Is Gaming the Transplant List an Ethical Dilemma?

NPR recently published a thought-provoking piece discussing an ethical dilemma doctors face when treating patients in need of organ transplants. Transplant list priority is designed to depend upon the relative sickness of patients, allocating organs to those who need them most. However, instead of lab results or other direct measures, the list uses the treatment a patient is receiving as a proxy for her condition. As a result, doctors have the ability to move their patients up the list by prescribing — or over-prescribing — more extreme and invasive treatments.

It’s understandable why this temptation exists — doctors go into medicine to heal, and I imagine it’s difficult to refrain from taking an action which could very well save a patient’s life. But should this be an ethical dilemma?

Bumping a patient up the transplant list could certainly save a life, but that life could come at the expense of another’s. The problem is that organ transplants are inherently zero-sum — if one patient goes up on the list, another must come down. If one person gets an organ, that means another doesn’t. Furthermore, over-treating to influence transplant priority has consequences that reach beyond any individual patient, potentially furthering inequality in the transplant system and contributing to unsustainable health care spending. Continue reading

DUE AUGUST 5: Call for Apps – Petrie-Flom Center Harvard Grad Student Fellowship

THE PETRIE-FLOM CENTER

STUDENT FELLOWSHIP PROGRAM, 2016-2017

CALL FOR APPLICATIONS 

The Center and Student Fellowship. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website.

Eligibility. The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.

Requirements. All student fellows will have the following responsibilities: Continue reading

Marking the 40th Anniversary of In re Quinlan’s Landmark Contribution to Death & Dying Jurisprudence

by Norman L. Cantor

In 1976, the N.J. Supreme Court issued a remarkably insightful ruling regarding the legal status of a permanently unconscious patient.  In re Quinlan served as a judicial beacon guiding development of death & dying jurisprudence.  Its impact is reminiscent of the judicial role played by Brown v. Board of Education in public education.

To appreciate the wondrous nature of Quinlan, recall the setting and background of the case.  In 1975, a 22 year-old woman, Karen Ann Quinlan, was lying unconscious in a N.J. hospital following 2 anoxic episodes caused by toxic ingestions.  She was sustained by a mechanical respirator and a naso-gastric tube.  The diagnosis was PVS (permanent vegetative state) and the prognosis was that the patient would inevitably die within a year without regaining consciousness.  Ms. Quinlan’s devoted parents reluctantly concluded that their daughter would not want to be maintained in her dismal, hopeless condition.  Their priest and spiritual advisor told them that Catholic doctrine would permit withdrawal of “extraordinary” medical intervention such as the respirator.   But when the parents asked the attending neurologist, Dr. Morse, to withdraw Karen’s respirator, he refused.  He contended that professional medical standards precluded that course.  The hospital concurred.  Facing this resistance, Ms. Quinlan’s father turned to the N.J. chancery court seeking formal appointment as his daughter’s guardian with explicit authorization to direct withdrawal of the respirator.

A variety of interested parties responded to Mr. Quinlan’s chancery petition and they all opposed it.  The county prosecutor asserted that pulling the respirator plug would constitute homicide and the state attorney general concurred.  The attending physicians and the hospital contended that pulling the plug would violate their professional responsibilities to the patient.  And a special guardian ad litem appointed to represent Karen Ann Quinlan insisted that it was in the helpless patient’s best interests to have her life prolonged.  The lower court denied the father’s petition and Mr. Quinlan appealed.

On appeal, the N.J. Supreme Court in 1976 faced the unenviable task of shaping legal policy toward medical conduct likely to precipitate the death of a helpless patient.  This was largely uncharted legal territory with no definitive precedents in state or federal courts.  Common sense said that it can’t be a legal mandate to keep pumping fluids and gases into moribund patients until the last possible breath.  Yet a chorus of naysayers proclaimed that pulling the respirator plug on Ms. Quinlan would be unlawful homicide, or a breach of professional medical responsibility to preserve patients’ lives, or a violation of a guardian’s fiduciary obligation to act in a ward’s best interests.  And even if some circumstances might warrant removal of life-preserving medical interventions, hard questions existed about who is entitled to be the decision maker and what test or criteria govern such surrogate decision making.

