Senior female woman patient in wheelchair sitting in hospital corridor with nurses and doctor

Care Quality Commission Annual Assessment of Health and Social Care

By John Tingle

The independent regulator for health and social care in England, the Quality Care Commission (CQC) has recently published its annual report on the real-time state of health and social care in England. It analyses trends, shares examples of outstanding, good, and poor health care care practices. It provides a true, unabashed account of issues facing the National Health Service (NHS) and health care delivery.

A Health System Stretched

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Hand placing wood toy block on top of a tower. The blocks all have images of medical-related items on them, like pills, stethoscope, syringe

Lost in the Jungle of Patient Safety Reports, Publications and Initiatives?

By John Tingle

In terms of the progress of developing a patient safety culture in the National Health Service (NHS) in England, the Daily Telegraph reports comments made by Professor Ted Baker, the Chief Inspector of Hospitals at the Care Quality Commission (CQC) at a recent conference in London. He held the view that “little progress” has been made improving patient safety in the NHS in 20 years, and that never events such as wrong site surgery were still happening because the overall culture is one of defensiveness. The Telegraph reported, “He told The Patient Safety Learning conference that hospital managers routinely hide evidence from the CQC, because they regard the organisation as out to blame them.”

The Telegraph also mentions an NHS estimate in July that 11,000 patients a year may be dying as a result of blunders, partly as a result of a “blame game” culture between staff.

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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!

NHS logo on the side of a building

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

Black silhouette of girl with a pony tail looking down in a dark tunnel

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

Digital text reading "No Signal"

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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