Confidentiality or Public Disclosure: Trump’s Gastroenterologist and an Ethical Dilemma

By Brad Segal

“If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency,” proclaimed Dr. Harold Bornstein. The gastroenterologist’s letter, released on the candidate’s website nine months ago, stumbles from the outset with a typo (“To Whom My Concern,”), then steamrolls over the most basic descriptions of health (medical school teaches us that vital signs are, well, vital), omits information pertinent to the public discourse (why does it fail to mention the medical reason exempting Trump from the Vietnam draft?), and strangely emphases non-medicalized traits (“His physical strength and stamina are extraordinary”). Most experts agree that this medical record, if we can even call it that, is at best hyperbole. It draws grandiose conclusions without medical justification. Even Dr. Bornstein conceded, “In the rush, I think some of those words didn’t come out exactly the way they were meant.”

Just this morning the Trump campaign released a second letter from Dr. Bornstein. But this time the doctor rather humbly concludes, “In summary, Mr. Trump is in excellent physical health.”  These letters from Dr. Bornstein’s letter demonstrate a modern-day moral dilemma in providing care for a party nominee. At conflict is the physician’s professional duty to respect patient confidentiality, and his or her obligations to care for society more broadly.

First, patient-doctor confidentiality is not merely a byproduct of the law—it is a moral obligation grounded in the core tenants of the medical profession. To put it simply, if a patient comes to expect that his doctor will tell the entire community about the patient’s most embarrassing bodily defects, the patient may understandably deny his worsening symptoms of poor health at the next office visit. In the long run, erosion of trust in the medical system could endanger the public’s health–everyone is thus better off when doctors uniformly respect patient privacy. It is important to point out, however, that an informed and competent person can voluntarily waive one’s right to patient-doctor confidentiality, such as when a patient gives a physician the permission to provide updates to family members. Or when then-candidate John McCain instructed his physicians all 1,100 pages in his medical records.

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Hospitals Should Think Before Performing Searches for Law Enforcement

By Shailin Thomas

In 2012, a Jane Doe suspected of transporting drugs was detained by U.S. Customs and Border Protection (CBP) agents without a warrant, and brought to University Medical Center in El Paso, Texas. Medical Center personnel — under the direction of the law enforcement agents — performed an X-ray, CT scan, and cavity search before determining that the woman was not in fact carrying any controlled substances. A few months after suffering this traumatic — and possibly illegal — event, the woman received a $5400 bill from the Medical Center for the services rendered as part of the search.

While the woman was compensated to some extent — she settled lawsuits with University Medical Center and the CBP to the tune of $1.1 million and $475,000, respectively — her story, and stories like hers, raise important questions about the ways in which hospitals should (or shouldn’t) work with law enforcement to perform invasive searches.

It’s understandable why hospitals and medical professionals are inclined to cooperate with law enforcement requests for invasive procedures and cavity searches — law-abiding citizens often don’t want to obstruct law enforcement agents from doing their jobs. But in the course of bringing suit against University Medical Center, Edgar Saldivar of the ACLU of Texas noted that the hospital and many of its personnel didn’t know where the obligation to assist the CBP stopped. Many medical professional don’t know that — according to the CBP’s own Personal Search Handbook — they are under absolutely no obligation to comply with requests by law enforcement to perform cavity searches with or without a warrant.

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Ambulances are Monopolies — and They Should Be Regulated Accordingly

By Shailin Thomas

You go to your local urgent care with a headache and a fever, and the doctor suggests a trip to the hospital for further evaluation — just to make sure there isn’t anything serious causing your symptoms. She offers an ambulance, and you accept. You could probably walk or Uber, but you’re not feeling well, and the doctor has offered to arrange the ride. Why not?

This was the story of Joanne Freedman. She didn’t think too much about it, until she received a $900 bill for the two-block ambulance ride she took to the hospital. While Joanne’s experience was particularly egregious, it is not wholly uncommon. Ambulance pricing is one of the most variable and least transparent components of health care costs, with rides ranging from tens to thousands of dollars. This is in part because there are many ambulance providers, and they all have different relationships with different insurance companies. It’s also in part because ambulance rates are generally set according to the services the ambulance is equipped to provide, not necessarily the services actually provided. Some ambulance companies have contracts with municipalities that make them the only game in town, while others are in more diverse markets with multiple providers competing for patients. All this combines to create an incredibly complex industry with very little consistency from ambulance to ambulance.

