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Event
AI in care: Its use and regulation – in conversation with CQC
Sam posted an event in Community Calendar
An update from CQC about their new guidance on the use of AI in social care settings with opportunities to ask questions. This webinar is an opportunity to hear updates from CQC on their approach to regulation and AI following the publication of their recent guidance: Artificial intelligence in health and social care: CQC’s role, expectations and plans – Care Quality Commission Hosted by the AI in Care Alliance – a collaborative focussed on the responsible use of AI in Adult Social Care. Register -
Content Article
This article provides an overview of an Adjournment Debate in the House of Commons discussing the implementation of recommendations from the Review of patient safety across the health and care landscape. The debate focused on the proposed transfer of functions of the Health Services Safety Investigations Body (HSSIB) to the Care Quality Commission (CQC). What is an Adjournment Debate? There is a 30 minute Adjournment Debate at the end of each day's sitting of the House of Commons. They provide an opportunity for an individual backbench MP to raise an issue and receive a response from the relevant Minister. Unlike many other debates, these take place without a question which the House of Commons must then make a decision on. Review of patient safety across the health and care landscape On 7 July 2025, the Department of Health and Social Care (DHSC) published the findings of the Review of patient safety across the health and care landscape in England, chaired by Dr Penny Dash. The review looked at six specific organisations that were established to either assure—or contribute to improving—the safety of care, while also making reference to the wider landscape of organisations influencing quality of care. Its final report issued a number of recommendations, which included several proposed changes organisational changes: Transferring the functions of the HSSIB to the CQC. Closing Healthwatch England, moving its functions to a new directorate for patient experience in DHSC. Combining the statutory functions of Local Healthwatch relating to healthcare with involvement and engagement functions in Integrated Care Boards (ICBs), with social care functions transferred to local authorities. Transferring the hosting arrangement of the Patient Safety Commissioner for England to the Medicines and Healthcare products Regulatory Agency (MHRA). Closing the National Guardian’s Office, transferring its functions to NHS England. Contributions from Bernard Jenkin MP This debate was tabled by Sir Bernard Jenkin MP. He made a number of points concerning the transfer of the functions of the HSSIB to the CQC. He said that safety management is intrinsic to safety and public confidence in other safety-critical activities, such as aviation, but is alien to NHS culture. He asked without HSSIB, which independent body will promote a coherent understanding of safety system management in health, and who is to hold the NHS and Government to account for safety failures. He stated his view that neither the National Quality Board (NQB) nor the CQC should control investigations. He noted that the Air Accidents Investigation Branch cannot be prevented from making independent recommendations by the Civil Aviation Authority, the Transport Secretary or airlines themselves. He asked therefore why should the NQB, which will be subject to political direction, be allowed to decide what safety recommendations should be made and what should be investigated. He highlighted that the Dash Review incorrectly states that HSSIB was originally established to look at specific cases or incidents of severe harm, but it has since broadened its work into making more systemic recommendations. He noted that it was always intended by Parliament that HSSIB should make systemic recommendations arising from the investigation of specific incidents or groups of incidents. He questioned whether the CQC in its role as regulator and compliance enforcer could also be an independent investigator. He said that the Dash Review also says that the CQC internal successor should collaborate through the NQB to agree the scope of any investigations it carries out and agree the recommendations. He described this proposal as a direct attack on the independence of investigations. He stated that the Dash Review fails to look at the comparative cost of HSSIB investigations versus the cost of public inquiries. He noted that HSSIB at the moment only costs £6.3 million per year. He suggested that to save money the Secretary of State should request that HSSIB conducts far more investigations into matters which he thinks are important, provided that he also provides the funding for the necessary capacity. An example he gave was that HSSIB, has conducted eight investigations into mental health suicides since 2023. Each was completed in a few weeks or months, costing a total of £850,000. In comparison, he noted that the Lampard inquiry