Jump to content

Search the hub

Showing results for tags 'Regulatory issue'.

More search options

  • Search By Tags

    Start to type the tag you want to use, then select from the list.

  • Search By Author

Content Type


Forums

  • All
    • Commissioning, service provision and innovation in health and care
    • Coronavirus (COVID-19)
    • Culture
    • Improving patient safety
    • Investigations, risk management and legal issues
    • Leadership for patient safety
    • Organisations linked to patient safety (UK and beyond)
    • Patient engagement
    • Patient safety in health and care
    • Patient Safety Learning
    • Professionalising patient safety
    • Research, data and insight
    • Miscellaneous

Categories

  • Commissioning, service provision and innovation in health and care
    • Commissioning and funding patient safety
    • Digital health and care service provision
    • Health records and plans
    • Innovation programmes in health and care
    • Climate change/sustainability
  • Coronavirus (COVID-19)
    • Blogs
    • Data, research and statistics
    • Frontline insights during the pandemic
    • Good practice and useful resources
    • Guidance
    • Mental health
    • Exit strategies
    • Patient recovery
    • Questions around Government governance
  • Culture
    • Bullying and fear
    • Good practice
    • Occupational health and safety
    • Safety culture programmes
    • Second victim
    • Speak Up Guardians
    • Staff safety
    • Whistle blowing
  • Improving patient safety
    • Clinical governance and audits
    • Design for safety
    • Disasters averted/near misses
    • Equipment and facilities
    • Error traps
    • Health inequalities
    • Human factors (improving human performance in care delivery)
    • Improving systems of care
    • Implementation of improvements
    • International development and humanitarian
    • Safety stories
    • Stories from the front line
    • Workforce and resources
  • Investigations, risk management and legal issues
    • Investigations and complaints
    • Risk management and legal issues
  • Leadership for patient safety
    • Business case for patient safety
    • Boards
    • Clinical leadership
    • Exec teams
    • Inquiries
    • International reports
    • National/Governmental
    • Patient Safety Commissioner
    • Quality and safety reports
    • Techniques
    • Other
  • Organisations linked to patient safety (UK and beyond)
    • Government and ALB direction and guidance
    • International patient safety
    • Regulators and their regulations
  • Patient engagement
    • Consent and privacy
    • Harmed care patient pathways/post-incident pathways
    • How to engage for patient safety
    • Keeping patients safe
    • Patient-centred care
    • Patient Safety Partners
    • Patient stories
  • Patient safety in health and care
    • Care settings
    • Conditions
    • Diagnosis
    • High risk areas
    • Learning disabilities
    • Medication
    • Mental health
    • Men's health
    • Patient management
    • Social care
    • Transitions of care
    • Women's health
  • Patient Safety Learning
    • Patient Safety Learning campaigns
    • Patient Safety Learning documents
    • Patient Safety Standards
    • 2-minute Tuesdays
    • Patient Safety Learning Annual Conference 2019
    • Patient Safety Learning Annual Conference 2018
    • Patient Safety Learning Awards 2019
    • Patient Safety Learning Interviews
    • Patient Safety Learning webinars
  • Professionalising patient safety
    • Accreditation for patient safety
    • Competency framework
    • Medical students
    • Patient safety standards
    • Training & education
  • Research, data and insight
    • Data and insight
    • Research
  • Miscellaneous

News

  • News

Find results in...

Find results that contain...


Date Created

  • Start
    End

Last updated

  • Start
    End

Filter by number of...

