REGISTER NOW! Ordeals in Health Care: Ethics and Efficient Delivery

Ordeals in Health Care: Ethics and Efficient Delivery
May 10-11, 2018 1:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
 

Economic ordeals are interventions that deliberately make access to products or services more difficult in an effort to improve resource allocation. In this vein, making patients wait in long lines to schedule an appointment with a specialist might discourage patients with needs that could be met by less qualified personnel from taking up the specialist’s time, thus freeing up time for those with complex needs. Similarly, putting brand-name medications at the bottom of a long list of options on clinicians’ computers might encourage them to prescribe a generic brand listed closer to the top.

Recent research in development economics, behavioral economics, and health policy suggests that some economic ordeals could help target health resources to patients who are more likely to utilize these resources, without the regressive effects of co-pays and other forms of financial participation on the part of patients. However, making health care deliberately less accessible raises ethical challenges. Is it not the case that ordeals discourage utilization by patients with acute needs? Do these ordeals affect some disadvantaged populations disproportionately? And do deliberate obstacles to health resource utilization violate the human right to health?

This workshop will bring together leading scholars in economics, ethics, health policy, public health, medicine, sociology, and law to explore these questions.

This event is organized by Nir Eyal, PhD, Associate Professor of Global Health and Population, Harvard T. H. Chan School of Public Health, and Anders Herlitz, PhD, Visiting Scientist, Harvard T. H. Chan School of Public Health and Researcher, Department of Philosophy, Linguistics and Theory of Science, University of Gothenburg, Sweden.

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

Co-sponsored by the Harvard T.H. Chan School of Public Health; the Edmond J. Safra Center for Ethics at Harvard University; the Petrie-Flom Center for Health Law, Biotechnology, and Bioethics at Harvard Law School; the Mossavar-Rahmani Center for Business and Government at the Harvard Kennedy School of Government; and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Register for and learn more about the event here!

Dementia And The Law: P/Review 2017–18

This new post by Francis X. Shen appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

Another year, another failed Alzheimer’s drug trial. In what is becoming routine news, in 2017, another Alzheimer’s drug failed in clinical trial, leading to the apt headline: “The List of Failed Alzheimer’s Drug Treatments Keeps Growing.” Moreover, there seem to be few evidence-based options even to limit cognitive decline. Research continues of course, and there remain multiple—and potentially promising—pharmacological interventions in the Food and Drug Administration (FDA) pipeline.

One of the reasons that successful drugs have been elusive is scientists are still trying to figure out the exact underlying neurobiology of Alzheimer’s. The past year saw the publication of a major scientific study showing that in mice, the gene variant ApoE4 (which is linked to a much higher risk for Alzheimer’s) affects both β-amyloid and tau buildup in the brain. The study’s implication of tau was important because the scientific community has been debating the “amyloid hypothesis,” whether the field’s sometimes singular focus on β-amyloid buildup was misguided. This debate is so intense that in 2017 it even made its way to the pages of The Atlantic. […]

Read the full post here!

Solitary Confinement: Torture, Pure and Simple

Cross-posted from the Psychology Today blog, where it originally appeared on January 15, 2018. 

By Gali Katznelson and J. Wesley Boyd

Let’s call it for what it is: Placing prisoners in solitary confinement is tantamount to torture and it needs to stop.

The practice of placing incarcerated individuals in solitary confinement dates back to the 1820s in America when it was thought that isolating individuals in prison would help with their rehabilitation. Yet, over the past two centuries, it has become clear that locking people away for 22 to 24 hours a day is anything but rehabilitative. Solitary confinement is so egregious a punishment that in 2011, the U.N. Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment condemned its use, except in exceptional circumstances and for as short a time as possible, and banned the practice completely for people with mental illnesses and for juveniles.

Despite its barbarity, the United States continues to place thousands of people, including individuals with mental illnesses and children, in solitary confinement, sometimes for decades. Thirty years ago, Dr. Stuart Grassian, who recently spoke at Harvard Medical School’s “Behind Bars: Ethics and Human Rights in U.S. Prisons” conference, evaluated 14 individuals placed in solitary confinement and found the same symptoms in many of them: hypersensitivity to external stimuli; perceptual disturbances, hallucinations, and derealisation experiences; affective disturbances, such as anxiety and panic attacks; difficulties with thinking, memory and concentration; the emergence of fantasies such as of revenge and torture of the guards; paranoia; problems with impulse control; and a rapid decrease in symptoms immediately following release from isolation. Taken together, Dr. Grassian proposed that these symptoms amount to a pathopsychological syndrome.

Read More

The Health Service Safety Investigations Body (HSSIB):The New Kid On The Patient Safety Block

By John Tingle

The Department of Health and the government in England have published a draft Bill for discussion which will create a Health Service Safety Investigations Body (HSSIB) with powers enshrined in law. The HSSIB replaces the current Healthcare Safety Investigation Branch (HSIB) which operates under the umbrella of NHS Improvement and came into operation in April 2017. Unlike the HSIB, the new HSSIB will be independent of the NHS, and have its own statutory power base. The HSSIB will not be responsible for investigating all serious patient safety incidents in the NHS and existing frameworks will remain.

Eight fact sheets have been published by the Department of Health to accompany the draft Bill which explain its purpose and rationale and how everything will work. It is expected that the HSSIB will investigate up to 30 serious patient safety issues a year and will have an annual budget of £3.8 Million.

