NHSX’s NHS Artificial Intelligence (AI) Laboratory is supporting the testing, evaluation and scale of promising AI-driven technologies through the £140 million AI in Health and Care Award. This includes automating early lung cancer detection and developing deep learning software that could improve the NHS Breast Screening Programme.

Last year, we announced the Digital Aspirant Fund to support National Health Service providers. The Digital Aspirant programme with investment of £28 million aims to accelerate the procurement, deployment and uptake of the technology that is needed to underpin digital transformation.

NHS Digital will receive historical data from healthcare providers on pelvic floor surgical procedures, including the use of mesh or its alternatives. Data collected will be in accordance with the data specification which has been designed in consultation with stakeholders, including patient representatives and is available at the following link:

https://digital.nhs.uk/about-nhs-digital/corporate-information-and-documents/directions-and-data-provision-notices/data-provision-notices-dpns/surgical-devices-and-implants

NHS Digital has started a programme of work under the Surgical Devices and Implants Direction to collect information on surgical implants and devices from healthcare providers in England, currently focussed on pelvic floor, or mesh and related procedures, as a priority.

Section 19 of the Medicines and Medical Devices Act 2021 will enable NHS Digital to establish a medical device information system (MDIS) which will collect and store relevant information on implantable devices from all National Health Service and private healthcare providers across the United Kingdom. This could include linking unique device identifiers to patients, clinicians, and the specific surgical procedure that implanted the device. Formal public consultation on the MDIS regulations will begin later this year with the aim of laying the regulations in 2022.

The regulatory approach adopted by the Medicines and Healthcare products Regulatory Agency (MHRA) in regards to LifeVac and other airway clearance device products placed on the United Kingdom market seeks to balance the need to support innovative products to be introduced whilst recognising that for such products it is extremely difficult to generate extensive pre-market clinical data to demonstrate performance and safety.

The use of suction devices does not currently fit within the current basic life support protocols in the UK and therefore the MHRA has agreed with these manufacturers that they will take all reasonable steps to ensure that their product should only be used in certain situations.

The Government has no current plans to establish a redress agency as set out in recommendation three of the Independent Medicines and Medical Devices Safety Review. The Government is able to establish redress schemes on individual issues without the need for a new organisation and has done so several times.

We have prioritised a new safety regime for devices to reduce the risk of harm occurring.

All 112 prisons in England have access to hepatitis C diagnosis. Local authorities decide which method is utilised to achieve diagnosis. This is usually either a ‘point of care’ antibody test, a dry blood spot test or onsite PCR testing machines. Prisons may also have access to other diagnostic kit such as portable fibroscanners, to assess liver cirrhosis.

NHS England and NHS Improvement have offered ‘point of care’ PCR testing machines to every trust leading hepatitis C diagnosis and treatment pathways, including prisons. NHS England and NHS Improvement also offer the option of taking machines into 30 prisons per year as a part of the ‘High Intensity Test & Treat’ programme, to supplement reception screening.

The Government has no current plans to do so.

At the current time, there are no plans to expand the scope of the MedTech Funding Mandate. To identify medical devices, diagnostics and digital products which are likely to meet the MedTech Funding Mandate criteria, NHSX will regularly review the National Institute for Health and Care Excellence’s guidance and recommendations. The launch of the fund has been delayed until at least April 2021 due to the suspension of the 2020/21 NHS Standard Contract and the 2020/21 National Tariff Payment System during COVID-19.

There are currently no plans to amend the definitions of medicines and medical devices through the Medicines and Medical Devices Bill. The Bill does not enable amendments to be made to the definition of ‘medicinal product’ in the Human Medicines Regulation 2012.The Bill does provide the powers to amend the definition in the Medical Devices Regulation 2002 for ‘medical device’, should a future need arise, for example to reflect innovative technologies not yet captured in the definition. Biocides are outside the scope of the Bill and are regulated by the Health and Safety Executive.

In order for spirometers to be placed on the market they need to meet the requirements of the EU Medical Devices Directive 93/42/EEC. This requires that their manufacturer will be assessed by a third party certification body (Notified Body) who will check that the metrology requirements for the devices, including their accuracy, have been met. The Medicines and Healthcare products Regulatory Agency (MHRA) does not perform this function itself.

Once on the market, manufacturers are responsible for the safety and performance of medical devices on the United Kingdom market. We would ask manufacturers to investigate if we became aware of any potential safety or performance issues. Safety issues or adverse incidents can be reported to the MHRA via their Yellow Card Scheme.

