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The rapid development and use of artificial intelligence (AI) in health and social care raises professional, ethical and legal questions. In February, the Professional Standards Authority for Health and Social Care hosted a participatory workshop in collaboration with academics from the University of Bristol, Dr Helen Smith and Professor Jonathan Ives to explore how we can guide and regulate health and care professionals who use AI. The workshop brought together professional regulators and Accredited Registers, as well as patients, service users and members of the public. Through group discussions and a series of real-world scenarios, participants explored themes such as AI safety, bias, transparency and accountability. In this blog, Patrick Murphy, Policy Advisor, reflects on the messages that came out of the workshop. The value of lived experience The workshop reinforced a key message, that the future of AI in health and care cannot be shaped by technical expertise alone. Creating spaces where patients and service users work alongside regulators and Accredited Registers supports safer innovation. Lived experience brings vital insight into how systems work in practice, where risks can emerge, what the public want and need from regulation, and how to build trust. It also helps support the safe and reliable integration of AI. The workshop was designed with participation in mind. Patients and service users took part alongside regulators and accredited registers on an equal footing. In a space that can sometimes feel highly technical, the workshop showed that meaningful public involvement is both possible and necessary. Participants with lived experience engaged confidently with topics such as assurance, transparency and accountability. Discussions also covered how regulation, standards and guidance are experienced by the people they are meant to serve. A consistent message throughout the day was that patients and service users are not just observers of AI policy and regulation, they are essential partners in getting it right. Their contributions raised practical questions and real-world examples, and kept the focus on how AI-enabled decisions can affect people’s lives, access to services and confidence in care. Equity, transparency and trust Patients, service users and members of the public highlighted several issues that deserve particular attention as AI becomes more common across health and care. If engagement only reaches the most confident, connected or well-resourced groups, AI tools and the rules around them risk being shaped by a narrow range of experience. True inclusion means actively involving people who are often overlooked, so innovation serves everyone and not just those who are easiest to reach. To support safe and fair innovation, tackling inequality needs to be built into every stage, from development, to procurement and service design, to long-term monitoring after deployment. Fairness and equity must be central, not an afterthought. Avoiding harm requires more than technical fixes. It also needs careful scrutiny of the data that feeds AI systems. That includes the data used to train models and the data used in designing health and care services. It is also essential to be clear about which outcomes are being measured and how success is defined. Trust depends on clarity, and it is important to give consideration to how AI is integrated in health and social care. Patients and service users should not feel like they are interacting with a 'black box'. It should be clear when AI is being used, what role it is playing in someone’s care and what options are available if something feels wrong. Empowering people helps them remain partners in their own health and care journey. The workshop highlighted challenges but also the opportunities for health and social care improvement presented by AI. As we navigate this technological transformation, patients and service users should remain empowered through co-production, helping to shape the standards, guidance and regulation that govern how AI is designed, deployed and monitored in practice. To find out more about the workshop and read the report, visit: Artificial intelligence - how to guide and regulate for health and social care professionals using AI- Posted
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Southport attack victim accuses trust of ‘cover up’ over care records breach
Patient Safety Learning posted a news article in News
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- Posted
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Martin Fletcher, hub topic lead for professionalisation and regulation, has been part of transformational change in professional regulation through his tenure as Chief Executive of the Australian Health Practitioner Regulation Agency (Ahpra). In a new blog for the hub, Martin asks: How do we better connect the work of professional regulation with a systems focus on improving patient safety? And how do we navigate this interface in a health and societal context which is rapidly changing? Zubin Austin writes eloquently about the challenges of the ‘chaotic tumult’ of the many wicked problems that face professional regulators and, indeed, our health system more widely.[1] These form both the context and scaffolding for our work in years to come. The rise of entrepreneurial and profit-driven models of care, telehealth, unregulated medicines for sale online, the role of social media and AI-driven therapeutics are disruptors which have introduced new risk profiles. Traditional regulatory frameworks and approaches to patient safety must adapt. These shifts demand new thinking around safety, accountability, transparency and equity. Traditionally, professional regulation has more narrowly focused on the conduct, competence and performance of individual health practitioners, with an emphasis on public protection. However, we know that the safety of patients is shaped by a wider range of inter-related factors, including clinical governance, team dynamics, design of systems and processes, technology and organisational safety culture. There can be no healthcare without a health workforce. And an ethical, safety-conscious, competent and accountable health workforce is critical for a safe, high quality healthcare system. I have previously written for Patient Safety Learning on the need to more closely link the work of service, product and system regulators, and patient safety improvement bodies. Shared goals, role clarity, information flows and aligned actions are critical. When we operate in silos, we risk missing the bigger picture. Without coordinated action across agencies, patients remain vulnerable. The rapidly growing cosmetic practices sector illustrates these challenges vividly. In both Australia and the UK, reviews have shown that regulating practitioners alone isn’t enough.[2] [3] Products, procedures, facilities, social media, information asymmetry, service licensing arrangements and weak professional ethics all contribute to the potential risk of harm to patients. More widely, there are significant opportunities to better use and share data and intelligence to both anticipate and understand risks of patient harm. The legalisation of medicinal cannabis in Australia powerfully illustrates this need. Incident reports, notifications and complaints are often lag indicators—we need to get ahead of emerging risks of harm to patients, especially in the face of the many healthcare disruptors we face. I hope the hub community is a vehicle for sharing ideas, strategies and real-world examples of how to build foundations and bridges between professional regulation and patient safety improvements more widely. New thinking and approaches are needed. And despite many differences in the way that health systems are organised and funded across the world, there are many common challenges. References Austin Z, Haji A. Regulation of wicked problems: opportunities, responsibilities, and threats. J Med Regulation. 2023;109(3):6–11. doi:10.30770/2572-1852-109.3.6. Brown A, Duggan A, Kirkland A, McCausland R. Independent review of the regulation of medical practitioners who perform cosmetic surgery: Final report. Melbourne: Australian Health Practitioner Regulation Agency; August 2022. UK Parliament. The regulation of non-surgical cosmetic procedures in England. House of Commons Library, 10 September 2025. Further blogs on the hub from Martin Professional regulation and patient safety systems: parallel planets or partners in improvement?- Posted
