Senior citizen woman in wheelchair in a nursing home.

COVID-19 and Nursing Homes: The New York State Experience

By James W. Lytle 

While New York State has generally earned high marks for its response to the COVID-19 pandemic, nagging questions continue over whether more might have been done to protect patients in nursing homes and other congregate settings — and whether some of the state’s policies even may have made matters worse.

Lessons from the New York State experience may prove helpful to those regions that have displaced New York as the epicenter of the American pandemic, and may help ensure that adequate steps are taken to protect the most frail and vulnerable among us from any resurgence of COVID-19 or from some future disease.

Although New York was among the hardest hit states, with the highest number of deaths thus far (over 32,000, more than twice as many as California), the aggressive steps taken by Governor Andrew Cuomo and his administration have been widely credited with reducing the spread of the disease in the State.

But a key, sustained criticism of the Governor’s handling of the pandemic focuses on the state’s nursing homes.

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Money.

Conflicts of Interest in the Hospital Sector: A Q&A with Rina K. Spence

By Chloe Reichel

Brigham and Women’s Hospital recently made headlines when the Boston Globe reported that the hospital’s president, Dr. Elizabeth Nabel, held a seat on the board of Moderna, a Cambridge biotech company that is working to develop an mRNA COVID-19 vaccine. The hospital has a major role in a national study of the vaccine.

The hospital maintained that safeguards were put in place to protect against conflicts of interest during the collaboration. Nevertheless, amid public outcry, Nabel stepped down from the board.

But this story is just one high-profile case of what is commonplace in the hospital sector. A 2014 research letter published in the Journal of the American Medical Association found that 40 percent of pharmaceutical company boards of directors had at least one member who also held, at the same time, a leadership role at an academic medical center.

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NHS building

The Long and Winding Road of NHS Complaints System Reform

By John Tingle

Sadly, the NHS (National Health Service) has not been able to get its complaint system right, even after decades of trying.

Despite several reports published over two and half decades detailing the challenges the complaint system faces, as well as potential solutions, it still is not fit for purpose. Most recently, the Parliamentary Health Service Ombudsman (PHSO) has produced a report on complaint handling with a focus on the NHS. It is a good, hard-hitting report, which spells out clearly the problems, difficulties, and opportunities to put things right with NHS complaints.

It is, however, another good NHS complaint system reform report in a long line of others. The other reports failed to change adequately the NHS complaints culture and there is little evidence to suggest that this one will succeed where the others have failed.

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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.

Busy Nurse's Station In Modern Hospital

Finetuning Liability Protections in the COVID-19 Emergency

By James W. Lytle 

When the scope of the COVID-19 pandemic became apparent, legal commentators, physician organizations, and health care policymakers sounded the alarm over the potential civil and criminal liabilities that practitioners and facilities might face during the emergency.

In short order, the federal government and many states enacted liability limitations.  At least two states—Maryland and Virginia—had pre-existing legislation that was triggered by the emergency, while many other states enacted or are considering new legislation to limit liability during the crisis.

While the source (executive or legislative), scope (civil or criminal), and precise terms of these liability protections varied by jurisdiction, the speed with which they were enacted was remarkable, given the intensely contentious political battles that typically ensue over medical malpractice and civil justice reform.

Predictably, at least one state has already begun to tinker and fine-tune its liability limitations. Just three months and twenty-one days after liability protections were enacted, the New York State legislature sent a bill to Governor Andrew Cuomo that curbs those protectionsThe Governor signed the bill into law on August 3rd.

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NHS building

First Do No Harm: The Independent Medicines and Medical Devices Safety Review

By John Tingle

A new hard-hitting report on medicines and medical device safety published in the U.K. presents controversial proposals that have the potential to improve National Health Service (NHS) patient safety.

The report, The Independent Medicines and Medical Devices Safety Review, was published on July 8th, 2020 after a two year investigation chaired by Baroness Julia Cumberlege. The review investigated two medications — Primodos and sodium valproate — and one medical device — pelvic mesh.

The reviews remit was to examine how the healthcare system in England responded to reports about harmful side effects from medicines and medical devices and how best to respond in the future.

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Woman surfing.

#MedBikini and Social Media Peer Review

By Louise P. King

Recently, #MedTwitter was awash with pictures of medical professionals in bikinis as a unique and effective protest to a flawed, and now retracted, journal article.

Those posting objected to the methods used and implicit bias contained in a recently published article in the Journal of Vascular Surgery. The authors replicated the methods and conclusions of a prior 2014 study, which did not garner the same attention at the time.

In both studies, various authors from different branches of surgery created fake accounts on social media and then used Accreditation Council for Graduate Medical Education (ACGME) lists of residents to scrutinize their public profiles for evidence of “unprofessional” conduct. Each of these studies was presented at a national meeting.

But having men create fake accounts to then secretly monitor residents’ social media profiles for what they personally find objectionable is not scientifically rigorous, and itself represents unprofessional behavior.

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