As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
The EDPB recently announced its second topic for coordinated enforcement. At a national level, data protection authorities in the EU will be looking into the position of the data protection officer. The results of these...more
Companies transferring personal data out of the EU or UK are reminded of key deadlines approaching for the contracts that govern these transfers. When the European Commission adopted the new Standard Contractual Clauses...more
The European Commission recently released a set of FAQs for the new EU standard contractual clauses (SCCs). The FAQs are based on feedback received from various stakeholders and currently address 44 different questions....more
It has been almost two years since the Privacy Shield was struck down as a valid data transfer mechanism in Schrems II. Many have been wondering “what’s next”? Will there be a replacement framework? When will that be...more
Following a similar case from Austria, the French data protection authority recently concluded that certain use of cookies placed by US data analytics tools violated GDPR. The case came before the CNIL as the result of a...more
Just as we thought 2022 was going to be significantly different than 2021, December 2021 and January 2022 events have thrown us for another (pandemic) loop. We anticipate that some of the privacy and cybersecurity...more
1/12/2022
/ Artificial Intelligence ,
Auto-Dialed Calls ,
Biometric Information ,
Biometric Information Privacy Act ,
California Consumer Privacy Act (CCPA) ,
California Privacy Rights Act (CPRA) ,
CAN-SPAM Act ,
CARU ,
CDPA ,
Consumer Privacy Rights ,
COPPA ,
Cross-Border Transactions ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Security ,
Employee Tracking ,
EU ,
FCC ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Identity Theft ,
Machine Learning ,
Mobile Privacy ,
Ransomware ,
SCOTUS ,
TCPA
The European Commission recently adopted an adequacy decision regarding the Republic of Korea’s data protection laws. As a result of this decision, personal data can freely flow between the EEA and South Korea without the...more
1/7/2022
/ Binding Corporate Rules ,
Cross-Border ,
Data Protection ,
Data Transfers ,
EU ,
European Commission ,
European Economic Area (EEA) ,
Korea ,
Privacy Laws ,
South Korea ,
Standard Contractual Clauses ,
UK
Starting this fall, companies transferring personal data from the European Economic Area (EEA) will likely begin to see a flurry of contract renegotiations. On June 4, 2021, the European Commission adopted long awaited new...more
6/17/2021
/ Cross-Border ,
Data Security ,
Data Transfers ,
EU ,
EU-US Privacy Shield ,
European Economic Area (EEA) ,
FISA ,
General Data Protection Regulation (GDPR) ,
International Data Transfers ,
Schrems I & Schrems II ,
Standard Contractual Clauses
Many supervisory authorities across Europe have reported increasing numbers of data breach notifications since the introduction of GDPR. While most companies are now familiar with the 72-hour reporting obligation for...more
2/1/2021
/ Cybersecurity ,
Data Breach ,
Data Management ,
Data Protection ,
Employee Training ,
Employer Liability Issues ,
EU ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
Notification Requirements ,
Policies and Procedures
Many in the world have been watching the Brexit deal closely, including privacy lawyers and others who deal with global data transfers. Under the recently-announced deal, a temporary solution will allow companies to continue...more
12/29/2020
/ Cross-Border Transactions ,
Data Protection ,
Data Transfers ,
EU ,
European Economic Area (EEA) ,
Exceptions ,
General Data Protection Regulation (GDPR) ,
International Data Transfers ,
Personal Data ,
UK ,
UK Brexit
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Companies who transfer data from the EU to the U.S. are struggling to determine the appropriate basis under which they can make these transfers. Continuing our examination of the outcome of this decision, we think now about...more
U.S. companies are in a bind in the wake of the recent EU decision rejecting the validity of the Privacy Shield. While it is clear that the EU will not accept Privacy Shield participation as a basis for transferring data from...more
On July 16, 2020, in the case colloquially known as “Schrems II,” the Court of Justice of the European Union (CJEU) struck down the EU-US Privacy Shield, finding it an invalid mechanism for transferring data from the EU to...more
A number of private and government entities have released apps and software development kits (SDKs) relying on location tracking data to help tackle the COVID-19 pandemic. While the use of such technologies are being hotly...more
Following its 20th plenary session on April 7, the European Data Protection Board (EDPB) selected geolocation and health data to focus on in its upcoming COVID-19 guidance. This follows in response to the EDPB’s earlier broad...more
The EU Commission concluded its third annual review of the EU-U.S. Privacy Shield and found that it continues to provide an adequate level of protection for EU personal data. The program was created as a mechanism to...more