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Understanding the Patient Safety Framework
Patient Safety Learning posted an event in Community Calendar
untilHow the Patient Safety Framework and related investigations should work when serious incidents happen Join Making Families Count for a new series of lunchtime online seminars for families, carers, and health professionals. These free one-hour sessions bring together expert speakers with family carers to explore key issues in mental health care, patient confidentiality, suicide bereavement, and patient safety. Each event will include the opportunity to submit questions in advance. Whether you are supporting a loved one, working in health services, or seeking to better understand these issues, these sessions aim to provide practical insight, clearer understanding, and greater confidence. Led by: Ashley Windebank-Brooks, Head of Patient Safety at North Bristol NHS Trust Respondent: [Name to be confirmed] About this session This session will explain how the Patient Safety Framework and related investigations should work when serious incidents happen. Topics will include: What patient safety investigations are for. What families should be entitled to expect. What good practice looks like. How learning and accountability should be handled. A valuable session for anyone wanting to better understand how safety investigations should support learning, transparency, and improvement. Register- Posted
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Last month, Public Policy Projects hosted their annual Patient Safety Forum in partnership with Patient Safety Learning. Held at the Royal College of Surgeons of England in London, it was attended by senior healthcare leaders, patient safety experts, representatives from the HealthTech industry, frontline healthcare professionals and patients. In this article, Patient Safety Learning reflects on one of the panel discussions—AI for patient safety: Innovation, assurance and strengthening communication. From AI-enabled ambient scribing tools that reduce the burden of administration, to predictive systems capable of detecting early warning signs before harm occurs, AI has significant potential to improve patient care and outcomes. Yet, alongside these benefits come risks—algorithmic errors, data bias, and challenges in maintaining trust, governance and oversight. At the Patient Safety Forum 2026 an expert panel was convened to discuss this topic, with the following members: Clive Flashman, Chief Digital Officer, Patient Safety Learning Dr Alison Cave, Chief Safety Officer, Medicines and Healthcare products Regulatory Agency (MHRA) Anil Mistry, AI Safety Lead, Guy’s and St Thomas’ NHS Foundation Trust Dr Basil Bekdash, Clinical Safety Officer, Sheffield Children’s NHS Foundation Trust Aleksander Alski, Head of Region – USA, Canada and UK, Vasco Electronics Panellists had a lively discussion with each other and the audience about how to balance innovation with assurance, to ensure that the use of AI in healthcare enhances safety rather than undermines it. They spoke about how AI should be understood as a support tool for healthcare professionals—it provides information and removes burden but, ultimately, staff treat patients. In this blog we highlight several key topics that emerged from this debate. Importance of patient safety A key theme running throughout the panel’s discussion was the importance of patient safety being built into AI development at the outset. Clive Flashman from Patient Safety Learning reflected on this point, suggesting that too often this is seen as a compliance ‘tick box’ or treated as an afterthought. Speaking to digital innovators, his message was that “you need to think about this from the very start when you are conceptualising the product”. Panellists also recognised that putting safety at the centre of discussions around AI and healthcare means involving all stakeholders, not just the healthcare professionals using these technologies but suppliers too. Alexander Alski from Vasco Electronics emphasised the importance of this being an area of shared responsibility between suppliers and healthcare providers. Getting regulation right Alison Cave from the MHRA spoke about the ongoing work of the National Commission into the Regulation of AI. This Commission was established by the MHRA to review current regulations and provide recommendations for a new regulatory framework for AI in healthcare. It held a public call for evidence which Patient Safety Learning responded to earlier this year. Discussing how to approach future regulation, she highlighted the importance of ensuring that “the risk is associated with the decision, not the technology itself”. It was noted that in some cases there may be very complex pieces of software in use, but these may be making very low-risk decisions. Panellists underlined the importance of having a risk-proportionate regulatory framework to support safe innovation. Predicting future harm The potential to use AI to identify patient safety issues is understandably an area of significant interest. Last year the Department of Health and Social Care announced that it planned to develop a world-first artificial intelligence (AI) early warning system to automatically identify safety concerns across the NHS. Panellists were asked to consider what examples they had seen of AI moving from reacting to incidents, to predicting and preventing future harm. They spoke about the value of AI as a support tool for clinicians and more broadly how it might be used to identify emerging patient safety issues. Basil Bekdash from Sheffield Children’s NHS Foundation Trust spoke about work that had been trialled in this area, but noted that currently there have not been many examples where these have been proven on a significant scale, stating: “None of them have really quite got to the point where they're proven in widespread deployment and so I'm not going to predict that's going to happen in the next five years.” Tackling bias While an AI tool may be safe when properly implemented and used by a well-trained healthcare professional, it could be potentially dangerous if such training and support is absent. Panellists concurred that having appropriate training and tackling bias were issues of critical importance in ensuring the safety of AI in healthcare. In particularly they discussed risks presented by: Confirmation bias—healthcare professionals favouring AI outputs that align with their pre-existing view and overlooking signals that may challenge this. Automation bias—over-reliance on AI systems and accepting their recommendations without sufficient critical evaluation. Alison Cave from the MHRA said that part of the training should be ensuring that healthcare professionals understand the devices they are using and where there are trade-offs between sensitivity and a specificity. Basil Bekdash from Sheffield Children’s NHS Foundation Trust noted the importance of having in mind the different levels of digital competence of staff, stating that when designing AI systems: “It is best to test by using your least capable people who are the least digitally enabled and that's not a criticism that's just the reality of the normal spread of what people do, and their primary function is to look after patients.” Transparency and patient communication As use of AI grows in healthcare, it is vital that patients understand