into the Essex partnership university trust, also investigating patient safety concerns in mental health, is expected to cost more than £5 million. Contributions from other MPs Jeremy Hunt MP highlighted concerns that moving HSSIB into the CQC, which has a legal duty ot act on information it receives, creates a worry for people talking to HSSIB that the information that they give to it may no longer be protected as they currently are. Anna Dixon MP noted that recent inquiries into maternity services, infected blood and pelvic mesh underline that professionals and those working inside the NHS must be able to speak freely when things go wrong in order to learn lessons and that that this is only possible with an independent investigating organisation. James Naish MP stated his concerns about the abolition of Healthwatch. He noted that there is a strong desire to see independent patient voice maintained outside the system and that Healthwatch was established due to issues within health structures, including, notably, the Mid Staffordshire scandal. Jim Shannon MP emphasised the need for lessons learned on data collection, streamlined complaints and patient safety culture are shared with the Northern Ireland Assembly Minister, Mike Nesbitt, as health is a devolved matter. Rachael Maskell MP stated that there was a wider issue, which she felt that the Health Bill completely misses, around the accountability systems within the NHS. She stated that these reforms are not going to deliver accountability, but will weaken it, and as a result we will see more requests for investigations into patient safety. Government response Responding to this debate on the Government’s behalf, Preet Kaur Gill MP, Parliamentary Under-Secretary of State for Health Innovation and Safety, made the following points: The investigation function within the CQC will be expert and full time, and it will be able to conduct investigations in the same cheap and quick way that HSSIB does now. In future, there will be the same opportunity to use the CQC investigation function instead of needing a public inquiry as there is currently with HSSIB. The criteria for disclosing protected information outside the investigative function are set out in the Bill. Those criteria set a high bar for any disclosure—as high as it is currently with HSSIB—and the CQC will publish further guidance setting out much more detail. As the Bill sets out, the CQC will appoint a responsible person who will decide whether the case matches the criteria and whether it warrants information sharing outside the safe space. That person is likely to be the CQC’s chief executive officer. Dash reforms are not about saving money; they are about strengthening patient safety and patient voice across the system. She stated that the abolition of HSSIB and the transfer of its functions to the CQC play an important part in making the system of patient safety much more effective. The NQB has been revitalised by giving it a stronger role in providing a single, authoritative view of quality across the system. That will help reduce duplication, bring greater clarity to recommendations and ensure that effort is focused where it has the greatest impact. The purpose of these reforms is not to weaken investigation, but to strengthen the link between investigation, learning and improvement. The investigation function in the CQC will have autonomy to launch investigations into any part of the health system and will be able to make recommendations on any part of the system, just as HSSIB does now. There will be no barrier to an investigator finding out that CQC inspections are causing unintended harm. The Health Bill also allows for the investigation function to make recommendations to the CQC in its report, and the CQC would be legally required to respond to such recommendations. How to watch the debate You can watch the full debate here and find the full transcript on Hansard at the bottom of this page. Related reading Review of patient safety across the health and care landscape: Patient Safety Learning's response (15 July 2025) The future of the Health Services Safety Investigations Body: a recent discussion at the Patient Safety Management Network Is the patient voice fading? Reflections on patient safety in a changing NHS -
Content ArticleDon't risk your health: always check an online pharmacy is on our register before you use it All legitimate pharmacies operating in Great Britain have to be on the General Pharmaceutical Council’s register. Fake online pharmacies are operating illegally, and sell medicines that are unsafe and could cause you serious harm. Check the pharmacy register now.
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Drug Safety Update on ACE-inhibitors: Be aware of the distinction between bradykinin- and histamine-mediated angioedema, as treatment strategies differ significantly. Letters, medicines recalls and device notifications sent to healthcare professionals in June 2026 . News and guidance on: MHRA launches AI sandbox to accelerate medicines development and improve safety.
