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.

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

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

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

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!

What’s Next for the ACA?: A Lecture by Larry Levitt

What’s Next for the ACA?: A Lecture by Larry Levitt
October 3, 2017 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Join Larry Levitt for a talk about the future of the Affordable Care Act and health care in America.

Larry Levitt is Senior Vice President for Special Initiatives at the Kaiser Family Foundation and Senior Advisor to the President of the Foundation. Prior to joining the Foundation, he served as a Senior Health Policy Advisor to the White House and Department of Health and Human Services. He holds a bachelors degree in economics from the University of California at Berkeley, and a masters degree in public policy from Harvard University’s Kennedy School of Government.

This event is free and open to the public.

Sponsored by the Center for Health Law Policy and Innovation, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, and the Harvard Health Law Society, all at Harvard Law School.

TODAY, 10/2 at 5 PM: Health Law Workshop with Alicia Ely Yamin

October 2, 2017, 5-7 PM
Hauser Hall, Room 104

Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Democracy, Health Systems and the Right to Health: Narratives of Charity, Markets and Citizenship”

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

Alicia Yamin is the Program Director of the Health and Human Rights Initiative. Prior to joining the O’Neill Institute, Alicia was a Lecturer on Law and Global Health at the Harvard TH Chan School of Public Health, and the Director of the JD /MPH Program. Alicia was also the Policy Director at the François-Xavier Bagnoud Center for Health and Human Rights at Harvard, a Global Fellow at the Centre for Law and octal transformation in Norway, and was selected as the 2015-16 Marsha Lilien Gladstein Visiting Professor of Human Rights, University of Connecticut. Trained in both law and public health at Harvard, Yamin’s 20-year career at the intersection of health and human rights has bridged academia and activism.  From 2007 to 2011, Yamin held the prestigious Joseph H. Flom Fellowship on Global Health and Human Rights at Harvard Law School.  Prior to that, she served as Director of Research and Investigations at Physicians for Human Rights, where she oversaw all of the organization’s field investigations, and was on the faculty of the Mailman School of Public Health at Columbia University. Yamin was a member of the Board of Directors of the Center for Economic and Social Rights for 15 years and the Chair from 2009-2014. Continue reading

REGISTER NOW! Behind Bars: Ethics and Human Rights in U.S. Prisons

Behind Bars: Ethics and Human Rights in U.S. Prisons
November 30 – December 1, 2017
Harvard Medical School campus
Longwood Medical Area, Boston, MA

The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?

This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.

Registration for the conference is required. To learn more and to register, please visit the HMS Center for Bioethics website.

This event is cosponsored by the Center for Bioethics at Harvard Medical School, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Human Rights Program at Harvard Law School.

American Beverage Association v. San Francisco: When the First Amendment Jeopardizes Public Health

Crossposted from the Public Health Law Watch blog

By Micah BermanWendy E. Parmet, and Jason A. Smith

Last week, while the health law world focused on the Republicans’ renewed attempt to repeal and replace the ACA, the Ninth Circuit struck an ominous blow to public health. As we have noted previously, federal courts in recent years have relied on an increasingly expansive interpretation of the First Amendment to prioritize the rights of commercial speakers over the health and safety of the public.  This new-found appreciation for commercial speech has resulted in decisions striking down a wide-range of public health regulations and has led food and beverage companies to make “ever-bolder arguments aimed at limiting longstanding government authority to protect the public’s health.” In American Beverage Association v. City and County of San Francisco, those bolder arguments were accepted by the court, putting public health regulations in greater peril.

American Beverage Association concerned a challenge to a 2015 San Francisco ordinance requiring certain advertisements of sugar-sweetened beverages (SSBs) to display over at least 20% of the area of the advertisement a warning stating: “Warning: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.”

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Book Launch: Law, Religion, and Health in the United States

Book Launch: Law, Religion, and Health in the United States
September 27, 2017 12:00 PM
Wasserstein Hall, Milstein West A (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

In July 2017, Cambridge University Press will publish Law, Religion, and Health in the United States, co-edited by outgoing Petrie-Flom Center Executive Director Holly Fernandez Lynch, Faculty Director I. Glenn Cohen, and Elizabeth Sepper, Professor of Law at Washington University School of Law. This edited volume stems from the Center’s 2015 annual conference, which brought together leading experts to identify the various ways in which law intersects with religion and health care in the United States, examine the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

About the book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else – patient or physician, secular or devout – interested in how US law interacts with health care and religion.

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Orphan Drugs Designations and Approvals have Something to Say about Risks

This brief essay examines data from the U.S. Orphan Drug Act, including specifically the FDA designations of an indication for a drug to treat an orphan disease, and the likelihood that once the designation is made, the FDA will approve the drug for that indication. This is one empirical measure of the risks associated with the development of new drugs to treat U.S. defined orphan diseases.  Note that 75 percent of all novel cancer drugs approved in the United States from 2010 to 2016 qualified as orphan products.    The essay also reports the average time between the FDA designation and the FDA approval for orphan indications.

The main findings are that since 2010, the average time from orphan designation to approval is 5.3 years, and the likelihood of FDA approval for an orphan indication, which varies over time and across business cycles, was .22 from 1990 to 2017, and since 2010, was .25.

The essay concludes with a comparison to other studies of the risks of drug development.


On January 5, 1983, the U.S. Orphan Drug Act became law as Public Law 97-414. Over the past 34 years the Act has been amended numerous times, often extending or expanding the benefits, which currently include a 50 percent tax credit for qualifying clinical trials, exemptions or discounts on prescription drug user fees, an easier and faster path to FDA approval, and seven years of marketing exclusivity for an approved orphan indication. Continue reading