The NHS in England: Running to Stand Still?

By John Tingle

The Health and Social Care Regulator of the NHS in England, the Care Quality Commission (CQC) has published its latest annual report on the state of health and adult social care in England 2016/17.When reading the report ,the reader is left wondering whether the NHS as currently established can cope adequately with current future health and social care demands. The NHS turns seventy years of age next year and there is much to celebrate but there is also a lot of increasing concern about NHS efficiency, sustainability, safety and quality. The number of people aged 65 is projected to increase in all regions of England by an average of 20 % between mid-2014-and mid-2024.People are also increasingly presenting with complex, chronic or multiple conditions. The total number of people with Dementia is projected to reach one million by 2027.We are also living longer. Life expectancy at birth, 2013-2015 is 79 years for men and 83 for women. All these factors test the model of NHS care that we have and its long-term sustainability.

Like the previous year’s annual report,this year’s warns that the health and care system is operating at full stretch and that care quality in some areas is deteriorating. The situation can only get worse unless more resources are made available or new ways of the NHS operating are devised. The NHS faces an infinite public demand for its finite resources. Continue reading

The Illusion of Choice in Health Care Consumerism

The rhetoric of “choice” has been pervasive in U.S. health care reforms and the consumerist health care culture for a long time. The idea is that giving patients more choices over doctors and insurance plans would increase competition in the industry and consequently improve the quality of health care patients receive. However, Allison Hoffman made a convincing case debunking this seemingly intuitive idea in this week’s HLS health law workshop. She argued that reform efforts aimed at increasing consumer choice often fail to empower patients to make better health care choices, and instead, create a wasteful market bureaucracy that is anathema to free market ideals. Her argument reminds me of one of my earlier blog posts on U.S. drug prices, where I compared insurance companies to the Central Planner in a socialist economy. Indeed, there are ironically many institutions and features in the so-called market-driven U.S. health care system that resemble authoritarian and technocratic practices that are directly against the principles of a laissez-faire health care economy.

I will expand Professor Hoffman’s argument by making a few additional points. First, her presentation discusses a number of revealing ways in which the market-based competition creates a false sense of choice in health care. Even Obamacare, which is supposed to offer patients more choices in the Exchange, fails to transcend the falsity of consumer choice. Most patients do not make the best available choice, even when they’re “nudged” by experts in the decision-making process. I’d like to also point out that even if consumers are capable of making the best choice for themselves, whether by thinking with perfect rationality or by accepting “expert opinions,” the choice they ultimately make could still be suboptimal or even disastrous. To understand why this might be the case, it is important to realize that the target population for Obamacare is the minority of people who do not have adequate employer-sponsored plans. Thus, many people enrolled in Obamacare may not have stable jobs and income levels. Nonetheless, the mechanism that determines how much premium for which one qualifies is predicated on an estimation of that individual’s projected annul earnings – a number that is hard to know in advance for those without stable income levels. Hence, a person who made the “right choice” by selecting a silver plan with only $100 monthly premium after receiving a $900 subsidy to cover a $1,000 plan at the beginning of a year may find herself owing the federal government thousands of dollars at the end of the tax year, if she happens to end up with a much higher income level. Had she known the future outcome, she would have chosen a less expensive plan to begin with, but either choice would be a gamble for her. This arbitrariness must be attended to in future health reforms.

Second, the “moral hazard” rationale – that patients would engage in behaviors that undermine their own health if they are insured or that they would abuse their insurance during sickness – could actually influence consumer behaviors. To counter moral hazard, many advocate increasing patients’ cost-sharing obligations so that they would be less likely to abuse their insurance. While it is true that no one is likely to deliberately hurt themselves just because they have insurance to cover losses, some moral hazard based insurance policy may actually cause patients to behave differently or prevent people with “unhealthy” behaviors from joining. In my own research on HCSMs – alternative “non-insurance” cost-sharing ministries run by evangelical Christians “bearing each other’s medical costs” – have strict eligibility requirements and reimbursement restrictions on lifestyle choices. For example, medical costs resulting from tobacco or alcohol would not be reimbursed. Thus, if someone has tobacco-induced lung cancer, no cost sharing might be available. Additionally, STDs caused by sexual activities outside of heterosexual marriage would not be covered. These “moral hazard” policies could have a large deterrence effect on individual behaviors – making them strong “arbiters of morality.” Thus, under HCSMs, the costs to build a censoring mechanism based on moral hazard turn out to be saving these ministries a significant amount of money. Yet, the autocratic element of such measures remains strongly inconsistent with free market ideas.