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NOW AVAILABLE FOR PRE-ORDER! Nudging Health: Health Law and Behavioral Economics

This volume, edited by I. Glenn Cohen, Holly Fernandez Lynch, and Christopher T. Robertson, stems from the Petrie-Flom Center’s 2014 Annual Conference “Behavioral Economics, Law, and Health Policy.” Pre-order your copy today!

Nudging HealthBehavioral nudges are everywhere: calorie counts on menus, automated text reminders to encourage medication adherence, a reminder bell when a driver’s seatbelt isn’t fastened. Designed to help people make better health choices, these reminders have become so commonplace that they often go unnoticed. In Nudging Health, forty-five experts in behavioral science and health policy from across academia, government, and private industry come together to explore whether and how these tools are effective in improving health outcomes.

Behavioral science has swept the fields of economics and law through the study of nudges, cognitive biases, and decisional heuristics—but it has only recently begun to impact the conversation on health care. Nudging Health wrestles with some of the thorny philosophical issues, legal limits, and conceptual questions raised by behavioral science as applied to health law and policy. The volume frames the fundamental issues surrounding health nudges by addressing ethical questions. Does cost-sharing for health expenditures cause patients to make poor decisions? Is it right to make it difficult for people to opt out of having their organs harvested for donation when they die? Are behavioral nudges paternalistic? The contributors examine specific applications of behavioral science, including efforts to address health care costs, improve vaccination rates, and encourage better decision-making by physicians. They wrestle with questions regarding the doctor-patient relationship and defaults in healthcare while engaging with larger, timely questions of healthcare reform.

Nudging Health is the first multi-voiced assessment of behavioral economics and health law to span such a wide array of issues—from the Affordable Care Act to prescription drugs.

Read the introduction on SSRN and pre-order your book now!

NOW ONLINE! Oxford Union Debating Society DNA Manipulation Debate

DNA fingerprints.The Oxford Union Debating Society at Oxford University has published full video of its DNA Manipulation Debate, filmed on May 26. The Motion under debate was, “This House Believes the Manipulation of Human DNA is an Ethical Necessity.” Oxford billed its DNA Manipulation Debate as “historic” in a year when rapid advances in gene editing and genome synthesis suddenly confront humans with the possibility of being able to write, edit, re-write, and ultimately control their own genetic destinies.

The team supporting the Motion was led by Sir Ian Wilmut, famous for cloning Dolly the Sheep and now Chair of the Scottish Centre for Regenerative Medicine at the University of Edinburgh, and included Oxford’s noted moral philosopher Julian Savulescu and Oxford student debater Lynda Troung, a fast-rising star in RNA research.

The team opposing the Motion included Dr. Norman Fost, professor emeritus of pediatrics and director of the medical ethics program at the University of Wisconsin; Professor Barbara Evans, Director of the Center for Biotechnology & Law at the University of Houston Law Center and a frequent participant in Petrie-Flom conferences; and Oxford student debater Dr. Rahul Gandhi, a young medical doctor and monk focusing on rural healthcare, who is pursuing an MBA at Oxford this year as a prelude to seeking an MPH at Harvard next year.

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National Academies Report Recommends Withdrawing the NPRM and Calls for a New Belmont Report

[Crossposted from Ampersand – The PRIM&R Blog]

By Elisa A. Hurley

On June 29, the National Academies of Science, Medicine, and Engineering released Part 2 of their report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century. The report, written by the Committee on Federal Research Regulations and Reporting Requirements in response to a Congressional request, examines the impact of regulations and policies governing federally funded academic research in the United States. Part 1, released in September 2015, concluded that the continued expansion of federal regulations is “diminishing the effectiveness of the U.S. research enterprise, and lowering the return on federal investment in basic and applied research by diverting investigators’ time and institutional resources away from research and toward administrative and compliance matters” (xii). It made specific recommendations to reduce regulatory burden, and also recommended the creation of a “public-private Research Policy Board to streamline research policies.”

