The Development and Certification of Decision Aids: Promoting Shared Decision-Making for Patients with Serious Illness

The Development and Certification of Decision Aids: Promoting Shared Decision-Making for Patients with Serious Illness
April 18, 2018 8:30 AM – 4:30 PM
Wasserstein Hall, Milstein East AB (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Decision aids can be highly-effective tools to promote shared decision making and support patients in becoming engaged participants in their healthcare.  Join us for the first-ever convening with leaders behind a Washington experiment in certifying decision aids, as state officials, health systems, and on-the-ground implementation experts share lessons learned and discuss policy recommendations for national or statewide approaches to decision aid certification.  

Program Overview

Person-centered care presents a unique opportunity to achieve the Quadruple Aim, especially during serious illness when people are the most vulnerable. Building on the work of NQF and others, it is now clear that healthcare purchasers (states, plans, care providers) committed to person-centered care should also be committed to shared decision-making.

A number of policy initiatives have sought to increase the use of decision aids as an effective way to further shared decision making and person-centered care. Washington is the first – and so far only – state to recognize and act on this opportunity by establishing a process to certify decision aids across the health continuum, including during serious illness when people are the most vulnerable. The program will examine the Washington experience and also explore policy barriers for replication of the Washington model at the state and national levels.

This event is free and open to the public, but seating is limited and registration is required. Register now!

This event is part of the Project for Advanced Care and Health Policy, a collaboration between the Petrie-Flom Center and the Coalition to Transform Advanced Care (C-TAC), a non-partisan, non-profit alliance of over 130 national organizations dedicated to being a catalyst to change the health delivery system, empower consumers, enhance provider capacity and improve public and private policies in advanced illness care.

Learn more about the event here!

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 February. The selections feature topics ranging from tertiary patenting of drug-device combinations; to off-label promotion and adherence to FDA guidelines among direct-to-consumer advertisements; to the impact of FDA label changes. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Beall RF, Kesselheim AS. Tertiary patenting on drug-device combination products in the United States. Nat Biotechnol. 2018 Feb 6;36(2):142-145.
  2. Bothwell LE, Avorn J, Khan NF, Kesselheim AS. Adaptive design clinical trials: a review of the literature and BMJ Open. 2018 Feb 10;8(2):e018320.
  3. Chang HY, Murimi I, Faul M, Rutkow L, Alexander GC. Impact of Florida’s prescription drug monitoring program and pill mill law on high-risk patients: A comparative interrupted time series analysis. Pharmacoepidemiol Drug Saf. 2018 Feb 28. [Epub ahead of print]
  4. Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS. Application and impact of run-in studies. J Gen Intern Med. 2018 Feb 15. [Epub ahead of print]
  5. Klara K, Kim J, Ross JS. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. J Gen Intern Med. 2018 Feb 26. [Epub ahead of print]
  6. Powers JH, Evans SR, Kesselheim AS. Studying new antibiotics for multidrug resistant infections: are today’s patients paying for unproved future benefits? BMJ. 2018 Feb 22;360:k587.
  7. Sobel RE, Bate A, Marshall J, Haynes K, Selvam N, Nair V, Daniel G, Brown JS, Reynolds RF. Do FDA label changes work? Assessment of the 2010 class label change for proton pump inhibitors using the Sentinel System’s analytic tools. Pharmacoepidemiol Drug Saf. 2018 Feb 2. [Epub ahead of print]
  8. Wallach JD, Ross JS. Gabapentin Approvals, Off-Label Use, and Lessons for Postmarketing Efforts. JAMA. 2018 Feb 27;319(8):776-778.

Jeanne Lenzer on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

​We are joined by award-winning medical investigative reporter Jeanne Lenzer. We discuss her book, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It. Lenzer puts forward strong arguments that the medical device industry is under-regulated, and that whistleblowers are insufficiently protected. Woven through her analysis is the story of one patient’s dangers and difficult journey involving an implanted device together. Related stories about physicians and researchers help leaven the medico-legal loaf with the human impact of this massive industry.