Joined

  • Start

    End

Group

First name

Last name

Country

Join a private group (if appropriate)

About me

Organisation

Role

Found 473 results
  1. Content Article
    A medical device is any piece of equipment, material or apparatus used to diagnose or treat a medical condition. When a medical device is recalled because of safety concerns, it can affect a large number of patients, often on a global scale. However, manufacturers and regulators of these devices don’t often have effective ways to ensure patients know about safety concerns, understand the risks or know what to do if their medical device is recalled. This blog by Kath Samson, founder of the Sling the Mesh campaign, looks at some of the issues around medical device recalls. She suggests ways that device manufacturers and regulators can improve their communication with patients and healthcare staff when a medical device is recalled.
  2. Content Article
    'The state of care in NHS acute hospitals 2014 to 2016' presents findings from the Care Quality Commission (CQC's) programme of NHS acute comprehensive inspections. The report captures what has been learned from three years’ worth of inspections. It gives a baseline on quality that is unique in the world – and also shows that it is possible, even in challenging times, to deliver the transformational change that is needed if the NHS is to continue delivering high-quality care into the future.
  3. News Article
    GP practices will be included in the remit of a new patient safety watchdog, due to come in from 2023 under the new Health and Care Bill, the Department of Health and Social Care (DHSC) has said. DHSC said that it expects the new Health Services Safety Investigations Body (HSSIB) to be ‘fully operational’ in England from April 2023 – ‘subject to parliamentary clearances’. It confirmed that the statutory independent body will investigate NHS care in GP practices, although it said that the HSSIB’s ‘focus is likely to be predominantly on investigating patient safety incidents in NHS trusts’. The body will also investigate care provided by the independent healthcare sector. RCGP vice-chair Dr Gary Howsam said: ‘It is important that we have further details about how this regulator will interact with general practice, and the expectations it will have of GPs and our teams, including ensuring GPs are not implicated for systemic issues out of their control.’ Read the full article here
  4. News Article
    ‘Very heavy-handed, laborious and expensive’ inspections ‘have not been the right way’ of regulating hospitals, according to the Care Quality Commission’s (CQC) former chair. Speaking at a Royal Society of Medicine event on Wednesday, Lord David Prior, who is now the chair of NHS England, said “very few” physicians will have improved their work after reading a report from the regulator. He added that there is a role for the CQC to move in when “things are going wrong” although he is “sceptical” the regulator can actually drive improvement in hospitals. Lord Prior said: “I am highly sceptical as to whether or not CQC or any regulator can really drive improvement and drive the top hospitals to make them better. “And certainly I think there’ll be very few physicians who will say that their clinical work has improved as a result of reading a CQC report. “I think the sadness I have about CQC is that we have not been able, or it has not been able, to develop a series of predictive metrics that could replace these very heavy handed, very laborious and very expensive visits that we used to do.” Read full story (paywalled) Source: HSJ, 9 September 2021
  5. Content Article
    Ethics in medical science have been borne out of practices that occurred during the second world war, with the Nuremberg code being set up to prevent unethical experimentation on humans from being carried out.  This was further supported by the Declaration of Helsinki that strengthened the protection of participants within medical research by setting out the stipulations that informed consent should be obtained before research. It ensured that data should be kept confidential so that medical research that ultimately requires input from human participants would be able to be carried out with minimal risk to the individual.  Lara Carballo continues the 'Why investigate' blog series with a cautionary tale of why within Human Factors it is necessary to ensure that ethics are in place before embarking on research.
  6. Content Article
    The rise in opioid overdoses warrants a review of the symptoms of akathisia writes Russell Copelan.
  7. Content Article
    In this article in the Pharmaceutical Journal, Carolyn Wickware asks if liquid morphine should be reclassified. She cites research that Oramorph or oral morphine sulphate solution was directly linked to the cause of death in 13 reports since 2013.
  8. Content Article
    This document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning. It also identifies the transition points in the life cycle where transfers of responsibility occur, and the types of multi-lateral communication that are necessary at these transition points. This document also establishes a coherent concepts and terminology for other standards that address specific aspects of the safety, effectiveness, and security (including privacy) of health software and health IT systems.
