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.

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Amanda Pustilnik on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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First off, an urgent appeal: please consider donating to chef José Andrés, who is feeding tens of thousands of victims of Hurricane Maria in Puerto Rico. Donation link is here.

We have a particularly brainy episode this week, as we host Amanda Pustilnik, a Professor of Law at the University of Maryland whose research includes work on models of mind in criminal law, evidentiary issues presented by neuroscientific work on memory, and the role of pain in different legal domains. Amanda has also served as a Senior Fellow in Law & Neuroscience of the Center for Law, Brain & Behavior at Massachusetts General Hospital. She recently co-authored the Nature article “Brain imaging tests for chronic pain: medical, legal and ethical issues and recommendations.” She also organized a 2015 symposium here on Bill of Health, titled “Pain on the Brain.” Amanda is a recognized leader in the emerging area of Neuroscience and the Law. Our conversation includes a primer on the area and a discussion of criminal responsibility and the measurement of chronic pain.

Our lightning round concentrates on the current proposals and counter proposals surrounding the workings of the insurance exchanges and we take a close look at Iowa’s challenging individual insurance market. We also covered other health news. Links include: 1) an ongoing public health disaster in Puerto Rico, 2) the imploding Iowa ACA exchanges (and Iowa’s withdrawal of a waiver proposal that would have gutted the ACA there), 3) are AHPs the Trump University of health insurance?, and 4) sequelae of the opioid epidemic: HIV and hepatitis C.

Listen here, and be sure to rate the show on iTunes! 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.

TODAY, 10/23 at 5 PM: Health Law Workshop with Belinda Bennett

October 23, 2017 5-7 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Presentation: “Law, Transformative Technologies and the Automation Age: Lessons from the Past for a High-Tech Future” 

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.

Belinda Bennett is a Visiting Scholar at the Petrie-Flom Center in fall 2017. She is Professor of Health Law and New Technologies in the School of Law at Queensland University of Technology (QUT) in Brisbane, Australia. She leads the Governance and Regulation of Health Care program within the Australian Centre for Health Law Research at QUT. Her current research addresses health law and globalisation, global public health law, and the legal and ethical challenges associated with regulation of new technologies in health care. Her publications include: M Freeman, S Hawkes and B Bennett (eds) Law and Global Health: Current Legal Issues Vol 16 (OUP, 2014); B Bennett, Health Law’s Kaleidoscope: Health Law Rights in a Global Age (Ashgate, 2008); and B Bennett, T Carney and I Karpin (eds) Brave New World of Health(Federation Press, 2008).

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.

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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.

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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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