It will be important for the HSSIB to manage public and NHS expectations of what it can actually achieve given its small budget, staffing and the number of investigations that it intends to carry out. There are around 24,000 serious patient safety incidents a year in the NHS. The small-scale operation of the HSSIB can be justified as it will act as an exemplar of good investigative practice and will cascade down standards into the NHS.

The Bill Read More

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.

Read More

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. Read More

Privacy and Confidentiality: Bill of Health at Five Years and Beyond

In honor of the occasion of the Fifth Anniversary of Bill of Health, this post reflects on the past five years of what’s generally known as “privacy” with respect to health information.  The topic is really a giant topic area, covering a vast array of questions about the security and confidentiality of health information, the collection and use of health information for public health and research, commercialization and monetization of information, whether and why we care about health privacy, and much more.  Interestingly, Bill of Health has no categorizations for core concepts in this area:  privacy, confidentiality, security, health data, HIPAA, health information technology—the closest is a symposium on the re-identification of information, held in 2013.  Yet arguably these issues may have a significant impact on patients’ willingness to access care, risks they may face from data theft or misuse, assessment of the quality of care they receive, and the ability of public health to detect emergencies.

Over the past five years, Bill of Health has kept up a steady stream of commentary on privacy and privacy-related topics.  Here, I note just a few of the highlights (with apologies to those I might have missed—there were a lot!) There have been important symposia:  a 2016 set of critical commentaries on the proposed revisions of the Common Rule governing research ethics and a 2013 symposium on re-identification attacks.  There have been reports on the privacy implications of recent or proposed legislation: the 21st Century Cures Act, the 2015 proposal for a Consumer Privacy Bill of Rights, and the proposed Workplace Wellness Bill’s implications for genetic information privacy.  Many comments have addressed big data in health care and the possible implications for privacy.  Other comments have been highly speculative, such as scoping out the territory of what it might mean for Amazon to get into the health care business. There have also been reports of research about privacy attitudes, such as the survey of participants in instruments for sharing genomic data online.  But there have been major gaps, too, such as a dearth of writing about the potential privacy implications of the precision medicine and million lives initiative and only a couple of short pieces about the problem of data security.

Here are a few quick sketches of the major current themes in health privacy and data use, that I hope writers and readers and researchers and most importantly policy makers will continue to monitor over the next five years (spoiler alert: I plan to keep writing about lots of them, and I hope others will too): Read More

CAVEAT HOSPITIA: Suits Alleging Negligent Credentialing Against Hospitals Get Exemption from Tort Reform

By Alex Stein

Policymakers and scholars interested in medical malpractice and torts generally should read Billeaudeau v. Opelousas General Hospital Authority, — So.3d —-, 2016 WL 6123862 (La. 2016). In this recent and important decision, the Louisiana Supreme Court ruled that suits alleging negligent credentialing against a hospital sound in regular negligence, rather than medical malpractice, and consequently fall outside the purview of the state’s Medical Malpractice Act (MMA) and its limitations on liability. The Court made this decision in connection with the state’s cap on damages recoverable in medical malpractice actions, La. Rev. Stat. § 40:1231.2(B)(1), which limits the total amount that courts can award the victim to $500,000, plus interest and cost, on top of the victim’s future expenditures on medical care and support. For many victims of medical malpractice and their families this cap amount is meager, but the Court nonetheless upheld its constitutionality back in 1992. See Butler v. Flint Goodrich Hosp., 607 So.2d 517 (La. 1992).

The Court has now decided that suits alleging negligent credentialing against hospitals are not subject to this cap and that successful plaintiffs consequently will recover full compensation for any proven damage. Read More

The First Human Body Transplant – Ethical and Legal Considerations

By Ana S. Iltis, PhD

brain_glowingprofileTo what lengths should we go to preserve human life? This is a question many are asking after hearing that three men plan to make medical history by conducting the first human head transplant. Or, rather, whole body transplant. Italian neurosurgeon Dr. Sergio Canavero and Chinese surgeon Dr. Xiaoping Ren plan to provide a Russian volunteer, Valery Spiridonov, a new body. During the procedure, Spiridonov’s body and head would be detached and, with the help of a crane, surgeons would move the head and attach it to the donor body.  But is this ethical? What role might law and regulation play in monitoring them or in assessing their conduct after the fact?

Critics call the plan crazy, unethical, and sure to fail. The likelihood of success is very low and the risk of Spiridinov dying is high. Spiridonov says that as soon as animal studies confirm the possibility of survival, the risks will be worth taking. He has Werdnig-Hoffmann Disease, a genetic disorder that destroys muscle and nerve cells. He is confined to a wheelchair and has lived longer than expected. Body transplantation offers him the best chance at a life worth living. Read More

New Research: Legal Epidemiology in the Literature

It’s a rainy day on the East Coast; what better way to get through the damp than four new legal epidemiology articles? Our colleagues have published papers examining vaccine policies, telehealth reimbursement policies, scope of practice laws for health care providers, and the field of legal epidemiology as a whole:

Legal Epidemiology: The Science of Law
T Ramanathan, R Hulkower, J Holbrook, M Penn – The Journal of Law, Medicine and Ethics

The Latest in Vaccine Policies: Selected Issues in School Vaccinations, Healthcare Worker Vaccinations, and Pharmacist Vaccination Authority Laws
L Barraza, C Schmit, A Hoss – The Journal of Law, Medicine & Ethics

Legal Mapping Analysis of State Telehealth Reimbursement Policies
KE Trout, S Rampa, FA Wilson, JP Stimpson – Telemedicine and e-Health

Expanding Access to Care: Scope of Practice Laws
K Hoke, S Hexem – The Journal of Law, Medicine & Ethics