Lastly, I’d like to suggest a rather radical idea that may be too far-fetched to even think about in our current political environment. I wonder whether the fact that market competition fails to produce good health care outcomes has more to do with the market itself than the principle of competition. In other words, could competition work better if a competitor with significant competitive edge enters the deadlocked American health care marketplace? What if, hypothetically, insurance companies from Canada and Mexico start contracting with American providers and provide appealing, low cost choices for consumers? Or, these transnational insurance companies could even create border-crossing incentives for American patients to use foreign providers at a significantly cheaper cost? Since drug prices and medical expanses are significantly lower in other developed countries, allowing transnational health care access might create competitions that would not be possible for any American insurance company. I know that many Taiwanese Americans seek healthcare back in Taiwan, where high-quality universal health care is the norm. If such transnational health-seeking endeavors could be happening much more frequently and closer to American borders, it might be able to disrupt existing norms in the U.S. market and potentially drive health care costs down. Similarly, a radically cheaper federal-insurance option or single-payer system might also create such disruptions and norm-shifting competitions. Nonetheless, these conversations can never happen unless there is enough political will to seriously question some fundamental assumptions our current health care system relies on.

The Mexico City Rule and Maternal Death

By Clíodhna Ní Chéileachair

The ‘Mexico City Rule’ is a Reagan-era regulation which bars US funding to worldwide NGOs which provide counselling relating to abortion, or referrals for abortion services, or which advocate for the expansion of abortion access. The regulation is a sticking point for the two-party reality of US politics, and has been rescinded by every Democratic president since Reagan, and reinstated by each Republican president. Trump is no exception, and his administration’s approach to the policy has been exceedingly expansionist; where the policy traditionally only applied to aid tied to family planning projects, the policy now extends to all international health care aid provided by the US government, amounting to almost $9 billion every year, and covering US aid policies in the areas of family planning and reproductive health, infectious diseases, TB treatment, children’s health, nutrition, HIV/AIDS prevention, water and sanitation programs, and tropical diseases.

The effect of the policy extends past the years in which it is actively in place. Population Action International reports on a reluctance on the part of US governmental officials and non-governmental partners to enter into agreements with organizations that may be ineligible for funding in the future based on the putative reinstatement of the policy, in effect operationalizing the policy beyond the times in which it is in active effect. Beyond the expanded remit given to the policy by the Trump administration, and the temporal expansion based on likely reinstatement, the wording of the policy itself goes some way to expanding the scope of the policy beyond what might be necessary in a vacuum. The structural effect of the policy is to prevent the funding of abortion access with US aid money (an outcome which is illegal regardless through the Helms Amendment) and abortion advocacy. The policy contemplates a neat categorization of organizations such that it is possible to carve out the aspects of a healthcare organization that deal with abortion care as an aspect of reproductive health and justice. Continue reading

What does the Orphan Drug Tax Credit tell us about the Costs of Clinical Trials?

