This regular update (no. 59 | 16 August 2021) 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
8/23/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Popular ,
Regulatory Agenda ,
State Aid
NOTE FROM THE EDITORS -
The "dog days of summer" certainly provide a welcome, if brief, break in the extremely rapid pace of statutory, regulatory, and various other policy and industry efforts applicable to digital health....more
8/13/2021
/ Artificial Intelligence ,
Clinical Trials ,
Connected Items ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Digital Health ,
Health Information Technologies ,
Infectious Diseases ,
Information Blocking Rules ,
International Tax Issues ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Medical Marijuana ,
Medicare ,
Physician Fee Schedule ,
Popular ,
Public Health Emergency ,
Telehealth ,
Vaccinations
UNITED STATES -
Regulatory—Policy, Best Practices, and Standards -
President Biden Issues Cybersecurity Executive Order -
On May 12, 2021, President Biden issued an executive order that placed new standards on the...more
8/10/2021
/ Article III ,
Biden Administration ,
California Consumer Privacy Act (CCPA) ,
Cybersecurity ,
Cybersecurity Framework ,
Data Breach ,
Data Privacy ,
Data Protection ,
Enforcement Actions ,
Executive Orders ,
Facial Recognition Technology ,
Federal Trade Commission (FTC) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Technology ,
Mobile Apps ,
Personal Data ,
Popular ,
Ransomware ,
SCOTUS ,
Standing ,
TransUnion LLC v Ramirez
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
8/5/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Prescription Drugs ,
Regulatory Agenda ,
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
7/31/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Prescription Drugs ,
Regulatory Agenda ,
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
7/25/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Prescription Drugs ,
Regulatory Agenda ,
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
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
7/14/2021
/ Antitrust Provisions ,
Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
Dawn Raids ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Popular ,
Regulatory Agenda ,
State Aid
LATEST KEY DEVELOPMENTS -
Competition & State Aid -
• European Commission adopts first positive assessments of Recovery and Resilience Plans from 8 Member States
• European Commission approves new and amended Member...more
6/30/2021
/ Antitrust Provisions ,
Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Regulatory Agenda ,
State Aid
LATEST KEY DEVELOPMENTS -
Competition & State Aid -
• Executive Vice-President and Competition Commissioner Margrethe Vestager addresses competition policy’s role in supporting Europe’s recovery • EU General Court...more
6/30/2021
/ Antitrust Provisions ,
Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Regulatory Agenda ,
State Aid
On June 10, 2021, the Standing Committee of the 13th National People's Congress passed the long awaited People's Republic of China (China) Data Security Law ("DSL") after a final read of the third draft. The DSL, which takes...more
6/21/2021
/ China ,
Corporate Counsel ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Data Processing Rules ,
Data Processors ,
Data Protection ,
Data Security ,
General Data Protection Regulation (GDPR) ,
Information Technology ,
International Data Transfers ,
National Security ,
New Legislation ,
Regulatory Reform
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
6/21/2021
/ Antitrust Provisions ,
Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
EU ,
Export Controls ,
Infectious Diseases ,
International Trade ,
Medical Devices ,
Regulatory Agenda ,
State Aid
LATEST KEY DEVELOPMENTS
Competition & State Aid
• EU General Court annuls COVID-19-related State aid decisions for inadequate reasoning
• European Commission receives Recovery and Resilience Plans from 23 Member...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• Multilateral Working Group on pharmaceutical mergers launches a joint public consultation
• European Commission receives Recovery and Resilience Plans from 18...more
6/7/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
Export Controls ,
Medical Devices ,
State Aid ,
State of Emergency ,
Vaccinations
An interest group of EU banks that was formed to assist European financial institutions with their use of public cloud technology recently suggested model terms for the compliant use of cloud technology.
On May 17, 2021,...more
China recently released new drafts of its Data Security Law and its Personal Information Protection Law for public comment; when finalized the two laws will impose significant obligations on how companies collect, process,...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• European Commission publishes proposed Regulation on foreign subsidies distorting the internal market
• EU approves new and amended Member State measures to support the...more
The Development: On 21 April 2021, the European Commission ("Commission") unveiled a proposal for a "Regulation laying down harmonized rules on Artificial Intelligence" ("AI Regulation"), which sets out how AI systems and...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• European Commission receives Recovery and Resilience Plans from 14 Member States
• EU approves new and amended Member State measures to support the economy...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• European Commission adopts Communication on revised Guidelines on Regional State Aid
• European Commission launches public consultation on proposed revised State...more
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• Air Canada and Transat withdraw from proposed merger after European Commission rejects remedy package – Remarks from Executive Vice-President and Competition...more
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• European Commission issues Comfort letter on Cooperation at a Matchmaking Event – Towards COVID19 vaccines upscale production
• European Commission publishes...more
4/5/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Export Controls ,
Medical Devices ,
Member State ,
State Aid
LATEST KEY DEVELOPMENTS -
Competition & State Aid
• Commissioner McGuinness addresses EU’s bank crisis management and deposit insurance framework, including COVID-19 crisis and State aid concerns
• EU approves...more
4/5/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Export Controls ,
Medical Devices ,
Member State ,
State Aid
LATEST KEY DEVELOPMENTS
Competition & State Aid
• Launch of Multilateral Working Group of leading competition authorities to assess the effects of mergers in the pharmaceutical sector, including drug pricing
•...more
LATEST KEY DEVELOPMENTS
Competition & State Aid
• European Commission pursues Fit for Future Platform to simplify EU law, including in the area of State aid, particularly in response to the pandemic
• EU approves new...more
3/17/2021
/ Competition ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Data Protection ,
EU ,
European Commission ,
European Medicines Agency (EMA) ,
Export Controls ,
Medical Devices ,
Personal Protective Equipment ,
Popular ,
State Aid