Asked by: Chi Onwurah (Labour - Newcastle upon Tyne Central)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps her Department is taking to improve the (a) adoption and (b) spread of medical technologies across the NHS.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
In February 2023, the Government published its first ever strategy for MedTech, outlining our priorities for improving the adoption and spread of safe, effective and innovative medical technologies across the National Health Service.
As part of this effort, we are implementing solutions to streamline the innovation adoption pathway. We are focusing on clarifying signals to industry on what innovation the NHS needs, reforming regulation, providing product assessments based on real world evidence, and improving procurement processes.
We recently launched the Innovative Devices Access Pathway pilot in September 2023. The pilot will test a pre-regulatory, access pathway for eight pilot technologies that meet a clinical unmet need in the NHS. This accelerated pathway will support the adoption of transformative technologies into the NHS and to patients.
The Government is investing £30 million in the Health Tech Adoption and Acceleration Fund. Funding has been disseminated to all 42 integrated care systems to invest in proven technology that will help cut waiting lists, speed up diagnosis and deliver new and improved ways to treat patients.
The Department has partnered with the National Institute for Health and Care Excellence to develop and pilot a process for evaluations that compare similar MedTech products in use across the NHS. These evaluations will improve NHS decision makers ability to identify which products offer value for money and are worth adopting more widely.
The Medicines and Healthcare products Regulatory Agency is updating the medical device regulatory framework. The new framework is designed to protect patient safety, support innovation within the United Kingdom’s life sciences sector and improve access to innovative medical devices.
Asked by: Christopher Chope (Conservative - Christchurch)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, on what date work on digitally linking Medicines and Healthcare products Regulatory Authority Yellow Card information to NHS clinical records (a) began and (b) is expected to be completed.
Answered by Andrew Stephenson - Minister of State (Department of Health and Social Care)
The Medicines and Healthcare products Regulatory Agency (MHRA) has been working with the National Health Service to explore approaches to facilitate digital linkage of Yellow Card information to clinical records, and to potentially enable faster access to information, where considered necessary for an assessment. Any such approach would be subject to strict information governance controls and prior consultation with stakeholder groups.
In 2020, the MHRA began delivery of a substantially enhanced Yellow Card platform under the SafetyConnect programme, aligned to the recommendations in Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review. The new infrastructure is designed with the intent of enabling connectivity to other systems, to facilitate the exchange of information. During that time the MHRA has engaged with the NHS around the evolving technical options for robust and secure connectivity and enhanced user journeys. The first step in these enhancements is use of the common NHS login capability within Yellow Card, which is expected to go live in 2024.
Deeper connectivity between systems will be subject to internal and external stakeholder engagement and substantial information governance controls, with elements completed over a phased and multi-year work plan.
Mar. 11 2024
Source Page: New action to tackle ethnic and other biases in medical devicesFound: New action to tackle ethnic and other biases in medical devices
Mar. 11 2024
Source Page: New action to tackle ethnic and other biases in medical devicesFound: New action to tackle ethnic and other biases in medical devices
Apr. 30 2024
Source Page: MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030Found: MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030
May. 29 2024
Source Page: Letters and medicine recalls sent to healthcare professionals in April 2024Found: Letters and medicine recalls sent to healthcare professionals in April 2024
Mar. 14 2024
Source Page: Freedom of Information responses from the MHRA - week commencing 6 November 2023Found: I would request to have all contact info rmation of each registered entity and would ask to be advised
Mentions:
1: Lord Markham (Con - Life peer) The Medicines and Healthcare products Regulatory Agency—MHRA—is the UK regulator for medical devices, - Speech Link
2: Baroness Finlay of Llandaff (XB - Life peer) easy access and attractions for those developing in vitro devices. - Speech Link
Written Evidence Jan. 24 2024
Committee: Health and Social Care Committee (Department: Department of Health and Social Care)Found: medicines and medical devices.3 This commitment was legislated for through the Medicines and Medical
Jan. 02 2024
Source Page: MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024Found: The IRP will help bring life-saving medicines to UK patients and has been developed by the MHRA following