  9. Content Article
    The Care Quality Commission's (CQC) new strategy strengthens its commitment to deliver their purpose: to ensure health and care services provide people with safe, effective, compassionate, high-quality care and to encourage those services to improve.
  10. News Article
    Serious patient safety issues are being buried in confidential hospital reports, BBC Panorama has found. Freedom of Information requests revealed 111 reports, written by medical royal colleges, which NHS trusts have a duty to share. Eighty reports were given to the BBC but only 26 had been shared in full with regulators, and 16 published. The Department of Health would not comment on whether it might change the law to ensure publication. Since the 2015 Morecambe Bay maternity scandal in which 11 babies and a mother died, NHS Trusts are supposed to publish summaries of external reviews, and share them with the regulator. An earlier review into the hospital had previously identified concerns but had not been made public. Dr Bill Kirkup, who led a 2015 investigation into the Morecambe Bay scandal, said Panorama's findings were a "great disappointment". "People should know that there is something that is important enough to be looked at and they should know what the results of that scrutiny are. I can't understand what the rationale would be for withholding the existence of a report or the findings of the report. These are important matters of accountability in the public service." Read full story Source: BBC News, 19 May 2021
  11. News Article
    Ten junior doctors have been removed from a struggling hospital over concerns they were being left without adequate supervision on understaffed wards. Health Education England (HEE) removed the 10 foundation year one doctors, all on a general medicine rota, from Weston General Hospital last month. The General Medical Council said the trust’s previous efforts to address the issues “have not been sufficient or sustainable”. University Hospitals Bristol and Weston Foundation Trust did not say which services HEE had removed the juniors from or what mitigations had been put in place. However, the trust told HSJ none of the positions concerned were from the hospital’s emergency department, where the GMC has already imposed conditions on juniors’ training. HEE very rarely uses its power to withdraw trusts’ trainees. HSJ reported last June the regulator had only removed two posts at trusts under enhanced monitoring since the start of 2019. William Oldfield, University Hospitals Bristol and Weston FT medical director, said in a statement to HSJ: “We recognise the seriousness of the step taken by HEE to temporarily suspend the training programme for a small number of junior doctors at Weston General Hospital. ”We are working to provide the assurance HEE require to allow this training to recommence, and in the meantime we have appropriately mitigated the impact on services at Weston.” Read full story (paywalled) Source: HSJ, 10 May 2021
  12. Content Article
    NICE will speed up patients’ access to the latest and most effective treatments, and dynamic guideline recommendations will be put in the hands of healthcare professionals more quickly under plans unveiled by National Institute for Health and Care Excellence (NICE) in its 5-year strategy.
  13. News Article
    Regulators have sent an improvement director into a North West acute trust amid multiple allegations of poor care and ‘cover up’ across different specialties. University Hospitals of Morecambe Bay Foundation Trust, which spent 18 months in special measures midway through the last decade, is again now the subject of significant regulatory intervention from NHS England. The regulator has appointed Simon Bennett as a board-level improvement director, which comes after he undertook a similar assignment at the struggling Stockport FT. It comes amid ongoing external investigations into the trust’s urology and trauma and orthopaedics specialties, where serious allegations have been made about attempts to cover up poor care. The trust has a troubled history of care failings and regulatory intervention, including a major maternity scandal which culminated in the Kirkup Inquiry in the first half of the 2010s, and being placed in special measures in 2014. It was widely recognised that positive progress was subsequently made to implement the inquiry recommendations and improve services, which culminated in the trust exiting special measures in late 2015, and being rated “good” by the CQC in early 2017. However, the recent allegations and investigations have again brought regulatory intervention. Read full story (paywalled) Source: HSJ, 20 April 2021
  14. Content Article
    In this opinion piece, Kath Sansom, Founder of the Sling the Mesh Campaign, argues that the UK regulatory systems for medicines and healthcare have not been fit for purpose for a number of years. Framed within the context of the Cumberlege Review, Kath uses evidence and personal insight to highlight flaws in the system, and to make the case for urgent reform. 
  15. Content Article
    The Department of Health and Social Care (DHSC) published its consultation 'Regulating healthcare professionals, protecting the public' with proposals to modernise the legislation of the health professional regulators. Here the Professional Standards Authority gives their views of these proposals.