But is this disjointed, free-market system the best way to structure emergency transportation? The arguments underlying the justification of a free, unregulated market hinge on the ability of consumers to police the industry through choice. If the seller of a good sets the price too high, consumers will buy from a different seller until she brings the price down to what consumers are willing to pay.  This is, in theory, what allows markets to find the right prices for goods and services more efficiently than any government agency or regulator ever could. Continue reading

Legal Dimensions of Big Data in the Health and Life Sciences

By Timo Minssen

Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH).  The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.

The symposium, which was inspired by the wonderful recent  PFC & Berkman Center Big Data conference,  featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.

Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.

“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”

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From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

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The Curious Case Of The Docs Versus The Glocks: Firearms, The First Amendment, And Physician Speech

By Wendy Parmet

This new post by Wendy Parmet appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

On February 3, 2016 the full U.S. Court of Appeals for the 11th Circuit agreed to rehear the appeal inWollschlaeger v. Florida, commonly known as the case of the “docs versus the glocks.” Wollschlaegerconcerns a Florida law that bars physicians from routinely asking their patients whether they have guns or store them safely. In agreeing to rehear the appeal, the full court vacated a decision issued last December by a three-judge panel which had replaced two of its own prior opinions. Each of the panel’s three decisions upheld the law, and each raised serious questions about the ability of health professionals to provide their patients with relevant health information.

Public health professionals have long viewed gun safety as a major public health problem. Likewise, many physicians believe that good primary care includes questioning and counseling patients, especially those with children, about firearm safety, just as they talk to patients about seatbelts, cigarettes, and the need to exercise. […]

Read the full post here.

Should healthcare systems implement routine recontacting services in clinical practice? Some legal and logistical considerations

By Daniele Carrieri, Angus Clarke, Anneke Lucassen, Susan Kelly

Advances in genetic and genomic medicine are resulting in better diagnosis and treatment of some health conditions, and the question of whether former patients should be recontacted is therefore timely. Recontacting patients to inform them of new information or new testing, that could be relevant to their health or that of their biological relatives is made more pressing by the increasing use of whole genome approaches in healthcare, where variants previously of unknown significance (VUSs) may now have known disease effects.  However, there is currently no consensus about whether or not healthcare professionals have a duty or responsibility to recontact former patients in light of this new information. There is also very little empirical evidence in this area. In a recent article published in Genetics in Medicine, we present the results of a survey of recontacting practices of clinical genetics services across the United Kingdom (UK). As far as we know, this is the first study that specifically explores current recontacting practices in clinical genetic services.

One of the questions of the survey asked was whether clinical genetics services should implement routine recontacting systems. The majority of genetic services were undecided for several reasons.  The main arguments given in favor of implementing such systems revolved around patient choice and the idea of keeping patients up to date.  The main arguments against pointed to the logistical difficulties of implementing recontacting systems and the possible legal implications of doing so, if that were seen as establishing a new standard of care without the additional resources required for this to be a sustainable activity. Continue reading

Bill Sage Webcast on Health Law v. Health Policy

As part of the Regulatory Science series at University of Arizona:
Health Law and Health Policy: A Frictional Account
William M. Sage, MD, JD, University of Texas
Today 12/2 — Noon (AZ Time) / 2pm Eastern / 11am Pacific
The talk will be webcast live, and available as an archive:

Participants in the live webcast will have the opportunity submit questions and comments.  Please do!

When Law and Medical Ethics Conflict: The Case of Mohammad Allan

By Maayan Sudai

Mohammad Allan was an administrative detainee in Israel, a Palestinian who had been hunger striking since June 16 to protest his indefinite incarceration. Allan’s health has been deteriorating gradually, and the latest examinations raised concerns that he suffered irreversible brain damage. The crisis in Allan’s health created a tangle for the Israeli government, since releasing Allan was feared to serve as a precedent that would encourage more hunger strikes and symbolize submission to this type of protest, whereas force-feeding him might be considered unethical-illegal torture. This dilemma has brought a head-on clash between Israeli government officials and the Israeli National Medical Association, and led to an internal split between medical professionals regarding their positions on the ethics of the controversial practice of force-feeding.