how this is being applied if they are to have confidence in its safety. Panellists discussed issues around how to inform patients when AI influences their care, particularly when it affects clinical judgments. Anil Mistry from Guy’s and St Thomas’ NHS Foundation Trust suggested that: “If the AI result is going to affect their patient’s care, and it's going to limit their access to finite resources like a waiting list or appointments or ICU beds, then absolutely have that sort of communication.” However, he also spoke about some of the challenges this raises; for example, if a patient asked about whether AI has been used in their care. In practice this could cover a very broad range of areas, from the use of ambient scribes to take notes to tools that analyse images from scans. Panellists indicated that transparency needed to be balanced and proportionate to both the risk and impact on individual care. Governance requirements AI healthcare technologies have significant scope to evolve and change over time. When they iterate rapidly (with new versions being released at regular intervals) it can be difficult for existing governance frameworks, designed for other types of medical devices, to keep up. Panellists discussed the importance of having flexibility to governance arrangements. There was the suggestion that lower risks tools (such as those in Class 1 for Medical Devices under the MHRA framework in the UK) should have greater flexibility, with higher levels of scrutiny reserved for decision-influencing tools. It was also made clear that any new regulation will need to carefully consider the level of ongoing evaluation that will be required to account for these systems evolving and changing over time. This may be much longer than for other medical devices and change at significant pace. One audience member commented that with these tools becoming increasingly complex, in the future “realistically there is going to be a need for an AI tool that assesses AI tools”. Panellists also considered how procurement processes could act as potential leverage mechanisms for AI technologies in healthcare. It was noted they offer the potential opportunity to embed the open standards we want to see being used by AI technologies in the earliest stages of their design, putting safety concerns at the centre of the product before it ever reaches patients. Improving the quality of data Data accuracy, completeness and representativeness is key to ensuring AI technologies work safely in health and care environments. Panellists noted that poor foundational data standards undermine AI model training and lead to unreliable outputs. Their discussion reflected that a significant proportion of time is often spent on data cleaning before even applying AI. Improving this would have wider benefits for research, operational efficiency and public healthcare. As we increase the use of AI health technologies, it is vital that we do not embed existing health inequalities. Following on from comments in an earlier session from Professor Bola Owolabi from the Care Quality Commission, Alison Cave from the MHRA noted a “perennial challenge in all of our areas is to ensure that the training data is representative”. Training data for AI systems must be representative of diverse populations and care settings. Sharing insights from the frontline If healthcare organisations, professionals and suppliers are to share responsibility for the safe implementation of AI technologies in healthcare, this must go hand in hand with shared learning. Panellists discussed the need for sustained and transparent feedback loops between suppliers, regulators and healthcare organisations. On this point an audience member asked: “How do we ensure our learning keeps pace so that existing insight from frontline teams that really know the business can optimally inform the evolution of products, but without stifling the pace?” Panellists highlighted the absence of standardised mechanisms for frontline staff to provide real-time, structured feedback to AI suppliers on safety issues. One proposed suggestion to this was the potential to mandate native feedback functionality within AI health technologies. This would mean that feedback mechanisms are built directly into the AI tool’s user interface and workflow, allowing those using them to provide input about the AI’s output without leaving the system. Find out more about the Patient Safety Forum 2026 You can read more about different discussions and panel sessions at this year’s event in the below: Patient voice, safety and the NHS 10 Year Plan: Reflections from the Patient Safety Forum 2026 Safe systems, safe cultures: reflections from the Patient Safety Forum 2026- Posted
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At its best, the NHS is capable of extraordinary openness and compassion. But when things go wrong, time and again we see a shift towards defensiveness, organisational protection and, at its worst, outright dishonesty. Despite the introduction of the Duty of Candour more than a decade ago, this problem has evidently not gone away. The recent interim report from the National Maternity and Neonatal Investigation described families as “feeling that there had been a ‘cover up’ and defensiveness from NHS trusts”, including instances of medical notes being amended or redacted. In the long term, a key enabler of cultural change would be wholesale structural reform of the litigation system. There is much to learn from no-fault compensation systems such as those implemented in Japan. But such reform will require significant legislative change. In the meantime, there are immediate steps we can and should take writes Jeremey Hunt in a commentary for the Health Service Journal.- Posted
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In Northern California and beyond, healthcare systems are rapidly integrating artificial intelligence (AI) and digital tools to transform how pain is recognised, measured, and managed. From algorithm-guided assessments to wearable sensors and predictive analytics, these tools promise to augment clinical decision-making and improve patient outcomes. Yet significant controversies remain, including concerns over algorithmic accuracy, bias, data privacy, and the extent to which technology should complement or potentially displace human clinical judgment. -
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The Department of Health's Being Open Framework for Health and Social Care Northern Ireland is aimed at supporting a culture of openness, honesty, and transparency across health and social care in Northern Ireland. The Framework provides a standardised, yet flexible, regional approach to help create the conditions where a culture of openness and trust can flourish between those who use our services, their families and carers, health and social care staff and leaders and organisations. Purpose of the framework The Framework aims to promote and support a culture of openness, transparency and accountability reflected through compassionate communication with staff, patients, service users and their families and carers, and where ongoing learning enhances and improves patient safety and quality of care. The Framework will help ensure that all staff understand the expectations and responsibilities upon them to operate in an open, just and learning culture, and that they are supported to do so by health and social care organisations, leaders and managers. It is designed not only to guide staff when things go wrong, but also to promote openness, transparency and honesty as part of everyday practice and patient care, and to create a supportive and psychologically safe environment for all. By supporting an open, just and learning culture, patient safety, public confidence and support for staff will be improved. Aims of the Framework Improve patient safety and quality of care by supporting an open, just and learning culture. Normalise openness as a valued everyday behaviour rather than