Technical illustration of a respirator device

Why Medical Device Regulation?

By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

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

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, 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 July. The selections feature topics ranging from the price increases of protected-class drugs in Medicare Part D, to the impact of price regulation on the availability of new drugs in Germany, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

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Fazal Khan on ‘The Week in Health Law’ Podcast

By Nicolas Terry

This episode was recorded at the annual meeting of the Southeastern Association of Law Schools during a panel reviewing the year in healthcare financing. This episode features a talk by Professor Fazal Khan who teaches Health Law & Policy, Bioethics, Public Health Law and International Products Liability at the University of Georgia School of Law. His current research focuses on several major themes: reform of the American health care system, the effect of globalization on health care, and the challenge of regulating emerging biotechnologies. His talk was on the financing of telemedicine and the slow alignment of the technologies with health care value and other models.

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 and @WeekInHealthLaw.

Subscribe to TWIHL here!

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Testing the Temperature of Patient Safety in the NHS

In terms of transparency and accountability the National Health Service ( NHS) in England is excellent at producing insightful, well-produced reports on health quality and patient safety. It does this on a regular basis and one of the great difficulties faced by NHS nurses and doctors today is the sheer volume of reports published. It’s an impossible task for nurses and doctors to keep up to date with all the reports published and to maintain heavy workloads in resource constrained environments. It’s also hard for health care staff to know which reports to prioritize and which are authoritative.

There is an urgent need for the NHS to create a one stop, patient safety information hub which collects reports from all NHS sites and other important global sites, putting everything into one accessible place. Some recent reports on written patient complaints have been published which are helpful in assessing, testing patient safety and health quality in the NHS. Read More

Suicide Prevention and Patient Safety

Suicide prevention needs to be taken more seriously globally by governments, health systems as an urgent public health concern.

WHO (World Health Organisation) states that close to 800,000 people die due to suicide every year, which translates to one person dying every 40 seconds. For each adult who died by suicide there may have been more than 20 others attempting suicide. Suicide is the second leading cause of death among 15 to 29-year-olds globally, and occurs throughout the lifespan. Read More

UCL A&E entrance

The NHS Complaints System: Wither the Toxic Cocktail Image?

The National Health Service in England has been trying for many years to get its complaints system right, but it has never succeeded. A great number of reports have been published on the system over the years, some dating back for at least a quarter of a century.

The Care Quality Commission (CQC ) the independent regulator of health and social care in England have just published a report launching a “Declare Your Care” campaign, which raises several important issues about the NHS complaints system. Read More

Patient Safety and Communication Breakdown

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 states 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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Patient Safety Failings in Independent Acute Hospitals in England

By John Tingle

One thing that strikes the UK visitor to the USA is the vast array of  large public and private hospitals that exist with many having trauma and emergency rooms. Private hospitals don’t exist on this scale in the UK. Our major hospitals are public, state run NHS (National Health Service) hospitals. Independent, private acute hospitals are generally small in size, have no emergency rooms and maintain a bespoke health care provision. The focus is on patients with a single condition and routine elective surgery. The myriad number of complex multiple conditions, dementia etc that the NHS regularly face as a norm are not covered in the independent sector here with such cases being screened out. This limited focus on the type of care provided does mean that staff within independent acute hospitals have a sheltered and more controlled work remit and environment. This is a significant patient safety issue.

The Independent Health and Social Care Regulator of England, the Care Quality Commission (CQC) have recently published their findings of independent acute hospital inspections. They inspected and rated 206 independent acute hospitals and the majority were assessed as providing high quality care. At 2nd January 2018, 62% were rated as good,16 (8%) as outstanding. The report contains some very positive findings on health care provision in these hospitals but also some major governance and patient safety failings were found which are very concerning.

The Independent Newspaper reported back in 2015 reported that private hospitals ‘lack facilities to deal with emergencies’, and quoted a study that found that between 2010 and 2014, 800 patients, including those referred by the NHS, died unexpectedly in private hospitals. Read More

Simulated Side Effects: FDA Uses Novel Computer Model to Guide Kratom Policy

By Mason Marks

FDA Commissioner Scott Gottlieb issued a statement on Tuesday about the controversial plant Mitragyna speciosa, which is also known as kratom. According to Gottlieb, kratom poses deadly health risks. His conclusion is partly based on a computer model that was announced in his recent statement. The use of simulations to inform drug policy is a new development with implications that extend beyond the regulation of kratom. We currently live in the Digital Age, a period in which most information is in digital form. However, the Digital Age is rapidly evolving into an Age of Algorithms in which computer software increasingly assumes the roles of human decision makers. The FDA’s use of computer simulations to evaluate drugs is a bold first step into this new era. This essay discusses the potential risks of basing federal drug policies on computer models that have not been thoroughly explained or validated (using the kratom debate as a case study).

Kratom grows naturally in Southeast Asian countries such as Thailand and Malaysia where it has been used for centuries as a stimulant and pain reliever. In recent years, the plant has gained popularity in the United States as an alternative to illicit and prescription narcotics. Kratom advocates claim it is harmless and useful for treating pain and easing symptoms of opioid withdrawal. However, the FDA contends it has no medical use and causes serious or fatal complications. As a result, the US Drug Enforcement Agency (DEA) may categorize kratom in Schedule I, its most heavily restricted category.

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