pill bottle - buprenorphine / naloxone

Protecting the Vulnerable Substance Use Disorder Population During COVID-19

By Brandon George and Nicolas P. Terry

Introduction

Earlier this month, Dr. Nora Volkow, director of the National Institute on Drug Abuse identified those with substance use disorder (SUD) as a particularly vulnerable population during the COVID-19 pandemic. She highlighted the negative effects of opioid or methamphetamine use on respiratory and pulmonary health in addition to the disproportionate number of those with SUD who are homeless or incarcerated.

We detail the additional challenges faced by the SUD population and, specifically, the opioid use disorder (OUD) sub-group at this time, identify positive ameliorative steps taken by federal, state, and local governments, and recommend additional steps.

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Can Bedside Consent Apps Improve Informed Consent During Childbirth?

By Alexa Richardson

Informed consent in childbirth is under fire by advocates, who stress that there is a widespread absence of meaningful informed consent during birth. While informed consent in medical settings always poses challenges, informed consent in childbirth raises particular concerns. Labor unfolds in real-time, and people are heavily reliant on their provider for information during birth. Providers may not adequately seek informed consent out of a belief that they should make decisions in the fetal interest, rather than the parent. Furthermore, laboring people make choices that are more than medical: birth is a value-laden process entwined with beliefs about parenting, life-meaning, and fetal interests.  A new solution is on the table that could help improve the process of informed consent in childbirth: guided decision-making apps. This year, multiple mobile apps are in the works that would assist laboring people and clinicians in real-time decision-making during labor and birth.

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A calculator, a stethoscope, and a stack of money rest on a table.

Why Our Health Care Is Incomplete: Review of “Exposed” (Part II)

By: Daniel Aaron

Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. Part II of this book review offers an analytical discussion of “cost exposure,” the main subject of his book with a focus on solutions. Read Part I here.

Baby solutions

Prof. Robertson writes two chapters on solutions. In the first, titled “Fixes We Could Try,” he offers reforms, from mild to moderate, that would make cost exposure less harmful. The chapter largely retains the analytical nature of the prior chapters, but it comes across like a chapter he might have rather not written. This is evident in the following chapter’s title, “What We Must Do.” It’s also evident because some of the proposals do not seem fully considered, and in some ways appear more controversial than the more comprehensive solution offered later. Read More

A calculator, a stethoscope, and a stack of money rest on a table.

Why Our Health Care Is Incomplete: Review of “Exposed” (Part I)

By: Daniel Aaron

Just last month, Professor Christopher T. Robertson, at the University of Arizona College of Law, released his new book about health care, entitled Exposed: Why Our Health Insurance Is Incomplete and What Can Be Done About It. This book review will offer an analytical discussion of “cost exposure,” the main subject of his book.

What is cost exposure in health care?

Cost exposure is payments people make related to their medical care. There are many ways patients pay – here are a few common ones.

  • Deductible – Patient is responsible for the first, say, $5,000 of their medical care; after this point, the health insurance kicks in. Resets each year.
  • Copay – Patient pays a specific amount, say $25, when having an episode of care.
  • Coinsurance – Patient pays a specified percentage, say 20%, of care.

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Picture of doctor neck down using an ipad with digital health graphics superimposed

Practice Fusion: it’s data use, not de-identification, that matters

By Leslie Francis

Practice Fusion, an electronic health record (EHR) vendor, just settled with the Department of Justice to pay a $145 million fine for alleged kickbacks from an unnamed pharmaceutical company.  The DOJ contended that the company had taken kickbacks in exchange for including practice alerts to encourage physicians to prescribe opioids.  But paid-for prescription alerts were not the only practices engaged in by Practice Fusion with de-identified patient data.

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Illustration of a person running away carrying "stolen" 1's and 0's

Measuring Health Privacy – Part II

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the 2021 Winter Issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In this two-part post for the Promises and Perils of Emerging Health Innovations blog symposium Ignacio Cofone engages in a discussion centered on the importance of addressing patients’ concerns when introducing new health technologies. While privacy risks may not always be avoided altogether, Cofone posits that privacy risks (and their potential costs) should be weighed against any and all health benefits innovative technology and treatments may have. To do so, Cofone introduces the concept of using health economics and a Quality-Adjusted Life Year (QALY) framework as a way to evaluate the weight and significance of the costs and benefits related to health technologies that may raise patient privacy concerns.

Measuring Health Privacy – Part II

By Ignacio N. Cofone

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Illustration of cascading 1's and 0's, blue text on a black background

Measuring Health Privacy – Part I

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the 2021 Winter Issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, and improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In this two-part post for the Promises and Perils of Emerging Health Innovations blog symposium, Ignacio Cofone engages in a discussion centered on the importance of addressing patients’ concerns when introducing new health technologies. While privacy risks may not always be avoided altogether, Cofone posits that privacy risks (and their potential costs) should be weighed against all health benefits innovative technology and treatments may have. To do so, Cofone introduces the concept of using health economics and a Quality-Adjusted Life Year (QALY) framework to evaluate the weight and significance of the costs and benefits related to health technologies that may raise patient privacy concerns.

Measuring Health Privacy – Part I

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A sick child lies in a hospital bed. An IV pole is visible in the foreground

Ethical Reflections on the Recent Critical Shortage of Pediatric Cancer Drug

By Beatrice Brown

Recently, news broke that there is a critical shortage of vincristine, a drug that is integral for treating pediatric cancers. According to the Children’s Oncology Group, Pfizer communicated that they were experiencing a shortage of the drug due to a manufacturing delay. Pfizer is now the sole supplier of vincristine in the United States after the other supplier, Teva Pharmaceuticals, ceased production of the drug after making a “business decision.” Although the FDA announced that deliveries of the drug should resume in late October, it is predicted that there will still be a supply shortage until December or January.

Vincristine is “the single most widely used chemotherapeutic in childhood cancer,” according to Yoram Unguru, MD, a pediatric hematologist and oncologist at the Herman and Walter Samuelson Children’s Hospital at Sinai and Johns Hopkins Berman Institute of Bioethics in Baltimore, Maryland. Unguru stated, “Nearly every child with cancer in the U.S. will receive multiple doses of vincristine over the course of their treatment. For some children with cancer, vincristine comprises one half of all chemotherapy administered.”

The shortage is even more critical given that there is no other manufacturer that can pick up the slack. According to Unguru, the shortage was predictable once Teva halted production. Given that there is no substitute for vincristine, doctors are in a tough position. Thus, there are two ethical issues I wish to explore here: 1) the issue of resource allocation/drug rationing; and 2) the moral obligations of pharmaceutical companies to patients. I will take up each of these issues in turn. Read More

Couple sitting on a couch, leaning forward to have a serious conversation with a doctor or counselor

Genetic Testing: Is There a “Duty to Warn” At-Risk Family Members?

By Shelly Simana

Genetic information is quite distinguishable from much medical information due its familial nature and its unique ability to predict future health. The fact that genetic testing supplies comprehensive information about the genetic make-up of patients and their family members underlies the ethical and legal challenges faced by physicians and patients when deciding whether to disclose genetic information to family members. Failure to disclose information may “lead to harm, particularly when knowledge could result in avoidance, treatment, or prevention of a genetic condition or in significant changes to reproductive choices or lifestyle.” Due to the potential harm, one may ask herself if there is a legal “duty to warn” family members about the presence of defective genes, and if so, upon whom should it be imposed.

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