something that is only important in certain circumstances. Position and frame openness as part of mainstream business, not as an optional add-on. Ensure those who use services, their families, carers and staff are listened to and are treated openly, fairly and with compassion and respect; and their experiences and views are recognised as having a valuable contribution to learning and improvement. Ensure HSC staff experience visible, engaged and inclusive leadership at all levels that demonstrates and promotes an open, just and learning culture – including from those in the most senior leadership positions. Enable leaders at all levels of the organisation to drive cultural improvements. Create psychologically safe spaces for all staff to speak up and to learn. Support a move from blame to balanced accountability, and a focus on system-based learning when an event or incident has occurred or where concerns are raised. Support open and prompt sharing of learning across the organisation and beyond as appropriate, both when things go wrong and when they go well. Ensure that all staff understand the expectations and responsibilities upon them to operate in an open, just and learning culture, and that they are supported to do so. Achieve a sustained focus by leaders at all levels, including senior leaders, on embedding an open culture that is informed by both qualitative and quantitative data. Related reading ‘Being Open’ Framework and Duty of Candour in Northern Ireland: Consultation response (Patient Safety Learning, 28 March 2025)- Posted
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Patient safety, speaking up and the role of Royal College reviews in the NHS
Anonymous posted an article in Florence in the Machine
‘Neo’, an Allied Health Professional working on the frontline, reflects on the role of Royal College reviews in the NHS, why they matter and the unintentional consequences that can occur when shared in the public domain. Patient safety sits at the heart of the NHS’s founding principles. Every policy, pathway and performance metric ultimately exists to serve one core purpose: to deliver safe, effective care to patients. Yet ensuring patient safety in a complex, high-pressure healthcare system is not a static achievement. It requires continual reflection, learning and the courage to confront uncomfortable truths. One of the most important—and often misunderstood—mechanisms for doing this within NHS Trusts is the commissioning of Royal College reviews. These reviews offer expert, independent insight into clinical services, workforce challenges, governance arrangements and patient pathways. At their best, they are a powerful method for organisations to speak up, surface risk and identify areas for improvement before harm occurs. However, when these reviews enter the public domain, the resulting media scrutiny and public reaction can create unintended consequences that threaten their future use. What are Royal College reviews and why do they matter? Royal College reviews are typically commissioned by NHS Trusts, Integrated Care Boards or national bodies when there are concerns about service delivery, staffing, outcomes or sustainability. They are conducted by experienced clinicians and system leaders with deep specialty expertise, bringing an external and credible perspective. Crucially, these reviews are not disciplinary processes. They are diagnostic tools. They aim to identify systemic issues—such as workforce shortages, governance gaps, training pressures or service configuration challenges—rather than assign individual blame. In this way, they align closely with the NHS’s stated commitment to a “just culture”, where learning and improvement are prioritised over punishment. For many Trusts, commissioning a Royal College review is an act of organisational maturity. It signals a willingness to ask difficult questions, to listen to expert advice and to address risks proactively. Often, the issues identified will already be known internally but require external validation to unlock support, resources or system-wide change. Transparency versus trust: when reviews go public The challenge arises when Royal College reviews are published or leaked into the public sphere. Transparency is a core NHS value, and patients and the public have a legitimate interest in understanding how services are performing. However, the way these reports are reported and received can significantly distort their purpose. Media coverage frequently focuses on the most alarming language within a report—phrases such as "unsafe”, “not sustainable” or “significant risk”. Stripped of context, these terms can understandably cause public concern and distress. Headlines may imply negligence or crisis, even where a service continues to deliver care safely under immense pressure. For staff working within those services, this can feel deeply demoralising. Clinicians and managers who have actively sought external review in the interests of patient safety may find themselves portrayed as presiding over failure. In some cases, public narratives overlook the structural factors underpinning the findings—national workforce shortages, funding constraints or system-wide demand—and, instead, focus on perceived local shortcomings. The chilling effect on commissioning and publishing reviews Perhaps the most worrying consequence of this dynamic is its potential to deter Trusts from commissioning or publishing reviews at all. If seeking external advice is consistently followed by reputational damage, regulatory escalation or hostile media scrutiny, organisations may understandably become more risk averse. This creates a paradox. The very tools designed to surface risk early and prevent harm can become perceived as liabilities. In extreme cases, this may encourage a culture of silence, where concerns are managed internally or issues are allowed to persist unexamined for fear of public outcry. History has shown the cost of such silence. Major patient safety failures across the NHS have repeatedly been associated with ignored warnings, suppressed concerns and a reluctance to challenge the status quo. Reviews and inspections only become 'bad news stories' when systems fail to listen and act early. Reframing reviews as a sign of strength, not failure If Royal College reviews are to continue playing a meaningful role in patient safety, a shift in narrative is needed—not only within the NHS, but across media, regulators and public discourse. Commissioning a review should be understood as a sign of organisational openness and responsibility. Publishing a review, even when its findings are uncomfortable, should be seen as an act of transparency and commitment to improvement. Reports should be read as starting points for action, not verdicts on competence or care quality. There is also a role for NHS leaders to provide clearer context when reviews are released. This includes explaining why the review was commissioned, what immediate actions have already been taken and how recommendations will be supported at system and national level. Without this framing, reports risk being interpreted in isolation, detached from the wider pressures facing the service. Supporting staff while protecting patients At the centre of this issue are NHS staff—clinicians, nurses, allied health professionals and managers—who are often working at or beyond capacity. Reviews frequently highlight risks arising from workforce shortages or unsustainable rotas, yet public reactions can inadvertently place blame on the very people raising those concerns. Protecting patient safety and supporting staff are not competing priorities. In fact, they are inseparable. A system that punishes honesty, discourages speaking up or treats external review as failure, ultimately undermines both. Royal College reviews offer a rare opportunity: expert insight combined with professional credibility, focused on learning rather than blame. To lose or weaken that mechanism because of fear would be a significant setback for patient safety. Moving forward The NHS is at a critical juncture. Demand continues to rise, resources remain constrained and the margin for error is slim. In this context, the ability to speak openly about risk, invite external challenge and learn from expert review has never been more important. Rather than asking whether Royal College reviews are damaging to public confidence, we should ask a different question: what does it say about a system if organisations are afraid to look honestly at themselves? Patient safety is not protected by silence. It is protected by courage, transparency and a shared commitment to improvement—even when that improvement begins with uncomfortable truths. What are your thoughts and experiences of Royal College Reviews? We'd be interested to hear your views. Add your comments below—you'll need to be a hub member and signed in (sign up here). Further reading on the hub: Read more blogs from staff on the frontline in our Florence in the Machine series.- Posted