By James Love

Summary:

  • The number of patients enrolled in the trials used to support the registration of novel orphan product are significantly smaller that non-orphan products.  One measure of this is the difference in the enrollment of trials cited in the FDA drug trials snapshots.
  • Since 2015, the average number of trials cited in the FDA trials snapshots for novel drugs were 439 for orphan products, and 2,736 for non-orphans.
  • Data from the Orphan Drug Tax Credit provides insights into the costs of drug development, or more specially, the costs of the clinical trials used to support an FDA approval.
  • From 2010 to 2016, the average qualifying trial costs claimed for the orphan drug credit was $86 million to $102 million, per FDA approved orphan indication (assuming 2 to 3 year average years of lag between the credit claimed and the approval date).  Companies were able to take a credit of $43 to $51 million, on average, for each FDA approval.
  • The $86 to $102 million in pre-credit outlays is far lower than the average of $965 million on trial costs for a new drug approval, estimated by DiMasi and others in 2016.  Some of the differences are explained by the smaller trials for orphan drugs and other differences in methodologies, although both figures include the costs of failed trials and exclude pre-clinical or cost of capital costs.
  • In 2013, the last year for which we have actual rather than projected data on the credit (from the IRS Statistics of Income), the total amount of the credit from all 132 corporate tax returns that claimed the credit was just over $1 billion, nearly the same amount as the DiMasi estimate of $965 million for a single drug. But in 2013, the FDA granted 265 orphan designations and approved 33 orphan indications, including 8 novel products which were approved for an orphan drug lead indication.
  • The data from the orphan drug tax credit illustrates the large gap between the known facts about the costs for R&D for orphan drug development, and the astronomically larger R&D costs claimed by DiMasi (and frequently quoted by other researchers, policy makers and journalists) as averages that should guide policy making.
  • These data underline the need for greater transparency of R&D costs, and more sophistication and realism by policy makers regarding the costs of research and development for drugs qualifying as orphan products.
  • The data from the orphan drug tax credit also provides additional perspective on the estimates of drug development costs provided by Vinay Prasad and Sham Mailankody in their 2017 JAMA paper.

Continue reading

Save The Date! 2/22/18: The Jaharis Symposium on Health Law and Intellectual Property

On February 22, 2018, join DePaul University, located in downtown Chicago, for The Jaharis Symposium on Health Law and Intellectual Property: Technological and Emergency Responses to Pandemic Diseases.

Hosted by DePaul University’s Mary and Michael Jaharis Health Law Institute and the Center for Intellectual Property Law and Information Technology (CIPLIT®), this one day conference will focus on “best practices” in response to emerging pandemic diseases.

Connect with keynote speakers Lawrence Gostin–University Professor and Faculty Director, O’Neill Institute for National and Global Health Law, Georgetown University– and Richard Wilder–Associate General Counsel, Global Health Program, Bill and Melinda Gates Foundation.  They will be joined by other esteemed panelists during this timely and important discussion.

@DepaulHealthLaw

Housing Equity Week in Review

Here’s the latest news from housing law and equity, for the week of November 6-10, 2017:

  • The Public Health Institute released a study that calculates the number of children with lead poisoning in the United States.
  • A new law in Seattle will prevent landlords from screening tenants based on their criminal history, via The Regulatory Review.
  • “It’s time to stop ignoring our crumbling housing code enforcement” — coverage of APHA2017 sessions on housing code enforcement, featuring CPHLR Director Scott Burris and the Five Essential Public Health Law Services Framework developed in collaboration with ChangeLab Solutions and the Network for Public Health Law, via Public Health Newswire.
  • San Jose has a new plan to get downtown landlords to clean up their vacant storefronts using a pilot program that would create a registry of vacant buildings and fine property owners who are neglecting their properties, via NextCity.
  • Civil rights groups are fighting the suspension of a HUD rule they say helps low-income families move to better neighborhoods, via CityLab.
  • Texans voted to loosen some of the tightest home lending restrictions in the country. via Governing.

Bioethics in Islam: Principles, Perspectives, Comparisons

An important questions in Islam, recurrent across time and space, is whether Islamic political theory recognizes rights claims against the state as distinct from rights claims against other members of the community. This continues to be an important subject today, intersecting the fields of law, religion, and moral philosophy. The classical tradition is divided on the matter, with the legal theory of the Shafi’i school of jurisprudence saying that rights are to be accorded viareligious authority, while the Hanafi school emphasized the universality of the notion of human inviolability (dhimma)—and the innate rights that derive from it—as God-given, universal, and applicable to all societies from the beginning of time.