Part 2 concludes the analysis of regulations governing federally funded research and includes, in Chapter 9, a critical examination of the ethical, legal, and regulatory framework for human subjects research. The chapter begins by acknowledging that the research landscape has changed dramatically since the publication nearly 40 years ago of the Belmont Report, which established the three basic principles that provide the ethical foundation for the conduct of human subjects research in the United States. Changes in research methodologies and technologies, including comparative effectiveness research, research on de-identified biospecimens, observational studies of large datasets, cluster randomized trials, and research in emergency settings—as well as longstanding questions about the applicability to social and behavioral research of rules written for the biomedical research context—raise challenging questions about how to apply and balance the Belmont principles of respect for persons, beneficence, and justice across much of today’s research enterprise. Continue reading

Trial by Fire: CRISPR takes the next step

CRISPR-Cas9 has drawn applause for being one of the biggest technological advancements in recent history, but it also raises important ethical issues. This technology, an efficient genome editing tool, is now taking its next big step: CRISPR might be going in for human trials for its potential use in fighting cancer (namely, by altering T-cells to treat cancer cells as “foreign bodies”). Trials have been proposed to be conducted at three sites over a period of two years. The Recombinant DNA Advisory Committee (RAC) at the NIH gave its unanimous approval for these trials earlier this week. Now permissions from FDA and Institutional Review Boards remain before this becomes a reality.

Whether or not the studies will get that approval is uncertain. The RAC already expressed concerns about conflict of interest, and the ghosts of the trial involving Jesse Gelsinger 17 years ago at UPenn have resurfaced.  There are also important questions about risks, uncertainty, and informed consent from the research participants.

The scientific community and regulators have been wary of the gravity of the implications of genome editing. When a Chinese study involving gene editing in human embryos was submitted for publication, there was a hue and cry over whether journals should accept it, given ethical concerns. Currently, there is a moratorium on altering DNA that will subsequently pass on to new generations. Even when the CRISPR technology was approved for editing human embryos in the UK, it was mandated that embryos be destroyed within fourteen days.

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Whole Woman’s Health – Some preliminary thoughts on benefits, purposes, and fetal status

The Supreme Court’s decision in Whole Woman’s Health is sure to be dissected in the coming days, weeks, and months.  In the meantime, I wanted to quickly reengage the discussion about the status of the “purpose prong” of Casey and what, if anything, Whole Woman’s Health tells us about it.  While Justice Breyer’s analysis in the majority opinion does not seem to be couched expressly in terms of Casey’s purpose prong, the majority’s willingness to assess the applicable laws’ benefits may ultimately be purpose dressed in different clothing.  If there is not sufficient evidence of a law’s benefit, there could be a problem.

As a quick refresher, recall that Casey prohibits laws that have either the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus.  While most folks can readily associate Casey’s “undue burden” test in terms of abortion restrictions that have the effect of placing obstacles, Priscilla Smith and Caitlin Borgmann, have written about courts seemingly ignoring Casey’s other mandate that laws should not have the purpose of even trying to place such obstacles (regardless of whether they succeed in creating that effect).  This avoidance of the purpose prong coupled with great deference to the asserted justifications of the legislature (without the kind of benefits inquiry seen in Whole Woman’s Health) has historically led to many TRAP (targeted regulation of abortion provider) laws being upheld.

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Introducing our 2016 Summer Student Bloggers

The Petrie-Flom Center is pleased to welcome Kelly Dhru and Shailin Thomas to Bill of Health as our 2016 Summer Student Bloggers!

Kelly Dhru - photo1 (2)Kelly Amal Dhru is an incoming LLM student at the Harvard Law School, and a 2016-17 Fulbright-Nehru Master’s Fellow in Public Health Law and Bioethics from India. Previously, Kelly has completed her BCL (Distinction) and MPhil in Law from University College, University of Oxford, where thesis focused on the gap between rights and duties in the context of laws preventing cruelty to animals. Kelly holds a law degree from Gujarat National Law University, and has been the Research Director at Research Foundation for Governance in India, where she has been involved in drafting laws relating to public health, bioethics and human rights. Kelly has been a research assistant for Public Health Law at King’s College London, taught the Law of Tort, Jurisprudence and Bioethics at the University of Oxford, and Ethics and Philosophy at Ahmedabad University in India. She is a co-founder and storywriter for Lawtoons: a comic series on laws and rights, and been involved spreading awareness about public health and human rights through the use of street theatre.

