ISSUES AND UPDATES -
Trade Secret Litigation Trends in Life Sciences -
Trade secret litigation has risen sharply in recent years, driven by increased employee mobility, complex collaboration agreements, and heightened...more
5/8/2026
/ Artificial Intelligence ,
Biotechnology ,
Clinical Trials ,
Drug Pricing ,
Employee Benefits ,
Enforcement Actions ,
ERISA Litigation ,
EU ,
European Commission ,
Executive Orders ,
Health Insurance ,
Intellectual Property Protection ,
Life Sciences ,
Pharmaceutical Industry ,
Proposed Legislation ,
Regulatory Reform ,
Trade Secrets ,
Transparency ,
Trump Administration
On December 16, 2025, the European Commission (the "Commission") published a proposal for a European Biotech Act (the "Proposed Biotech Act" or "Proposal"). The Proposed Biotech Act is a central pillar of the Commission's...more
5/8/2026
/ Biotechnology ,
Clinical Trials ,
Data Privacy ,
Data Protection ,
EU ,
European Commission ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
Life Sciences ,
New Legislation ,
Popular ,
Proposed Legislation ,
Regulatory Reform ,
Regulatory Requirements ,
Research and Development
The Trump administration has moved to impose a 100% tariff on imports of brand-name, patented pharmaceutical products and ingredients, while extending lower rates for jurisdictions that have entered into bilateral agreements...more
4/10/2026
/ Brand Name Prescription Drugs ,
Drug Pricing ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Most-Favored Nations ,
National Security ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs ,
Section 232 ,
Tariffs ,
Trump Administration ,
U.S. Commerce Department ,
US Trade Policies
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
4/8/2026
/ Competition ,
Cyber Threats ,
Economic Sanctions ,
EU ,
European Commission ,
Export Controls ,
Geopolitical Risks ,
Medical Devices ,
National Security ,
Public Health ,
Risk Management ,
Russia ,
State Aid ,
Ukraine
On 16 February 2026, the UK's Medicines and Healthcare products Regulatory Agency ("MHRA") opened a public consultation on proposals to indefinitely recognise CE‑marked medical devices and in vitro diagnostic medical devices...more
3/3/2026
/ Clinical Laboratory Testing ,
Comment Period ,
EU ,
Healthcare ,
International Regulatory Standards ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Public Consultations ,
Regulatory Reform ,
Regulatory Requirements ,
Supply Chain ,
UK
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
2/19/2026
/ Competition ,
Cyber Threats ,
Cybersecurity ,
Economic Sanctions ,
EU ,
European Commission ,
Export Controls ,
Geopolitical Risks ,
Infrastructure ,
Medical Devices ,
National Security ,
Public Health ,
Russia ,
State Aid ,
Ukraine
2025 was an incredibly busy year for digital health, and 2026 is likely to be no different. This edition of Vital Signs covers numerous developments, along with a look to 2026 in Industry Insights. Thank you to our Jones Day...more
2/10/2026
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
DEA ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Medicare ,
New Legislation ,
Request For Information ,
State and Local Government ,
Telehealth
EMA and FDA have jointly issued guiding principles for the safe and responsible use of AI across the medicines life cycle, aiming to harmonize the path for drug developers using AI-driven programs to advance innovation that...more
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
1/12/2026
/ Competition ,
Cyber Threats ,
Cybersecurity ,
Economic Sanctions ,
EU ,
European Commission ,
Geopolitical Risks ,
Healthcare ,
International Trade ,
National Security ,
Public Health ,
Regulatory Reform ,
Risk Management ,
Russia ,
Ukraine
The Background: After more than two years of negotiation following the European Commission's April 2023 proposal to overhaul the EU pharmaceutical framework, the EU institutions have finally converged on a package.
