Call for Papers – DePaul Journal of Health Care Law

The DePaul Journal of Health Care Law is a student-run peer-reviewed journal published by the DePaul University College of Law. Founded in 1996, the JHCL publishes articles analyzing the legal complexities of the rapidly evolving health care world on topics of interest to health care practitioners, legal researchers, scholars and health care professionals. The editors welcome submission of manuscripts on health law topics, as well as on topics in the broader field of health care where matters of ethics, medical practice or economics have legal implications.

If you are interested in publishing a recent work, we invite you to contact us with your submission as soon as possible. Submissions should be accompanied by a CV and submitted to DePaul.JHCL@gmail.com.  The JHCL is not currently accepting student-authored pieces.

Don’t miss today’s Health Law Workshop with Christina S. Ho!

October 15, 2018 5:00 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “Health Impact Assessment: A Negative Right to Health”

Professor Christina S. Ho is Professor of Law at Rutgers Law School. She joined the Rutgers faculty in 2010 from the O’Neill Institute for National and Global Health Law at Georgetown University Law Center, where she was a Senior Fellow and Project Director of the China Health Law Initiative. She was previously Country Director and senior policy advisor for the Clinton Foundation’s China program. During the Clinton Administration, she worked on the Domestic Policy Council at the White House and later led Senator Hillary Rodham Clinton’s health legislative staff.

Professor Ho received her AB from Harvard College, her MPP from Harvard’s John F. Kennedy School of Government, and her JD from Harvard Law School.

What kinds of digital tools can help states implement disability exemptions for Medicaid recipients?

This year, several states applied for and received permission from the federal government to implement work requirements in their Medicaid programs. Policy designs vary by state, but all states build in considerations for people with disabilities. These considerations include exemptions and exceptions from work requirements for individuals unable to work due to a disability.

But how can states implement these policies in a way that is accurate, efficient, and fair?

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Patient Safety and Communication Breakdown

By John Tingle

Good communication is an essential prerequisite for good and safe patient care. To effectively communicate is an everyday life skill and it’s one of the most basic that we all must master in some way. From a patient safety context poor health carer communication practices are a worldwide problem which continues to cause global patient harm.The WHO state that communication failures are the leading cause of inadvertent patient harm.Successive Health Service Ombudsman in England have maintained that communication failures are a leading cause of patient complaints. In 2014-2015 poor communication, including quality and accuracy of information, was a factor in one third of all health care complaints.

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Designing an Economic Bioethics

By Mark Robinson and Joseph M. Gabriel

In a previous post, one of us has argued that bioethical deliberation needs to incorporate an analysis of “market forces in health-related decision-making” under what might be called “economic bioethics.”

To a certain extent, of course, bioethicists already do this. Industry-physician relations, for example, attracts substantial attention from the field. Other notable topics include the price of health-care services and technologies (and drugs in particular), patenting biological material, debates about funding controversial types of medical research, and debates about the allocation of resources during times of scarcity.

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Medicaid Expansion Goes to the Polls

By Rahul Nayak

With the 2018 midterm elections fast approaching, there are key some voter propositions with important health implications.

Most notably, this November, voters in three conservative states — Idaho (Proposition 2), Utah (Proposition 3), and Nebraska (Initiative 427) — will be deciding on whether to expand Medicaid. In addition, voters in Montana will decide whether to permanently extend their state’s Medicaid expansion. This is coming at the heels of the closely watched November 2017 referendum where Mainers decisively supported Medicaid expansion 59 percent  to 41 percent.

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The Intersection of Immigration Law and Health Policy, Friday, October 26, 2018, Indiana University

By Nicolas Terry

We are delighted to announce this year’s Hall Center for Law and Health: Indiana Health Law Review Symposium, The Intersection of Immigration Law and Health Policy, Friday, October 26, 2018, Indiana University Robert H. McKinney School of Law.  Registration link. Our speakers include, in order of appearance:

  • Wendy E. Parmet, JD, Matthews Distinguished University Professor of Law and Director, Center for Health Policy and Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs
  • Melissa D. Anderson, MD, Assistant Professor of Clinical Medicine – Nephrology, Indiana University School of Medicine
  • Brietta R. Clark, JD, Professor of Law and J. Rex Dibble Fellow, Loyola Law School Los Angeles
  • Y.Y. Brandon Chen, JD, MSW,  Assistant Professor Faculty of Law, University of Ottawa
  • Grace E. Shelton, JD, Attorney, Hall Render Killian Heath & Lyman, P.C.
  • Maurice Henein, MD FAAFP, Program Director, Community East Family Medicine Residency, Indianapolis
  • Lori A. Nessel, JD, Professor of Law, Center for Social Justice Director, Seton Hall University School of Law
  • Emma Mahern, JD, Associate Attorney, Muñoz Legal
  • Sister Tracy Horan, Sisters of Providence of Saint Mary of the Woods, Bilingual Community Organizer Archdiocese of Indianapolis Justice for Immigrants Campaign
  • Medha D. Makhlouf, JD, Assistant Professor of Law, Director, Medical-Legal Partnership Clinic, Penn State’s Dickinson School of Law
  • Valarie K. Blake, JD, MA, Associate Professor, West Virginia College of Law
  • Jonathan Todres, JD, Professor of Law, Center for Law Health and Society, Georgia State University College of Law
  • Ellen Einterz, MD, Marion County Public Health Department
  • Polly J. Price, JD, Asa Griggs Candler Professor of Law, Emory University School of Law
  • Cecilia S. Obeng, PhD, Associate Professor of Applied Health Science, Indiana University Bloomington School of Public Health

 

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

By Ameet Sarpatwari, Michael S. Sinha, 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, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of September. The selections feature topics ranging from the impact of the FDA Amendments Act of 2007; to the estimated cost of pivotal trials for FDA-approved novel therapeutic agents, to labeling changes and costs for clinical trials performed under the FDA pediatric exclusivity extension. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Avorn J, Kesselheim A, Sarpatwari A. The FDA Amendments Act of 2007 – Assessing Its Effects a Decade Later. N Engl J Med. 2018 Sep 20;379(12):1097-1099.
  2. Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH. Changes in Drug Pricing After Drug Shortages in the United States. Ann Intern Med. 2018 Sep 18. [Epub ahead of print]
  3. Moore TJ, Zhang H, Anderson G, Alexaner GC. Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration. JAMA Intern Med. 2018 Sep 24. [Epub ahead of print]
  4. Nishikawa G, Prasad V. Diagnostic expansion in clinical trials: myocardial infarction, stroke, cancer recurrence, and metastases may not be the hard endpoints you thought they were. BMJ. 2018 Sep 19;362:k3783.
  5. Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS. Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012. JAMA Intern Med. 2018 Sep 24. [Epub ahead of print]

The Way We Do Bioethics

By James Toomey

Professor S. Matthew Liao of NYU presented a paper last week at the Health Law, Bioethics, and Biotechnology Workshop. Liao’s theory of rights-worthiness is based on the presence of a genetic basis for a moral sense. So babies, fetuses, the vetegative, all are human rights-holders, other animals are presumptively not (but could be if we found they had the genes for moral sense) and, with a little line drawing about the nature of an organism, corpses are excluded.

It is, perhaps, a somewhat strained effort to justify a deep moral intuition that all human beings, no matter how brain-damaged, are entitled on their own merit to a full panoply of human rights.

Personally, I’m skeptical. Continue reading

Health Care for All Requires More than Funding, It Requires Building Trust

By Mark Satta

The slogan “healthcare for all” typically stands as a proxy claim for “health insurance for all.” Given the Trump Administration’s recurrent attempts to decrease the effectiveness of President Obama’s comprehensive health insurance regulation reform law, the Affordable Care Act, it’s understandable that health insurance would be a major focus of those concerned with reforming the health care system. Millions of Americans remain uninsured and/or unable to pay for the health services they need, so continued efforts to reform our health insurance system remain vital.

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Hurricane Florence and the health effects of climate change

NC hog lagoon

Photo by picstever/Flickr

By Alexandra Slessarev

Among the coverage of the aftermath of Hurricane Florence, news stories about the overflowing waste from North Carolina pig lagoons were among the most stomach-turning. North Carolina is home to a slew of concentrated animal feeding operations, or CAFOs, and these industrial livestock farming operations often involve storing massive volumes of pig manure in contained “lagoons.”

The driving rain from Hurricane Florence caused at least 110 of these lagoons to swell over. CAFOs are, in themselves, a topic of concern among public health and environmental justice advocates. But this specific example of what happens when CAFOs and extreme weather patterns collide provides an opportunity to reflect on the unique relationship between public health and climate change.

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Health care, disease care, or killing care?