Thomas Shailin PhotoShailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine.  He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology underlying social phenomena.  His interests lie at the intersection of clinical medicine and the legal forces that shape it.  Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society.  He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology.  A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari 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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of May. The selections feature topics ranging from a review of progress in the fight against multidrug-resistant bacteria, to the role regulators can play in increasing the affordability of drugs, to an assessment of the strength of the surrogate-survival relationship for cancer drugs approved on the basis of surrogate endpoints. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015. Ann Intern Med. 2016 May 31. [Epub ahead of print]
  2. Eichler HG, Hurts H, Broich K, Rasi G. Drug Regulation and Pricing–Can Regulators Influence Affordability? New Engl J Med. 2016 May 12;374(19):1807-9.
  3. Hey SP, Weijer C. What questions can a placebo answer? Monash Bioeth Rev. 2016 May 17. [Epub ahead of print]
  4. Kapczynski A, Kesselheim AS. ‘Government Patent Use’: A Legal Approach To Reducing Drug Spending. Health Aff. 2016 May 1;35(5):791-7.
  5. Kim C, Prasad V. Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration’s Approval of Oncology Drugs. Mayo Clin Proc. 2016 May 10. [Epub ahead of print]
  6. Outterson K, McDonnell A. Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy. Health Aff. 2016 May 1;35(5):784-90.
  7. Patel MS, Day SC, Halpern SD, Hanson CW, Martinez JR, Honeywell S Jr, Volpp KG. Generic Medication Prescription Rates After Health System-Wide Redesign of Default Options Within the Electronic Health Record. JAMA Intern Med. 2016 May 9. [Epub ahead of print]
  8. Yeh JS, Franklin JM, Avorn J, Landon J, Kesselheim AS. Association of Industry Payments to Physicians With the Prescribing of Brand-name Statins in Massachusetts. JAMA Intern Med. 2016 May 9. [Epub ahead of print]

Surrogacy Contracts, Abortion Conditions, and Parenting Licenses

By Dov Fox

Everything went fine the last time for Melissa Cook, when the 48-year old mother of four carried a child for a family back in 2013 to supplement her office job salary. This time was different. First were the triplets. She had been impregnated with three embryos, created using eggs from a 20-something donor and sperm from the intended father who paid for everything. Then, it was that the man, Chester Moore, turned out to be a deaf 50-year-old postal worker who lived with his parents. Finally, was that Moore asked Cook to abort one of the fetuses. He said that he had run out of money to support a third child and worried the high-risk multiple pregnancy would endanger the health of any resulting children.

Cook, who is pro-life, refused. A battle over parental rights of the triplets, all boys, began even before they were born (prematurely, at 28 weeks). Moore argued that his surrogacy contract with Cook, explicitly enforceable under California law, made clear that he was the sole legal parent. Cook sued for custody, notwithstanding her prior agreement that any children resulting from the pregnancy would be his to raise. She argued that the statute, by authorizing private contracts for gestation of a human being, reduces children to “commodities” for sale, and a surrogate like her to a “breeding animal or incubator.” Continue reading

Harvard Grad Students Apply Now! Petrie-Flom Center Student Fellowship, 2016-2017

PFC_Logo_300x300The Center and Student Fellowship: The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support student research in these areas. More information on our current fellows and their work, is available on the Center’s website.

Eligibility: The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.

Resources: The Center will award each fellow a $1,500 stipend, paid at the end of the academic year once all fellowship requirements (including submission of an acceptable paper) are completed. Additionally, fellows may be eligible to request additional funding to cover reasonable costs associated with their research projects (e.g., copying, publications, conference fees, travel).

Application: Applications will be accepted on a rolling basis until 9AM, Friday, August 5, 2016. Notifications of awards will be made by August 19, 2016.

Apply now! View the full requirements and application instructions on our website: http://petrieflom.law.harvard.edu/fellows/student-application.

REGISTER NOW! Aligning Policy and People: Why the Time is Right to Transform Advanced Care

hands_Ingram Publishing_slideJune 21, 2016, 9am – 1pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

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

Description

Please join us for the inaugural event of the Project on Advanced Care and Health Policy, a collaboration between the Coalition for Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This conference will feature policymakers, thought leaders, family caregivers, clinicians, consumer advocates, and others working to identify the timely, practical, and actionable opportunities to transform care for people with advanced illness nearing end-of-life.

