Search the hub
Showing results for tags 'Regulatory issue'.
Found 468 results
-
Content Article
NICE health technology evaluations: the manual (31 January 2022)
Patient Safety Learning posted an article in NICE
This guide describes the methods and processes, including expected timescales, that NICE follows when carrying out health technology evaluations. The methods and processes are designed to produce robust guidance for the NHS in an open, transparent and timely way, with appropriate contribution from stakeholders. Organisations invited to contribute to health technology evaluation development should read this manual in conjunction with the NICE health technology evaluation topic selection: the manual. All documents are available on the NICE website. -
EventuntilThis upcoming webinar will focus on CQCs approach for rolling out the new regulatory approach and provider portal to all health and social care providers. This one-hour webinar will be an opportunity for providers and professionals who work in health and social care services, organisations who represent them and other stakeholders to hear the latest updates about our new regulatory approach. The webinar will be led by Chris Day, our Director of Engagement and Amanda Hutchinson, our Head of Regulatory Change. Register
-
Event
Ethics and regulation for AI in health
Patient Safety Learning posted an event in Community Calendar
untilAs the adoption of artificial intelligence (AI) in health and care continues to progress rapidly, it's essential that clinicians ensure this technology is used for the benefit of patients and to assist us in providing equitable and high-quality care both now and in the future. However, it's also crucial that we are aware of the potential risks and unintended consequences of using AI. This month, the RSM will delve into the development of machine learning (ML) and AI and their applications to healthcare. It will also debate the need for ethical guidelines and regulation in this field. By attending this event, you will understand: What is machine learning and artificial intelligence. How AI is being currently applied to healthcare and the potential future uses. How data drives AI and the potential bias within the data. The way ML and AI can lead to errors and harm. The ethical issues surrounding the use of AI in healthcare. The need for regulations and governance, both in healthcare and the broader society. Register -
EventuntilThis one-hour webinar will be an opportunity for providers and professionals who work in health and social care services, organisations who represent them, other stakeholders, local authorities, integrated care systems and stakeholders that represent the public to hear about CQC's approach to assessing integrated care systems and what it means for them. The webinar will be led by Amanda Williams, CQC's Interim Director of integration, inequalities and improvement. Register
-
Event
CQC's new regulatory approach webinar
Patient Safety Learning posted an event in Community Calendar
untilThis one-hour webinar will be an opportunity for providers and professionals who work in health and social care services, organisations who represent them and other stakeholders to hear the latest updates about CQC's new regulatory approach. The webinar will be led by Kate Terroni, CQC's Deputy Chief Executive and Chris Day, director of engagement. There will be a presentation and time to answer your questions from the live chat. Register -
Event
CQC: Local authority assessments webinar
Patient Safety Learning posted an event in Community Calendar
untilThe Health and Care Act 2022 gives the Care Quality Commission (CQC) new powers that allow them to provide a meaningful and independent assessment of care at a local authority level. This one-hour webinar will be an opportunity for providers and professionals who work in health and social care services, organisations who represent them, other stakeholders, local authorities, and stakeholders that represent the public to hear about CQC's approach to assessing local authorities and what it means for you. Register -
EventuntilThis conference from the Westminster Health Forum will focus on the future for diagnostics and medical devices in England - looking at developments and next steps for strategy and regulation. The discussion takes place in the context of the upcoming MedTech strategy from DHSC, and will be an opportunity to examine priorities for improving flexibility and transparency in MedTech supply and procurement, securing value for money, and supporting the adoption of innovation in healthcare settings. Delegates will discuss implementation of the MHRA update to the regulation of medical devices, as well as priorities for safety, assessment and contribution to better patient outcomes. Overall, areas for discussion include: Regulation and evaluation: transition to the new medical device regulations and the updated evaluation process - implementation of the new MHRA medical device regulation proportionate regulation and support for businesses - addressing capacity constraints of authorisation of Approved Bodies patient access: establishing new device frameworks for supporting adoption of innovative medical technology - supporting patient access to devices currently on the market the supply chain: flexibility, transparency and responsiveness in the procurement and supply of medical technology collaboration between healthcare providers and suppliers - engaging healthcare professionals in procurement. Supporting the NHS: workforce efficiency and earlier diagnosis - innovation in diagnostic pathways to address backlogs and wait times - improving patient outcomes and the speed of recovery the role of the new community diagnostic centres - encouraging adoption of new diagnostic methods in the centres and across the NHS. Register
-
EventuntilThis FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics in distributed manufacturing and point of care manufacturing. Further information
-
EventJoin this Royal Society of Medicine conference to learn some of the key medico-legal issues that impact upon GPs/primary care. The overarching aim is to improve patient safety in both primary and secondary care via learning from incidents and better understanding the indemnity provisions in place for GPs/primary care and how that feeds back into learning. The aim of this meeting is to review and promote an understanding of recent legal and regulatory developments, with a specific emphasis on inquests, clinical negligence and incidents in the primary care sector, and their impact upon patient safety. Additionally, we will also discuss issues that those in secondary care should also be aware of. Register
-
Content ArticleThe government brought forward an amendment to the Health and Care Act 2022 which gives the Secretary of State for Health and Social Care the power to bring into force a licensing scheme in England for non-surgical cosmetic procedures. The purpose of the scheme is to ensure that consumers who choose to undergo a non-surgical cosmetic procedure can be confident that the treatment they receive is safe and of a high standard. Under the proposed scheme, practitioners will need to be licensed to perform specific procedures and the premises from which they operate will also need to be licensed.