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News Article
New maternity inspection ‘unit’ demanded by government review
Patient Safety Learning posted a news article in News
Ministers should create a new specialist unit to assess maternity services because the Care Quality Commission does not have the credibility to do so, a government review has concluded. Baroness Valerie Amos’ national maternity and neonatal investigation, established by former health secretary Wes Streeting a year ago, published its final report, recommendations and 12 trust-level investigations today. Among the eight national recommendations, it says ministers must establish a “specialist regulatory unit” to provide assessment for maternity and neonatal services. The report said: “We do not consider that CQC has credibility as the regulator of maternity and neonatal care with clinical teams, executive teams, or families.” The Department of Health and Social Care’s oversight of the regulator has also been “insufficient”, with “limited evidence… that [it] has addressed the significant problems CQC continues to experience”. Baroness Amos cited a recent example of a service being rated “good” despite serious safety concerns being raised with her team. The report says officials should “work with CQC to improve its effectiveness immediately and start work to put in place a specialist regulatory unit…[which] must include clinicians from a range of professional backgrounds”. Asked by HSJ, the review team said it intended for this to be a dedicated unit within the CQC. Read full story (paywalled) Source: HSJ, 30 June 2026 -
News Article
Regulators poised to strip back AI rules
Patient Safety Learning posted a news article in News
Regulators are about to significantly strip back regulation of ambient voice technology (AVT) – one of the fastest-growing healthcare AI tools – HSJ has learned. The Medicines and Healthcare products Regulatory Agency will make clear that some AVTs, also known as AI scribes, will no longer be classed as a medical device, according to several well-placed sources. This would remove a key oversight mechanism for a rapidly developing area and a provider market that NHS leaders have likened to the Wild West. National leaders are seeking to accelerate roll-out of the tech, which will potentially release huge amounts of medics’ time by automating entry into medical records and other admin. Under guidance that HSJ understands is due to be published shortly by the MHRA, most suppliers would no longer need to seek medical device classification for their ambient scribes. The regulator will stress that this is only required for AVTs with a “medical intended purpose” – effectively only advanced products which also profess to make medical diagnoses or have a therapeutic function. The move would mark a major departure from NHS England policy over the past year. NHSE’s national AVT registry, launched just five months ago to tackle what a national official called a “Wild West” market, requires suppliers to hold at least self-certified Class I accreditation (the lowest risk category of medical device registration). And a year ago, NHSE warned trusts against adopting “non-compliant” AI technology, stating that tools must have at least Class I accreditation and Class IIa for enhanced “capabilities” such as “generative diagnoses, management plans or other medical referrals and calculations”. Read full story (paywalled) Source: HSJ, 29 June 2026 -
News ArticlePost-market surveillance of AI health tools must be “beefed up” to protect doctors as well as patients, England’s patient safety commissioner says. Henrietta Hughes also told The BMJ it was vital to establish clarity on where clinical liability sits when, not if, AI tools harm patients. Hughes, a GP and a former medical director at NHS England, is deputy chair of the National Commission into the Regulation of AI in Healthcare. The commission was set up by the Medicines and Healthcare Products Regulatory Agency (MHRA) to help guide development of a new regulatory framework for AI medical devices. The commission published interim findings from its consultation and engagement process last week. Hughes said some clear themes had already emerged during the process of engagement with patients, the public, and doctors. Among the most pressing was the need for greater surveillance of AI tools after approval, so the MHRA can act if patients are at risk. Hughes told The BMJ, “It’s really important that real time, real life monitoring happens when a device like AI is deployed in a real life clinical environment, particularly if the population of patients may be different from the population used to feed the model.” Hughes added that while medicines have to pass an “extremely high hurdle” and evidence base to reach the market, AI—where new products are rapidly launched and updated—is different. “We know that AI can change once it’s actually deployed, and so it’s important that the regulations are able to be updated to take account of that and to ensure that all medical devices, and particularly AI, are safe across its whole life cycle,” she said. “Whether we’re using the yellow card system or other kinds of ‘always-on’ postmarket surveillance and postmarket monitoring, that side of things really needs to be significantly beefed up if we’re going to lower the hurdles for products to come onto the market.” Read full story Source: BMJ, 18 June 2026
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News Article
Judge advanced AI systems like doctors, says government review
Patient Safety Learning posted a news article in News
