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Keep up to date with the latest news, research and activity in patient safety.

‘Catastrophic’ gaps in tech regulation plans

Proposed amendments to UK medical device regulations are “a disgrace” and risk creating the lowest barrier to entry for high-risk AI devices in the developed world, sector experts have told HSJ.
Under the draft rules, which have been submitted to the World Trade Organisation ahead of being laid before Parliament, software designed to diagnose a condition can face greater regulatory scrutiny than software designed to treat one.
This means a company could deploy an AI chatbot designed to treat patients with severe mental health problems without independent regulatory scrutiny by self-certifying its own safety in the same category as a walking stick.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published draft pre-market regulatory requirements for medical devices and in vitro diagnostic devices entering the market.
This was the most significant update to the UK Medical Device Regulations (MDR) 2002 since Brexit, when the UK left the EU MDR.
However, regulatory leaders have aired concerns about the draft amendments, particularly around the risk classification of software.
Read full story (paywalled)
Source: HSJ, 18 May 2026
Patient Safety Learning

USA: Supreme court allows abortion pill mifepristone to continue to be available by mail

The US supreme court upheld nationwide access to mail-order mifepristone, an abortion medication, in a shadow-docket decision on Thursday.
Louisiana sued the US Food and Drug Administration (FDA) in October in a bid to curtail the regulatory agency’s rules on prescribing mifepristone remotely, arguing that it interfered with the state’s ban on abortion.
The fifth circuit ruled in Louisiana’s favor on 1 May, effectively banning mail-order mifepristone for the entire country. Two mifepristone manufacturers, Danco Laboratories and GenBioPro, filed an emergency request with the supreme court, which granted a temporary stay until at least Thursday.
In a 7-2 decision with dissents from justices Clarence Thomas and Samuel Alito, the court sided against the fifth circuit, ending the ban – for now.
In his dissent, Thomas called the mailing of mifepristone to patients “criminal enterprise”. He also noted that the 1873 Comstock Act, which broadly banned people from using the mail to send anything “obscene, lewd or lascivious”, including “any article or thing designed or intended for the prevention of conception or procuring an abortion”, should apply to mifepristone.
Medication accounts for approximately two-thirds of abortions in the US. In large part because of mailed medication, abortion rates have stayed steady in the US despite bans in several states.
Years of research have shown that abortion medications are safe and effective. The recent legal challenges, after the Dobbs decision that upended nationwide access to abortion, have been based on politics rather than evidence, experts say.
Read full story
Source: The Guardian, 14 May 2026
Patient Safety Learning

Crucial progress to stop women and babies dying in childbirth is now in reverse

Hard-won successes in efforts to stop women and babies dying in childbirth have faced a serious setback with recent cuts to foreign aid – and the trend is now reversing in some countries, new figures show.
Significant progress in tackling preventable maternal mortality across the globe had seen the rate decline by 40% in the last two decades.
However, the latest data from the World Health Organisation (WHO) suggests this progress has slowed in recent years, and recent aid cuts by the US, as well as other countries including Britain, will start to reverse those crucial gains.
With Donald Trump in particular slashing America’s foreign assistance programmes by 57%t last year, global aid fell by 23% cent in 2025 compared to 2024, and is projected to drop by a further 5.8% in 2026.
Maternal mortality is particularly acute in parts of Africa, and is already playing out in the Central African Republic, which has the second-highest rate of neonatal deaths globally, according to the UN.
Monica Ferro, head of the United Nations Population Fund’s London office, said that the work over the last 20 years had given the world “hope that finally the world would be on track to reach zero preventable maternal deaths”.
“We know that when funding is cut, services are shut down and women die. It is that simple. It may sound cruel, but it is that simple, and we have the evidence to prove it.”
“It is very disappointing. The women and girls who are losing access to services will not forgive us for promising them a world with more dignity and then failing them because funding is being withdrawn.”
Read full story
Source: The Independent, 10 May 2026
Patient Safety Learning

Antidepressants in pregnancy do not raise children’s risk of autism or ADHD, study finds