-
Content ArticleHealthcare is where the "most exciting" opportunities for artificial intelligence (AI) lie, an influential MP has said, but is also an area where the technology's major risks are illustrated. Greg Clark, chairman of the Commons Science, Innovation and Technology Committee (SITC), said the wider adoption of AI in healthcare would have a "positive impact", but urged policy makers to "consider the risks to safety". He said: "If we're to gain all the advantages, we have to anticipate the risks and put in place measures to safeguard against that." An interim report published by the Science, Innovation and Technology Committee sets out the Committee’s findings from its inquiry so far, and the twelve essential challenges that AI governance must meet if public safety and confidence in AI are to be secured.
-
Content ArticleIn this blog, Sling the Mesh founder Kath Sansom highlights the variation in medical treatment depending on where you live in the world. Describing patient safety advocacy as "like a giant game of chess—but a hideous version where innocent people get hurt," she describes recent developments in the use of pelvic mesh globally. New Zealand recently suspended the use of a particular type of pelvic mesh at the same time as a Canadian study recommended its use for stress urinary incontinence (SUI). Kath gives a brief history of mesh sling suspension and argues that patient safety needs joined up thinking to protect women around the world.
-
Content Article
A patient harmed by orthodontic treatment shares their story
Anonymous posted an article in Patient stories
In this anonymous blog, a patient shares their experience of orthodontic treatment which they undertook to reduce overcrowding of their teeth. However, instead of solving the problem, the treatment caused multiple, complex dental issues that have resulted in severe pain and a high financial cost. The patient talks about how their orthodontist has been unwilling to take any responsibility for the issues caused, threatening legal action if the patient pursues any claims against them. They also discuss the reluctance of other orthodontists to get involved in trying to treat the issues they now face, and call for regulators and governments to look into the issue of negligent orthodontic treatment.- Posted
- 1 comment
-
- (and 4 more)
-
Content ArticleIn June 2022, General Sir Gordon Messenger and Dame Linda Pollard published their final report on the review of leadership and management in the health and social care sector, as commissioned by the Secretary of State for Health and Social Care in October 2021. This briefing by NHS Providers summarises the key areas covered by the report, grouping recommendations under the following headings: Training Development Equality, diversity and inclusion Challenged trusts, regulation and oversight
-
Content ArticleThe Health and Safety (Sharp Instruments in Healthcare) Regulations 2013 aimed to: minimise burdens on public, independent and third sector employers and ensure businesses in UK are not placed at competitive disadvantage relative to EU counterparts offer good standards of protection to healthcare workers from risk of sharps injury at work see a fall in sharps injury numbers. This post implementation review (PIR) aimed to assess the success of these objectives. It found that: stakeholder consultation provided evidence of the increasing use of safer sharps across all healthcare sectors. evidence from RCN research and HSE inspections indicates that risks to healthcare workers from sharps injuries remains high. The policy conclusion from this evidence is that the Regulations are still required, and that the Regulations’ objectives cannot be met with a system that imposes less burden to business.
