Official Statistics: Excess mortality in England: weekly reports
Weekly excess mortality in England – broken down by age, sex, geographical areas, ethnic group, level of deprivation, cause of death and place of death.
Weekly excess mortality in England – broken down by age, sex, geographical areas, ethnic group, level of deprivation, cause of death and place of death.
This weekly summary highlights changes in the number of people visiting GPs, going to emergency departments and calling NHS 111.
These measures demonstrate the UK’s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes.
The exciting and fast developing field of software and artificial intelligence (AI) as a medical device has an increasingly prominent role within health systems. Applications of AI to be regulated as medical devices can range from screening, to diagnosis, to treatment, and to management of chronic conditions. Regulatory measures will be updated to further protect patient safety and take account of these technological advances.
The MHRA has developed an extensive work programme to inform regulatory changes including key reforms across the software as a medical device lifecycle, from qualification to classification, to requirements that apply pre and post-market. This programme will consider challenges and opportunities posed by AI as a medical device, ensuring these devices are appropriately evidenced and address issues of human interpretability (lack of transparency of AI) and adaptivity (retraining of AI models).
These bold reforms will ensure that patients and public are protected and provide manufacturers with clear guidance to interpret requirements as well as the tools to demonstrate conformity. The changes will transform medical device regulation as it applies to software and AI, providing a regulatory system that is robust and dynamic for the future.
While the UK remains a leading destination for cutting-edge healthcare, we are always searching for new and innovative ways we can improve the health and care system for NHS patients.
Software and artificial intelligence in medical devices offer the potential to transform people’s lives and these updated regulations will make a significant difference in the diagnosis and treatment of a variety of conditions.
I look forward to seeing the tangible impact these changes will have on improving patient safety and care for years to come.
Today’s announcement of an exciting step change in the regulatory approach in this fast moving area underpins the MHRA’s commitment to support responsible innovation that champions patient safety. Reforms will build on wider changes to medical device regulation already underway. We have also today launched our public consultation on proposed legislative changes in the Consultation on the future regulation of medical devices in the United Kingdom and we are encouraging everyone with an interest in these products and the way they are regulated to contribute their views.
We will continue to evolve our regulations and guidance to respond to this fast-paced field and carry out further research into how best to manage the challenges posed by artificial intelligence as a medical device.
In addition to our overhaul of the regulations for AI and software as a medical device, today BEIS announced that the MHRA are recipients of a grant from the Regulatory Pioneers Fund.
The grant for £194,000 supports the MHRA’s drive to become a global leader in regulating this field by carrying out further research into how adaptive AI algorithms in medical devices ‘change’ and how to regulate their decisions.
The MHRA is supported in bringing forward this programme of change thanks to support from NHSX, partners such as NICE, and input from academic and industry partners.
Industry Working Group of experts to improve standards, reliability and security in electronic signatures.
The Ministry of Justice has established an Industry Working Group of experts to improve standards, reliability and security in electronic signatures and other means of legally executing documents, and to address best practice in this area.
The Group was set up following a recommendation by the Law Commission which the Lord Chancellor welcomed and has implemented, with the membership recruited via a public appointments campaign.
The Group is chaired by Mr Justice Fraser under the oversight of Lord Justice Birss, and assisted by Professor Sarah Green of the Law Commission. Members are experts drawn from the legal, business and technology sectors.
The Group began meeting in summer 2021 and is aiming to produce an interim report by the end of the year, setting out its initial thoughts and areas to be explored further, together with those areas that may require public consultation
Its terms of reference include best practice guidance for the use of electronic signatures, analysis of different technologies’ security and reliability and investigating solutions and safeguards for video-witnessing of deeds.
The Group will make recommendations for reform to government as well as provide guidance which will insist businesses and professional practitioners.
The government sees the Groups as playing an important role, alongside existing law reform projects, in ensuring the UK is a centre for legal excellence in developing the law to support and facilitate digital trade and commerce.
Notes for Editors
Published 16 September 2021
New plans to capitalise on the freedoms from Brexit so that our rules and regulations best serve the UK national interest have been announced today by Minister of State at the Cabinet Office, Lord Frost.
Thousands of individual EU regulations automatically kept on the statute book after Brexit – known as Retained EU Law – will be scrutinised by the Government to ensure they are helping the UK to thrive as a modern, dynamic, independent country and foster innovation across the British economy. The review will aim to remove the ‘special status’ that EU retained law still enjoys in our legal framework and will determine how best to ensure that UK courts can no longer give undue precedence to EU-derived laws in future. This will be done while providing businesses and citizens with legal certainty and will continue the process of restoring the UK Parliament to its proper constitutional position.
Additionally, the Government is setting out a package of individual regulatory reforms to laws inherited while a member of the EU, building on recommendations recently submitted to Government by the Taskforce for Regulatory Reform, Innovation and Growth.
In the coming weeks, Secretaries of State across Whitehall will set out bold strategies and proposals for keeping the UK at the forefront of innovation and technology, including on:
This follows the proposed reforms to create a pro-growth, trusted data rights regime, which is more proportionate and less burdensome than the EU’s GDPR rules.
The Government also plans to establish a new Commission through which the public will be able to identify additional opportunities for cutting or reforming red tape and bureaucracy. Any individual will be able to submit proposals. The Commission will then consider these ideas and make recommendations for change to the Government – but only if they go in the direction of reducing or eliminating regulation.
Minister of State at the Cabinet Office, Lord Frost, said:
From rules on data storage to the ability of businesses to develop new green technologies, overbearing regulations were often conceived and agreed in Brussels with little consideration of the UK national interest.
We now have the opportunity to do things differently and ensure that Brexit freedoms are used to help businesses and citizens get on and succeed.
Today’s announcement is just the beginning. The Government will go further and faster to create a competitive, high-standards regulatory environment which supports innovation and growth across the UK as we build back better from the pandemic
Further reforms announced today include:
A full list of individual regulatory reforms announced can be found here.