Oversight of advanced AI systems capable of making autonomous decisions should “mirror” the assessment of healthcare professionals, a government commission has proposed. The National Commission into the Regulation of AI in Healthcare has proposed that agentic AI systems, which can autonomously plan and execute tasks with limited human supervision, should be required to demonstrate capability over time before being allowed to undertake more complex work. The minutes to the commission’s latest meeting, seen by HSJ, stated: “Commissioners advised that approaches to deploying AI systems should mirror that of human professional style progression.” This would involve AI agents needing “to demonstrate capability over time before being exposed to higher risk activities”. The commissioners were responding to a discussion paper on agentic AI systems, “which explored regulatory approaches to oversee AI systems that are capable of autonomously planning and taking actions with limited human supervision”. The paper proposed “a tiered regulatory framework, which uses levels of agent autonomy as a basis to determine what regulation and risk controls are required”. The commissioners “welcomed the proposal for a tiered regulatory framework”, but suggested, “further work should be undertaken to identify other potential factors relevant to determine the appropriate level of regulation”. Read full story (paywalled) Source: HSJ, 22 June 2026 -
News Article
NHS ‘can’t be sure more patients won’t be harmed’ at scandal-hit trust
Mark Hughes posted a news article in News
NHS England has taken enforcement action against a major health trust over multiple safety concerns, warning that it cannot be sure more patients won’t be harmed. The sanction means Northern Care Alliance NHS Foundation Trust, in Greater Manchester, could be fined or lose its license to provide care if it does not improve. It comes after a string of serious concerns were raised about patient safety, including in its gynaecological services, after an audit of hundreds of cases at Salford Royal Hospital in 2024 found dozens of women, including cancer patients, were “harmed” after their diagnosis and treatment were delayed due to admin failures. Now, a damning document, seen by The Independent, reveals NHS England found the trust has been “unable to provide assurance” that it has a clear and consistent structure “that will ensure no further patients may suffer harm”. Read full article. Source: The Independent, 19 June 2026 -
News Article
NHS staff battling wave of food supplement disinformation
Patient Safety Learning posted a news article in News
Social media misinformation about the use of dietary supplements such as turmeric, St John’s wort and magnesium is now so common that dispelling online claims has become a routine part of NHS clinicians work. Two out of five frontline health workers say they encounter patients who raise inaccurate or misleading information about supplements at least once a week. Polling by YouGov for the World Cancer Research Fund found that the figure is even higher (53%) among nurses and midwives, with false information about nutrition and supplements now taking up what doctors describe as “precious time” in NHS consultations. The WCRF says it fears that patients’ belief in unproven dietary regimes, vitamins and minerals is putting their health in danger and increasing their risk of getting cancer. Dr Philippa Kaye said she saw the consequences of health misinformation every week in her GP surgery. “My patients arrive clutching newspaper stories, social media screenshots, printouts from wellness websites or saved videos from TikTok. “What particularly worries me is the widely held belief that if something is sold over the counter, marked as ‘natural’ or endorsed online, then it must automatically be safe and harmless, while prescribed medicines are somehow toxic,” she added. “As doctors, we know this simply is not true.” Read full story Source: The Guardian, 14 June -
Content ArticleThese two reports summarise findings from the National Commission into the Regulation of Artificial Intelligence (AI) in Healthcare’s research and engagement activities and call for evidence. The Commission’s purpose is to advise the Medicines and Healthcare products Regulatory Agency (MHRA) on improving its regulatory framework and to accelerate safe access to AI in healthcare and across the NHS. You can read a summary of Patient Safety Learning’s response to this call for evidence here. The work brought together evidence from patients and the public, healthcare professionals, industry, academics and wider health system stakeholders through public polling, surveys, stakeholder engagement, deliberative research, an open call for evidence, a public Ask Me Anything session and insights from the MHRA’s AI Airlock programme. Thorough analysis of this evidence, 10 key findings have been identified. The report summarises these as follows: 1. There is a clear call for a proportionate, lifecycle-based approach to regulation Stakeholders noted that the current framework, which is designed for more static medical devices, is not well suited to iterative and adaptive AI systems. Across groups, stakeholders called for a proportionate approach that is risk-based, considers patients’ safety and fairness, with clear practical guidance and addresses existing duplication and fragmented oversight. Stakeholders also underlined the importance of strengthening clinical evidence requirements, with strong support for enhancing post-market surveillance and improving coordination. With a more proportionate approach seen as essential for balancing innovation with patient safety. 2. There is strong consensus for significant regulatory reform Across respondent groups of healthcare professionals, healthcare providers and industry, most people said that the existing regulatory framework needed “significant reform” but did not need a “complete overhaul”. Amongst patients and the public, the number of respondents calling for “significant reform” and a “complete overhaul” were similar, with 34% asking for “significant reform”, and 35% for a complete overhaul. 