Asked by: Baroness Ritchie of Downpatrick (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the Independent Medicines and Medical Devices Safety Review report First Do No Harm, published on 8 July 2020.
Answered by Lord Markham - Shadow Minister (Science, Innovation and Technology)
The Independent Medicines and Medical Devices Safety (IMMDS) Review was clear in its finding that the healthcare system failed to listen to patients’ concerns on the issues covered by the review. The Government’s 2021 response to the review set out which of the review’s recommendations the Government had accepted. We also published an update in an online-only format in December 2022 setting out progress made against those recommendations, which includes appointing the first ever Patient Safety Commissioner in England to champion patients’ voices in relation to the safety of medicines and medical devices. In April 2023, the Government also responded to the recommendations made by the Health and Social Care Committee in its report ‘Follow-up on the IMMDS report and the Government’s response’, published in January 2023. A copy of the follow-up report is attached.
Asked by: Baroness Merron (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what assessment they have made of the risk of being pressured into showing confidential medical records on the NHS App to third parties faced by (1) patients requesting covert contraception forbidden in their home or relationship, (2) patients who are suffering domestic abuse, and (3) other vulnerable groups including the elderly.
Answered by Lord Markham - Shadow Minister (Science, Innovation and Technology)
The Government wants people to be able to have access to their own records if they choose to do so. There is widespread international consensus about the benefits to patients and the effectiveness of the health system in providing digital on-demand access to personal health information.
For most, online record access is beneficial, but for a minority, having access could cause harm or distress. NHS England is taking an active approach to ensuring safe and secure patient record access, seeking to identify and provide additional protections to vulnerable people if they request access to their medical records online.
NHS England has engaged extensively with at-risk groups, professional bodies, patient groups, charities and safeguarding leads to support general practice and patients in preparing for this change safely and effectively. Communication packs have been provided to over 50 charities that support at-risk individuals. NHS Digital has published guidance in an online-only format for organisations, Supporting victims and survivors of domestic or sexual abuse, to support people when accessing their personal health information online.
Before viewing their record in the NHS App, users are advised what to do if they are being pressured to share their information. Patients can prevent access by disabling their National Health Service login with a simple online process or can ask their general practitioner (GP) for the details of specific consultations or treatment decisions to be redacted. When an individual first requests access, they cannot see information already recorded; they will only be able to access information recorded from that point onwards.
The expert safeguarding group has identified theoretical risks, which have fed into NHS England’s patient and GP communications packs and advice, messaging on the NHS App and NHS.uk and improvements made by GP IT system suppliers.
More than 23 million patients have viewed their records over nine million times, with no significant incidents relating to personal safety or security reported. Lower-level incidents, such as people finding out their diagnosis before being told by a clinician, have been reported, and some issues have been investigated and classed as low-risk and/or resolved.
NHS England continues to monitor this and would take action if an issue was identified or raised.
Asked by: Baroness Merron (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what consideration has been given to making it simpler to switch off access to patient health records through the NHS app, particularly for vulnerable groups.
Answered by Lord Markham - Shadow Minister (Science, Innovation and Technology)
The Government wants people to be able to have access to their own records if they choose to do so. There is widespread international consensus about the benefits to patients and the effectiveness of the health system in providing digital on-demand access to personal health information.
For most, online record access is beneficial, but for a minority, having access could cause harm or distress. NHS England is taking an active approach to ensuring safe and secure patient record access, seeking to identify and provide additional protections to vulnerable people if they request access to their medical records online.
NHS England has engaged extensively with at-risk groups, professional bodies, patient groups, charities and safeguarding leads to support general practice and patients in preparing for this change safely and effectively. Communication packs have been provided to over 50 charities that support at-risk individuals. NHS Digital has published guidance in an online-only format for organisations, Supporting victims and survivors of domestic or sexual abuse, to support people when accessing their personal health information online.
Before viewing their record in the NHS App, users are advised what to do if they are being pressured to share their information. Patients can prevent access by disabling their National Health Service login with a simple online process or can ask their general practitioner (GP) for the details of specific consultations or treatment decisions to be redacted. When an individual first requests access, they cannot see information already recorded; they will only be able to access information recorded from that point onwards.
The expert safeguarding group has identified theoretical risks, which have fed into NHS England’s patient and GP communications packs and advice, messaging on the NHS App and NHS.uk and improvements made by GP IT system suppliers.