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Trusts scramble to improve reviews of babies’ deaths
Patient Safety Learning posted a news article in News
Trusts have been scrambling to make reviews of babies’ deaths more “fair and transparent”, after a new national requirement for independent input. Maternity providers are required to review all perinatal deaths, and it has long been a national recommendation that they should involve at least one external, independent reviewer. However, in April 2024, it became a formal requirement from NHS Resolution to have an external reviewer in at least half of the cases. Figures obtained by HSJ show that at least 19 trusts did not meet this benchmark overall in 2024. NHSR, which runs the NHS clinical negligence indemnity scheme, said the requirement “ensures that reviews are conducted with fairness and transparency built on open, honest conversations and free from any internal bias”. One trust did not use external reviewers at all to look at late miscarriages, stillbirths and neonatal deaths, while others only used them for a small fraction of cases. The external reviewer is required to be a relevant senior clinician who is not part of any trust involved in the case. Read full story (paywalled) Source: HSJ, 26 January 2026- Posted
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An NHS trust has admitted that a highly vulnerable baby died because of contaminated feed that it gave her, after denying that for more than a decade. At an inquest on Tuesday, Guy’s and St Thomas’ trust said it had given Aviva Otte a nutritional product containing deadly bacteria in January 2014. It had previously insisted to her mother, a coroner and the Guardian on multiple occasions that she had died of natural causes. The change in GSTT’s explanation of Aviva’s death came during the second day of an inquest into her death and the deaths of two other babies in a separate outbreak of Bacillus cereus five months later. Giving evidence at Southwark coroner’s court in London, Dr Grenville Fox – a senior consultant neonatologist who worked in the neonatal unit where Aviva was treated – said that it was now his opinion that the parenteral nutrition she received was the main cause of her death. His statement represents a significant U-turn by GSTT. It also raises questions about its conduct and honesty over the first outbreak of Bacillus cereus in late 2013 and early 2014, in which four babies including Aviva were infected, which the Guardian first revealed in June 2022. Read full story Source: The Guardian, 10 September 2024 -
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The NHS is striving to become the “most transparent health service in the world”, its deputy chief has said. In an exclusive interview with HSJ, NHS England’s interim deputy CEO David Probert also said he was hopeful the organisational turmoil in the health service would “settle down” next year and system leaders could start “to look forward”. Read the full article (paywalled) via the link below.- Posted
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Government refuses move to force industry to disclose payments
Mark Hughes posted a news article in News
The government has rejected calls for legislation requiring industry to disclose its payments to the healthcare sector, five years after a major review said statutory rules should be introduced. It will produce guidance for both the pharmaceutical and medical devices industries instead, it has announced in a new consultation outcome document. This will set out which payments should be reported, as well as the format and frequency of the reporting. This was one of the recommendations from the 2020 Cumberlege Review, which investigated three women’s health scandals. It found transparency of payments in the healthcare sector was needed to guard against both real and perceived conflicts of interest. There was concern that such conflicts could be encouraging the use of unsafe devices and practices. Read full article (paywalled). Source: Health Service Journal, 19 December 2025- Posted
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From the 4 September to 16 October 2023 the Department of Health and Social Care held a public consultation seeking views on the possible introduction of regulations mandating the disclosure of industry payments to the healthcare sector. This report sets our the UK Government's formal response to the findings of this consultation. The Government response is stated as follows: The government wishes to express its gratitude to all of those who contributed to this consultation, and their patience while the analysis and response was finalised. It is clear from the majority of responses that there is a need for better transparency regarding payments made between industry and: registered healthcare professionals healthcare provider organisations organisations connected to the provision of healthcare The government fully supports this sentiment, recognising the importance in enabling patients to make informed decisions about their own care and improving the transparency of industry payments. In response to this consultation, the government will develop and publish clear guidance in relation to disclosing payments made by the medicines and medical devices industries to the healthcare sector. This guidance will set out best practice for industry to follow, which will advise on: which payments should be reported the format of the reporting the frequency of the reporting The government will monitor the uptake of this forthcoming guidance. While the government acknowledges that a number of stakeholders favoured a legislative approach to payment disclosures, this guidance-based approach will allow patients to benefit from industry reporting more quickly, without further delays that could have followed the introduction of legislation and the establishment of a government reporting and compliance system. This positive step towards transparency will add clarity to the relationship between industry and healthcare professionals, assisting patients in making informed decisions about their care. Over the coming months, officials will work with stakeholders to develop a robust set of guidelines, with careful consideration given to the range of valuable suggestions provided by respondents to the consultation. This will ensure that the guidance is comprehensive and captures all relevant payments to healthcare-related professionals. To date, no formal government guidance has been available for industry to follow and against which patients can hold the sector to account. This step will provide certainty for industry and stakeholders, as well as a clear path to improve transparency and improve public safety. This decision is also aligned with the government’s commitment to reduce regulatory burden on industry. It will provide industry with the space to show leadership and a commitment to transparency, while minimising regulatory requirements that could be especially detrimental to small and micro businesses.- Posted