Whereas in Western law there is generally a separation between law and ethics, in the Islamic tradition, there is more of a dialectical tension between the two: Where religious inwardness is more highly developed, attitude and intention are weighed more heavily, whereas in its absence however formalism and legalism are advanced as the ethical ideal.

Continue reading

AI Citizen Sophia and Legal Status

By Gali Katznelson

Two weeks ago, Sophia, a robot built by Hanson Robotics, was ostensibly granted citizenship in Saudi Arabia. Sophia, an artificially intelligent (AI) robot modelled after Audrey Hepburn, appeared on stage at the Future Investment Initiative Conference in Riyadh to speak to CNBC’s Andrew Ross Sorkin, thanking the Kingdom of Saudi Arabia for naming her the first robot citizen of any country. Details of this citizenship have yet to be disclosed, raising suspicions that this announcement was a publicity stunt. Stunt or not, this event raises a question about the future of robots within ethical and legal frameworks: as robots come to acquire more and more of the qualities of human personhood, should their rights be recognized and protected?

Looking at a 2016 report passed by the European Parliament’s Committee on Legal Affairs can provide some insight. The report questions whether robots “should be regarded as natural persons, legal persons, animals or objects – or whether a new category should be created.” I will discuss each of these categories in turn, in an attempt to position Sophia’s current and future capabilities within a legal framework of personhood.

If Sophia’s natural personhood were recognized in the United States, she would be entitled to, among others, freedom of expression, freedom to worship, the right to a prompt, fair trial by jury, and the natural rights to “life, liberty, and the pursuit of happiness.” If she were granted citizenship, as is any person born in the United States or who becomes a citizen through the naturalization process, Sophia would have additional rights such as the right to vote in elections for public officials, the right to apply for federal employment requiring U.S. citizenship, and the right to run for office. With these rights would come responsibilities: to support and defend the constitution, to stay informed of issues affecting one’s community, to participate in the democratic process, to respect and obey the laws, to respect the rights, beliefs and opinions of others, to participate in the community, to pay income and other taxes, to serve on jury when called, and to defend the country should the need arise. In other words, if recognized as a person, or, more specifically, as a person capable of obtaining American citizenship, Sophia could have the same rights as any other American, lining up at the polls to vote, or even potentially becoming president. Continue reading

TOMORROW, 11/9! Book Launch: Specimen Science – Ethics and Policy Implications

Book Launch: Specimen Science: Ethics and Policy Implications
November 9, 2017 12:00 PM
Countway Library, Lahey Room
Harvard Medical School, Boston, MA

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera. This edited volume stems from a conference in 2015 that brought together leading experts to address key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The conference was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center  for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.

Continue reading

The Care Quality Commission (CQC) in England: End of Term Report Card

By John Tingle

In terms of NHS health quality and patient safety regulation, the Care Quality Commission (CQC) occupies a pivotal role as the independent regulator of health and social care in England. How well it performs its function is fundamental to the health of the nation. The CQC functions and operations has been recently put under the microscope by the National Audit Office (NAO).The NAO scrutinises public spending for Parliament, making sure it is well spent. Both good and bad findings are made on the work of the CQC in the report and a number of recommendations are made.

On reading the report it’s fair to say that overall the CQC is doing a good job but there are deficiencies identified which need to be remedied. The report is divided into four parts: Continue reading

Housing Equity Week in Review

An update from the world of housing law and equity, for the week of October 30-November 3, 2017

  • New viewpoint article in the Journal of the American Medical Association, from Megan Sandel, MD, MPH and Matthew Desmond, PhD, says investing in housing for health improves mission and margin.
  • An analysis from the Seattle Times asks, “Will allowing more housing types in some single-family zones make Seattle’s whitest neighborhoods more racially diverse?”
  • As sea levels rise, wealthy people can more easily afford to move to high ground, making gentrification worse, via Yale Climate Connections.
  • A new study finds a correlation between the number of patents a city produces and economic segregation within its limits, via the Atlantic.
  • Benjamin Somogyi argues in the Regulatory Review, to solve the next foreclosure crisis, look to Sacramento
  • New York, Philadelphia and Washington, D.C., have approved funding to provide legal defense to low-income tenants at risk of eviction. A look at how free legal help could prevent evictions, via Huffington Post.

