including chemotherapy, respirators, dialysis, or artificial nutrition and hydration).  A competent patient’s prerogative to reject medical life support has been recognized as a basic legal right in every jurisdiction.  Continue reading

Introducing New Blogger Leslie Griffin

We are pleased to introduce our newest contributor, Leslie Griffin, to Bill of Health.

Dr. Leslie C. Griffin is the William S. Boyd Professor of Law at the University of Nevada, Las Vegas, William S. Boyd School of Law. She holds a Ph.D. in Religious Studies from Yale University and a J.D. from Stanford Law School. She is author of the Foundation Press casebook, Practicing Bioethics Law (2015), which was co-authored with Joan H. Krause, Dan K. Moore Distinguished Professor of Law at the University of North Carolina School of Law, and Bill of Health blogger. Before becoming a law professor, Professor Griffin clerked for the Honorable Mary M. Schroeder of the U.S. Ninth Circuit Court of Appeals and was an assistant counsel in the Department of Justice’s Office of Professional Responsibility, which investigates professional misconduct by federal prosecutors. Before joining the UNLV faculty, Professor Griffin held the Larry & Joanne Doherty Chair in Legal Ethics at the University of Houston Law Center and was a tenured member of the faculty at the Santa Clara University School of Law.

Representative Publications Continue reading

Medical Bills are Open-Price Contracts: A Victory for the Little Guy

This blog has often covered the problem of outrageous medical bills, and explored whether patients have a responsibility to pay the balance on charges that are not covered by insurance.  One common pattern is that the patient agrees to pay “all reasonable charges” when they arrive at the emergency room or other provider, and then months later receives an incomprehensible bill for seemingly outrageous amounts.  The costs of the same healthcare can vary wildly from provider to provider, even in the same locale, and there seems to be little rhyme or reason.  (This is a common refrain of Elizabeth Rosenthal’s 2017 book.)

According to very basic contract law, when the agreement between a buyer and seller does not specify the prices to be charged (aka an “open price contract”), the seller may not demand more than a “reasonable” amount.   Years ago, I was involved in nationwide litigation against non-profit hospitals, raising this theory and alleging that their billing practices contradicted their state and federal “charitable” tax exemptions, since they were driving poor people into bankruptcy and foreclosure.  That litigation had a few notable wins, when several hospital systems agreed to adopt explicit charity care policies and stop some of the more egregious practices, such as putting liens on their patients’ houses.  Some of these reforms became an industry standard and then part of the Affordable Care Act.

Overall, however, this litigation was challenging, because courts tended to hold that the reasonableness of each patient’s medical bills had to be litigated individually – often with expert witnesses and comparable data from the healthcare provider and other competitors.  With only a few thousand dollars at stake for each patient, the courts’ refusal to aggregate the litigation left many consumers without an effective recourse to challenge their unreasonable bills. Contingent-fee attorneys tend to look for larger stakes to make their investment of time and expenses worthwhile. Continue reading

Autopsy of a Failed Health Insurance Experiment: Did It Die of Natural Causes, or Was It Murdered?

By Anthony Orlando

It was just another week for the Trump administration. A senior official resigned after admitting to major ethics violations, the President insulted millions of innocent brown-skinned Americans on Twitter, and quietly—so quietly that almost no one noticed—the Department of Health and Human Services pulled another Jenga block out of the teetering tower that is the Affordable Care Act. Fortunately, it did not fall.

But it did become more expensive. And in that understated tragedy, we find our mystery: Was that HHS’s intent all along?

It all started back in February when Gov. Mary Fallin announced that Oklahoma would submit a 1332 waiver request to the Centers for Medicare and Medicaid Services. At the time, no one really knew how 1332 waivers would work. All they knew was that Oklahoma needed to try something different.

Oklahoma had the same problem that a lot of heavily rural states had. Even with the subsidies in the ACA, it wasn’t very profitable for health insurers to compete in many counties. Sparsely populated areas have always been harder to service. It’s why Lyndon Johnson led the charge to electrify Texas, why rural phone rates went up after the courts broke up Ma Bell, and why small-town Post Offices are closing around the country. Add in the fact that rural Americans pose higher health risks on average, and it’s not hard to see why insurers are wary of setting up shop in these communities. Continue reading

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States

The Cost of Medications: Current Realities and the Future of Pharmaceutical Pricing Regulations in the United States
October 4, 2017 12:00 PM
Wasserstein Hall, Milstein East B (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.

This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.

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Introducing New Blogger Anthony W. Orlando

Anthony W. Orlando is joining Bill of Health as a regular contributor.

Anthony is an Assistant Lecturer in the Sol Price School of Public Policy at the University of Southern California, where he is completing his PhD in Public Policy and Management. He also contributes to the Huffington Post. He hosts the podcast “Our American Discourse,” sponsored by the USC Bedrosian Center. He received his bachelor’s degree in economics from The Wharton School of the University of Pennsylvania, as well as a master’s in economic history from the London School of Economics and Political Science. He is a member of the American Society of Law, Medicine & Ethics.

Representative publications:

Please join us in welcoming Anthony!