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Trust told to open up about ‘maternity scandal’ meeting
Mark Hughes posted a news article in News
A trust under fire for quality and governance failures has been reprimanded by a watchdog for withholding information about a meeting of its senior leaders over maternity failures. The row relates to a meeting of the CEO, chief medical officer and chief nurse of Leeds Teaching Hospitals Trust with the chair and director of corporate governance at Swansea Bay University Health Board in February this year. Swansea has, like Leeds, been subject to major concerns about maternity and neonatal care failures in recent years, and in the summer was criticised in an independent review. The online meeting was held weeks after LTHT admitted that the deaths of 56 babies and two mothers may have been preventable, as its maternity and neonatal services came under increased scrutiny. Read full article (paywalled). Source: Health Service Journal (21 November 2025) -
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Healthcare organisations risk harming patients and their families twofold. First, through the physical, emotional and/or financial harm caused by safety incidents themselves, and second, through the organisational response to incidents. The former is well-researched and targeted by interventions. However, the latter, termed ‘compounded harm’ is rarely acknowledged. This study aimed to explore the ways compounded harm is experienced by patients and their families as a result of organisational responses to safety incidents and propose how this may be reduced in practice. The authors identified six ways that patients and their families experienced compounded harm because of incident responses. These were feeling: (1) powerless, (2) inconsequential, (3) manipulated, (4) abandoned, (5) de-humanised and (6) disoriented. It is imperative to reduce compounded harm experienced by patients and families. The authors propose three recommendations for policy and practice: The healthcare system to recognise and address epistemic injustice and equitably support people to be equal partners throughout investigations and subsequent learning to reduce the likelihood of patients and families feeling powerless and inconsequential. Honest and transparent regulatory and organisational cultures to be fostered and enacted to reduce the likelihood of patients and families feeling manipulated The healthcare system to reorient towards providing restorative responses to harm which are human centred, relational and underpinned by dignity, safety and voluntariness to reduce the likelihood of patients and families feeling abandoned, de-humanised and disoriented.- Posted
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HSSIB's investigation criteria (18 December 2024)
Patient Safety Learning posted an article in HSSIB investigations
As the Health Services Safety Investigations Body (HSSIB) came into operation on 1 October 2023 one of the key priorities was to develop a new strategy, outlining HSSIB's long-term goals and themes that underpin our objectives. They also reviewed their investigation criteria. The criteria is designed to allow assessment across the available evidence, extent of risk and potential for improving care provision. It sets out the criteria and principles for HSSIB investigations. The criteria are designed to allow assessment across the available evidence, looking at potential harm, scale of the issue, health inequalities and potential to drive improvement. Table setting out criteria for HSSIB investigations (Click on table to enlarge it) Key principles for investigation HSSIB do not attribute blame or liability in our investigations. HSSIB underpin investigations with the most appropriate and robust safety science methodologies. HSSIB investigations take a system perspective and aim to reduce the likelihood of incidents happening. HSSIB involve patients, families, and healthcare staff in our investigations. HSSIB consider how to improve care for those subjected to health inequalities in all our investigations. HSSIB will have a multidisciplinary team approach to investigations using skilled investigators. HSSIB involve appropriate subject matter advisors in our investigations. HSSIB recommendations will be impactful, and will work with the system to ensure there is maximum effect. HSSIB will be open and transparent about how they work whilst protecting the disclosure of specific evidence that they gather during the investigations. HSSIB will undertake investigations in a timely manner, and in the most cost-effective way.- Posted
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Wanted - The Good Hospital Guide (12 September 2024)
Patient-Safety-Learning posted an article in Data and insight
In this Substack post, journalist Rory Cellan-Jones looks at a privately-funded project that aimed to give patients a better idea of how safe different hospitals were—the Good Hospital Guide. He speaks to Alex Kafetz, who worked on the Good Hospital Guide over a decade ago and was also a witness at the Mid Staffs inquiry in 2013. The project spotted and alerted Stafford Hospital to its high adjusted mortality rate ahead of the scandal, but the hospital rejected its data and findings. The Good Hospital Guide project was discontinued after its parent company was taken over, and nothing like it has been developed since, in spite of its success in identifying data patterns that indicated patient safety issues. Rory also highlights the lack of accessible data about hospital performance and mortality rates available to patients and highlights the need for making its data more accessible and transparent.- Posted
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The Royal College of Physicians (RCP) has published new interim guidance on the scope, supervision and employment of physician associates (PAs) working in the medical specialties (also known as the physician specialties). The interim guidance covers scope of practice for general internal medicine, supervision and employment of PAs, and how PAs should describe their role to patients, employers, other healthcare professionals and the public. It will be reviewed in collaboration with stakeholders, including RCP fellows and members, following the publication of the report of the Leng review. In the guidance, the RCP is clear that: PAs must support – not replace – doctors, have a nationally defined ceiling of practice, and have a clearly defined role in the multidisciplinary team (MDT). PAs must never function as a senior decision maker, nor should they decide whether a patient is admitted or discharged from hospital. Resident doctors are not, and must not be expected or asked to be, responsible for the clinical supervision of PAs. PAs should only be supervised by consultants, specialist or associate specialist doctors. PAs cannot prescribe medications regardless of any prior healthcare background while working as a PA. PAs must clearly explain their role to patients, their families and carers, as well as colleagues and supervisors, and provide details of their educational and clinical supervision when required.- Posted
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The laws which regulate the way clinical trials are carried out in the UK are changing. The Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been working for the past two years to draft proposals to update clinical trials regulations. The updated regulations will be debated in the new year and after a 12 month implementation period will come into force in early 2026. Updating this law started in 2022 with a public consultation which asked for feedback on how the regulation of clinical trials could be improved and strengthened in the UK. The statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 was laid before Parliament on 12 December 2024. This article explains the changes to the regulations which aim to create a faster, more efficient, more accessible and more innovative clinical research system in the UK.- Posted