3. There was broad consensus that AI systems will increasingly require continuous post-market surveillance and monitoring Several stakeholders highlighted the need to upgrade current approaches to post market surveillance and monitoring, so they are better suited to AI systems. There was strong consensus that performance and risk cannot be adequately assessed through one-off approvals alone but instead require ongoing, real-world oversight across the lifecycle. Through qualitative evidence, stakeholders called for a more continuous and ongoing approach which helps track performance, monitor safety, and manage compliance across the AI system lifecycle. They also suggested that upgraded approaches need to help manage performance drift, validate performance in real world settings, and track changes in performance over time. 4. Responsibility should be shared across the system, with each individual and institution understanding their essential role and responsibilities There was strong consensus that accountability should not rest with a single person or institution, with respondents favouring a model which better distributes liability across the lifecycle. Patients and members of the public called for a comprehensive approach to accountability that addresses current gaps, healthcare professionals stressed that clinical accountability should be maintained whilst healthcare providers emphasised the need for robust governance structures and clear organisational responsibility. Stakeholders also highlighted uncertainty in how roles, responsibilities, and liability are defined and applied in practice. There were differing views on where liability should sit when an AI system causes or contributes to harm. Some respondents believed that liability should sit with the healthcare professional using the AI system. Another group of respondents argued that liability should sit with the healthcare provider who deploys the AI system. Others suggested that liability should sit with manufacturers, given their role in developing the technology and then maintaining their AI system’s performance. Across responses, there was a consistent emphasis on the need for greater clarity and consistency in how liability is allocated. Many respondents called for structured approaches to distributing liability that reflect the roles of different actors, including manufacturers, healthcare providers, and healthcare professionals. Suggested approaches included shared or distributed liability models that apportion responsibility based on specific circumstances. Stakeholders noted that clearer and more consistent frameworks would help address uncertainty and support the safe use of AI systems in healthcare. 5. Human oversight and responsibility for clinical judgment should be retained There was strong consensus from respondents that AI systems should continue to augment the work of professionals and should not be fully responsible for clinical decision making. Patients and the public emphasised the importance of human involvement in their care, including expectations that clinical decisions involving AI should be checked and validated by a human clinician. Healthcare professionals and professional bodies highlighted the risk of over-reliance on AI outputs at the expense of professional judgement. Industry respondents were supportive of ‘human-in-the-loop' safeguards. 6. Transparency and explainability will be key for the ongoing deployment of AI systems The ability to easily understand how an AI system works and to interpret its outputs will be key for building trust, enabling deployment, and ensuring the safety of an AI system. Patients, public and professionals advised that explanations of AI system outputs need to be clear, and providers called for greater transparency in the procurement process for sourcing AI systems. Industry organisations commented on the need for clearer and more structured regulatory documentation. 7. Data access and use is central to the role of AI in healthcare moving forward Respondents to the Call for Evidence noted that healthcare data is simultaneously an enabler and a barrier to the development and deployment of AI systems in healthcare. Patients and public expressed strong concerns about current approaches to consent for data access and how data is used by commercial entities. Some respondents cited governance and compliance burdens and fragmented data infrastructure as key barriers to development and deployment. Industry respondents called for clear and robust frameworks for accessing data including shared data governance templates and clearer guidance on data standards. 8. There is a need for robust training and improved AI literacy The Call for Evidence found a clear view that robust, ongoing training and clear understanding of AI in healthcare is critical for safe adoption. Healthcare professionals highlighted the risks of a lack of AI-specific training can bring such as increased risk of automation bias. Healthcare providers called for more structured workforce training on AI moving forward. Industry respondents advised that training is also needed for individuals who oversee the governance of AI systems in healthcare. 9. There is a need to improve incident reporting and learning mechanisms There were widespread calls for standardised reporting mechanisms for AI systems. Patients and public called for greater transparency and accountability over where AI is involved in care, including clearer communication when things go wrong. Healthcare professionals raised concerns about underreporting of safety incidents in healthcare more broadly, noting that workload pressures are a significant contributing factor. Responses also suggested limited awareness amongst some healthcare professionals that the existing Yellow Card scheme already applies to medical devices, including AI enabled devices. Healthcare providers highlighted the operational challenges of implementing incident reporting consistently across different settings. Industry respondents called for clearer guidance on how incident reporting should work within AI specific post-market surveillance frameworks. Several respondents also proposed improvements to surveillance and monitoring approaches, including establishing a national reporting system for AI incidents and providing guidance for healthcare professionals on what to report. 10. Patient and public engagement, trust, and communication will continue to be key for the deployment of AI systems. Through the Call for Evidence, trust emerged as a core enabler of AI adoption in healthcare. Patients and the public called for consistent involvement, consent, and clarity over the role of AI systems, whilst professionals highlighted the need to take a proportionate approach to explaining how AI is being used to patients. Providers advised that clear and consistent transparency and communication frameworks are needed whilst industry respondents recognised that trust is key for the uptake of AI systems in healthcare.
