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Written Question
Ultrasonics
Wednesday 25th October 2023

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to protect patients from (1) unregulated, and (2) unqualified, non-medical ultrasound practitioners.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

The Government is clear that the regulatory oversight of health and care professions must be proportionate to the risks to the public. Statutory regulation of healthcare professionals should only be used where the risks to patient protection cannot be addressed through employer oversight, system regulation, or accredited voluntary registration.

Services offering diagnostic and screening procedures that use ultrasound to examine the body must register with the Care Quality Commission (CQC). Providers must demonstrate that they provide enough suitably qualified, competent, skilled, and experienced staff to meet the needs of the people using the service to comply with the CQC’s regulatory requirements to operate.

Some sonographers are qualified and registered to practice in another healthcare profession that is subject to statutory regulation. The Professional Standards Authority for Health and Social Care manages the Accredited Registers Programme which independently assesses organisations who operate voluntary registers for practitioners who are not regulated by law. Sonographers can register with the accredited Register of Clinical Technologists.

The Government keeps the healthcare professions subject to statutory regulation under review and recently ran a consultation seeking views on the criteria used to decide when regulation is necessary, and whether there are any unregulated professions that should be brought into statutory regulation. The Government will publish its response to the consultation in due course.


Written Question
NHS: Safety
Monday 19th June 2023

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask His Majesty's Government what plans they have, and over what timescale, to further implement Scan4Safety and increase the percentage of NHS Trusts scanning products at the point of care.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

The Medical Device Outcome Registry (MDOR) will significantly improve the quality of data available to improve patient safety and outcomes in high-risk medical device procedures.

NHS England will monitor data quality in the MDOR via regular audits and feedback reports so they can make improvements and provide additional support where required. They are also expanding upon the Data Quality provider certification and award scheme currently active in the National Joint Registry. This is with a view to covering all registry procedures with a particular emphasis on collecting data on medical devices and consultants, Patient Reported Outcome Measures and patient feedback indicators. NHS England have mandated registry submission and will be monitoring compliance and ascertainment against Secondary Uses Service procedure data, to resolve any data completeness or quality issues.

MDOR has native barcode scanning, including Unique Device Identifier (UDI) barcodes, so will result in the whole of England having an available UDI scanning solution without having to implement a separate system. The registry will accept bulk uploads from existing providers’ solutions, including Scan4Safety, that meet the data quality and completeness requirements. The Outcomes and Registries programme will support provider adoption of digital solutions that enable medical device traceability on the electronic patient record. The aim is to have full data submission by NHS England and independent sector providers by the end of the year.

NHS England will be working with various Scan4Safety programme initiatives across England and the four nations, focussing upon medical device traceability and device-based procedures to enable scanning of device data into the patient record.


Written Question
Medical Equipment: Registration
Monday 19th June 2023

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask His Majesty's Government what safeguards they have in place to ensure high quality and precise data are entered into the medical devices outcomes register.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

The Medical Device Outcome Registry (MDOR) will significantly improve the quality of data available to improve patient safety and outcomes in high-risk medical device procedures.

NHS England will monitor data quality in the MDOR via regular audits and feedback reports so they can make improvements and provide additional support where required. They are also expanding upon the Data Quality provider certification and award scheme currently active in the National Joint Registry. This is with a view to covering all registry procedures with a particular emphasis on collecting data on medical devices and consultants, Patient Reported Outcome Measures and patient feedback indicators. NHS England have mandated registry submission and will be monitoring compliance and ascertainment against Secondary Uses Service procedure data, to resolve any data completeness or quality issues.

MDOR has native barcode scanning, including Unique Device Identifier (UDI) barcodes, so will result in the whole of England having an available UDI scanning solution without having to implement a separate system. The registry will accept bulk uploads from existing providers’ solutions, including Scan4Safety, that meet the data quality and completeness requirements. The Outcomes and Registries programme will support provider adoption of digital solutions that enable medical device traceability on the electronic patient record. The aim is to have full data submission by NHS England and independent sector providers by the end of the year.

NHS England will be working with various Scan4Safety programme initiatives across England and the four nations, focussing upon medical device traceability and device-based procedures to enable scanning of device data into the patient record.


Written Question
General Practitioners: Pharmacy
Tuesday 11th April 2023

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask His Majesty's Government, further to the remarks by Lord Evans of Rainow on 20 March (HL Deb col 1529), what is the source of their data for saying that six percent of GP services could be provided by pharmacies; and what is the evidence base for those data.

