March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more
3/27/2025
/ Cybersecurity ,
Data Privacy ,
Data Protection ,
Digital Health ,
Electronic Medical Records ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Intellectual Property Protection ,
Privacy Laws ,
Regulatory Requirements
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
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
+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
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
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 Coronavirus (COVID-19) pandemic poses an acute health risk to the population. One key to successfully combating COVID-19 lies in clinical research. Currently, almost all major research-based pharmaceutical companies, many...more
Across the US and EU, life sciences companies are pushing diagnostics, antibody testing, vaccines and other efforts forward to flatten the Coronavirus (COVID-19) curve. Our multidisciplinary cross-border life sciences team...more
5/5/2020
/ Acquisitions ,
Contact Tracing ,
Coronavirus/COVID-19 ,
Cross-Border Transactions ,
Diagnostic Tests ,
Digital Health ,
Divestiture ,
Due Diligence ,
Foreign Investment ,
Health Care Providers ,
Intellectual Property Protection ,
Joint Venture ,
Life Sciences ,
Medical Testing ,
Mergers ,
Partnerships ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Vaccinations ,
Virus Testing ,
Webinars
Health apps and other digital medical devices are making increasingly important contributions to healthcare. While in the past such medical devices were reimbursed by statutory health insurance funds on a case-by-case basis...more
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
3/24/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Emergency Management Plans ,
Exports ,
Germany ,
Market Access Rule ,
Medical Devices ,
Moratorium ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply and Demand
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more
2/3/2020
/ Cybersecurity ,
EU ,
EU Directive ,
Information Technology ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Risk Assessment ,
Software
McDermott’s cross-functional team of life sciences professionals present the inaugural Munich Life Sciences Bootcamp focusing on issues and trends important to life sciences companies. This half-day program is designed for...more
11/13/2019
/ Data Protection ,
Digital Health ,
Events ,
Food and Drug Administration (FDA) ,
Germany ,
Health Care Providers ,
Health Technology ,
Healthcare ,
Life Sciences ,
Mobile Apps ,
Pharmaceutical Industry ,
Popular ,
Reimbursements ,
Technology Sector
Data Inspections in China: Increased Supervision and Compliance -
Data protection inspections have become more frequent for companies with operations in China. Many companies are struggling for guidance on how to...more
On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) have been published in the European Official Journal. The Regulations will become effective 20 days after...more
On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more
On 11 July 2013 Regulation (EC) No 1223/2009 (Regulation) will replace the Cosmetics Directive of 1976 that used to rule cosmetic products in the European Union. Major aims of the Regulation are health protection, animal...more
The European Commission has issued two proposals that, if approved, will fundamentally amend EU law on medical devices and in vitro diagnostics. The proposed legislation will significantly broaden the scope of medical device...more