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
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
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
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
9/15/2023
/ Acquisitions ,
Austria ,
Capital Markets ,
Denmark ,
France ,
Germany ,
Global Market ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Investment ,
Investors ,
Italy ,
Jurisdiction ,
Life Sciences ,
Mergers ,
Netherlands ,
Poland ,
Regulatory Agenda ,
Spain ,
Switzerland ,
UK ,
United States
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
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
3/3/2023
/ Data Collection ,
Data Protection ,
Data-Sharing ,
EU ,
European Economic Area (EEA) ,
General Data Protection Regulation (GDPR) ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Life Sciences ,
Personal Information ,
Regulatory Agenda ,
UK
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
12/9/2022
/ Capital Markets ,
Digital Health ,
EU ,
Healthcare ,
Investment ,
Investors ,
Life Sciences ,
Pharmaceutical Industry ,
Private Equity ,
Technology ,
UK
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
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
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
4/29/2022
/ Clinical Trials ,
Data Privacy ,
Data Security ,
Data Transfers ,
Draft Guidance ,
EU ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Privacy Laws ,
Regulatory Agenda ,
Research and Development ,
UK
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
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
9/20/2021
/ Austria ,
Cannabis Products ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Data Protection ,
Denmark ,
Digital Health ,
EU ,
France ,
Germany ,
Healthcare ,
Information Technology ,
Investment ,
Italy ,
Medical Devices ,
Netherlands ,
Pharmaceutical Industry ,
Poland ,
Procurement Guidelines ,
Proposed Legislation ,
Spain ,
Supply Chain ,
Switzerland ,
Telemedicine ,
UK ,
UK Brexit ,
Whistleblowers
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
7/13/2021
/ Acquisitions ,
Annual Reports ,
Competent Authority (CA) ,
Due Diligence ,
Duty of Care ,
Environmental Social & Governance (ESG) ,
EU ,
France ,
Germany ,
Human Rights ,
Italy ,
Liability ,
Mergers ,
Modern Slavery Act ,
New Legislation ,
Risk Management ,
Sanctions ,
Supply Chain ,
Sustainability ,
UK ,
United States ,
Whistleblowers
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
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
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
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
12/3/2020
/ Capital Markets ,
Digital Health ,
Entrepreneurs ,
EU ,
Healthcare ,
Investment ,
Investment Adviser ,
Investors ,
Life Sciences ,
Pharmaceutical Industry ,
Private Equity ,
UK ,
Venture Capital
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
10/28/2020
/ Applications ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Exports ,
Imports ,
Licenses ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Regulations ,
UK ,
UK 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
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
5/27/2020
/ Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Competition Network (ECN) ,
Exports ,
Force Majeure Clause ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Imports ,
Intellectual Property Protection ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Remote Working ,
UK ,
Wine & Alcohol
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
4/2/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Export Bans ,
Medical Devices ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
State of Emergency ,
Supply Chain ,
UK ,
UK Brexit
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
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
7/3/2019
/ Biotechnology ,
Certification Requirements ,
Code of Conduct ,
Digital Health ,
EU ,
Innovation ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Member State ,
New Regulations ,
No-Deal Brexit ,
Regulatory Oversight ,
UK
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
3/25/2019
/ Article 50 Treaty of the EU ,
Banking Sector ,
Court of Justice of the European Union (CJEU) ,
Data Protection ,
EU ,
European Securities and Markets Authority (ESMA) ,
Financial Institutions ,
General Data Protection Regulation (GDPR) ,
Hague Agreement ,
International Data Transfers ,
International Labor Laws ,
International Tax Issues ,
Pharmaceutical Industry ,
Supply Chain ,
UK ,
UK Brexit ,
Value-Added Tax (VAT) ,
Withdrawal Agreement ,
WTO
Introduction -
The past year was an active one for data privacy and security legislation and enforcement. Protection for certain personal data was enhanced internationally by the EU General Data Protection Regulation...more
1/29/2019
/ Biometric Information ,
Biometric Information Privacy Act ,
California Consumer Privacy Act (CCPA) ,
Cybersecurity ,
Data Protection ,
Digital Health ,
Electronic Protected Health Information (ePHI) ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Personally Identifiable Information ,
State Data Breach Notification Statutes ,
UK