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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.

Photograph of a green cow statue in a field

Exploring the Future of Meat: Academy of Food Law & Policy 2nd Annual Conference at Georgia State University, Dec. 10, 2019

By Nicole Negowetti

Sustainably feeding a growing population with healthy diets is a pressing global challenge. The role of meat in such diets is a deeply contentious issue that has public health, animal welfare, food systems, farming, and environmental experts and advocates weighing in on the issue. As we learn more about the impacts of meat production and consumption on human and environmental health and animal welfare, meat consumption is changing. In North America, eaters are heeding recommendations to reduce, replace, or eliminate meat in their diets; however, global meat production and consumption continues to rise.

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Cover of the book "Transparency in health and health care in the US"

Order Now: “Transparency in Health and Health Care in the United States”

Transparency is a concept that is becoming increasingly lauded as a solution to a host of problems in the American health care system. Transparency initiatives show great promise, including empowering patients and other stakeholders to make more efficient decisions, improve resource allocation, and better regulate the health care industry.

Nevertheless, transparency is not a cure-all for the problems facing the modern health care system. The authors of this volume present a nuanced view of transparency, exploring ways in which transparency has succeeded and ways in which transparency initiatives have room for improvement. Read More

Graphical image of a genetic screen merging with algorithmic code

Do You Own Your Genetic Test Results? What About Your Temperature?

By Jorge L. Contreras

The popular direct-to-consumer genetic testing site AncestryDNA claims that “You always maintain ownership of your data.” But is this true?  And, if so, what does it mean?

For more than a century, US law has held that data – objective information and facts – cannot be owned as property. Nevertheless, in recent years there have been increasing calls to recognize property interests in individual health information. Inspired by high profile data breaches and skullduggery by Facebook and others, as well as ever more frequent stories of academic research misconduct and pharmaceutical industry profiteering, many bioethicists and patient advocates, seeking to bolster personal privacy and autonomy, have argued that property rights should be recognized in health data. In addition, a new crop of would-be data intermediaries (e.g., Nebula Genomics, Genos, Invitae, LunaDNA and Hu.manity.org) has made further calls to propertize health data, presumably to profit from acting as the go-betweens in what has been estimated to be a $60-$100 billion global market in health data. Read More

Call for Proposals: Addressing the Health Care Needs of Justice-Involved Populations

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law & Life Sciences invite original submissions for presentations at our Thirteenth Annual Health Law Symposium: Addressing the Health Care Needs of Justice-Involved Populations. The Symposium will take place at Loyola University Chicago School of Law on Friday, November 15, 2019 beginning at 9:00am.

The Symposium will explore legal barriers that justice-involved populations face in accessing health care, and address how those barriers can be alleviated. “Justice-involved populations” generally refers to individuals who are incarcerated in prisons, jails, immigrant detention centers, juvenile detention centers, on probation, or individuals who are otherwise involved with the U.S. justice system. Read More

Call for Papers: Wiet Life Science Law Scholars Workshop

Loyola University Chicago School of Law’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for the annual Wiet Life Science Law Scholars Workshop on Friday, September 6, 2019.

Loyola is currently soliciting 750-1,000 word abstracts reflecting early to mid-stage ideas for the purpose of workshopping full drafts with expert commentators and other scholars.

Modeled after successful events for law professors and scholars in other areas, we will organize scholars in topical panels of authors plus an expert commentator, where all panelists have read the material of panel members. We will allot each author time for presentation, followed by intensive discussion with expert commentators and scholar attendees.  Full article drafts will be available at least two weeks prior to the event to all scholar participants so that participating scholars can review these to provide effective feedback to all other scholars.

To ensure effective feedback, the workshop aims to select a maximum of eight scholars. Read More

Image of the backs of two police officers

Security and Health: Police as Key Players in Public Health

For more than a decade, a variety of scholars and practitioners in public health, policing and the broader domain of security have been stoking a conversation about the links between their disciplines and the need to do a better job integrating the disciplines and practices.

This week, The Lancet published a special series on Security and Health. A global set of authors, myself included, make the case that military and police forces should be recognized as key players, rather than intruders, in public health, and therefore we need these relationships to be backed by investment in partnerships and reform. Take a look. You may even be inspired to put the next global Law Enforcement and Public Health Conference on your agenda, set for Edinburgh in October.

 

petri dish with DNA fingerprint

3 Things You Should Know About the Petrie-Flom Center’s 2019 Annual Conference

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive, and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

We are excited, therefore, to have many major thought leaders in this space discuss these issues at the Petrie-Flom Annual Conference, “Consuming Genetics: Ethical and Legal Considerations of New Technologies,” which will take place at Harvard Law School in May. Read More

Call for Proposals: ASLME Health Law Professors Conference

Loyola University Chicago School of Law and the American Society of Law, Medicine & Ethics look forward to hosting the 42nd Annual Health Law Professors Conference on June 5-7, 2019 in Chicago.

We welcome your proposals for the conference program, which should be submitted via this form by January 15, 2019.

We are also pleased to introduce a new opportunity to publish your work in a special post-conference issue of the Journal of Law, Medicine & Ethics. Further details are provided below the fold.

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