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
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
12/16/2024
/ Artificial Intelligence ,
Breach Notification Rule ,
Center for Drug Evaluation and Research (CDER) ,
Clinical Trials ,
Data Breach ,
Data Protection ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Information Technology ,
Life Sciences ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Telehealth ,
Telemedicine
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
11/21/2024
/ Competition ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
EU ,
Export Controls ,
Foreign Trade Regulations ,
Geopolitical Risks ,
Medical Devices ,
Pharmaceutical Industry ,
State Aid
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
1/15/2024
/ Competition ,
Crisis Management ,
Cybersecurity ,
Data Collection ,
Data Management ,
EU ,
European Commission ,
Export Controls ,
Foreign Subsidies ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
State Aid
In Short -
The Situation: The EU Product Liability Directive 85/374/EEC ("PLD") was adopted nearly 40 years ago and has remained almost unchanged since its inception....more
11/13/2023
/ Burden of Proof ,
Damages ,
Distributors ,
EU ,
European Commission ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Product Defects ,
Proposed Regulation ,
Regulatory Agenda ,
Retail Market ,
UK
This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more
3/22/2023
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
State Aid
This regular update (no. 95 | 9 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more
1/31/2023
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Medical Devices ,
Pharmaceutical Industry ,
Policy Updates ,
Regulatory Agenda ,
State Aid ,
Trade Policy
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion....more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion.
...more
9/26/2022
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Export Controls ,
Infectious Diseases ,
Pharmaceutical Industry ,
State Aid ,
Vaccinations
COMPETITION & STATE AID -
State Aid -
European Commission approves new and amended Member State measures to support the economy -
Since the onset of the coronavirus outbreak, the Commission has adopted a significant number...more
7/5/2022
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Infectious Diseases ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Reform ,
State Aid
COMPETITION & STATE AID -
State Aid -
European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine -
On 23 March 2022, the Commission adopted a Communication on a...more
4/28/2022
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
State Aid
COMPETITION & STATE AID -
State Aid -
European Commission publishes first Report on implementation of Recovery and Resilience Facility -
On 1 March 2022, the Commission published its first Report to the European...more
3/24/2022
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Pharmaceutical Industry ,
Regulatory Agenda ,
State Aid ,
Vaccinations
COMPETITION & STATE AID -
Competition -
Commission publishes Competition Policy – 2021 at a glance.
On 22 December 2021, the European Commission published its Competition Policy – 2021 at a glance.
...more
2/4/2022
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
State Aid ,
Vaccinations
COMPETITION & STATE AID -
Competition-
European Commission expresses views on IAG’s (aborted) intended acquisition of Air Europa, including in light of impact of COVID-19 restrictions -
On 16 December 2021, the...more
1/20/2022
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Healthcare Reform ,
Infectious Diseases ,
International Trade ,
Pharmaceutical Industry ,
Regulatory Agenda ,
State Aid ,
Vaccinations
COMPETITION & STATE AID -
Competition -
Executive Vice President and Competition Commissioner Margrethe Vestager speaks at U.S. Chamber of Commerce's Transatlantic Business Works Summit.
...more
1/6/2022
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
State Aid ,
Vaccinations
COMPETITION & STATE AID -
State Aid -
European Commission adopts revised Guidelines on State aid to promote risk finance investments-
On 6 December 2021, the Commission published its Communication on Guidelines on...more
12/15/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
State Aid ,
Vaccinations
COMPETITION & STATE AID -
State Aid -
European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI).
On 25 November 2021, the Commission published a...more
12/9/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Foreign Direct Investment ,
Infectious Diseases ,
International Trade ,
Pharmaceutical Industry ,
Popular ,
Regulatory Agenda ,
State Aid ,
Vaccinations
COMPETION & STATE AID -
European Commission adopts Communication on a Competition Policy Fit for New Challenges -
On 18 November 2021, the European Commission adopted a Communication on a Competition Policy Fit for New...more
12/3/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Pharmaceutical Industry ,
Regulatory Agenda ,
State Aid ,
Vaccinations