Taking antidepressants during pregnancy does not increase the risk of children going on to develop autism or attention deficit hyperactivity disorder (ADHD), according to an analysis of more than half a million pregnancies.
The study, conducted by researchers at the University of Hong Kong and published in the Lancet Psychiatry, analysed data from 37 existing studies that included 600,000 pregnant women who had taken antidepressants, and 25 million women who had no antidepressant use during their pregnancies.
Before controlling for key factors such as pre-existing mental health conditions, the analysis found that antidepressant use by the mother during pregnancy was associated with a 35% increased risk of ADHD and a 69% increased risk of autism.
However, when controlling for confounding factors such as pre-existing mental health conditions, this risk became non-significant. This means the meta-analysis found no significant link between antidepressant use during pregnancy and a greater risk of autism and ADHD in children, after controlling for the mother’s mental health or other influencing factors such as genetics.
Dr Wing-Chung Chang, a professor at the University of Hong Kong and lead author of the study, said: “We know many parents-to-be worry about the potential impact of taking medication during pregnancy; our study provides reassuring evidence that commonly used antidepressants do not increase the risk of neurodevelopmental disorders such as autism and ADHD in children.
“While all medications carry risks, so too does stopping antidepressants during pregnancy due to an increased risk of relapse. Therefore, for women with moderate-severe depression, doctors and patients must carefully weigh the potential risks and benefits of continuing antidepressant treatment during pregnancy against the potential harms of untreated depression.
“Although our study found a small increase in the risk of autism and ADHD in the children of women who had used antidepressants during pregnancy, it also found that this risk disappeared when we accounted for other factors. The increased risk was also seen in the children of fathers who took antidepressants and of mothers with antidepressant use before, but not during, pregnancy.
“Together, this suggests that it is not the antidepressants themselves causing an increased risk in autism and ADHD but it is more likely to be due to other factors, including genetic predisposition to conditions such as ADHD, autism, and mental health conditions.”
Read full story
Source: The Guardian, 14 May 2026
Patient Safety Learning

'We're right on track,' says Streeting as key target for hospital waiting times hit

The government has hit an interim target for speeding up hospital treatment in England.
The goal was for 65% of patients to be treated within 18 weeks by March 2026 – and it hit that, but only just, with the figure reaching 65.3%.
It was seen as the first stepping stone to hitting the 92% target by the end of the Parliament in 2029 – a key manifesto pledge of Labour's.
The news came just hours before Wes Streeting resigned as health secretary, saying there needed to be a leadership challenge as he had lost confidence in the Prime Minister.
Speaking before he resigned, he hailed the achievement – performance was below 59% when Labour came to power.
He said: "It means we are right on track to deliver the fastest reduction in waiting times in the history of the NHS.
"That is thanks to the government's investment, modernisation, and the remarkable efforts of staff right across the country.
"Lots done, lots more to do."
Read full story
Source: BBC News, 14 May 2026
Patient Safety Learning

Southport attack victim accuses trust of ‘cover up’ over care records breach

Hospital staff inappropriately accessed the medical records of victims of the 2024 mass stabbing at a dance class in Southport, HSJ can reveal.
Three young girls – Elsie Dot Stancombe, Alice da Silva Aguiar, and Bebe King – were killed in the attack on 29 July 2024, while 10 others were injured. The perpetrator was jailed for life last year.
Some of the injured were treated at University Hospitals of Liverpool Group. HSJ has learned that a “standard” information access audit carried out by the trust in the days after the incident revealed that 48 staff accessed their records without a good reason. However, this information was not given to the patients involved until this week, following HSJ’s inquiries.
Leanne Lucas survived the Southport attack and was one of UHLG patients whose records were inappropriately accessed.
She told HSJ: “I am absolutely devastated and horrified that my privacy has been invaded when I was at my most vulnerable.  Nothing will take away my gratitude to the staff who saved my life, but 48 people not involved in my care abused their position of trust to access the files of victims who have suffered unspeakable trauma. The decision to keep this from me for almost two years is a new low. I am speaking out as I want this scandal and the attempted cover-up by senior management exposed for what it is.”
The trust denies any attempt at a cover-up. Its board had originally planned to tell those involved about the breach. However, HSJ understands its leadership changed their mind sometime in 2025, after trust directors decided that informing the patients would not be in their best interests, as it risked retraumatising them.
Read full story (paywalled)
Source: HSJ, 14 May 2026
Patient Safety Learning