  16. Content Article
    Two professionals who treated Jack Adcock before his death were convicted of gross negligence manslaughter, receiving 24-month suspended sentences. His nurse, Isabel Amaro, was erased from the nursing register; but after reviews in the High Court and Court of Appeal, his doctor, Hadiza Bawa-Garba, was merely suspended. Nathan Hodson explores the proposition that nurses are at greater risk of erasure than doctors after gross negligence manslaughter through a close reading of the guidance for medical and nursing tribunals informed by analysis from the High Court and Court of Appeal in the Bawa-Garba cases. 
  17. Content Article
    The Medicines and Medical Devices Bill has received royal assent and has become law. The new Act will enable the Department of Health and Social Care (DHSC) to implement a number of policies to amend the existing regulatory frameworks, although generally regulations under the Act must first be introduced. The potential changes include: Supporting the availability of medicines: enabling hub and spoke arrangements between different legal entities, to ‘support wider use of automation to bring increased efficiencies’; requiring manufacturers to provide electronic patient information leaflets; and increasing the professions able to prescribe and supply certain medicines. Protecting the public: developing a UK medicines verification system; introducing a national registration scheme for online sellers of medicines; and facilitating supply of medicines and medical devices during non-pandemic public health emergencies.
  18. Event
    until
    While the pandemic didn’t cause all the shifts happening in healthcare, it had a major hand in accelerating and shaping the changes that will alter the healthcare landscape far into the future. Join Fierce Healthcare as we examine the tectonic transformation across healthcare. We’ll explore changing consumer expectations in access to care, the moves by major tech players and providers to reach their customers and strategies for actually paying for everything. Register
  19. Content Article
    In this blog, Patient Safety Learning outlines the key points included in its response to the Care Quality Commission’s (CQC) consultation on their new strategy from 2021, identifying the opportunities this presents for the health and social care regulator to help improve patient safety.
  20. News Article
    A regulator has admitted “concerns” over the software Babylon Healthcare uses in one of its digital health solutions and is exploring how to address this. The Medicines and Healthcare products Regulatory Authority’s (MHRA) concerns relate to Babylon’s symptom checker “chatbot” tool. This is used by thousands of patients, including those registered with digital primary care practice GP at Hand. Two senior figures within the agency set out the MHRA’s concerns about the tool in a letter, seen by HSJ, which was sent to consultant oncologist David Watkins following a meeting between the parties last October. Dr Watkins has raised doubts over the tool’s safety for several years, including repeatedly documenting alleged flaws in the chatbot through videos posted online. However, last year, Babylon said only 20 of Dr Watkins’ 2,400 tests resulted in “genuine errors” being identified in the software. In the letter, dated 4 December, the MHRA’s clinical director for devices Duncan McPherson and head of software related device technologies Johan Ordish said Dr Watkins’ “concerns are all valid and ones that we share”. In the letter to Dr Watkins, the two MHRA directors also said the regulator is further exploring some of the issues highlighted and the work could “be important as we develop a new regulatory framework for medical devices in the UK”. Read full story (paywalled) Source: HSJ, 4 March 2021
  21. News Article
    The development of coronavirus vaccines tweaked to target new variants will be fast-tracked in the UK and four other countries, Britain’s regulator has said, adding that “robust evidence” on effectiveness and safety will still be required for authorisation. The approach, similar to the regulatory process for the modified flu vaccine, will not need a brand new approval or “lengthy” clinical studies, the Medicines and Healthcare Products Regulatory Agency (MHRA) said on Thursday. This will "significantly reduce" the length of time it takes for the vaccines to be ready, with concern mounting over the threat posed by the South African and Brazilian variants and their ability to partially evade the body’s immune response. Under the new guidance, developers will need to provide clear evidence their adapted vaccines produce a strong immune response to the variant and meet the high safety standards outlined by the MHRA. “This is based on scientific principles and does not cut any corners on safety or effectiveness,” said Dr Christian Schneider, chief scientific officer at the MHRA. Read full story Source: The Independent, 4 March 2021
  22. News Article
