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ICO Publishes New Transparency Guidance for Health and Social Care Sector

Healthcare sector organisations are increasingly deploying new technologies that use large amounts of personal information to support both direct care and secondary purposes, such as planning and research. Although these...more

Lowest-risk Clinical Trials Will Benefit From a New Notification Scheme and a Shorter Period for Application Processing

On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more

UK-US Data Bridge: An Extension to EU-US Data Privacy Framework

The UK government has published the Data Protection (Adequacy) (United States of America) Regulations 2023 (SI 2023/1028) (the UK-US Data Bridge Regulations) which adopted an adequacy decision for the US (the UK-US Data...more

Investing in Healthcare & Life Sciences - An International Guide to Regulatory and Transactional Issues Across the Sector -...

As macroeconomic forces and geopolitical dynamics continue to shape the M&A and investment climate globally, health and life sciences transactions continue to remain high priority sectors presenting both high growth and...more

Great Britain and European Union Timelines: What Are the Key Dates for Transition?

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more

Health Data in the EU and UK – Regulatory Trends and Developments

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

HPE Europe 2022 | Key Takeaways

Key Trends & Opportunities in Life Sciences and Healthcare Investing - The current macroeconomic environment is creating challenges for healthcare and life sciences businesses, which have been impacted hard by wage...more

UK Medical Device Regulator Proposes a 12 Month Delay for UKCA Requirements and the New Medical Device Regulations

On Friday 21st October 2022, the Medicines and Healthcare Products Regulatory Agency (MHRA) wrote to the medical device industry to explain its intention: - To extend the current standstill period by twelve months from...more

Proposals to Reform the UK Data Protection Regime

On 10 May 2022 and as part of the Queen’s speech, which sets out the programme of legislation for the forthcoming parliamentary session, the government announced proposals to table a Data Reform Bill (the Bill) to reform the...more

Special Report: Developments in UK Life Sciences – Spring Update 2022

MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

MHRA Launches UK Clinical Trial Regulation Consultation

The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more

Investing in European Healthcare - What's on the Horizon for 2022? - Regulatory and Legal Changes

Today’s global healthcare marketplace is marked by unprecedented transformation. The seismic shifts in healthcare delivery and drug development during COVID-19 have, in 2021, continued to demonstrate the power and capacity...more

The New German Supply Chain Due Diligence Act (With a View Across the Border)

On 11 June 2021, the German Federal Parliament approved the draft bill on corporate due diligence in supply chains (Supply Chain Due Diligence Act), which was approved by the German Federal Council without any changes on 25...more

Changes To Public Procurement In The United Kingdom Post Brexit

The UK Government has proposed changes to the procurement regime for public sector contracts in the UK. The proposals mark a radical divergence from the European procurement regimes post Brexit. The proposals are set out in a...more

EU and UK Data Sharing: UK Adequacy Decision

On February 19 2021, the European Union Commission issued its draft adequacy decision for data flows between the European Union (EU) and United Kingdom (UK). Whilst widely expected, this draft decision will provide some...more

Special Report - NHS Legislative Proposals - February 2021

On February 11, 2021 the UK Department of Health and Social Care published its White Paper setting out legislative proposals for a Health and Care Bill. The White Paper proposes wide changes to the structure of the NHS in...more

BVCA Healthcare Sector Forum 2020: Rounding Up

McDermott was delighted to partner with the BVCA (British Venture Capital Association) on its recent virtual Sector Forum Series: Healthcare event. The event gathered industry experts – from entrepreneurs, to investors and...more

Brexit and COVID-19: Changes to the Regulation of Medicines

The combination of the Coronavirus (COVID-19) pandemic and the imminent end of the Brexit transition period means a fast-changing regulatory environment for medicines. On 16 October 2020, the UK Government made changes to...more

Regulating Medical Devices Post Brexit

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published guidance on the new rules that will govern the regulation of medical devices and in vitro diagnostic medical devices placed on the market in...more

International News: COVID-19 Global Pandemic - May 2020

The Legal Impact in Europe on Pharmaceutical and Medical Device Companies - The current crisis mode has triggered legal and commercial issues that affect the pharmaceutical and medical device industry across...more

Legal Implications of COVID-19 for Pharmaceutical and Medical Device Companies in the United Kingdom

The impact of Coronavirus (COVID-19) on pharmaceutical and medical device companies has been unique as, not only have these businesses had to set up emergency management systems practically overnight in order to maintain...more

Brexit Update - February 2020

The United Kingdom is no longer a member of the European Union and has entered into a transition period until December 31 2020, unless an extension of 1 or 2 years is agreed by July 1 2020 (the Brexit Long Stop...more

Digital Health in the United Kingdom: The New Regulatory Environment Under the Medical Device Regulation

The MDR and other recent developments in the health care regulatory landscape pose new opportunities and challenges for medical software companies and investors in digital health in the United Kingdom. Although the regulatory...more

Brexit Update - March 2019

SPECIAL REPORT - BREXIT: CHALLENGES AND OPPORTUNITIES - In this report, we explain some of the key legal implications associated with the United Kingdom leaving the European Union (EU) without a deal for future...more

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