More than 23 million patients have viewed their records over nine million times, with no significant incidents relating to personal safety or security reported. Lower-level incidents, such as people finding out their diagnosis before being told by a clinician, have been reported, and some issues have been investigated and classed as low-risk and/or resolved.
NHS England continues to monitor this and would take action if an issue was identified or raised.
Asked by: Baroness Merron (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government what advice is being provided to domestic abuse survivors and other at-risk groups about medical apps they have downloaded on their devices.
Answered by Lord Markham - Shadow Minister (Science, Innovation and Technology)
The Government wants people to be able to have access to their own records if they choose to do so. There is widespread international consensus about the benefits to patients and the effectiveness of the health system in providing digital on-demand access to personal health information.
For most, online record access is beneficial, but for a minority, having access could cause harm or distress. NHS England is taking an active approach to ensuring safe and secure patient record access, seeking to identify and provide additional protections to vulnerable people if they request access to their medical records online.
NHS England has engaged extensively with at-risk groups, professional bodies, patient groups, charities and safeguarding leads to support general practice and patients in preparing for this change safely and effectively. Communication packs have been provided to over 50 charities that support at-risk individuals. NHS Digital has published guidance in an online-only format for organisations, Supporting victims and survivors of domestic or sexual abuse, to support people when accessing their personal health information online.
Before viewing their record in the NHS App, users are advised what to do if they are being pressured to share their information. Patients can prevent access by disabling their National Health Service login with a simple online process or can ask their general practitioner (GP) for the details of specific consultations or treatment decisions to be redacted. When an individual first requests access, they cannot see information already recorded; they will only be able to access information recorded from that point onwards.
The expert safeguarding group has identified theoretical risks, which have fed into NHS England’s patient and GP communications packs and advice, messaging on the NHS App and NHS.uk and improvements made by GP IT system suppliers.
More than 23 million patients have viewed their records over nine million times, with no significant incidents relating to personal safety or security reported. Lower-level incidents, such as people finding out their diagnosis before being told by a clinician, have been reported, and some issues have been investigated and classed as low-risk and/or resolved.
NHS England continues to monitor this and would take action if an issue was identified or raised.
Asked by: Baroness Merron (Labour - Life peer)
Question to the Department of Health and Social Care:
To ask His Majesty's Government whether any concerns about risk to personal safety and security have been identified by the expert safeguarding group reviewing the implementation of NHS App.
Answered by Lord Markham - Shadow Minister (Science, Innovation and Technology)
The Government wants people to be able to have access to their own records if they choose to do so. There is widespread international consensus about the benefits to patients and the effectiveness of the health system in providing digital on-demand access to personal health information.
For most, online record access is beneficial, but for a minority, having access could cause harm or distress. NHS England is taking an active approach to ensuring safe and secure patient record access, seeking to identify and provide additional protections to vulnerable people if they request access to their medical records online.
NHS England has engaged extensively with at-risk groups, professional bodies, patient groups, charities and safeguarding leads to support general practice and patients in preparing for this change safely and effectively. Communication packs have been provided to over 50 charities that support at-risk individuals. NHS Digital has published guidance in an online-only format for organisations, Supporting victims and survivors of domestic or sexual abuse, to support people when accessing their personal health information online.
Before viewing their record in the NHS App, users are advised what to do if they are being pressured to share their information. Patients can prevent access by disabling their National Health Service login with a simple online process or can ask their general practitioner (GP) for the details of specific consultations or treatment decisions to be redacted. When an individual first requests access, they cannot see information already recorded; they will only be able to access information recorded from that point onwards.
The expert safeguarding group has identified theoretical risks, which have fed into NHS England’s patient and GP communications packs and advice, messaging on the NHS App and NHS.uk and improvements made by GP IT system suppliers.
More than 23 million patients have viewed their records over nine million times, with no significant incidents relating to personal safety or security reported. Lower-level incidents, such as people finding out their diagnosis before being told by a clinician, have been reported, and some issues have been investigated and classed as low-risk and/or resolved.
NHS England continues to monitor this and would take action if an issue was identified or raised.
Asked by: Baroness Bennett of Manor Castle (Green Party - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what assessment they have made of the report in the Lancet First, do no harm: time for a systems approach to address the problem of health-care-derived pharmaceutical pollution, published in December 2022; and what steps, if any, they plan to take regarding its recommendations.