Confirmed Speakers

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Making Big Data Inclusive

Guest post by Sarah Elizabeth Malanga, Fellow, Regulatory Science Program, James E. Rogers College of Law, University of Arizona, based on her presentation at the Petrie-Flom Center’s 2016 Annual Conference, “Big Data, Health Law, and Bioethics,” held on May 6, 2016, at Harvard Law School.

Cross-posted from the Hastings Center’s Bioethics Forum.

Big Data, which is derived from a multitude of sources including, social media, “wearables,” electronic health records, and health insurances claims, is increasingly being used in health care and it can potentially improve the way medical professionals diagnose and treat illnesses.

But what happens when Big Data only captures a snapshot of the population, rather than an overall picture of the population as a whole? The sources that generate Big Data – the Internet and credit card use, electronic health records, health insurance claims – are not utilized by everyone. Certain demographics may be missing from or underrepresented in Big Data because they do not own smartphones, have access to the Internet, or visit doctors on a regular basis because they lack health insurance. These sectors of the population disproportionately include low-income individuals, minority groups such as blacks and Hispanics, and the elderly. Continue reading

Use of Estimated Data Should Require Informed Consent

Guest post by Donna M. Gitter, Zichlin School of Business, Baruch College, based on Professor Gitter’s presentation at the Petrie-Flom Center’s 2016 Annual Conference, “Big Data, Health Law, and Bioethics,” held May 6, 2016, at Harvard Law School.

Cross-posted from the Hastings Center’s Bioethics Forum.

The Icelandic biotech firm deCODE Genetics has pioneered a means of determining an individual’s susceptibility to various medical conditions with 99 percent accuracy by gathering information about that person’s relatives, including their medical and genealogical records. Of course, inferences have long been made about a person’s health by observing and gathering information about her relatives. What is unique about deCODE’s approach in Iceland is that the company uses the detailed genealogical records available in that country in order to estimate genotypes of close relatives of individuals who volunteered to participate in research, and extrapolates this information in order to make inferences about hundreds of thousands of living and deceased Icelanders who have not consented to participate in deCODE’s studies. DeCODE’s technique is particularly effective in Iceland, a small island nation that, due to its largely consanguineous population and detailed genealogical records, lends itself particularly well to genetic research.

While Iceland’s detailed genealogical records enable the widespread use of estimated data in Iceland, a large enough U.S. database could be used to make similar inferences about individuals here. While the U.S. lacks a national database similar to Iceland’s, private companies such as 23andme and Ancestry.com have created rough gene maps of several million people, and the National Institutes of Health plans to spend millions of dollars in the coming years sequencing full genome data on tens of thousands of people. These databases could allow the development of estimated data on countless U.S. citizens.

DeCODE plans to use its estimated data for an even bolder new study in Iceland. Having imputed the genotypes of close relatives of volunteers whose DNA had been fully catalogued, deCODE intends to collaborate with Iceland’s National Hospital to link these relatives, without their informed consent, to some of their hospital records, such a surgery codes and prescriptions. When the Icelandic Data Protection Authority (DPA) nixed deCODE’s initial plan, deCODE agreed that it will generate for only a brief period a genetic imputation for those who have not consented, and then delete that imputation from the database. The only accessible data would be statistical results, which would not be traceable to individuals.

Are the individuals from whom estimated data is gathered entitled to informed consent, given that their data will be used for research, even if the data is putatively unidentifiable? In the U.S., consideration of this question must take into account not only the need for privacy enshrined in the federal law of informed consent, but also the right of autonomy, which empowers individuals to decline to participate in research. Although estimated DNA sequences, unlike directly measured sequences, are not very accurate at the individual level, but rather at the group level, individuals may nevertheless object to research participation for moral, ethical, and other reasons. A competing principle, however, is beneficence, and any impediment to deCODE using its estimated data can represent a lost opportunity for the complex disease genetics community.

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REGISTER NOW: Aligning Policy and People: Why the Time is Right to Transform Advanced Care

hands_Ingram Publishing_slideJune 21, 2016, 9am – 1pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

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

Description

Please join us for the inaugural event of the Project on Advanced Care and Health Policy, a collaboration between the Coalition for Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This conference will feature policymakers, thought leaders, family caregivers, clinicians, consumer advocates, and others working to identify the timely, practical, and actionable opportunities to transform care for people with advanced illness nearing end-of-life.

