The Situation: With COVID-19 vaccination campaigns underway throughout Europe, employers are now evaluating how the availability of vaccines may impact their own workforce, including whether they can make vaccination...more
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• Use of EU COVID-19 recovery funds to roll out very high capacity telecoms networks must adhere to State aid rules
• EU approves new and amended Member State measures to...more
The Situation: The health care sector is currently going through a digital transformation phase with the promise of achieving improved patient care and higher efficiency—and the implementation of cloud-based services is a...more
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• European Commission launches public consultation on revision of IPCEI Communication
• EU approves new and amended Member State measures to support the...more
3/1/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency
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.
LATEST KEY DEVELOPMENTS -...more
2/24/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Popular ,
State Aid ,
State of Emergency
Competition & State Aid
• EU approves new and amended Member State measures to support the economy
Trade / Export Controls
• EU and India launch the High-Level Dialogue on Trade and Investment, with a particular...more
2/24/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency
LATEST KEY DEVELOPMENTS
Competition & State Aid
• European Commission prolongs and further expands Temporary Framework to support economy in context of coronavirus outbreak
• EU approves new and amended Member...more
Note from the Editors -
Digital technologies have transformed almost every aspect of the health care and life sciences industry—from electronic health records and telemedicine, to diagnostics and therapeutics augmented by...more
1/29/2021
/ Artificial Intelligence ,
Asia Pacific ,
CARES Act ,
Centers for Disease Control and Prevention (CDC) ,
Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Emergency Use Authorization (EUA) ,
European Commission ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Facilities ,
HIPAA Privacy Rule ,
Machine Learning ,
Popular ,
Telehealth ,
Telemedicine
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• European Commission launches public consultation on fair taxation in the digital economy
• European Commission proposes to further prolong and adjust State aid...more
1/25/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Personal Protective Equipment ,
Popular ,
Relief Measures ,
State Aid ,
State of Emergency
LATEST KEY DEVELOPMENTS
Competition & State Aid
• EU approves new and amended Member State measures to support the economy
Trade / Export Controls
• European Commission announces export transparency mechanism...more
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• €25 billion Pan-European Guarantee Fund deployed for the first time
• EU approves new and amended Member State measures to support the economy
Trade / Export...more
1/13/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• European Commission addresses State aid support in Communication on tackling nonperforming loans in the aftermath of COVID-19 pandemic
• European Commission...more
1/7/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Personal Protective Equipment ,
Relief Measures ,
State Aid ,
State of Emergency
This regular update (no. 29 | 15 December 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more
12/15/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• EU approves new and amended Member State measures to support the economy
• Executive Vice-President and Competition Commissioner Vestager speech on the future of State...more
12/2/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Popular ,
State Aid
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• EU approves new and amended Member State measures to support the economy
• European Commission Executive Vice-President Margrethe Vestager speech on COVID-19 State...more
11/30/2020
/ Competition ,
Coronavirus/COVID-19 ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Relief Measures ,
State Aid ,
State of Emergency
The Development: Belgium's financial regulator, the Financial Services and Markets Authority ("FSMA"), published a recent opinion on "Considerations and good practices with respect to inside information disclosures by listed...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.
LATEST KEY DEVELOPMENTS...more
11/17/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency ,
Value-Added Tax (VAT)
This regular update (no. 24 | 13 October 2020) 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
10/22/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
Popular ,
State Aid
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.
LATEST KEY DEVELOPMENTS...more
10/20/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency
This regular update (no. 23 | 29 September 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more
10/2/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Member State ,
Personal Protective Equipment ,
State Aid ,
State of Emergency
This regular update (no. 22 | 22 September 2020) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal...more
10/1/2020
/ Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
Medical Supplies ,
Member State ,
Personal Protective Equipment ,
Public Health ,
State Aid ,
Supply Chain
At long last, the new French health care anti-gift regime, modified in 2017, should be applicable as of October 1, 2020, thanks to implementing regulations adopted over the summer.
The French anti-gift regime, which...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
9/1/2020
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Member State ,
Relief Measures ,
State Aid ,
State of Emergency
Note From the Editors -
With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more
7/21/2020
/ Acquisitions ,
Buyouts ,
CARES Act ,
Coronavirus/COVID-19 ,
Digital Health ,
FCC ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Foreign Direct Investment ,
Global Dealmaking ,
Investors ,
Life Sciences ,
Market Participants ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Popular ,
Private Equity ,
Public Health Emergency ,
Regulatory Requirements ,
Startups ,
Telehealth ,
Telemedicine ,
Venture Capital
Digital health technologies have brought a number of significant breakthroughs to clinical trial programs, including faster patient recruitment, more efficient data collection, and better tracking of biometric information....more
6/2/2020
/ Biometric Information ,
Clinical Trials ,
Consent ,
Data Collection ,
Data Integrity ,
Data Privacy ,
Data Security ,
Digital Health ,
Health Care Providers ,
Health Technology ,
Research and Development