Elderly Care in the Age of Machine and Automation

By Aobo Dong

Would you be willing to accept a professional care-giving robot as a replacement to a human companion when your loved ones are far away from you? During last week’s HLS Health Law Workshop, Professor Belinda Bennett provided a great overview on the imminent age of machine and automation and the legal and ethical challenges the new era entails, especially in health care law and bioethics. After discussing three areas of potential health law complications, Professor Bennett argued that the field of health law is undergoing a transition from the “bio” to the “digital” or “auto,” and that instead of playing a catching-up game with rapidly evolving technologies, more focus should be placed on learning from past and existing laws and regulations in order to meet new demands from the “second machine age.” However, I wish to propose a closely-related but alternative paradigm, that is, using the issues raised by new technologies as a vehicle for improving existing laws and reshaping social norms that once made existing laws inadequate or flawed. I will elaborate on my point through the author’s own example of elderly care.

Despite the fact that the author advocates a revisionist approach for thinking about health law and technology, her paradigm is still about laws serving the needs and solving concerns of the tech industry intersected with health care. I wonder whether it would be productive to view the issue from the opposite direction, that is, how could new technologies and the challenges they raise inform us about existing laws (revealing blind spots or providing opportunity to improve unjust/unfair/discriminatory laws). Viewed this way, we could not only strengthen connections between past laws and future technologies, but also be guided by a clearer sense of how future legal reforms and regulations could redress past neglect and meet new challenges. Continue reading

What are Our Duties and Moral Responsibilities Toward Humans when Constructing AI?

Much of what we fear about artificial intelligence comes down to our underlying values and perception about life itself, as well as the place of the human in that life. The New Yorker cover last week was a telling example of the kind of dystopic societies we claim we wish to avoid.

I say “claim” not accidently, for in some respects the nascent stages of such a society do already exist; and perhaps they have existed for longer than we realize or care to admit. Regimes of power, what Michel Foucault called biopolitics, are embedded in our social institutions and in the mechanisms, technologies, and strategies by which human life is managed in the modern world. Accordingly, this arrangement could be positive, neutral, or nefarious—for it all depends on whether or not these institutions are used to subjugate (e.g. racism) or liberate (e.g. rights) the human being; whether they infringe upon the sovereignty of the individual or uphold the sovereignty of the state and the rule of law; in short, biopower is the impact of political power on all domains of human life. This is all the more pronounced today in the extent to which technological advances have enabled biopower to stretch beyond the political to almost all facets of daily life in the modern world. Continue reading

Book Launch: Specimen Science: Ethics and Policy Implications

Book Launch: Specimen Science: Ethics and Policy Implications
November 9, 2017 12:00 PM
Countway Library, Lahey Room
Harvard Medical School, Boston, MA

In September 2017, MIT Press will publish Specimen Science: Ethics and Policy Implications, co-edited by Holly Fernandez Lynch (outgoing Petrie-Flom Executive Director), Barbara Bierer, I. Glenn Cohen (Faculty Director), and Suzanne M. Rivera. This edited volume stems from a conference in 2015 that brought together leading experts to address key ethical and policy issues raised by genetics and other research involving human biological materials, covering the entire trajectory from specimen source to new discovery.  The conference was a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center  for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center.  It was supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.

Continue reading

Patient Safety at the Crossroads

By John Tingle

The NHS (National Health Service) in the UK is 70 next year: it was founded on 5th July 1948 and celebrations are being planned. Clearly a lot has changed since it was founded. Our concept of wellness has changed, we go to the doctor for reasons that would never have been considered appropriate in 1948. Health today is not just about the absence of physical diseases.

