E-signatures to receive new standardizing scrutiny

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. Minister for Innovation Lord Bethell said: 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. MHRA Director of Devices Graeme Tunbridge said: 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.

The UK 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 videowitnessing 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.