In the midst of Allan’s health deterioration, the Israeli parliament passed a new law called “Hunger Strike Damage Prevention Act” also known as the “force-feeding law”. The law allows doctors to force-feed prisoners in immediate and imminent danger of irreversible severe damage or death, with a court order. The court could allow such force-feeding after hearing the prisoner (if possible) and an ethics committee recommendation. Moreover, the forced feeding should be carried out in a dignified manner, avoiding pain and suffering for the prisoner. It was declared that physicians will not be forced to comply with force-feeding under this law if they refuse.

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NPRM Summary from HHS

As Michelle noted, the Notice of Proposed Rule Making (NPRM) on human subjects research is out after a long delay. For my (and many Bill of Health bloggers’) view about its predecessor ANPRM, you can check out our 2014 book, Human Subjects Research Regulation: Perspectives on the Future.

Here is HHS’s own summary of what has changed and what it thinks is most important:

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.  A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register.  The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015.  There are plans to release several webinars that will explain the changes proposed in the NPRM, and a town hall meeting is planned to be held in Washington, D.C. in October. Continue reading

Call for Papers: Designing Ethical Review Processes for Big Data Research

By Michelle Meyer 

The Future of Privacy Forum is hosting an academic workshop supported by the National Science Foundation to discuss ethical, legal, and technical guidance for organizations conducting research on personal information. Authors are invited to submit papers for presentation at a full-day program to take place on December 10, 2015. Papers for presentation will be selected by an academic advisory board and published in the online edition of the Washington and Lee Law Review. Four papers will be selected to serve as “firestarters” for the December workshop, awarding each author with a $1000 stipend. Submissions, which are due by October 25, 2015, at 11:59 PM ET, must be 2,500 to 3,500 words, with minimal footnotes and in a readable style accessible to a wide audience. Publication decisions and workshop invitations will be sent in November. Details here.

New York Times Op-Ed on the A/B Illusion & the Virtues of Data-Driven Innovation

By Michelle Meyer

I have an op-ed with Christopher Chabris that appeared in this past Sunday’s New York Times. It focuses on one theme in my recent law review article on corporate experimentation: the A/B illusion. Despite the rather provocative headline that the Times gave it, our basic argument, made as clearly as we could in 800 words, is this: sometimes, it is more ethical to conduct a nonconsensual A/B experiment than to simply go with one’s intuition and impose A on everyone. Our contrary tendency to see experiments—but not untested innovations foisted on us by powerful people—as involving risk, uncertainty, and power asymmetries is what I call the A/B illusion in my law review article. Here is how the op-ed begins:

Can it ever be ethical for companies or governments to experiment on their employees, customers or citizens without their consent? The conventional answer — of course not! — animated public outrage last year after Facebook published a study in which it manipulated how much emotional content more than half a million of its users saw. Similar indignation followed the revelation by the dating site OkCupid that, as an experiment, it briefly told some pairs of users that they were good matches when its algorithm had predicted otherwise. But this outrage is misguided. Indeed, we believe that it is based on a kind of moral illusion.

After the jump, some clarifications and further thoughts.

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Two Cheers for Corporate Experimentation

Rubin's vase2By Michelle Meyer

I have a new law review article out, Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Innovation, arising out of last year’s terrific Silicon Flatirons annual tech/privacy conference at Colorado Law, the theme of which was “When Companies Study Their Customers.”

This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).

Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Continue reading

Arizona Enacts “Abortion Reversal” Law

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

On Wednesday, March 25, Arizona legislators passed a bill prohibiting women from buying insurance plans that cover abortions on the federal health exchange.  Senate Bill 1318 also includes a provision on medical abortions, which are typically used during the first nine weeks of gestation. Medical abortions involve taking two pills within a few days of each other.  The law requires doctors performing such abortions to tell their patients that if they reconsider their abortion after taking their first pill, they should return to the doctor for a procedure that can allegedly “reverse” the abortion.  The law amends Arizona Statute § 36-2153 to add that at least twenty-four hours before an abortion is performed, the physician must orally and in person inform the woman that “it may be possible to reverse the effects of a medication abortion if the woman changes her mind but that time is of the essence.” The law also requires the Department of Health Services to update its website to include information about the potential ability to reverse a medical abortion.  Republican Governor Doug Ducey, who opposes abortion rights, signed the law on March 30, 2015.