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 If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

The Right of the Child against Compulsory Religious Belonging

The recent bill in Iceland that would make nonmedical infant circumcision for boys a crime reminds me once again how international human rights standards are still ambiguous with regard to balancing the right of the child with the right of the religious parent. The bill, already sponsored by at least a quarter of Iceland’s doctors and more than 1000 nurses and midwives, inevitably met with criticism from religious groups that practice male circumcision. The drafters of the bill denied the suspicion that the legislation is an attack on religious freedom, citing health reasons as its primary motivation. Unsurprisingly, the controversy is framed in terms of whether certain public health mandates for children should trump the religious freedom of parents not to conform to these mandates. In Iceland, the issue is magnified by the extremely small Jewish and Muslim populations in the country – adding charges of xenophobia to the controversy. In this blog post, I will not focus on recounting the history of the debate of male circumcision and international law, but to articulate my general frustration with a discourse like this that takes the right of religious parents to impose religious memberships and beliefs onto their biological children for granted. Why is it so rarely discussed, that the child born into a religious household may have a form of agency not yet recognized by our current legal and ethical discourse? Why should we grant parents the benefit of the doubt that they have “the best interest of their child” in mind when acting as proxies in medical and health matters?

Unlike the ICCPR, which gives a blanket statement that allows parents “to ensure the religious and moral education of their children in conformity with their own convictions” (ICCPR, Art. 18 (4)),” the United Nations Convention on the Right of the Child does not simply conflate the religious freedom of children with that of their parents and recognizes the agency of children to a much greater extent. Art. 13 (1) states that:

“The child shall have the right to freedom of expression; this right shall include freedom to seek, receive and impart information and ideas of all kinds, regardless of frontiers, either orally, in writing or in print, in the form of art, or through any other media of the child’s choice.”

The freedom to “seek, receive and impart information and ideas of all kinds” indicates that a diverse source of information is important for the child to formulate his/her own views and expressions. Coupled with Art. 14(1) that asks state parties to respect the right of the child “to freedom of thought, conscience, and religion,” the child should be able to have access to more than one source of information, other than their parents, in regard to which religious views or non-religious views to adhere and practice. Thus, these provisions seem to help the case that children have the right to not follow the religious views of their immediate family or culture, and should not be compelled to do so. However, the second part of Art. 14 takes a step back to reaffirm the agency of the religious parents:

“States Parties shall respect the rights and duties of the parents and, when applicable, legal guardians, to provide direction to the child in the exercise of his or her right in a manner consistent with the evolving capacities of the child.”

If the parent has the “rights and duties” to “provide direction” to the child’s religious formation, it does not necessarily mean that they have the right to “impose.” Nonetheless, the last part of the sentence, “in a manner consistent with the evolving capacities of the child,” likely suggests that the degree to which a parent can influence a child’s religious formation is inversely proportional to the age of the child. In other words, parents may be able to raise their children in accordance with their own religious faith and practice, but they should gradually grant the child more freedom on religious matters as they mature into adulthood. Continue reading

Heather Howard on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

We welcome back one of the pod’s most popular guests. Heather Howard is a member of the faculty at Princeton University’s Woodrow Wilson School of Public and International Affairs. Previously, she served as New Jersey’s Commissioner of Health and Senior Services from 2008-2010. With her help we unpack the latest flurry of Section 1115 waiver approvals and Medicaid refractive surveillance apparatus. Some seem ripe for considerable skepticism, threatening the healthcare of many. Others, current or proposed, give some cause for cautious optimism.

In our lightning round, we discuss the latest judicial challenge to the ACA, a non-severability argument reprising themes of the key NFIB v. Sebelius dissent. We also discuss states’ asserting increasing ability to ignore aspects of the ACA, and the grim prospect of lifetime limits on Medicaid beneficiaries.

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 If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Gun Violence and Public Health: The Need for Federal Research Funding

By: Gali Katznelson

In the wake of yet another school massacre, ‘thoughts and prayers’ are not enough. But if we don’t get more laws and regulations soon, we should at least get more facts and figures.

Though approximately 30,000 people die of gun related violence each year in America, a 2017 study found that gun violence is the least studied of the top 30 causes of death in America. To put this into perspective, gun violence kills as many people in America as sepsis, yet gun violence research has just 0.7% of the funding that sepsis does, and only 4% of its publication volume.

Bioethicists have been criticized for staying out of the gun violence debate. So here’s my bioethical opinion: withholding government funding for lifesaving research as children are massacred across the country is unethical.

