The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices...more
Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including:
- The EU’s new Unified Patent Court...more
6/17/2024
/ Artificial Intelligence ,
EU ,
Financial Regulatory Reform ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Life Sciences ,
Machine Learning ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector ,
Unified Patent Court
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
As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more
4/16/2024
/ Artificial Intelligence ,
Cybersecurity ,
Data Management ,
EU ,
European Parliament ,
General Data Protection Regulation (GDPR) ,
Information Governance ,
International Medical Device Regulators Forum (IMDRF) ,
Life Sciences ,
Machine Learning ,
Med Tech ,
Medical Devices ,
Regulatory Requirements ,
Regulatory Standards ,
Risk Management ,
Technology Sector
Hear from a global team on the crucial legal and regulatory topics investors need to know when buying or investing in Clinical Trial Site Management Organizations.
Investing in pharma services is complicated, but our team...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
240+ leading individuals in healthcare, life sciences and private equity gathered at The Langham Hotel in central London for HPE Europe 2023 for a day packed with fireside chats, in-depth plenary sessions and an abundance of...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
HPE Europe is back!
Join the biggest names in healthcare, life sciences and private equity for an unforgettable day of thought-provoking discussions, cutting-edge insights and valuable networking opportunities at the...more
8/16/2023
/ Artificial Intelligence ,
Digital Health ,
Events ,
Health Care Providers ,
Health Information Technologies ,
Health Technology ,
Healthcare Facilities ,
Investment Banks ,
Investment Opportunities ,
Investors ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds
During this session, the panel discussed strategies and business considerations when addressing compliance with the wide array of data protection and privacy laws and regulations across the United States and abroad. The panel...more
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
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community.
Join us for insightful discussion about the latest regulatory and reimbursement developments....more
2/1/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Diagnostic Tests ,
Eliminating Kickbacks in Recovery Act of 2018 (EKRA) ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Laboratory Developed Tests ,
Legislative Agendas ,
Medicare Administrative Contractors (MAC) ,
Prior Authorization ,
Regulatory Agenda ,
Reimbursements
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
Today’s global healthcare marketplace is marked by unprecedented transformation. This presents both challenges and opportunity to today’s market participants. We know how important it is to structure cross-border investments...more
6/1/2022
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Cross-Border ,
Global Market ,
Healthcare ,
Investment ,
Investors ,
Life Sciences ,
Medical Technology Companies ,
Merger Controls ,
Pharmaceutical Industry ,
Technology Sector ,
Telemedicine
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
Two years into the global COVID-19 pandemic, Private Equity interest in healthcare and life sciences remains at an all-time high. Sharon Lamb looks at the fields that are poised to offer the most promising opportunities in...more
This wide ranging discussion, sponsored by our Paris office, focuses on navigating cross border collaborations, insights for entering the US life sciences market as well as strategies for capitalizing on the growth of digital...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
McDermott is proudly sponsoring the 2021 Cross-Border M&A and Private Equity Virtual Conference (MUMAC) which will be held virtually, streamed live from the Bayerischer Hof in Munich.
Sessions will include:
- Keynote...more
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