Like any law addressing abortion, the law is controversial. Abortion opponents lauded the bill, stating that Wednesday, March 25th was a “great day for women in Arizona who are considering getting an abortion to get all the facts they need.” On the other hand, women’s rights and health care providers’ groups oppose the coverage exclusion and vehemently oppose the abortion “reversal” provisions.  Senate Minority Leader Katie Hobbs called it “junk science” and “quack medicine.”  Arizona-based gynecologist Ilana Addis stated that there is no evidence to support this provision and women would essentially be “unknowing and unwilling guinea pigs.” Continue reading

Bioethicist Art Caplan: Pilots Need Mental Health Screening — And Doctors Do, Too

A new piece by contributor Art Caplan on Forbes:

The entirely predictable media obsession with the tragedy of the Germanwings jetliner that crashed into the French Alps on March 25 is moving forward full force. The media, especially cable television, love airline disasters. Once German prosecutors revealed that Andreas Lubitz, the pilot at the controls of the Germanwings jetliner when it crashed, had a mental illness but had kept the diagnosis hidden from his employer, all media hell broke loose.

One of the key questions raised by the spectre of mental illness was whether the pilot’s doctors tried to establish Lubitz’s mental fitness to fly and if they were concerned should they have revealed their worries to his employer. Despite a whole lot of talking heads jawing on these points few had anything useful to say since almost none of the experts consulted seemed familiar with the accuracy of mental health screening, or with the nature of German requirements for health screenings for crews or mechanics, or with German privacy law. When the discussion shifted to what about America, things still stayed fuzzy. […]

Continue reading here.

Pakistan’s “Last-Ditch Effort” To Eradicate Polio

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

In a previous post, I discussed three possible methods of increasing vaccination and decreasing vaccine refusals in the United States. One of these options was using tort law and allowing lawsuits against parents for refusing/failing to vaccinate their children. The Pakistani government has recently taken it one step further, arresting and issuing arrest warrants for parents refusing to vaccinate their children against polio. Last week,  approximately 512 people, 471 in Peshawar and 41 in Nowshera, were arrested and jailed and arrest warrants were issued for 1,200 more parents for refusing to vaccinate their children.

Currently, the government allows parents to be released from jail and return home if they sign an affidavit promising to vaccinate their children. Despite the fact there is no law requiring polio vaccination, some view the recent crackdown as “a blessing in disguise” for unvaccinated children. This drastic approach responds to high rates of refusal, a contributing factor to Pakistan’s significant number of polio cases. According to the World Health Organization, in the period since March 2014 Pakistan registered 296 polio cases, the most in the world and drastically higher than even the second-highest rate of 26 cases registered by Afghanistan. Why is Pakistan’s vaccination rate so low? For many reasons, including religious beliefs, attacks on medical workers, displacement of individuals due to ongoing military operations, and a lack of trust in health care workers and the vaccine. Continue reading

Open Payments: Early Impact And The Next Wave Of Reform

This new post by Tony Caldwell and Christopher Robertson appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

The Physician Payments Sunshine Act, a provision in the Affordable Care Act, seeks to increase the transparency of the financial relationships between medical device and drug manufacturers, physicians, and teaching hospitals. Launched on September 30, 2014 by the Centers for Medicare & Medicaid Services (CMS), the Open Payments database collects information about these financial relationships and makes that information available to the public.

As of early February, the Open Payments database includes documentation of 4.45 million payments valued at nearly $3.7 billion made from medical device and pharmaceutical manufacturers to 546,000 doctors and 1,360 teaching hospitals between August 2013 and December 2013. This included 1.7 million records (totaling $2.2 billion) without the names of physicians or teaching hospitals who received the payments.

These records were intentionally de-identified by CMS because the records had not been available for review and dispute for 45 days, or because the records were not matched by CMS to a single physician or teaching hospital due to missing or inconsistent information within the submitted records. Future reports will be published annually and will include data collections from a full 12 month period. […]

Continue reading here.