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News Article
‘Innovation freeze’ threatening NHSE AI plans
Patient Safety Learning posted a news article in News
NHS England has warned that it may be unable to lawfully deploy AI features on the NHS App from next year, due to incoming medical device regulation changes. A new entry on NHSE’s operational risk register, published last week, flags the risk of an “innovation freeze” in which the organisation cannot place new and updated software and AI medical devices into clinical use in a lawful manner from spring 2027. The freeze could delay key commitments in the 10-Year Health Plan, including plans for AI-led triage on the NHS App – central to the government’s ambition to give every patient a “doctor in your pocket”. It comes as draft amendments to UK Medical Device Regulations are due to be laid before Parliament, before being implemented in 2027. NHSE said that, as a developer of its own digital tools, it must meet the new conformity assessment and classification requirements as they come into force. It confirmed that services currently in use, including in the NHS App, remain compliant under current legislation. Read full story (paywalled) Source: HSJ, 10 June 2026 -
News ArticleA health minister has acknowledged that restricted access to weight loss drugs on the NHS may be driving individuals to seek unregulated alternatives, as officials face urgent calls to investigate deaths linked to black market obesity jabs. Health officials were directly challenged by MPs on the Health and Social Committee regarding measures to curb illicit sales of anti-obesity treatments. A stark warning was issued to NHS and Department of Health officials: "People have already died as a result of this, and there is a chance that this could get worse." Conservative MP Gregory Stafford questioned whether current NHS access constraints were creating a patient safety risk, citing evidence that barriers were pushing patients to "unregulated and potentially unsafe sources." Professor Aidan Fowler, national director of patient safety for NHS England, informed MPs that discussions with the MHRA (Medicines and Healthcare products Regulatory Agency) frequently address risks around medicine safety, including black market issues, drawing parallels with cosmetic surgery. However, committee chairwoman Layla Moran delivered a harrowing account, stating: "I’ve met with families whose loved ones have tragically passed away because they did access on the black market, they then got sepsis and died, and the coroner report is still ongoing. “But the concern is it was the injection itself and its administration that caused the death, they don’t feel that the MHRA are on top of it, and I’m not sure that they will have heard today’s evidence and felt that you guys are either, and I really hope, minister, that when you go away and look at this that you bear in mind the fact people have already died as a result of this, and there is a chance that this could get worse." Read full story Source: The Independent, 3 June 2026
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Content ArticleThe Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents. This month's Safety Roundup includes: Drug Safety Update on Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse. Drug Safety Update on Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction. Device safety Information on Kimal Procedure Packs containing recalled components: Namic Angiographic Syringe with the risk of syringe disconnection; Namic Manifolds with the risk of foreign particulates. Important guidance for use in urgent procedures where there are no alternatives. Device safety Information on Risk of severe harm from use of incorrect giving (administration) set for blood transfusion. Device safety Information on Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation. Letters, medicines recalls and device notifications sent to healthcare professionals in May 2026. News and guidance on: Dostarlimab (Jemperli) and immune-related skin adverse reactions: updates to the product information. BNF and BNFC updated guidance on medicines that cause drowsiness to help prevent co-sleeping deaths.
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Content ArticleThe use of artificial intelligence (AI) continues to increase across health and social care. As England’s independent regulator of health and social care, the Care Quality Commission (CQC) encourages the use of innovative technologies, including AI, where the technology benefits people and results in more effective and efficient services. AI presents enormous opportunities, though not without risks. The CQC have outlined some of the benefits and risks of AI and set out how CQC’s regulatory work has a role in ensuring AI contributes to safe, equitable and person-centred care. The principles of good use of AI provide a high-level illustration of what this means for providers of health and social care services.