What is clear is that ever since 1948 the NHS has been shortage of resources in the face of a seemingly insatiable demand for its services. Balancing finite resources against near infinite demands is no easy task. Seventy years on, it is most concerning that a vast amount of money in the NHS is now being spent on clinical negligence claims. In their latest annual report and accounts, NHS Resolution estimates the total amount for clinical negligence claims it owes is £65 Billion. Damages paid to patients rose significantly from £950.4 million to £1,083.0 million, an increase of 14%. The high cost of clinical negligence is not sustainable and something must be urgently done to reduce the number of claims against the NHS. The issues were recently considered by the National Audit Office (NAO), which found:

  • The cost of clinical negligence claims is rising at a faster rate year-on-year, than NHS funding.
  • Even if successful, NHS Resolution and the Department’s current actions are unlikely to stop the growth in the cost of clinical negligence claims.
  • The government lacks a coherent cross-government strategy, underpinned by policy, to support measures to tackle the rising cost of clinical negligence.

Continue reading

Errors in Patent Grants: More Common in Medical Patents

By James Love

Recently I have become interested in the frequency of a “certificate of correction” on a granted patent, after two efforts to establish federal rights in patents granted.

The first case involved the University of Pennsylvania.  We had identified five patents on CAR T technologies granted to five inventors from the University of Pennsylvania where there was no disclosure of federal funding on the patents when they were granted by the USPTO, as is required by law.  All five patents had been filed in 2014.    We had reason to believe the five patents should have disclosed NIH funding in the invention, and we were right. But the error had been corrected by Penn, and five “certificate of correction” documents were granted by the USPTO in May 2016, something we had overlooked, in part because the corrections to patents are published as image files, and were not text searchable.

The second case involved the Cold Spring Harbor Laboratory.  KEI had identified two patents listed in the FDA Orange Book for the drug Spinraza,  which were assigned to Cold Spring Harbor, and which had not disclosed federal funding.  KEI was interested in pursuing a march-in case for Spinraza, on the grounds of excessive pricing.  The cost of Spinraza in the first year was $750,000, and the maintenance doses were priced at $375,000 per year.  Researchers listed on the two patents had received funding from the NIH to work on the subject of the two patents. Continue reading

Instagram and the Regulation of Eating Disorder Communities

By Clíodhna Ní Chéileachair

I’m sure not how much time the average health law enthusiast spends on Instagram, but as a rare opportunity to see health regulation in real-time, I’d encourage logging onto the site, which curates content based on user profiles and by tags, and searching for the following tags; #thinspo, #thighgap, and #eatingdisorder. The site will either return no results, or will present the searcher with a warning message that “Posts with words or tags you’re searching for often encourage behavior that can cause harm and even lead to death” and encouraging the user to reach out for help, though the flagged content is still accessible if the user clicks-through. #thinspo (short for another neologism, ‘thinspiration’) is exactly what it sounds like – images designed to inspire an individual to restrict their diet, and exercise to attain what will generally be an underweight physique. Many social media sites have enacted similar bans on content as a reaction to the role that online communities can play in promoting eating disorders.

As a suite of illnesses, eating disorders have severe, and sometimes life-threatening medical complications. Anorexia nervosa has the highest death rate of all psychiatric illnesses; bulimia carries severe medical complications associated with starvation and purging including bone disease, heart complications, digestive tract distress, and even infertility, and EDNOS (eating disorder not otherwise specified) while carrying subclinical status in DMS-IV, carries similar levels of eating pathology and general psychopathology to anorexia nervosa and binge eating disorder, and a similar degree of danger to physical health to anorexia. Instagram had been criticised for its inaction in the face of an explosion of pro-eating disorder community activity on its site after Tumblr and Pinterest enacted bans on ‘thinspiration’ content, at which point many users migrated to Instagram’s platform. Five years on from the initial ban, some terms, like #starve and #purge will display the above warning message; other obvious tags for the pro-eating disorder community, like #skinnyinspiration and #thinspire attract no warning message and display images of emaciated women, romanticizations of eating disorders, images of individuals destroying food, and in line with clinical understandings of how eating disorders manifest themselves, images of self harm.

Continue reading

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.

 

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.

Continue reading

“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