Confirmed Speakers

Continue reading

Healthcare complaints matter: the need to improve the system

Today consumerism is an essential part of the fabric of British society and complaint systems are heralded in many retail and professional environments. The British public have got used to complaining over the years and this attitude has seeped into the provision of health care services.

Records levels of complaints about the National Health Service (NHS) can be seen to be made every year but the NHS just does not seem to be able to get to grips with developing a good patient complaints handling system.

The Health Service Ombudsman (HSO) lies at the top of the NHS complaints structure and makes the final decisions on complaints that have not be resolved by the NHS in England. The HSO has looked into the quality of NHS complaint investigations where serious or avoidable harm has been alleged.Systemic failings in complaint, patient safety investigations were revealed. Failures which unsurprisingly have appeared in numerous complaints reports over the years before.

For the report, the HSO reviewed 150 NHS complaint investigations where avoidable harm or death was alleged. The HSO also spoke to six different trusts and surveyed over 170 NHS complaint managers to gain insights. An advisory group was later convened by the HSO to test findings.

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Henrietta Lacks and the Great Healthdata Giveaway

Part Seven of Seven-Part Blog Series by Guest Blogger Patrick Taylor

A suggestion runs through the debate on the NPRM to amend the Common Rule that the proposed changes are a tribute to Henrietta Lacks, a necessity so her story is not repeated.

That story was told in a the national bestseller  The Immortal Life of Henrietta Lacks, a moving biography of the young woman whose  aggressive tumor was the source of the ubiquitous HeLa cells (probably without her consent, certainly without her awareness of what followed); her family;  the  cells’  (and her) dehumanization into a research tool to be exploited unthinkingly; and the poverty, disconnection, racism,  lack of health care and lack of concern for her family. Society and scientists received a bonanza, and did nothing for her family in return.  The book criticizes phony consent, and advocates sharing  cell line proceeds with donors and their families. It rekindled discussion of consent and racist legacies, while urging that injustice required social change.

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TWIHL Special: Wendy Mariner Analyzes the New Wellness Regulations

By Nicolas Terry and Frank Pasquale

twihl 5x5A special TWIHL episode with analysis of the new EEOC regulations under the ADA and GINA on Employer Wellness Plans. Nic is joined by Professor Wendy Mariner. Professor Mariner is the Edward R. Utley Professor of Health Law at Boston University School of Public Health, Professor of Law at Boston University School of Law, Professor at Boston University School of Medicine, and Co-Director of the J.D.-M.P.H. joint degree program, and a member of the faculty of the Center for Health Law, Ethics and Human Rights at BUSPH. Professor Mariner’s research focuses on laws governing health risks, including social and personal responsibility for risk creation, health insurance systems, implementation of the Affordable Care Act, ERISA, health information privacy, and population health policy.

Our discussion concentrated on the ADA regulation and examined how the agency responded to comments (including ours), the concept of voluntariness, the status of EEOC v. Flambeau, Inc., data protection (including issues raised when  employers research the health of their employees), and the policy flaws in the wellness space.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 iTunes, listen at Stitcher RadioTunein and 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

NPRM Symposium: Consent, Causality, and Castles in the Air

Part Six of Seven-Part Blog Series by Guest Blogger Patrick Taylor

Reading the NPRM and its government commentary, one is subtly, slowly led to a sense of inevitability.  Arguments from abstract principles emerge, leave a footprint and then, in the wake of another tide of interests and arguments, another principal supplants them.  But we are to believe that each previous  footprint endures intact.  There’s “autonomy,” said to require expanding opportunity to consent to honor individual preferences, overtrodden by scientific convenience, which demands just one-time consent, and suggests that world-changing choices to be privacy-bare may be irrevocable.  There’s privacy demanding that information meet HIPAA deidentification standards at least some of the time; but there is some undisclosed vector requiring that there is no limit on who government may share your medical information with.  Surrender to the illusion that these are not inconsistent,  and the proposal is the best of all possible worlds, in which every inconsistent good is maximized and every tradeoff ignored.  Surrender the illusion itself and one sees a mix of juxtaposed  partial-prints going different directions, each incomplete.

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