By Stephen Wood
COVID-19 and other diseases aren’t the only threat to health care workers. Violence in the workplace is a common occurrence and on the rise.
Despite these troubling trends, the policy response at both federal and state levels has, so far, been lacking.
In a recent survey of nurses, 59% reported that they had been the victims of workplace violence. More than half of those respondents went on to report that they were not satisfied with how the incidents were handled.
By John Tingle
The second World Health Organization (WHO) World Patient Safety Day was held on September 17th, 2020.
WHO made a call for global support, commitment, and collective action by all countries and international partners to improve patient safety. The theme for the year is “health worker safety: a priority for patient safety.”
The annual WHO World Patient Safety Day campaign is a welcome one, especially in the context of the COVID-19 pandemic.
By John Tingle
Adding to the enormity of the challenges facing the NHS in developing a patient safety-focused culture, NHS Resolution and the Care Quality Commission (CQC) have recently produced important reports on NHS litigation and poor care. The analysis of these reports will help to reveal the full nature and extent of the NHS’s patient safety problems.
On August 19, 2020, the Constitutional Court of Uganda passed a landmark judgment in which it pronounced that the Government of Uganda’s omission to adequately provide basic maternal health care services and emergency obstetric care in public health facilities violates the right to health, the right to life, and the rights of women as guaranteed under the country’s Constitution.
Uganda’s maternal mortality rate is unacceptably high, at 343 per 100,000 live births. This means that Uganda loses 15 women each day from pregnancy and child birth related causes.
In its judgment, the Court directed the Government of Uganda to prioritize and provide sufficient funds in the national budget for maternal health care. The Court also ordered, through the Health Minister, that all the health care workers who provide maternal health care services in Uganda be fully trained and all health centers be properly equipped within the next two financial years (2020/2021 and 2021/2022).
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.
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, Spotify, Tunein 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.
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.
By Beatrice Brown
The COVID-19 pandemic has prompted several states to take steps to temporarily authorize therapeutic substitution of drugs experiencing sudden shortages, whether due to spikes in demand or supply chain disruptions.
Although these instances of replacing patients’ typical prescription drugs with different drugs intended to have the same therapeutic effects have been prompted by necessity, therapeutic substitution more generally might reduce drug spending in the United States.
In a recent piece in the BMJ, Jonathan Darrow, Jessica Chong, and Aaron Kesselheim explore using state laws to expand the authority of pharmacists to substitute clinically similar alternatives in order to help cut spending. Actions taken by states to temporarily allow therapeutic substitution can help them gain experience with this strategy and potentially lead to broader and more permanent drug substitution policies that could help decrease drug spending.
This is the first 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.
By John Tingle
As the dust begins to settle around the COVID-19 pandemic, a clearer picture is beginning to emerge of possible litigation trends against the United Kingdom’s NHS (National Health Service) for actions taken during the crisis.
Many NHS services have been reduced or suspended during the crisis. Negligent delays in treatment are a common cause of action in clinical negligence and medical malpractice cases. Legal claims could be made by patients who argue that they have suffered, and continue to suffer, because of lack of access to care and treatment due to COVID-19 NHS emergency restrictions. These claims raise tort, public law and human rights concerns, and some law firms have already been approached by patients asking for advice in this area.