    Health secretary Matt Hancock has said integrated care systems (ICS) will be rated by the Care Quality Commission (CQC). The government’s recent white paper for a new NHS bill did not discuss any change in the CQC’s legal framework to allow it to rate ICSs, which sparked uncertainty around how ICSs would be regulated. However, speaking in the House of Commons today of the “crucial” role the regulator plays in rating hospitals, Mr Hancock said: “I think that it is vital that the CQC has a similar role when it comes to ICSs.” The CQC has not confirmed what, if any, legal changes it is seeking. Currently, if the regulator wants to inspect how well a system is working, it must ask permission from the secretary of state to do so. It has carried out around 25 inspections of systems since 2017, but has not issued ratings. Giving evidence at a Parliamentary committee meeting earlier today, Sir Robert Francis, Healthwatch England chair, said: “A rating [from the CQC] that summarises the performance of the organisation to the public is a form of accountability. It doesn’t affect patient choice in quite the same way as a provider rating does, but it may be a way of explaining to the public how their system is doing.” He added that if inspectors are “continually being directed to go to the places the secretary of state chooses” then they may not carry the authority or credibility of an independent process. Read full story (paywalled) Source: HSJ, 2 March 2021
  23. Event
    Here is how to obtain a quick overview of the new Acceptable Means of Compliance (AMC) and Guidance Material (GM) addressing software published in October 2019 (Reference: ED Decision 2019/022/R). Note: Participation to Basics of regulation on the 02/03/2021 is recommended if you don't know what are AMC, GM and structure of 2017/373. Register
  24. News Article
    Plans to give the health secretary control over a patient safety watchdog risks “massive untold consequences” for the NHS, experts have warned. Under proposals, Matt Hancock would be able to determine which incidents the Healthcare Safety Investigation Branch (HSIB) should investigate, while also being able to remove protections for NHS staff that mean they can give evidence without fear of reprisals. The move, outlined as part of wider reforms to the NHS, would give the health secretary far greater control over the HSIB than ministers currently have over the Air Accident Investigation Branch – on which the watchdog was modelled. Experts said the proposals cut across the original intention of an independent body that would act without fear or favour and earn the confidence of NHS staff. It is designed to operate under a so-called “safe space” for NHS staff to provide evidence of what went wrong during an incident without their testimony being used against them. Martin Bromiley, chair of the Clinical Human Factors Group and member of the expert panel that recommended the creation of HSIB in 2016, said he was seriously concerned over the plans. He said: “I am concerned about the reference to lifting safe space. As it stands with the Air Accident Investigation Branch people can apply to the High Court for it to be lifted and that makes sense because a judge can consider the whole case and the longer-term impact." Carl Macrae, Professor of Organisational Behaviour and Psychology at Nottingham University Business School, told The Independent: “I am very pleased to see there are concrete plans to establish HSIB as an independent body, but I am concerned this independence appears to be undermined by giving the secretary of state the power to tell it what to investigate." “People need to be able to trust that the healthcare investigator is acting with the sole purpose of improving safety and isn’t subject to political interference.” Read full story Source: The Independent, 24 February 2021
  25. News Article
    Staff at one of England’s largest hospital trusts have been threatened with disciplinary and regulatory action if they attempt to get their second COVID-19 vaccine dose early, HSJ has learned In an all staff email today, University Hospitals Birmingham Foundation Trust said: “Any staff trying to obtain a second dose ahead of their booked sessions could be considered deliberately attempting to deceive the NHS in order to obtain medicines and, as such will be a professional conduct issue which may result in disciplinary action and/or regulatory action being taken against you. The new note indicates the FT may have had a particular problem with staff seeking and/or getting second doses. The email said that if they attended vaccination centres, staff would be refused a second dose, and be asked to leave. Staff were also asked not to try and book another appointment at a different vaccination centre or “re-enter” the system through over means. The email added: “The current supply of vaccines is allocated to us to ensure all priority groups can receive their first dose and provide protection to as many as possible.” In December the trust’s executives were heavily criticised by unions for getting their first vaccine doses, after patients didn’t show up for appointments. The trust, which has been dealing with very large numbers of covid patients especially in intensive care, has also been the subject of concerns over culture and management in recent months. Read full story (paywalled) Source: HSJ, 20 February 2021
×
×
  • Create New...

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.

 Accept Cookies  Reject Cookies