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently bound by the European Union Regulations, the Medical Devices and the In-Vitro Diagnostic Devices Regulations, and its transparency provisions and therefore cannot currently publish information relating to approved clinical investigations from 1 January 2006.

The Medicines and Medical Devices Bill currently going through parliament will give the MHRA the power to update and amend the legislative frameworks that governs human medicines, medical devices and veterinary medicines. These powers will also enable transparency to support patient safety work. Clinical investigations work will be part of these future considerations.

NHS England and NHS Improvement with the National Institute for Health and Care Excellence and other bodies access HealthTechConnect to identify innovative products for use in the National Health Service, including those still in development. In the specific case of introducing a polymeric heart valve device (PoliValve) it is noted however that this is still in research and has not yet had clinical trials in humans. It would also need to have the appropriate regulatory approvals in place that relate to safety of medical devices. Further information is available at the following link:

https://www.healthtechconnect.org.uk

We are aware that clinicians view this as a potentially exciting development if it can be demonstrated it is both effective and safe compared to current therapeutic options.

Medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). All trials of new medical devices being developed for the United Kingdom market are reviewed by the MHRA before the devices are used on humans in these trials in the UK. The MHRA maintains a record of all such trials whether approved or refused. Plans are in place to make this information available to the public in future. The MHRA only has oversight of medicines and medical devices trials and therefore do not have oversight of all non-drug trials.

All non-drug trials (including device studies) are centrally reviewed for ethical approval by the Health Research Authority (HRA). If they meet a set of additional legal and policy criteria, they are granted approval to proceed in the National Health Service.

All clinical trials must be conducted in accordance with the Policy Framework for Health and Social Care, which describes the roles and responsibilities of those involved in research oversight.

There is an expectation that all trials are registered and a lay summary made available on the HRA website.

We have created a home testing programme that provides access to testing to anyone, anywhere in the United Kingdom. As such over 1.5 million people have been able to access testing in the privacy of their own homes.

We have grown our capability so that within two weeks of establishing the programme we went from dispatching test kits to under 500 people to over 19,000. The programme now has the capacity to deliver approximately 155,000 tests a week.

The number of home test kits processed each week since the launch of NHS Test and Trace (28 May 2020) is published at the following link:

https://www.gov.uk/government/publications/nhs-test-and-trace-statistics-england-16-july-to-22-july-2020

We do not hold data in this format.

Testing is a key part of the United Kingdom’s response to COVID-19. 15,197,099 tests have either been processed or sent out. Information linked to the cost of tests is commercially sensitive and as such, we would not be able to release the information requested. Spending for the Department will be published in the Annual Report and Accounts, which is expected in summer 2021. We also publish other data in relation to COVID-19 testing on a daily basis. This can be found at the following link:

https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public

Between 13 April 2020 and 1 June 2020 17,503 tests were allocated to Queen Elizabeth Hospital Gateshead testing labs. We do not hold information in relation to the proportion of testing for the Tyne and Wear area carried out at Queen Elizabeth Hospital Gateshead testing lab.

The General Medical Council already has guidance covering financial and commercial arrangements and conflicts of interest, which all medical practitioners must adhere to and which came into effect on 22 April 2013. We will consider whether these arrangements should be strengthened.

National Health service prescription charge exemptions are in place to help those with greatest need.

The Government will consider the recommendations in the First Do No Harm report published on 8 July very carefully.

NHS England is currently reviewing high-throughput testing capability in close collaboration with our pathology testing laboratories to support access to high throughput testing platforms across each of our 29 pathology laboratory networks.

There are various testing platforms in use throughout the National Health Service and Public Health England (PHE) testing laboratories, including high throughput and lower throughput platforms. This review will enable the NHS to sustainably increase Reverse transcription polymerase chain reaction (RT-PCR) testing capacity across England.

Nine PHE labs provide diagnostic testing capacity to support pillar 1 of the Government’s testing strategy. The size and nature of the laboratories vary, and they do not all use the same machines. PHE labs have a number of ‘open’ molecular extraction, liquid handling and molecular amplification platforms as well as a number of high throughput end-to-end platforms which are being used to undertake a significant proportion of COVID-19 testing.

There is a sufficient number of platforms to meet the demands on PHE for testing under pillar 1 of the Government’s testing strategy. PHE and NHS laboratories, together with a PHE partnership with Roche, achieved the target for pillar 1 of 25,000 tests a day by the end of April.