Continue reading

Forced Christian Arbitration Agreements Trivialize Health Care

It is no secret that more and more for-profit companies and non-profit organizations are using binding religious arbitration agreements as a means to bypass legal liability. It has been reported that entities that have little or no religious purpose, such as bamboo floor vendors and vocation cabin rental agencies, have quietly inserted binding arbitration clauses into everyday agreements. In the event of a dispute the consumers or victims cannot take these entities to a secular court, but rather to a religious tribunal that claims to be capable of settling any dispute using their interpretations of the Bible. A common reaction against these questionable practices follows this line of critique: shouldn’t religious arbitration, if tolerated at all, only be used for disputes concerning religious or spiritual matters on which the secular courts cannot adjudicate? What does buying bamboo floors or renting a vocation cabin have anything to do with Christian doctrines?

Unfortunately, these questions cannot adequately challenge the religious reasoning behind Christian arbitration agreements. This is due to the counter-intuitive fact that, according to relevant biblical texts, disputes settled in a so-called Christian arbitration tend not to be about important spiritual matters, but trivial matters instead. Here is the text pertaining to lawsuits among Christian believers:

“When one of you has a grievance against a brother, does he dare go to law before the unrighteous instead of the saints? Do you not know that the saints will judge the world? And if the world is to be judged by you, are you incompetent to try trivial cases? Do you not know that we are to judge angels? How much more, matters pertaining to this life! 4    (1 Corinthians 6: 1-4)

At first look, these verses seem to make a strong case for Christian arbitrations. However, upon a closer look, it could be argued that Christians can still settle disputes with others in court under certain circumstances. Verse 1 suggests that Christians shouldn’t “dare to go to law before the unrighteous instead of the saints,” but it only excludes the court system if we assume that the judges at the civil courts are all “unrighteous sinners”. What if they’re not? What if some judges turn out to be devout Christians in private or possess “righteous” and “saintly” qualities? The remaining verses all point to the scope of judging powers the believers are entitled to, since they are to judge the entire world and even angels. Nonetheless, the structure of these rhetorical questions is meant to convince the believers that because they are qualified to judge angels, trivial earthly matters should be a piece of a cake. Since the disputes between Christians are not at all about angels or the whole world, these lines essentially imply that the matters that fall under the purview of Christian arbitrations are precisely trivial matters pertaining to this life on earth, not complicated spiritual affairs. Continue reading

FDA Commissioner Rolls Back 40 Years of Orthodoxy on Cost-Exposure

FDA Commissioner Scott Gottlieb

Speaking yesterday at America’s Health Insurance Plans’ (AHIP) National Health Policy Conference, FDA Commissioner Scott Gottlieb railed against patient cost-exposure (e.g., copays).   His prepared speech said:

Patients shouldn’t be penalized by their biology if they need a drug that isn’t on formulary. Patients shouldn’t face exorbitant out of pocket costs, and pay money where the primary purpose is to help subsidize rebates paid to a long list of supply chain intermediaries, or is used to buy down the premium costs for everyone else. After all, what’s the point of a big co-pay on a costly cancer drug? Is a patient really in a position to make an economically-based decision? Is the co-pay going to discourage overutilization? Is someone in this situation voluntary seeking chemo?  Of course not.  Yet the big co-pay or rebate on the costly drug can help offset insurers’ payments to the pharmacy, and reduce average insurance premiums. But sick people aren’t supposed to be subsidizing the healthy.

Wow.  This may seem like common sense to some readers, but it is revolutionary to hear from a senior American government official, and indeed a Republican one no less.

In a new paper, Victor Laurion and I have chronicled the ways in which American politicians at the highest levels have blindly embraced the opposite point of view for half-a-century.  This sort of ideological adherence to simplistic economic reasoning (which James Kwak calls ‘economism‘) is  why U.S. health insurance exposes patients to all sorts of deductibles, copays, and coinsurance.  As a result, even insured Americans find themselves “underinsured” — denied access to care or falling into bankruptcy if they stretch to pay nonetheless. Continue reading

Psychoneuroimmunology and the mind’s impact on health

If you are a skier like me, you likely revelled in watching the alpine skiing events during this years’ Olympic Winter Games held in Pyeongchang, South Korea. Having raced myself when I was younger, I recall the feeling of being in the starting gate with all the anticipation and excitement it brings. But my memories are more than mere recollections of “images” in my head, for I also have vivid muscle memory, and when watching and cheering for Lindsey Vonn and Ted Ligety, I can literally feel my leg muscles contract as if I were on the course myself. Because I skied for so much of my life, my experience now as a spectator brings me back to the hardwired responses that I can call up even to this day in a very intuitive way simply by visualizing a course.