The...more
12/19/2025
/ Biosimilars ,
Drug Pricing ,
EU ,
European Medicines Agency (EMA) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
New Legislation ,
Orphan Drugs ,
Pharmaceutical Industry ,
Regulatory Reform ,
Regulatory Requirements ,
Research and Development ,
Supply Chain ,
Supply Shortages
The Trump administration's "America First" agenda is reshaping pricing, manufacturing, and regulation of the pharmaceutical landscape, with a reported central objective of lowering U.S. drug prices by promoting stronger...more
12/18/2025
/ America First Trade Policy ,
China ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Most-Favored Nations ,
Onshoring ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Section 340B ,
Supply Chain ,
Trump Administration
The Food and Drug Administration ("FDA") issued two draft guidance documents that would largely eliminate clinical efficacy and switching studies and instead rely on the precision of modern analytical methods to accelerate...more
12/4/2025
/ Biosimilars ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
New Guidance ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Regulatory Requirements
This update (No. 123 | 8 October 2025) covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber...more
12/1/2025
/ Artificial Intelligence ,
Critical Infrastructure Sectors ,
Cyber Threats ,
Cybersecurity ,
Economic Sanctions ,
ENISA ,
EU ,
European Commission ,
Export Controls ,
Foreign Policy ,
Geopolitical Risks ,
Healthcare ,
International Trade ,
National Security ,
Public Health ,
Public Health Emergency ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management ,
Russia ,
Supply Chain ,
Ukraine
With the aim of accelerating approval of biosimilars, the U.S. Food and Drug Administration ("FDA"), in its draft guidance "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated...more
11/4/2025
/ Biosimilars ,
Clinical Trials ,
Draft Guidance ,
Efficacy Claims ,
FDA Approval ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements
Italy is the first EU Member State to enact national legislation on Artificial Intelligence ("AI"), thereby positioning itself as a frontrunner in shaping AI rule-making within the European Union....more
10/16/2025
/ AI Act ,
Artificial Intelligence ,
Data Centers ,
Data Privacy ,
Data Protection ,
EU ,
General Data Protection Regulation (GDPR) ,
Healthcare ,
Information Technology ,
Intellectual Property Protection ,
Italy ,
Machine Learning ,
New Legislation ,
Popular ,
Regulatory Reform ,
Regulatory Requirements
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
10/2/2025
/ Competition ,
Cyber Threats ,
Cybersecurity ,
Economic Sanctions ,
EU ,
European Commission ,
Export Controls ,
Foreign Policy ,
Geopolitical Risks ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Public Health ,
Russia ,
State Aid ,
Ukraine
Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing...more
10/1/2025
/ Administrative Procedure Act ,
Biologics ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Pharmaceutical Industry ,
Supply Chain ,
Tariffs ,
Trump Administration
The Product Regulation and Metrology Act 2025 reforms the UK's post-Brexit product safety, metrology, and consumer protection frameworks....more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
6/4/2025
/ Artificial Intelligence ,
Clinical Trials ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Drug Pricing ,
Executive Orders ,
FDA Approval ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Telehealth
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
6/3/2025
/ Competition ,
Cyber Threats ,
Cybersecurity ,
Data Protection ,
Economic Sanctions ,
EU ,
European Commission ,
Export Controls ,
Geopolitical Risks ,
Healthcare ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Management ,
Russia ,
State Aid ,
Trade Policy ,
Ukraine
Artificial intelligence is revolutionizing life science R&D (particularly in the realm of drug discovery) and challenging the traditional "human inventorship" requirement for U.S. patents. Recent guidance from the USPTO...more
4/9/2025
/ Artificial Intelligence ,
Drug Pricing ,
Earn-Outs ,
Federal Funding ,
Foreign Aid ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Intellectual Property Protection ,
Inventions ,
Inventors ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Private Equity ,
Trump Administration ,
USPTO
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
4/7/2025
/ Competition ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Exports ,
Geopolitical Risks ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Russia ,
State Aid ,
Ukraine
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
2/12/2025
/ Competition ,
Cybersecurity ,
Data Protection ,
Economic Sanctions ,
EU ,
Export Controls ,
Geopolitical Risks ,
Medical Devices ,
National Security ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Oversight ,
Regulatory Reform ,
Russia ,
State Aid ,
Ukraine
On January 14, 2025, China's State Administration for Market Regulation ("SAMR"), the primary regulatory agency in China for overseeing market supervision, issued its Compliance Guidelines for Health Care Companies to Prevent...more
1/30/2025
/ Anti-Corruption ,
Bribery ,
China ,
Corporate Governance ,
Enforcement Actions ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
1/3/2025
/ Competition ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
EU ,
Export Controls ,
Foreign Trade Regulations ,
Geopolitical Risks ,
Medical Devices ,
Pharmaceutical Industry ,
State Aid