Ebola… again: What have we learned?

By Alicia Ely Yamin

As Susan Sontag eloquently noted decades ago, illness conjures metaphors that reveal a great deal about how we think about, and, in turn, address them. None more so than the lethal Ebola, which monstrously disfigures bodies before killing the infected person and spreading rapidly through the routines of everyday life.

In the West, Ebola evokes images of illness as a deadly foreign invasion, while in the West African pandemic we know that first those who were afflicted—and later those who survived—were stigmatized as possessing demons.

The growing outbreak in the DRC has produced calls for greater physical and financial involvement from the US government by a number of health law scholars, citing the potential for exponential spread if it reaches highly populated areas, and underscoring it as a global health security issue.  Thus far, WHO’s Director General has not declared it a “Public Health Emergency of International Concern” (PHEIC), which triggers consideration of both trade and travel restrictions, as well as international assistance and under the International Health Regulations. Read More

the week in health law podcast logo

Abbe Gluck, Michael Froomkin, Nicholson Price on ‘The Week in Health Law’ Podcast

I am joined by Abbe Gluck, Professor of Law and the Faculty Director of the Solomon Center for Health Law and Policy at Yale Law School.

In November 2018 her team pulled together an excellent roundtable on “The Law and Policy of AI, Robotics, and Telemedicine in Health Care.”

This episode of TWIH is the first of two taking a deeper dive into just a few of the  issues that were so well presented at the roundtable.

Here we were joined by Michael Froomkin, the Laurie Silvers and Mitchell Rubenstein Distinguished Professor of Law at the University of Miami School of Law and by Nicholson Price, Assistant Professor of Law at The University of Michigan Law School. Topics ranged from consent in the next generation of healthcare research to data protection, and appropriate regulatory models. Read More

Public Charge and the Expressive Effects of Immigration Law

In early October, the Department of Homeland Security published a proposed redefinition of the Immigrant and Nationality Act’s “public charge” provision, stirring serious concern among health-care and immigrant advocacy groups.

The “public charge” provision of the INA currently allows immigration officers to deny green cards to legal immigrants who are likely to become “primarily dependent on the government for subsistence.”

DHS’s proposed rule would widen the scope of “public charge” to include any legal immigrant who uses cash or non-cash government benefits. In expanding the scope of the public charge inadmissibility determinations, DHS would empower immigration officers to consider immigrants’ current or prior use of programs like Medicaid and SNAP in evaluating applications. Read More

A row of colored medical records folders

The Troubling Prevalence of Medical Record Errors

With plenty of potential healthcare concerns and complications arising out of medical diagnoses and treatments themselves, errors in medical records present an unfortunate additional opportunity for improper treatment.

A recent article from Kaiser Health News (KHN) discussed several examples of dangerous medical record errors: a hospital pathology report identifying cancer that failed to reach the patient’s neurosurgeon, a patient whose record incorrectly identified her as having an under-active rather than overactive thyroid, potentially subjecting her to harmful medicine, and a patient who discovered pages someone else’s medical records tucked into in her father’s records. In addition to incorrect information, omitting information on medications, allergies, and lab results from a patient’s records can be quite dangerous.

The goal of “one patient, one record” provides a way to “bring patient records and data into one centralized location that all clinicians will be able to access as authorized.” This enables providers to better understand the full picture of a patient’s medical condition. It also minimizes the number of questions, and chances of making errors, that a patient must answer regarding their medical conditions and history when they visit a provider.

Other benefits, such as cost and care coordination, also add to the appeal of centralized records.

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hand reaching for blue pills

Should Non-opioid Analgesics have “Opioid Sparing” as a Label Claim?

Most meetings of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) are held to review a New Drug Application (NDA), usually for a novel opioid preparation. But, on November 15, the AADPAC discussed the concept and implications of “opioid sparing” as a potential product label claim for a non-opioid type of medication.

Although trends in outpatient opioid prescriptions appear to be heading in an encouraging direction (see figure below), the demonstration that a non-opioid medication could further decrease the overall use of opioids for acute pain has obvious implications for the amount of opioids prescribed and taken by patients who undergo painful surgical procedures. This will also decrease exposure in the community where prescribed opioids may become diverted for recreational use.

In recent years, some across-the-board measures (e.g. state laws that limit the duration of prescribed opioids) have attempted to reduce opioid prescribing, but as the FDA emphasized in their presentation at the meeting, these “one size fits all” strategies will not account for individual patient variation, and may lead to inadequate pain treatment in some patients. Read More

Science and ethics experts still reeling from #CRISPRbabies fallout

Watching David Baltimore open the #GeneEdit Summit last week brought back a memory of the last time I saw the Nobel laureate in such a role. The 2015 #GeneEditSummit concluded with a Q&A about the summit’s statement — which many considered was a moratorium on gene editing of embryos.

An audience member, with a sense of the promise of the science but concern for buy-in from a distrustful public, asked whether the statement might be translated into clearer language for those hard-pressed to understand CRISPR even with the acronym spelled out for them. To which Baltimore replied: “You mean it isn’t?”

That exchange convinced me that even gene editors need an editor. Especially gene editors. Indeed, if He Jiankui read that 2015 moratorium before he altered his own future in unintended ways, he did not see it as a red light.

In a tweet, director Francis Collins (@NIHdirector) clarified that the National Institutes of Health considers the light red: “The work of Dr. He Jiankui presented at #GeneEditSummit is profoundly disturbing & tramples on ethical norms. We need to develop binding international consensus on limits for this research. #NIH does not support the use of gene-editing in human embryos.”

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The Tricky Task of Defining AI in the Law

By Sara Gerke and Joshua Feldman

Walking her bike across an Arizona road, a woman stares into the headlights of an autonomous vehicle as it mistakenly speeds towards her. In a nearby health center, a computer program analyzes images of a diabetic man’s retina to detect damaged blood vessels and suggests that he be referred to a specialist for further evaluation – his clinician did not need to interpret the images. Meanwhile, an unmanned drone zips through Rwandan forests, delivering life-saving vaccines to an undersupplied hospital in a rural village.

From public safety to diagnostics to the global medical supply chain, artificial intelligence (AI) systems are increasingly making decisions about our health. Legislative action will be required to address these innovations and ensure they improve wellbeing safely and fairly.

In order to draft new national laws and international guidelines, we will first need a definition of what constitutes artificial intelligence. While the examples above underscore the need of such a definition, they also illustrate the difficulty of this task: What is uniquely common between self-driving cars, diagnostic tools, and drones? Read More

Friday: FDA Chief Counsel Stacy Cline Amin and more at 7th Annual Health Law in P/Review

This year brought with it a wave of interesting issues in the health law arena—be it questions of limiting health care access to immigrants, the ongoing challenges of the opioid epidemic, or the ever-changing landscape of drug pricing.

Join us as we unpack the major health law developments of 2019 and discuss what to watch for in the year to come. Over the course of the day, leading experts will consider hot topic issues such as, health policy under the current administration, pharmaceutical policy, and global health. Featured panel discussions include “Challenges Facing Health Care General Counsels” and “AI in Health Care.”

In addition to panel discussions and speaker presentations, the conference will feature a special Fireside Chat between Glenn Cohen and Stacy Cline Amin, who serves as Chief Counsel of the Food and Drug Administration and Deputy General Counsel of the Department of Health and Human Services. She previously served as Special Assistant to the President and Senior Associate Counsel to the President, serving as the senior legal advisor on matters relating to the Department of Health and Human Services. Stacy will offer a window into what 2019 holds for the FDA.

 

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

The Seventh Annual Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.