The Week in Health Law podcast logo twihl.com

New TWIHL: Equity in All Policies with Sarah de Guia

This week, my special guest is Sarah de Guia, Chief Executive Officer of ChangeLab Solutions. Along with Scott Burris, Wendy Parmet, Lance Gable, and Donna Levin, Sarah and I worked together on our report, Assessing Legal Responses to COVID-19, which was just published. Our broad discussion looks at the report’s terminology, general approach to equity, and local strategies for change, along with some specific examples drawn from the assessment.

Read More

Assessing legal responses to COVID-19 graphic.

New Report Assesses Legal Responses to COVID-19

Assessing Legal Responses to COVID-19 is a new, in-depth analysis of U.S. legal and policy responses to the pandemic.

In the report, 50 top national experts offer a new assessment of the U.S. policy response to the crisis. The research details the widespread failure of the country’s leadership in planning and executing a cohesive, national response, and how the crisis exposed weaknesses in the nation’s health care and public health systems.

The report’s authors also offer recommendations on how federal, state and local leaders can better respond to COVID-19 and future pandemics. Their proposals recommend how to strengthen executive leadership for a stronger emergency response; expand access to public health, health care, and telehealth; fortify protections for workers; and implement a fair and humane immigration policy.

Read More

The Week in Health Law podcast logo twihl.com

TWIHL: Innovation and Protection: The Future of Medical Device Regulation, Episode 3

This is the last of three episodes of “Innovation and Protection: The Future of Medical Device Regulation,” a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic.

These episodes highlight a selection of papers that were written for the conference, which was organized in collaboration with the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program. All of the papers will be published in an edited volume.

This third episode looks at recent advances in medical device regulation in the U.S. and abroad, and the effects of the COVID-19 pandemic on national and international medical device regulation.

First, Timo Minssen, Professor of Law and Director, Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen and Researcher in Quantum Law, Lund University, interviews Helen Yu, Associate Professor at the University of Copenhagen, Faculty of Law and Associate Director of CeBIL about her paper “Regulation of Digital Health Technologies in the EU: Intended vs. Actual Use.”

Minssen returns to talk with Janos Meszaros, Postdoctoral Research Fellow at Taiwan’s National Academy of Science about “Challenges at the Interface of EU Medical Device Regulation and the GDPR: Do the Rules on Privacy and Scientific Research Impair the Safety of AI Medical Devices?”

Finally, Christopher Robertson discusses “Preventing Medical Device-Borne Disease Outbreaks: Improving High-Level Disinfection Policies for Scopes and Probes,” with author Preeti Mehrotra, Attending Physician, Beth Israel Deaconess Medical Center and Instructor of Medicine, Harvard Medical School.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

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 me on Twitter @nicolasterry or @WeekInHealthLaw.

The Week in Health Law podcast logo twihl.com

New TWIHL: Ethical Issues in Development of a COVID-19 Vaccine

This episode is the first of a series of shows dealing with health care and research ethics related to COVID-19.

Here, Tara Sklar from The University of Arizona James E. Rogers College of Law introduces Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor, Founding Head of the Division of Medical Ethics, and Co-Chair of the Working Group on Compassionate Use and Preapproval Access (CUPA) at NYU Grossman School of Medicine. Dr. Caplan discusses ethical issues in development of a COVID-19 vaccine.

The series is co-sponsored by the NYU Grossman School of Medicine Division of Medical Ethics and the University of Arizona Health Law and Policy Program.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

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 me on Twitter @nicolasterry or @WeekInHealthLaw.

The Week in Health Law podcast logo twihl.com

TWIHL 212: Substance Use Privacy Before and After CARES

By Nicolas Terry

In this episode, I welcome back Kirk Nahra, a partner and Co-Chair of the Cybersecurity and Privacy Practice at Wilmer Hale in DC. He has been a leading authority on privacy and cybersecurity matters for more than two decades. Mr. Nahra counsels clients across industries, from Fortune 500 companies to startups, on implementing the requirements of privacy and data security laws across the country and internationally.

And, after all this time, finally I welcome Melissa Goldstein, Associate Professor in the Department of Health Policy and Management at the Milken Institute School of Public Health at the George Washington University, where she teaches courses in bioethics (including genomics, reproductive ethics, end-of-life, and research ethics issues), health information technology policy, and public health law and conducts research on health information privacy and the legal and policy aspects of health information technology. Our excuse for getting together is that we recently co-authored a piece on the Health Affairs blog titled COVID-19: Substance Use Disorder, Privacy, And The CARES Act.

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

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 me on Twitter @nicolasterry or @WeekInHealthLaw.

Kirkland, WA / USA - circa March 2020: Street view of the Life Care Center of Kirkland building, ground zero of the coronavirus outbreak in Kirkland.

How COVID-19 Could Drive Improvements in Care Facilities (Part II)

By Nicolas Terry, LLM and Tara Sklar, JD, MPH

This post is part II of a two-part series on COVID-19 and care facilities. In the first installment we assessed the centrality of care facilities to the COVID-19 pandemic and outlined the infection risks for residents and workers. In this second installment we will explore how improved regulation and enforcement, combined with liability rules, provide the best path forward to improve an industry that, despite its deficiencies, claims it deserves exceptional immunity.

Read More

Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

How COVID-19 Could Drive Improvements in Care Facilities (Part I)

By Nicolas Terry, LLM and Tara Sklar, JD, MPH

Introduction

This post is part I of a two-part series on COVID-19 and care facilities. In this first installment we assess the centrality of care facilities to the COVID-19 pandemic and outline the infection risks for residents and workers. In the second installment we will explore how improved regulation and enforcement, combined with liability rules, provide the best path forward to improve an industry that, despite its deficiencies, claims it deserves exceptional immunity.

Read More