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Adverse event reporting is critical for advancing patient safety within healthcare systems. A significant factor in enhancing reporting rates is establishing a 'just culture'; a framework that emphasises accountability and learning over punitive measures. While just culture significantly enhances adverse event reporting, its successful implementation requires robust commitment at all organisational levels. Reporting adverse events is essential for ensuring patient safety and fostering a culture of continuous improvement in healthcare. Adverse events, defined as unintended injuries or complications arising from healthcare management, offer crucial insights into systemic weaknesses that, if addressed, can prevent future harm. However, underreporting such events remains a significant challenge, often driven by fear of punitive actions, reputational damage or legal repercussions. To address these concerns and promote a robust reporting culture, healthcare organisations must adopt a just culture by implementing standardised frameworks for evaluating errors and establishing robust reporting systems. Transparency in handling reported incidents is critical for building trust among healthcare professionals. Understanding just culture Just culture represents a shift from a blame-oriented approach to one that balances accountability with a focus on systemic improvement. Originating in high-risk industries such as aviation, the concept emphasises that errors result from flawed processes rather than individual negligence. In a just culture, individuals are held accountable for their actions within a fair and transparent system that prioritises learning and improvement. Central to the philosophy of just culture is the idea of psychological safety. When healthcare professionals feel confident reporting errors will not lead to unjust punishment, they are more likely to disclose incidents. This openness enables organisations to identify trends, address root causes and implement preventive measures. Moreover, just culture recognises the distinction between human errors, at-risk behaviours, and reckless conduct, advocating for tailored responses that align with the nature of the behaviour. Barriers to adverse event reporting Despite its potential, the implementation of just culture faces several obstacles. A predominant challenge is the deeply ingrained blame culture within many healthcare organisations. Historical reliance on punitive measures has created an environment where professionals fear repercussions, discouraging transparency. Additionally, managerial inconsistency in addressing errors often undermines trust in the system. For instance, discrepancies in how similar incidents are handled can create perceptions of unfairness, further discouraging reporting. Another barrier is the lack of understanding and awareness of just culture principles among healthcare staff. Without proper training and education, employees may misinterpret the approach as being lenient or as failing to hold individuals accountable. Legal and regulatory pressures also pose challenges, as concerns about litigation can deter organisations from fully embracing non-punitive reporting frameworks. Strategies for implementing just culture Implementing a just culture in healthcare requires a multifaceted approach that addresses organisational, managerial and individual factors. Leadership commitment is paramount; leaders must model just cultural behaviours, demonstrate accountability and prioritise safety over blame. Developing clear policies and guidelines for error classification and response is equally important as it ensures consistency and fairness in how incidents are addressed. Education and training programmes are vital in promoting awareness and understanding of just culture principles. These programmes should emphasise the distinction between human errors, at-risk behaviours and reckless conduct, providing staff with the tools to respond appropriately. Role-playing scenarios, workshops and case studies can help reinforce these concepts and demonstrate their practical application. The integration of non-punitive reporting systems is another critical component. Such systems should be designed to facilitate easy and confidential reporting, with mechanisms to protect the anonymity of reporters when appropriate. Feedback loops are essential for ensuring that staff are informed about the outcomes of reported incidents, which can reinforce the value of reporting and build trust in the system. Measuring the impact of just culture Assessing the effectiveness of just culture initiatives requires the development of standardised metrics and evaluation tools. Key performance indicators may include reporting rates, staff perceptions of psychological safety and the frequency of systemic improvements resulting from reported incidents. Periodic surveys and interviews can provide valuable insights into staff attitudes and identify areas for improvement. Case studies from organisations that have successfully implemented just culture can also serve as benchmarks for best practices. For instance, hospitals that report significant increases in adverse event reporting rates following the adoption of just culture principles often attribute their success to strong leadership, comprehensive training, and consistent application of policies. Sustaining cultural change Sustaining a just culture requires ongoing commitment and adaptability. Organisations must regularly evaluate their policies and practices to ensure alignment with just culture principles. Staff feedback should be actively sought and incorporated into decision-making processes, fostering a sense of ownership and engagement. Continuous education and training are essential for reinforcing just culture behaviours and addressing emerging challenges. Additionally, leadership succession planning should prioritise candidates who are committed to upholding just culture principles, ensuring continuity in organisational values. Conclusion Adverse event reporting is a fundamental component of patient safety, and the principles of just culture provide a robust framework for enhancing reporting rates and fostering systemic improvements. By balancing accountability with a focus on learning and improvement, just culture creates an environment where healthcare professionals feel empowered to report incidents without fear of retribution. Leadership commitment, staff education and integrating non-punitive reporting systems are critical for overcoming barriers and sustaining cultural change. A just culture represents a paradigm shift in addressing adverse events, emphasising systemic improvement over individual blame. Its successful adoption has the potential to transform healthcare organisations, making them safer and more resilient. Future research should focus on developing standardized metrics to evaluate just culture initiatives and exploring their applicability across diverse healthcare settings.- Posted
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In this interview series, NHS whistleblower Peter Duffy and Patient Safety Learning’s Chief Executive Helen Hughes explore how the healthcare system responds when its staff raise concerns about patient safety. In each episode, Helen and Peter interview someone who has spoken up about patient safety issues in healthcare organisations, or who works to help staff raise concerns where they see unsafe care. In this interview, Peter and Helen speak to Helené Donnelly OBE, who spoke up about unsafe care she witnessed while working as a nurse at Mid Staffordshire NHS Foundation Trust. Helené contributed as a witness to the inquiry led by Sir Robert Francis KC into failings at the trust and was also an advisor in the Freedom to Speak up Review in 2015, where she called for the creation of Freedom to Speak Up Guardians in the NHS. Helené explains why she decided to raise concerns about the quality of nursing care at Stafford Hospital A&E and describes the bullying and threats she received from other staff as a result. She discusses with Peter and Helen the barriers that still prevent staff speaking up today and what can be done to create a more open and responsive culture in teams and organisations. Helené highlights the need to reform how human resources departments respond to staff raising concerns and the vital role of embedding speaking up and organisational culture in the curriculum of all healthcare professional training courses. Subscribe to our YouTube podcast to keep up to date with the latest episodes. View a transcript of this interview Read a blog from Peter and Helen about the interview series- Posted
