European life sciences businesses have been closely tracking geopolitics and global policy changes over the past 12 months, particularly as the new administration in the United States heightens its focus on drug pricing....more
11/3/2025
/ Artificial Intelligence ,
China ,
Clinical Trials ,
Drug Pricing ,
EU ,
Healthcare ,
Investment ,
Life Sciences ,
Pharmaceutical Industry ,
Private Equity ,
Research and Development ,
UK
It has been nearly two years since NHS England established the Independent Patient Choice and Procurement Panel (the Panel), following the Provider Selection Regime (PSR) coming into force on 1 January 2024. The Panel was...more
10/10/2025
/ Bid Protests ,
Competition ,
Disclosure Requirements ,
Documentation ,
Enforcement Actions ,
Government Agencies ,
Health Care Providers ,
Healthcare ,
Judicial Review ,
Procurement Guidelines ,
Public Procurement Policies ,
Regulatory Oversight ,
Transparency
On September 8, 2025, the European Commission issued a “Call for Evidence” about ways to simplify the current European medical device and in vitro medical device regulations.
The European Commission acknowledges that while...more
9/17/2025
/ Artificial Intelligence ,
Digital Health ,
EU ,
European Commission ,
Healthcare ,
Medical Devices ,
New Regulations ,
Proposed Rules ,
Public Consultations ,
Regulatory Oversight ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Chain
On 4 September, the ECJ handed down a major and eagerly awaited decision on the scope of personal data, accepting the point that pseudonymised data may be anonymised in the hands of a third party. The ECJ’s approach is...more
9/9/2025
/ Court of Justice of the European Union (CJEU) ,
Data Controller ,
Data Protection ,
Data Transfers ,
EDPS ,
EU ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
Personal Data ,
Third-Party ,
Transparency ,
UK
In late July 2025, the UK government published its response to a consultation held between November 2024 and January 2025 about international reliance, UK Conformity Assessed (UKCA) marking and in vitro diagnostic devices. In...more
What new guidance on anonymisation from the UK Information Commissioner’s Office (ICO) means for healthcare and life sciences companies....more
Pharmaceutical companies promoting prescription-only medicines to health professionals and other relevant decision makers in the UK must now adhere to revised industry standards that came into operation from 1 October 2024...more
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