Increase in corridor care ‘haemorrhaging morale’, trust told

Governors at one of the largest trusts in the country have warned that moving patients from beds to chairs to free up space is a risk to staff and public morale.
University Hospitals Birmingham Foundation Trust has been moving patients from beds on wards to trolleys and chairs in corridors for at least the past two months, to make way for patients who need beds after arriving in an ambulance or attending A&E.
However, staff raised concerns during a governors’ meeting last month that it had also begun moving patients from beds in the middle of the night, and in a way that undermined their privacy.
Staff governor Lee Williams said this was “sitting very uneasily with the staff” and “badly affecting morale”.
Mr Williams said: “My big fear is the advances the trust has made in terms of its morale in the clinical areas is going to haemorrhage away.”
He added: “Sometimes the [location] of these temporary escalation spaces is preventing other healthcare professionals providing the care that they would like to in cramped spaces in bays… and relatives are very unhappy with the situation too.”
Another governor, Gerry Moynihan, described the situation as “shocking”. He questioned if patients are being displaced “so that we can have statistics that say we’ve offloaded ambulances quickly”. He said that at Heartlands Hospital, patients were being offloaded “very quickly”.
Read full story (paywalled)
Source: HSJ, 14 May 2026
Further reading on the hub:
How corridor care in the NHS is affecting safety culture Corridor care guidance needs to move beyond what “should” happen and grapple honestly with why it isn’t Corridor care: are the health and safety risks being addressed?
Patient Safety Learning

Rise in sickle cell disease prompts NHS call for more Black blood donors

Demand for blood needed to treat rare disorders such as sickle cell has soared by more than 130% in 10 years, forcing the NHS to ask for more donors to come forward.
Requests for haemoglobin S (HbS)-negative blood, the type most used in blood transfusions for sickle cell anaemia patients, stood at 82,181 units in 2015. But last year, more than 191,000 units were needed, a 132% increase.
HbS is a type of haemoglobin commonly found in people with sickle cell trait and sickle cell disorder. It gives red blood cells a crescent or ‘sickle’ shape, reducing the flexibility of the cells in blood vessels.
The NHS Blood and Transplant service (NHSBT) has highlighted the soaring demand from sickle cell disease patients and has made urgent appeals for Black people to donate. It has about 775,000 blood donors overall, about 21,500 of them of Black or mixed Black ethnicity.
John James, chief executive of the Sickle Cell Society, said: “These figures show an urgent need for more blood donors, especially from Black and brown heritage communities. The blood types most commonly needed for sickle cell patients are more prevalent in people of Black heritage, who remain under-represented in the donor pool.
“That’s why, working in partnership with NHS Blood and Transplant, we’ve developed our Give Blood, Spread Love programme to increase the number of Black-heritage donors. Giving blood is a simple act that can save or improve up to three lives, and for people with sickle cell it can be life-saving.”
The increase in demand has been attributed to a range of factors, including an ageing population, more use of transfusions where all of a patient’s blood is replaced and an increase in numbers from areas where sickle cell is more common. Many sickle cell patients develop antibodies that mean they require very closely matched blood.
Read full story
Source: The Guardian, 14 May 2026
Patient Safety Learning

NHS drugs go-ahead offers lifeline to children with rare muscle-wasting disease

Hundreds of children with a rare muscle-wasting disease will be able to receive two drugs that can improve their survival in a move parents hailed as a “lifeline”.
The National Institute for Health and Care Excellence (Nice) has published final draft guidance recommending that any patient who would benefit can have either drug.
The move means that anyone in England, Wales or Northern Ireland with spinal muscular atrophy will from Thursday be able to get either nusinersen, also known as Spinraza, or risdiplam, also known as Evrysdi, from the NHS.
SMA is a progressive genetic disorder that causes severe muscle weakness and can affect the ability to move, breathe and swallow. Without treatment, patients face devastating consequences including profound disability and reduced life expectancy. Children with the most severe form of SMA – type 1 – usually die before they reach two.
Prof James Palmer, NHS England’s national medical director for specialised services, said: “These lifeline treatments have offered a phenomenal step forward in care for children and families affected by such a debilitating condition and it is fantastic that they will now be available on the NHS in the long term.
“For parents who faced the unimaginable pain of thinking their child would not reach their second birthday, they now have hope of seeing them walk to school and play with their friends, thanks to these lifechanging new therapies.”
Read full story
Source: The Guardian, 14 May 2026
Patient Safety Learning