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News Article
Regulators demand answers on advice and guidance
Patient Safety Learning posted a news article in News
Answers are needed from NHS England and others on 11 issues to make sure its controversial expansion of advice and guidance is safe, the Care Quality Commission has declared. Advice and guidance allows GPs to seek pre-referral advice from specialist clinicians working in secondary care, and is designed in part to reduce referrals. NHS England has planned to substantially ramp up its use this year, including by making its use mandatory – rather than initial referral – in at least 10 locally-chosen specialties. This has proven controversial with many clinicians, particularly GPs. NHSE last month issued a letter seeking to clarify some aspects of the policy, including stepping back from a target that in the chosen specialties there would be a “diversion rate of at least 25 per cent by March 2027”. British Medical Association GP Committee chair Katie Bramall had also written to the Care Quality Comission in March to raise concerns express the BMA’s reservations relating to the national implementation of mandated A&G. Read full story (paywalled) Source: HSJ, 27 May 2026 -
News Article
UK nurses and midwives who should have been banned have worked for last 12 years
Patient Safety Learning posted a news article in News
Nurses and midwives who should have been banned from treating patients have practised over the last 12 years because of “potentially dangerous” failings by a medical regulator. The Nursing and Midwifery Council (NMC) has admitted that its “completely and utterly unacceptable” mistakes meant it failed to protect the public from about 15 professionals whom it should have banned from ever working in healthcare in the UK because they had broken the law. The nurses and midwives told the NMC about their criminal convictions when they applied to join or stay on the regulator’s register, which they need to be on in order to practise in Britain. However, NMC staff who assessed their applications did not then refer them on to an assistant registrar at the regulator to investigate and decide if they could treat patients, which they should have done. The 15 or so nurses and midwives involved now face being struck off because their law-breaking is so serious that they should not be allowed to keep having contact with patients. The Patients Association warned that the NMC’s failure to properly look into the background of those concerned undermines patients’ trust that health staff are safe to care for them. The Royal College of Nursing accused the regulator of an “astounding failure of its primary purpose to safeguard the public, as well as to provide assurance to the nursing workforce that they and their colleagues had all undergone the necessary checks to practise”. Read full story Source: The Guardian, 27 May 2026 -
News Article
Regulator ‘missing many AI incidents’
Patient Safety Learning posted a news article in News
Safety concerns linked to AI voice tech are not being properly reported because many providers are unaware of the regulation system or too busy to use it, experts have told HSJ. The Medicine and Healthcare products Regulatory Authority is responsible for ensuring ambient voice technology products, in which the NHS is about to invest heavily, are safe. Data shared with HSJ showed there had only been five reports under the regulator’s “yellow card” system covering the 12 months to the beginning of May. The regulator said the five reports covered “a range of issues relating to the system capturing incorrect information; file save errors; and concerns relating to patient consent of use of the product”. However, experts said five reports was fewer than they would have expected, considering AVT systems are already being used widely in primary care, and in secondary care under what providers are describing as pilots. HSJ checked each of the 23 AVT providers registered with NHSE against the MHRA’s “yellow card” reporting website, and only three were recognised. An MHRA spokesperson said in this case, complainants could fill out a separate form. However, after being asked by HSJ about the missing 20, the regulator said it had now added all of them. But Hugh Harvey, founder of healthtech consultancy Hardian Health, told HSJ: “The yellow card system is the recommended way for users to report issues with medical devices, but it is currently underused, partly due to a lack of awareness, and partly due to the friction involved in doing so.” Read full story (paywalled) Source: HSJ, 26 May 2026 -
Content ArticleThe letter attached is from Professor Catherine Ross, Chief Scientific Officer for Scottish Government, with an update on the work relating to ‘Healthcare Science in Scotland’ and the theme of ‘quality, safety and, assurance’ as set out in Healthcare Science in Scotland: Defining Our Strategic Approach. The Scottish Government has commissioned the Professional Standards Authority (PSA) to carry out a Right Touch Assurance (RTA) assessment of the Healthcare Science workforce. This work will examine the potential risk of harm to patients, particularly as many roles in Healthcare Science are not currently subject to statutory regulation. The assessment aims to inform future decisions about whether additional regulation may be needed to strengthen quality, safety and assurance across the profession. Stakeholder engagement will form a key part of the process, with opportunities to contribute evidence and views. A final report is expected by Spring 2027, after which the Scottish Government will consider next steps.