Researchers at Stanford have now corroborated what athletes and psychologists have long believed: that visualizing ourselves performing a task, such as skiing down a race course, or engaged in other routines, improves our performance and increases our success rate. The findings, reported by neuroscientists in Neuron, suggest that mental rehearsal prepares our minds for real-world action. Using a new tool called a brain-machine interface, the researchers have shown how mental learning translates into physical performance and offers a potentially new way to study and understand the mind.

Could this new tool assist us in replicating cognitive responses to real-world settings in a controlled environment? More studies will need to be carried out in order to further test these findings and better understand the results. And one potential point to take into account is that preforming a real action is different than performing the same task mentally via a brain-imaging interface given that one’s muscles, skeletal system, and nervous system are all working in tandem; but, a brain-imaging interface would indeed seem to have very practical implications for those who use prosthetics or are who are paralyzed. As our knowledge of biomechanics and neuroscience advances, as well as our capabilities to interface the two, we may be able to utilize this technology to assist us in creating more life-like prosthetics and perhaps, harnessing the mind’s inborn processes and complex synapses, help others walk again.

Looking toward the future, another interesting subject of research would be to use a brain-imaging interface to study psychoneuroimmunology. We may not have the technology or ability to conduct such a study at the moment, but it seems plausible that in the near future we could develop the tools needed to conduct more rigorous research on the interactions between psychological processes and the nervous and immune systems. If visualizing winning a ski race improves our performance, why not also envisioning good health outcomes: resilient bodies, strong immune systems, plentiful and efficient white blood cells. Simply willing ourselves to health might not be possible, but, to be sure, having a positive outlook has been shown to impact the outcome of disease, while conversely, increased levels of fear and distress before surgery have been associated with worse outcomes. These are but a few examples of the increasing evidence of the mind’s impact on health. It highlights the importance of recognizing a holistic approach that considers the roles of behavior, mood, thought, and psychology in bodily homeostasis. Continue reading

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“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 (1987).

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

Historically 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.

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Failings in care for patients being treated under the Mental Health Act 1983

By John Tingle

The Care Quality Commission (CQC)  is the independent regulator of health and social care in England and they have recently produced their annual report to Parliament on how health services are applying the Mental Health Act 1983 (MHA) .This report, shines a very strong light on failing health care practices in mental health care relating to the  MHA. Shocking failures are revealed and the errors are compounded by the fact that the poor practices have been identified in previous reports and are long standing in nature.

The CQC state that national data from the last 25 years shows an increasing use of the MHA to treat people in hospitals. From 2005/06 to 2015/16, the reported number of uses of the MHA to detain people in hospital increased by 40%. There was a 9% increase from 2014/15 to 2015/16 rising to 63,622 uses of the MHA. The CQC can find no single cause for the increases in detention rates over the last 10 years.

The CQC once again draw attention to the persistent theme present in its previous reports of black and minority ethnic over representation figures in the use of the MHA.

The CQC found that there are still services that continue to fail in their legal duties to give patients information about their rights, verbally and in writing as soon as possible after their detention or community treatment order commences. They found no evidence that staff had discussed rights with the patient on admission in 11 % (378) of patient records that they checked. In a further inspection of 9%, (286) of records, no evidence could be found to say that patients received the information in an accessible format.

Consent to treatment

The CQC state that they have concerns about whether the patient consents, refuses consent or is incapable of consent. They expect to see capacity assessments to support views and possibly evidence that staff have considered ways in which they could help the patient gain or regain capacity. They have frequently raised concerns over whether clinicians have recorded evidence of their conversations with patients who are detained over their proposed treatment and their views. Continue reading

Diane Hoffman on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week our guest is the Director of the Law and Health Care Program and Jacob A. France Professor of Health Care Law at the University of Maryland, Diane Hoffman. Diane has directed a groundbreaking, interdisciplinary team of researchers exploring the regulation of the human microbiome market, probiotics, and microbiota transplants. She was lead author on the 2017 Science article “Improving Regulation of Microbiota Transplants,” and recently published work in Gut Microbes, JLME, and the AJLM.

Diane has written influential articles in many subfields of health law, but today we focus on her work on the biome. The science is fascinating but the regulatory system is complex. Diane’s leadership in ELSI working groups researching these areas makes her the go-to source for ideas on the various options regulatory options (including by the FDA and FTC) and their potential impact on the growth of this new and rapidly evolving science.

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 If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.