By Hugo Caicedo

Traditional medical practice is rooted in advanced knowledge of diseases, their most appropriate treatment, and adequate proficiency in its applied practice. Notably, today, medical treatment does not typically occur until disease symptoms have manifested. While we now have ways to develop therapies that can halt the progression of some symptomatic diseases, symptomatic solutions are not meant to serve as a cure of disease but palliative treatment of late-stage chronic diseases.

The reactive approach in most medical interventions is magnified in that medicine is prone to errors. In November of 1999, the U.S. National Academy of Science, an organization representing the most highly regarded scientists and physician researchers in the U.S., published the report To Err is Human.

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Surgical ‘Never Events’ in the NHS

By John Tingle

NHS Improvement has just published a report on Surgical ‘Never Events’.The report presents an analysis of the local investigation reports into 38 surgical, ‘Never Events’ from across England that occurred between April 2016 and March 2017 (the last full year with data available).

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bioIP Faculty Workshop Call for Abstracts

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the 4th annual bioIP Faculty Workshop on Friday April 26, 2019, at Boston University.

The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

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Many Families with Down syndrome Children Would Consider Gene Modification, but with Serious Concerns

Photo by Andreas-photography/Flickr

By Marsha Michie, PhD and Megan Allyse, PhD

Scientists and bioethicists have been talking a lot recently about CRISPR/Cas9 and related technologies to alter genomes. But the voices of patients and families, especially those with genetic conditions, haven’t been nearly as audible in these conversations about so-called “gene editing”—despite calls for these voices from the National Academies and others.

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Now published: Consensus-based guidelines for the ethical oversight of Patient-Centered Outcomes Research

By Avni Gupta

Patient-Centered Outcomes Research (PCOR) is characterized by patients participating in various research roles other than merely the subjects. The Patient-Centered Outcomes Research Institute (PCORI), a major funder of PCOR research, defines patient engagement as including patients in all stages of research, “from topic selection through design and conduct of research to dissemination of results.”

However, while the concept of patient engagement in research and its potential for benefitting science are increasingly recognized by funders and investigators, IRBs’ comfort with patients in non-traditional roles in research protocols lags behind.

IRBs’ familiarity with patients in research has traditionally been with patients who are study participants or subjects, and are considered “vulnerable.” Therefore, many IRBs’ review process focuses on ensuring that adequate protective measures are in place to “protect” the patients, including measures such as a detailed written informed consent, continuing review, confidentiality measures, and so on.

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Why we need to “care” about healthcare

By Robert G. Urban

Humans often proclaim that “intelligence” is what sets our species apart – the ability to analyze, to imagine, to organize, to then cooperate and execute. A unique gift that enables us to be remarkable.

Monuments to humanity’s capability are sprinkled all across the world — early works are colossal demonstrations of ingenuity coupled to brute strength. Consider the statues of Easter Island, Rome’s colosseum, Egyptian and early American pyramids, or the Great Wall of China as examples, each demonstrating a singularly human ability (and need) to reshape our world and leave evidence of our presence.

And as time and talent has unfolded, the complexities of our contributions have advanced as well.

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‘Dignity’ and Biotechnology: Switzerland’s Sanctification of Nature

By James Toomey

Many countries are skeptical of biotechnology. Restrictions on cloning, in vitro fertilization, surrogacy, and genetic modification in agriculture are common. But perhaps no country goes quite as far as Switzerland.

In the early 1990s, Switzerland added to its constitution by popular referendum two articles that restrict the use of biological technologies in its Confederation. Article 119 bans the traditional bugaboos of human bio-conservatives (cloning, surrogacy, human genetic intervention, etc.), and further stipulates that legislation on any new technologies must “ensure[] the protection of human dignity.” Article 120 mandates that legislation related to biological technologies in other organisms must “take into account . . . the dignity of living beings . . .” What?

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Don’t miss today’s Health Law Workshop with Zack Buck

September 24, 2018 5:00 PM
Hauser Hall, Room 104
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA

Download the Presentation: “The Price of Universality: Sustainable Access and the Twilight of the ACA”

Zack Buck specializes in health law, and his scholarship examines governmental enforcement of laws affecting health and health care in the United States. Most recently, his writing has sought to evaluate how the enforcement of health care fraud and abuse laws impacts American quality of care, with a particular focus on the legal regulation of overtreatment. Over the last five years, his work has been published in the California Law Review, Boston College Law Review, Ohio State Law Journal, Maryland Law Review, Florida State Law Review, and U.C. Davis Law Review, among others.

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