Answered by Lord Markham - Parliamentary Under-Secretary (Department of Health and Social Care)

The source of the data that 6% of general practitioner (GP) services could be provided by pharmacies, as referenced by Lord Evans of Rainow on 20 March, is the report Making Time in General Practice, published by the Primary Care Foundation and NHS Alliance in October 2015. This research found that 5.5% of GP appointments were potentially avoidable by being directed instead to self-care/pharmacy. These findings were referenced in the later report General Practice Forward View, published by NHS England in April 2016. In this report the figure was rounded to 6%.

Copies of both reports are attached.


Written Question
Rare Diseases
Thursday 28th April 2022

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government what steps they are taking to ensure the standards set out in NHS service specifications for rare and complex diseases, such as cystic fibrosis, are adhered to; and to what extent these represent a statutory expectation of care that patients should expect to receive at a minimum.

Answered by Lord Kamall

It has not proved possible to respond to this question in the time available before Prorogation. Ministers will correspond directly with the Member.


Written Question
Medical Records: Data Protection
Thursday 10th March 2022

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the answer by Lord Bethell on 8 June 2021 (HL Deb cols 1219–20), what improvements they have made to the process for patients opting out of their medical data being used for research and planning; and how each patient can see where data about them are used.

Answered by Lord Kamall

Whilst no recent changes have been made to the patient opt-out process, we are considering further engagement with the public, patients, service users, staff and stakeholders. This will include raising awareness of the opt-out system, with the aim of making the process simpler and more transparent and how tools such as a transparency statement could help patients understand how their data is used. We will provide further details in the data strategy for health and social care, due for publication in spring 2022.


Written Question
Medical Records: Data Protection
Tuesday 1st March 2022

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the answer by Lord Bethell on 8 June 2021 (HL Deb, col 1319–20), what improvements they have made to the process for patients opting out of their health data being used for research and planning; and how each patient can see where data about them is used.

Answered by Lord Kamall

In July 2021, we committed that the General Practice Data for Planning and Research programme will not access patient data until the following criteria has been met:

- the ability to delete data if patients choose to opt-out of sharing their data with NHS Digital, even if this is after their data has been uploaded;

- the backlog of opt-outs has been fully cleared;

- a trusted research environment has been developed and implemented by NHS Digital; and

- patients have been made more aware of the scheme through a campaign of engagement and communication.

NHS Digital is redesigning the programme with input from stakeholders to take account of these commitments and professional, public and stakeholder feedback. Data collection will begin when the National Data Guardian, the Royal College of General Practitioners and the British Medical Association are satisfied with the proposed arrangements. As part of our data strategy, we will engage on how the opt-out system works in practice, with the aim of making the process simpler and more transparent.

Patients can view how data is used through NHS Digital’s data release register. This shows monthly information on who data has been shared with, which data has been shared and for what specific purpose.


Written Question
Medicines and Medical Devices Safety Independent Review
Tuesday 3rd August 2021

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the report by the Independent Medicines and Medical Devices Safety Review First do No Harm, published on 8 July 2020, what negotiations have taken place between the Department of Health and Social Care and Her Majesty’s Treasury about redress for those who have suffered harm from (1) Primodos, (2) sodium valproate, and (3) pelvic mesh.

Answered by Lord Bethell

The Department engaged with HM Treasury on redress prior to cross-Government approval of the response to the Independent Medicines and Medical Devices Safety Review.


Written Question
Medical Records: Data Protection
Tuesday 13th July 2021

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government how many people have registered an opt-out with their GP practice to prevent the sharing of personal data outside of their GP practice except for their own care as at 5 July; and how many people have registered an opt-out covering the broader health and care system, that is the National Data opt-out, as at 5 July.

Answered by Lord Bethell

Data on how many people have registered such an opt-out is not held centrally. NHS Digital reports that the current number of registered national data opt-outs is 3,066,543.


Written Question
Kidney Diseases: Medical Treatments
Friday 16th April 2021

Asked by: Baroness Cumberlege (Conservative - Life peer)

Question to the Department of Health and Social Care:

To ask Her Majesty's Government what plans they have to encourage greater uptake of home haemodialysis, in line with the NICE Guidelines, COVID-19 rapid guidelines: dialysis service delivery, published on 20 March 2020.

Answered by Lord Bethell

NHS England and NHS Improvement are undertaking a national Renal Transformation Programme starting later in 2021. As part of this, ways to incentivise home dialysis will be considered, which may include use of tariffs or other commissioning levers.