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In this interview, David Osborn, chartered occupational safety and health practitioner and member of the Covid-19 Airborne Transmission Alliance (CATA), speaks to Lotty Tizzard, Digital Content Manager at Patient Safety Learning, about how CATA was established during the pandemic to advocate for adequate respiratory protection for NHS employees. David explains how CATA advocated for the government and heath service to recognise that Covid-19 is passed on by aerosol transmission (through microscopic particles in the air). He also outlines why surgical masks do not adequately protect people against catching airborne viruses and describes how inadequate respiratory protective equipment (RPE) contributed to thousands of NHS staff catching Covid-19 at work. As a result, many healthcare workers died and a large number still live with the ongoing symptoms of Long Covid. David describes CATA's involvement as a Core Participant in the Covid-19 Inquiry and outlines what he hopes will be done to ensure the UK is better prepared for future pandemics. Patient Safety Learning is also a member of CATA. Clarification David wishes to clarify a point raised in the interview: "When talking about the “IPC Cell” I said that they 'didn’t produce minutes'. In fact, notes or minutes were taken at all IPC Cell meetings. The point I was making is that they were not published ('produced' in the sense of being released into the public domain), when the minutes of most other groups such as SAGE and NERVTAG were published. The few IPC Cell minutes that have trickled into the public domain have mostly been as a result of Freedom of Information requests by a colleague and a few that I have managed to obtain myself. In some cases, public authorities have taken around 18 months to disclose documents, and it has required the intervention of the Information Commissioner's Office. I anticipate that more minutes will be disclosed for public scrutiny as time goes on." You can read more about CATA and the Covid-19 Inquiry in David's blogs and presentations on the hub: Respiratory protective equipment: An unequal solution for healthcare workers? A blog by David Osborn Healthcare workers with Long Covid: Group litigation – a blog from David Osborn Covid-19 : A risk assessment too far? A blog by David Osborn CATA and the UK Covid-19 Public Inquiry: Presentation from David Osborn Join the conversation Were you working in health and social care during the pandemic? We'd like to hear about your experience of health and safety at work. Were you provided with adequate PPE to carry out your job safely? Did you catch Covid-19 while at work? You can join the conversation by commenting below (you'll need to sign up first) or get in touch with us directly by emailing [email protected]- Posted
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It is widely recognised that pharmaceutical marketing contributed to the ongoing US opioid epidemic, but less is understood about how the opioid industry used scientific evidence to generate product demand, shape opioid regulation and change healthcare professionals' behaviour. This qualitative study looks at select scientific articles used by industry to support safety and effectiveness claims and uses a novel database, the Opioid Industry Documents Archive, to look at industry and non-industry documents citing the scientific articles to advance each claim. The authors found that 15 scientific articles were collectively mentioned in 3666 documents supporting five common, inaccurate claims: Opioids are effective for treatment of chronic, non-cancer pain. Opioids are “rarely” addictive. “Pseudo-addiction” is due to inadequate pain management No opioid dose is too high Screening tools can identify those at risk of developing addiction. The articles contributed to the eventual normalisation of these claims by: symbolically associating the claims with scientific evidence building credibility expanding and diversifying audiences and the parties asserting the claims obfuscating conflicts of interest. These findings have implications for regulators of industry products and corporate activity and can inform efforts to prevent similar public health crises.- Posted
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This report presents the findings of a call for evidence on the statutory duty of candour for healthcare providers, conducted by the Department of Health and Social Care between 16 April and 29 May 2024. In essence, the duty places a direct obligation upon trusts to be open and honest with patients and service users, and their families, when something goes wrong that appears to have caused or could lead to moderate harm or worse in the future (known as a ‘notifiable safety incident’). Key findings from the call for evidence included: 2 in 5 respondents (40%) thought the purpose of the statutory duty of candour is clear and well understood. Some commented that the duty has become a tick-box exercise, with staff and providers going through the motions to fulfil the duty, and not demonstrating compassion, for example through the use of standard templates and wording in letters to patients and/or service users which appear impersonal. Over half of respondents (54%) did not think staff working for health and social care providers know of and understand the duty’s requirements. Respondents felt that application of the duty is inconsistent and open to (mis)interpretation. This may be due to confusion between organisational and professional duty of candour, variations in staff interpretation of criteria for triggering a notifiable safety incident, and some groups having less knowledge of the duty, such as non-clinical, new or agency staff. Less than 1 in 4 respondents said that the duty is correctly complied with when a notifiable safety incident occurs (23%). Some felt staff are reticent about complying with the duty for fear that it admits fault and liability and leaves them open to blame. Others reported instances where staff were empathetic and aimed to follow the process, but senior management did not support them, and they feared not being protected if considered a ‘whistleblower’. Some respondents also believed there to be a culture of covering up incidents, falsification of records and dismissal of complaints. Respondents were divided in their assessment of provider engagement with 94% of patients or service users disagreeing that providers engage meaningfully and compassionately with those affected after a notifiable safety incident, compared to 27% of health or care professionals. Some patients and service users do not understand their rights. Specifically, their rights to access documents and receive an apology or response from a healthcare provider, and what they can do if they feel their case meets the criteria, but communication has been inadequate, or processes not followed. Generally, respondents who were patients, service users, family members or caregivers were more critical of the duty and its application, compared to health and/or care professionals and organisations.- Posted
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