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1259316

	registered interest
	date	08/12/2020
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Diagnosis
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what plans he has to ensure equitable patient access to proven remote diagnostics to support home testing.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	126894
	answer	answer is ministerial correction date of answer 04/01/2021 answer text <p>The Department and the National Health Service are prioritising the improvement of connectivity and digitisation across all aspects of diagnostics in order to drive efficiency, deliver seamless care across traditional boundaries and facilitate remote reporting.</p><p>The first four phases of the Artificial Intelligence in Health and Care award included innovations in remote diagnostics, including the Neuronostics Limited smartphone-based app which can receive electroencephalogram recordings from wireless headsets to assist with assessing epilepsy treatment; Senti Tech Limited’s project enabling remote chest examination for respiratory patients through sensors embedded into a jacket; and Healthy.io UK Limited’s smartphone albuminuria self-test, which uses a home test kit and a mobile app to allow patients to self-test at home with clinical grade results.</p><p><ins class="ministerial">NHSX is supporting the COVID Oximetry @home services which remotely monitor the oxygen saturation levels of patients with COVID-19 symptoms. This offers both technology-enabled and standard services with paper diary and telephone check-in for those without smartphones. In some areas, devices are provided for people to use in their own homes. NHSX are also supporting the scaling of remote monitoring approaches across the seven regions in England. This includes a focus on vulnerable groups such as those living in care homes.</ins></p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 04/01/2021 14:53:16 question first ministerially corrected 15/04/2021 16:23:10 answering member 1481 label Biography information for Ms Nadine Dorries previous answer version 71400 answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green

1305770

	registered interest
	date	24/03/2021
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Vaccination
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what steps the Government is taking to accelerate the (a) adoption and (b) uptake of vaccines approved by the Medicines Healthcare Products Regulatory Agency.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	174872
	answer	answer is ministerial correction date of answer 15/04/2021 answer text <p>The vaccines approved for adoption in the United Kingdom have met strict standards of safety, quality and effectiveness set out by the independent Medicines and Healthcare products Regulatory Agency (MHRA). The Joint Committee on Vaccination and Immunisation regularly reviews MHRA approved vaccines and makes recommendations to the Department. These recommendations are considered thoroughly before putting in place new vaccines. Any vaccine that is approved must go through the same clinical trials and safety checks as other licensed medicines.</p><p>A range of actions have been implemented to improve vaccination uptake for children of all ages in England. This includes initiatives to improve access to the immunisation programme; communication with the public; data to better identify underserved individuals and populations; and training for healthcare professionals.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 15/04/2021 12:05:46 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green

1305771

	registered interest
	date	24/03/2021
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Coronavirus: Vaccination
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, whether covid-19 vaccines are eligible for the Medicines Healthcare Products Regulatory Agency’s Innovative Licensing and Access Pathway.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	174873
	answer	answer is ministerial correction date of answer 13/04/2021 answer text <p>In principle, COVID-19 vaccines are eligible for applying to the Innovative Licensing and Access Pathway (ILAP). Inclusion in the ILAP is subject to fulfilment of the Innovation Passport criteria.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 13/04/2021 09:09:54 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green

1259314

	registered interest
	date	08/12/2020
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Medical Equipment: Licensing
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what plans he has in place to expand the scope of the MedTech Funding Mandate to cover new products not previously included in the (a) Innovation and Technology Tariff and (b) Innovation and Technology Payment programmes.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	126893
	answer	answer is ministerial correction date of answer 17/12/2020 answer text <p>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.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 17/12/2020 16:39:41 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green

1245450

	registered interest
	date	21/10/2020
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Orphan Drugs: Brexit
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, when his Department will publish the criteria for determining orphan designation for medicines after the transition period; and whether he plans to consult with (a) patient groups, (b) industry and (c) other relevant stakeholders to help inform this criterion.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	107024
	answer	answer is ministerial correction date of answer 04/11/2020 answer text <p>The Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on 1 October 2020 on how orphan designation for medicines will be managed after the transition period on our website.</p><p>The Department and MHRA have held a series of engagement sessions which were open to all our stakeholders to inform on how medicines will be regulated including such medicines after the end of the transition period.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 04/11/2020 11:48:39 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green