One in seven in UK prefer consulting AI chatbots to seeing doctor, study finds

One in seven people are using AI chatbots for health advice instead of seeing their GP, a UK study has found.
The poll of more than 2,000 people found that – of the 15% turning to chatbots – one in four had done so because of long NHS waiting lists.
The study analysed by researchers at King’s College London revealed the potential risks of using AI for health advice. A fifth of respondents who did so said the technology did not encourage them to seek a professional opinion and a similar proportion said they decided against seeking a consultation because of something an AI chatbot had told them.
The research is the first to quantify the use of AI chatbots for health advice, according to the researchers, and signals how the technology is changing the way people are dealing with health problems.
Prof Graham Lord, the lead author of the study, said growing individual use of chatbots was creating “an unregulated AI healthcare system alongside the NHS”.
He added: “This research underlines the scale and pace at which AI is already shaping how people access healthcare. While the opportunities are significant, it also highlights concerns about safety and accountability.
“When something goes wrong with AI, responsibility is often placed on clinicians, even where they have limited control over how AI tools are introduced. To realise AI’s potential, we need greater transparency about what works, what is safe, how decisions are made and how issues are handled – so staff and patients can feel confident in its use. It is vital we respond to what the public are telling us and ensure we build and maintain trust with them and the AI tools we look to deploy.”
Read full story
Source: 13 May 2026
Patient Safety Learning

Trusts expect to miss emergency care target

Four of England’s 10 ambulance trusts are expecting to miss the headline response time target for 2026-27, according to their plans for the year.
Details of trusts’ plans as agreed with their commissioners, collected by HSJ, suggest Category 2 performance could be around 26 minutes 30 seconds nationally, rather than the 25m recovery target.
Recovering response times for Category 2 incidents – which include suspected heart attacks and strokes – has been a key ask from government and NHS England for several years, and has clear targets in the medium-term planning framework.
However, ambulance trusts typically agree their target times each year with integrated care board commissioners and NHSE, based on funding on offer and the expected impact of hospital handover delays, which take crews out of action. They then plan for on-road hours and the staffing needed.
An NHSE spokesperson said: “We have started the year well on track to hit ambitious national targets for category two calls, and we are supporting every ambulance trust to improve their response times and, in some cases, exceed the national target.”
Read full story (paywalled)
Source: HSJ, 13 May 2026
Patient Safety Learning

Repairing EPR data errors could cost NHS at least £13.5m in 2026

NHS trusts in England could spend more than £13.5 million in 2026 on correcting data problems that emerge after electronic patient record (EPR) go-lives, according to analysis by healthcare data specialists MBI Health.
The £13.5m estimate is based on MBI Health’s estimate of nine number of major acute trust EPR transitions expected to go live in England during 2026, multiplied by a typical post-go-live data remediation cost of £1.5m per trust.
The figure covers the direct cost of post-go-live remediation work needed to stabilise waiting list data, validate pathways, restore confidence in reporting and help trusts manage waiting lists.
It does not include wider productivity losses, internal staff time, longer-term optimisation costs, delayed benefits, or the impact of any patient safety incidents.
Dr Marc Farr, chair of the NHS Chief Data and Analytical Officer Network, said: “Too often, data experts are brought in too late in EPR programmes, when key decisions have already been made.
“If we want these transformations to succeed, data and analytics leaders need to be at the table from the outset, shaping how systems are designed, implemented and data assured.
“EPRs represent one of the largest digital and data investments NHS organisations will make. When issues emerge after go-live, they can take significant time and resource to resolve, delaying benefits and adding pressure to frontline teams.
“The reality is that many of these challenges originate long before implementation. By prioritising data quality and integrity and readiness early, organisations can reduce risk, avoid disruption, and ensure these programmes deliver the value that patients and staff need.”
The risks of EPR transitions extend beyond remediation costs. A recent national review by the Health Services Safety Investigations Body confirmed that new EPR programmes can contribute to missed, delayed or incorrect patient care due to issues in implementation, usability, training and optimisation.
Helen Hughes, chief executive at Patient Safety Learning, said: “Reliable patient records are fundamental to safe care, and when things go wrong, there is a risk that important clinical details are overlooked or that patients experience delays in their care.
“Investigations into EPR-related incidents have shown that these risks can contribute to situations where patients fall through the cracks, receive the wrong treatment, or come to harm in other ways, highlighting the importance of managing patient safety risks carefully during major digital transitions.”
Read full story
Source: Digital Health, 13 May 2026
Patient Safety Learning

FDA blocks publication of studies showing covid and shingles vaccines to be safe

Officials from the US Food and Drug Administration have blocked the publication of several studies of Covid-19 and shingles vaccines conducted by the agency’s own scientists, it has emerged.
Each blocked study showed the safety of widespread use of vaccines for both conditions.
A spokesperson for the Department of Health and Human Services has confirmed the move, first reported by the New York Times.
FDA scientists conducted the studies, in which they analysed millions of patient records, with the help of a data firm and millions in taxpayer dollars. Two Covid-19 vaccine studies were accepted for publication by medical journals, but in October 2025 the authors were told to withdraw them.
In February 2026 top FDA officials did not sign off two studies of Shingrix, a shingles vaccine. The abstracts required approval for submission to a conference on drug safety.
When questioned by The BMJ the Department of Health and Human Services (HHS), which oversees the FDA, defended the decision.
“The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data,” Emily Hilliard, HHS press secretary, told The BMJ. “The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.”
Critics said the blocks on the studies were another example of antivaccine sentiment from the HHS head, US health secretary Robert F Kennedy Jr.
Read full story
Source: BMJ, 8 May 2026
Patient Safety Learning