Answered by Lord Benyon - Lord Chamberlain (HM Household)
Defra and its agencies, including the Environment Agency, have not yet considered the report in full detail but will do so in due course. We will consider the recommendations in conjunction with officials in the Department for Health and Social Care. Defra has already noted that some of the suggested interventions in the Lancet paper may be relevant to veterinary medicines. The Veterinary Medicines Directorate within Defra is actively considering issues around pharmaceuticals in the environment, and conducts environmental risk assessments for all new veterinary medicines.
Asked by: Rachael Maskell (Labour (Co-op) - York Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what assessment he has made of the implications of the First Do No Harm report for pain and trauma management for women having hysteroscopy diagnosis tests.
Answered by Maria Caulfield
No specific assessment has been made. The First Do No Harm report does not refer to pain and trauma management for women having hysteroscopy diagnosis tests. The Government responded to the First Do No Harm report in July 2021 and published an update report in December 2022.
Asked by: Feryal Clark (Labour - Enfield North)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, when his Department plans to undertake a retrospective audit of mesh as called for in Baronness Cumberlege's First Do No Harm, The report of the Independent Medicines and Medical Devices Safety Review.
Answered by Maria Caulfield
We accepted the Independent Medicines and Medical Devices Safety Review’s recommendation to undertake a selective retrospective audit of a defined cohort of women who have undergone mesh procedures. NHS Digital has undertaken an audit of all pelvic floor surgery completed between 2006 and 2011 to generate a historical baseline of outcomes by procedure type and to support further research and analysis. This audit was conducted using initial procedures and re-operations/ follow up procedures recorded within Hospital Episode Statistics data. While the audit has been completed and is undergoing peer review, which may necessitate further enhancements, prior to publication in 2023.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Haltemprice)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the report of the Independent Medicines and Medical Devices Safety Review entitled First Do No Harm, published on 8 July 2020, if he will make an estimate of the number of people with stress urinary incontinence who have been treated with mesh (a) slings and (b) tapes in (i) July 2018 to July 2019, (ii) July 2019 to July 2020, (iii) July 2020 to July 2021 and (iv) July 2021 to 11 July 2022.
Answered by Caroline Johnson - Shadow Minister (Health and Social Care)
There are no plans to make a specific estimate. Routine summary information relating to procedures for the treatment of stress urinary incontinence is regularly published as part of NHS Digital’s Hospital Episode Statistics data. However, since 2021/22 NHS Digital and NHS England have confirmed with individual trusts that specific treatments are as described for the activity recorded and it has been identified that some trusts have mis-coded procedures in the data used to produce these statistics.
In line with recommendations from the Independent Medicines and Medical Devices Safety Review, NHS Digital has created a pelvic floor registry for mesh and non-mesh procedures. This will allow an accurate assessment of the number of people undergoing mesh sling and tape procedures in the future.
Since July 2018 there has been a restriction in practice and period of high vigilance for the use of surgical mesh and tape to treat stress urinary incontinence and pelvic organ prolapse. This restriction was reviewed and extended in March 2019 and remains in place. Clinicians can still carry out these procedures with the informed consent of the patient if a multidisciplinary team agrees there is clinical urgency to carry out the procedure and there is no suitable alternative.
Asked by: Emma Hardy (Labour - Kingston upon Hull West and Haltemprice)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, with reference to the report of the Independent Medicines and Medical Devices Safety Review entitled First Do No Harm, published on 8 July 2020, how many people with stress urinary incontinence have been treated with mesh (a) slings and (b) tapes at University Hospital Southampton NHS Foundation Trust between (i) 1 July 2018 and 1 July 2019, (ii) 2 July 2019 to 1 July 2020, (iii) 2 July 2020 to 1 July 2021 and (iv) 2 July 2021 to 11 July 2022.
Answered by James Morris
We are unable to provide the information requested on the number of patients with stress urinary incontinence treated with slings at University Hospital Southampton NHS Foundation Trust from 2 July 2019 to 1 July 2020. This is due to the small number of patients involved which could lead to the identification of individuals. However, no patients were treated with slings between 1 July 2018 and 1 July 2019 or between 2 July 2020 and 11 July 2022.
No patients with stress urinary incontinence were treated with mesh tape at the Trust between 1 July 2018 and 11 July 2022.