1199072

	registered interest
	date	01/06/2020
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Medical Equipment: Licensing
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what the Government's timeframe is for the (a) publication and (b) implementation of the MedTech Funding Mandate; and if he will make a statement.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	52079
	answer	answer is ministerial correction date of answer 10/06/2020 answer text <p>Due to COVID-19 NHS England and NHS Improvement have delayed the publication of the MedTech Funding Mandate and will not be launching this during 2020/21.</p><p>To maintain patient access to innovative devices, diagnostics and digital products NHS England and NHS Improvement continue to fund a range of technologies through the Innovation and Technology Payment.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 10/06/2020 18:19:44 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green

1185524

	registered interest
	date	16/03/2020
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Medical Equipment: Certification
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, how many staff members within the Medicines and Healthcare products Regulatory Agency are reviewing re-certification applications to comply with the Medical Devices Regulation.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	30174
	answer	answer is ministerial correction date of answer 25/03/2020 answer text <p>The new Medical Device Regulation (MDR), which will become United Kingdom law from 26 May 2020 as part of the European Union Withdrawal Act 2019, substantially strengthens the regulatory framework for medical devices and notified bodies and manufacturers are having to make significant changes to meet the enhanced requirements.</p><p>The Government recognises the importance of having competent notified bodies in place to ensure continuity of supply of products to the UK market. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with UK industry and notified bodies on an ongoing basis to ensure that they are prepared for the implementation of the MDR.</p><p>There are also transitional provisions in place which enable existing CE marked devices to remain valid for sale until the date of expiry of that certificate. This means in practice that all devices on the UK market do not require immediate re-certification.</p><p>The MHRA will publish further guidance on how we intend to support businesses who may struggle to obtain certification under the MDR and to ensure continuity of supply of medical devices to UK patients.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries grouped question UIN 30178 question first answered 25/03/2020 16:38:17 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green

1185528

	registered interest
	date	16/03/2020
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Medical Equipment: Certification
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that all medical device businesses are re-certified so that they comply with the Medical Device Regulation before the May 2020 deadline.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	30178
	answer	answer is ministerial correction date of answer 25/03/2020 answer text <p>The new Medical Device Regulation (MDR), which will become United Kingdom law from 26 May 2020 as part of the European Union Withdrawal Act 2019, substantially strengthens the regulatory framework for medical devices and notified bodies and manufacturers are having to make significant changes to meet the enhanced requirements.</p><p>The Government recognises the importance of having competent notified bodies in place to ensure continuity of supply of products to the UK market. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) has been engaging with UK industry and notified bodies on an ongoing basis to ensure that they are prepared for the implementation of the MDR.</p><p>There are also transitional provisions in place which enable existing CE marked devices to remain valid for sale until the date of expiry of that certificate. This means in practice that all devices on the UK market do not require immediate re-certification.</p><p>The MHRA will publish further guidance on how we intend to support businesses who may struggle to obtain certification under the MDR and to ensure continuity of supply of medical devices to UK patients.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries grouped question UIN 30174 question first answered 25/03/2020 16:38:17 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green

1147259

	registered interest
	date	30/09/2019
	answering body	Department of Health and Social Care
	answering dept id	17
	answering dept short name	Health and Social Care
	answering dept sort name	Health and Social Care
	hansard heading	Medical Equipment: EU Law
	house id	1
	legislature	25259 pref label House of Commons
	question text	To ask the Secretary of State for Health and Social Care, what recent assessment he has made of the capacity of Notified Bodies under the terms of the Medical Devices Regulation to meet the demand for their services.
	tabling member constituency	Bolton West
	tabling member printed	Chris Green
	uin	292265
	answer	answer is ministerial correction date of answer 07/10/2019 answer text <p>The Medical Devices Regulation 2017/745 (MDR) will overhaul the current regulatory framework for medical devices.</p><p>A key aspect of the MDR is more stringent requirements placed on notified bodies, which conduct third-party conformity assessments on higher risk products. All European notified bodies must undergo a designation process under the MDR to ensure their capacity to comply with the enhanced standards. There is less than a year until the Regulation will be applied in full, and currently five notified bodies are able to assess devices against the MDR, compared to over 50 under the current legislation.</p> answering member constituency Mid Bedfordshire answering member printed Ms Nadine Dorries question first answered 07/10/2019 14:26:15 answering member 1481 label Biography information for Ms Nadine Dorries
	tabling member	4398 label Biography information for Chris Green