Australia: Patients of retired dentist warned of bloodborne viruses, including HIV

Authorities in Australia have issued a warning to patients of a retired dentist, urging them to test themselves for bloodborne viruses due to "poor infection control practices" at the clinic.
Thousands of patients at Dr William Tam's clinic in Strathfield, western Sydney may have been exposed to hepatitis B, hepatitis C and HIV, the New South Wales state health ministry said in a statement on Wednesday.
The Ministry urged patients to see a doctor and test for such viruses, thought it noted that the "risk is low".
Tam is now retired and de-registered as a dentist, the statement said.
"The poor infection control practices at Dr Tam's practice means all former patients may be at low risk of a blood borne virus infection, which can have serious and long-lasting health impacts," Dr Leena Gupta, the public health clinical director of the Sydney Local Health District, said in the ministry statement.
"People with HIV, hepatitis B, or hepatitis C may not have any symptoms for decades, so it is important that people at risk of these infections are tested, so that they can access treatment as appropriate."
Gupta said they believed Tam had seen thousands of patients in the last 25 years, but there were no records that could be used to contact them.
Read full story
Source: The Guardian, 13 May 2026
Patient Safety Learning

Expert calls for safety review at Scotland's troubled superhospital

A risk assessment should be carried out on Glasgow's entire Queen Elizabeth University Hospital campus, a leading safety expert has told BBC Scotland News.
Andrew Poplett, who conducted safety reviews for the Scottish Hospitals Inquiry, said it was "incredibly difficult" to say whether the hospital was safe or unsafe for all patients.
NHS Greater Glasgow and Clyde has admitted there were failings with the hospital when it opened and now accepts that some patient infections were probably linked to contaminated water.
The board has said the whole hospital is now safe but families and lawyers for the public inquiry say they want to see further evidence to back this up.
The Scottish Hospitals Inquiry was ordered in 2019 after a number of deaths and high levels of infection at the QEUH campus, which had opened just four years earlier.
The inquiry drew to a close in January and Lord Brodie's final report is expected later this year.
Engineer Andrew Poplett was the independent expert who wrote reports on water and ventilation, external for the inquiry.
First Minister John Swinney and the health board have said Poplett's evidence supported the claim that both the QEUH and the Royal Hospital for Children, on the same site, were now safe.
But in an exclusive interview with BBC Scotland News, Poplett said it was "incredibly difficult to give a black and white 'safe or unsafe' answer".
He said this was because of the complexity of assessing risk when caring for vulnerable patients.
Popplett said: "If you want to reassure the public that this building is safe, do a risk assessment.
"You don't need to wait for a final report from the public inquiry."
Read full story
Source: BBC News, 12 May 2026
Patient Safety Learning

‘Unprecedented’ global effort gives new name to polycystic ovary syndrome – and new hope to millions of women

After more than a decade of global consultation, polycystic ovary syndrome (PCOS) – a condition that affects one in eight women – has been renamed.
The hormonal disorder, estimated to affect 170 million women worldwide, will now be known as polyendocrine metabolic ovarian syndrome (PMOS).
The name change was published in the Lancet and announced at the European Congress of Endocrinology in Prague on Tuesday, after 14 years of collaboration between international societies and patient groups across six continents.
The renaming was spearheaded by the endocrinologist Prof Helena Teede, the director of Melbourne’s Monash Centre for Health Research and Implementation. For too long, experts including Teede say, the misleading nature of the term “polycystic” in PCOS contributed to delayed diagnosis and inadequate medical care.
Announcing the new name at the European Congress of Endocrinology in Prague on Tuesday, Teede said the term PCOS didn’t capture the “multi-system burden that people with this condition have suffered”, and that it “directs attention to only one organ”.
PMOS is hoped to better reflect the condition’s complex nature – which affects not only the reproductive system in people assigned female at birth but also the metabolism and the risk of diabetes and cardiovascular disease.
Read full story
Source: The Guardian, 12 May 2026
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