-
Content ArticleIncreasing adverse events, hospital-associated infections, and other harm to patients have compounded and now fuel the call for the formation of a national patient safety board in the USA. But, with so many established health entities already within the government, will adding one create more complexities than it will oversight? A bill introduced in the House in December 2022 proposes such a body loosely modelled off the National Transportation Safety Board. The group behind the efforts for the board's creation note in a document that it still would not be the "sole solution" needed to properly address patient safety issues nationally, but rather is designed to "augment" the work of other federal agencies and patient safety organisations. The bill proposes that it would not be necessary to identify providers in reports that the board would investigate, and some patient safety experts say this is not the right approach, noting that it would not provide the accountability necessary — particularly since the board would be nonpunitive to begin with. But others argue that this structure could help promote voluntary reporting for more data collection. Three patient safety professionals shared their takes in Becker's Hospital Review.
-
Content Article
This is part of our series of Patient Safety Spotlight interviews, where we talk to people working for patient safety about their role and what motivates them. Kath talks to us about why she set up Sling the Mesh and the significant impact that campaigning has on her life. She also highlights the need to establish systems that will identify and prevent avoidable harm, including long term tracking to investigate trends of harm, reporting of industry payments to clinicians and making logging side effects mandatory for healthcare professionals. -
Content ArticleInvestigations suggest that, in some fields, at least one-quarter of clinical trials might be problematic or even entirely made up. This article in Nature looks at the findings of researchers who have been studying clinical trials and calling for greater regulatory scrutiny. It particularly examines the work of John Carlisle, NHS anaesthetist and editor at the journal Anaesthesia, who scrutinised over 500 studies with randomised controlled trials, over a period of three years. Carlisle found that 26% of the papers had problems that were so widespread that the trial was impossible to trust, either because the authors were incompetent or because they had faked the data. He called these ‘zombie’ trials because they had the semblance of real research, but closer scrutiny showed they were masquerading as reliable information.
-
Content Article
Mental Capacity and Mental Health Legislation
Patient_Safety_Learning posted an article in Consent and privacy
This guide, published by Patient, outlines some of the key elements of mental capacity and mental health legislation including: General principles of consent Emergency treatment Best interests Adults who are not competent to give consent Advance care planning Mental Health Act relevant to consent Section 57: Treatment requiring consent and a second opinion. -
Content ArticleThis factsheet from the General Medical Council sets out some of the key legislation and case law relating to medical decision making and consent in the UK. It is not intended to be a comprehensive list, nor is it a substitute for independent, up-to-date legal advice.
-
Content ArticleThe author of this blog published by Sling the Mesh, writes that ever year new healthcare treatments are launched underpinned by flawed, mischievous, flimsy and fraudulent scientific evidence – also known as cheating. They look at different types of cheating and argue that cheating helped push surgical mesh implants as ‘gold standard’.
-
Content ArticleThe Safe Care at Home Review is an important reminder that people with care and support needs may experience abuse and neglect, sometimes under the guise of ‘care’. Older people, or people with disabilities, may be particularly vulnerable to harm because of their dependence on others and the complexity of their care needs. They might rely on other people for physical, mental or financial support, and may face difficulties recognising or reporting harm. The review draws on a range of evidence, including the Home Office funded Vulnerability Knowledge and Practice Programme, which has highlighted that one in six domestic homicides involved people who were cared for by, or caring for, the suspect.
-
Content ArticleThe Professional Standards Authority (PSA) oversees the work of 10 statutory bodies that regulate health and social care professionals in the UK. In undertaking this oversight role, PSA strive to strike a proper balance between scrutiny on the one hand, and advice and support on the other. During 2022/23 they implemented changes to their performance review processes to ensure they continue to be proportionate and that they contribute to improvements in professional regulation. This year PSA have made further improvements to their performance reviews for the statutory regulators in health and social care and to their Accredited Registers programme. They published their Safer care for all report in September 2022.
-
Content ArticleFollowing an extensive process of internal and external engagement, the Medicines and Healthcare products Regulatory Agency has published their corporate plan for the next 3 years. Their priorities are: Maintain public trust through transparency and proactive communication Enable healthcare access to safe and effective medical products Deliver scientific and regulatory excellence through strategic partnerships Become an agency where people flourish alongside a responsive customer service culture.
-
Content Article
“I’ve been mocked, scolded and gaslighted”: a harmed patient’s experience of orthodontic treatment
Anonymous posted an article in Other conditions and diseases
In this opinion piece, a patient shares their experience of trying to access support from the healthcare system for debilitating jaw pain. They describe being dismissed and laughed at by doctors and orthodontists, highlight a knowledge gap around jaw issues and outline the need for more accountability in the orthodontics industry.