Hospital-Based Active Shooter Incidents: Sanctuary Under Fire

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the The Journal of the American Medical Association on active shooter incidents in hospital settings. From the article:

On January 20, 2015, Michael J. Davidson, MD, a cardiothoracic surgeon, was fatally shot on the premises of the Brigham and Women’s Hospital in Boston, Massachusetts. In the year leading up to this tragic day, a total of 14 active shooter incidents occurred in hospitals throughout the United States, leaving 15 fatalities in their wake. This reality and its potential amplification by copycats has reignited the debate over the adequacy of current and future hospital security arrangements. In this Viewpoint, we discuss the evolving frequency of hospital-based active shooter incidents, the relevant legal framework, and the role of hospitals and physicians in countering this threat.

As defined by the US Department of Homeland Security, an active shooter incident is one wherein “an individual is actively engaged in killing or attempting to kill people in a confined and populated area.” By several accounts, the overall prevalence of this otherwise rare occurrence is increasing. A study by the Federal Bureau of Investigation (FBI) reveals the overall number of active shooter incidents to have increased from 6.4 per year (2000-2006) to 16.4 per year (2007-2013). Similar rates have been reported for the hospital setting wherein the average number of active shooter incidents has increased from 9 per year (2000-2005) to 16.7 per year (2006-2011), claiming 161 lives in the process. It would thus appear that the frequency of hospital-based active shooter incidents has evolved to constitute at least a monthly occurrence. […]

The political paralysis plaguing gun laws notwithstanding, hospitals are not without recourse in seeking to mitigate the threat of active shooter incidents. On the local advocacy front, advancing and enacting bills for gun-free zones in health care settings constitutes a worthy effort in that a comparable federal statute remains unlikely. Concurrently, selective locale-specific enhancement of hospital security arrangements may increase deterrence, thereby mitigating risk and civil liability. […]

Read the full article here.

Art Caplan: Revoke the license of any doctor who opposes vaccination

A new opinion piece by Art Caplan, via the Washington Post:

Amateurs and hucksters are not the only people telling parents not to vaccinate their children. Unfortunately some doctors — men and women sworn to the Hippocratic Oath — are purveying junk science. They say that vaccines cause autism, as in the famous case of Andrew Wakefield, whose study drawing the link has been retracted. Or that measles isn’t that bad, so your child can skip the shots, as Jack Wolfson, a cardiologist in Arizona, says, adding that “the facts” show vaccines to be full of “harmful things” like “chemicals.” Or that, according to some parents, vaccines cause “profound mental disorders,” as Sen. Rand Paul, an ophthalmologist, warned before he walked the statement back. Or that vaccines cause “permanent disability or death,” in the words of Bob Sears, a pediatrician in California.

Thankfully, only a few physicians in America have embraced fear-mongering in the middle of this dangerous and costly measles epidemic. They deserve a place of honor next to climate-change skeptics, anti-fluoridation kooks and Holocaust deniers. They doubt the facts, ignore established evidence and concoct their own pet theories. They shouldn’t be allowed near patients, let alone TV cameras. But because their suggestions are so surprising and controversial, they often find themselves on cable news shows and in news reports about the “anti-vaxx” crowd. Their power, therefore, is radically disproportionate to their numbers. […]

Read more here.

Professionalism in Medicine

By Deborah Cho

As an update to my previous post here on medical students and professionalism, Judge Sutton writing for the Sixth Circuit found that a medical school could deny a degree to a medical student for failing to meet “professionalism” requirements.  According to the opinion, the medical student had come late to classroom sessions, allegedly behaved inappropriately at a formal dance, had to repeat his internal medicine rotation due to poor performance, and had been convicted of driving white intoxicated.  The Sixth Circuit found that Ohio, where the medical school is located, treats the relationship between a university and a student as contractual in nature, with that contract’s terms supplied by the student handbook.  As the handbook in this case included professionalism as part of the academic curriculum, the university’s determination that the student failed to meet professionalism requirements was an academic judgment and thus merited deference by the court.

Last summer, Judge Gwin of the Northern District of Ohio found that the medical school went beyond its scope of duty by extending its determination of professionalism well past academic or patient related matters.  The district court found for the student, noting that the “character judgments” found by the university were “only distantly related to medical education.”  In my last post, I noted that this separation of personal character from competence to practice medicine seemed troublesome.  The Sixth Circuit’s opinion reversing the district court shows similar concerns.

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