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News Article
Family wants 'Alice's Law' after mother's BBL death
Patient Safety Learning posted a news article in News
The family of a mother of five who died after getting a Brazilian butt lift (BBL) has written to the government to demand it brings in a new law to regulate the cosmetic industry. Alice Webb, 33, became unwell and later died in hospital after the treatment given by Jordan James Parke at his Gloucester salon in 2024. Webb's sister, April Palmer, and her former partner Ben Kingscote have written to health secretary James Murray calling on him to introduce Alice's Law, which would restrict liquid BBL procedures to qualified surgeons. Webb's family have said they are "disgusted" at the "extremely troubling" lack of progress since she died. The government insisted that it is "taking action". The family has previously backed the campaign launched by Save Face three years ago calling for greater regulation. The government has announced proposals to restrict BBLs and other high-risk procedures, but the family's letter criticised ministers for not acting soon enough, despite knowing the dangers. "Had the Government acted on those warnings when they were raised, Alice might still be with us," the letter from the family said. "Alice's Law is very important to us as a family, as we believe it could prevent avoidable harm and spare other families the same heartbreak," they said. "Every month of inaction risks further, entirely preventable fatalities." Read full story Source: BBC News, 22 May 2026 -
News Article
Growing private services creating ‘regulatory gap’ , claims watchdog
Patient Safety Learning posted a news article in News
There is a growing “regulatory gap” around several NHS services where private provision has grown rapidly, the Parliamentary watchdog has told HSJ. Paula Sussex, who became the Parliamentary and Health Service Ombudsman in August, said she received a large number of concerns about ADHD and autism services, and provision of wheelchairs. In relation to neurodiversity diagnosis, there has been rapid growth in NHS-funded and self-funded independent sector provision responding to growing demand, alongside an absence of agreed standards, qualifications, and training. As a result, Ms Sussex often receives complaints that other services are refusing to recognise and act on the diagnoses, she said. Wheelchair services, meanwhile, are often privately provided through block contracts and subject to regular concerns about long waits for equipment and repairs. These services are not registered with the Care Quality Commission as they are not counted as a healthcare service. Ms Sussex said private provision – which was patchy, sometimes poor quality and not properly regulated – was “driving more costs into the system”. She suggested the Department of Health and Social Care should examine “who is going to pick up” these “regulatory gaps”. She added: “That would give more clarity to [integrated care boards] and providers to say: ‘Is it okay to accept this diagnosis?’ or for them to know there is a body overseeing private sector provision.” Read full story (paywalled) Source: HSJ, 22 May 2026 -
Content Article
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 -
Content ArticleThis webinar, hosted by the International Association of Medical Regulatory Authorities (IAMRA), explored how medical and health profession regulators and broader patient safety systems can work more closely together to strengthen care and reduce harm to patients. It aims to help improve understanding of the opportunities to better connect people and system focused safety systems, including through potential partnership models, to best support and ensure a safe and competent health workforce. Facilitator: Professor Martin Fletcher, IAMRA Board Member Speakers: Helen Hughes, Chief Executive, Patient Safety Learning, UK, and Dr Gerry Hickson, Vanderbilt University Medical Center, USA. Related reading on the hub: Professional regulation and patient safety systems: parallel planets or partners in improvement? Professional regulation and patient safety: parallel systems or purposeful partners?
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News Article
‘Catastrophic’ gaps in tech regulation plans
Patient Safety Learning posted a news article in News
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 -
EventThis webinar, hosted by the International Association of Medical Regulatory Authorities, will explore how medical and health profession regulators and broader patient safety systems can work more closely together to strengthen care and reduce harm to patients. It aims to help improve understanding of the opportunities to better connect people and system focused safety systems, including through potential partnership models, to best support and ensure a safe and competent health workforce. Speakers include: Helen Hughes, Chief Executive, Patient Safety Learning Dr Gerry Hickson, Vanderbilt University Medical Center Professor Martin Fletcher, IAMRA Board Member You can sign up for the webinar here. Related reading Professional regulation and patient safety systems: parallel planets or partners in improvement?
