Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
7/22/2024
/ Algorithms ,
Artificial Intelligence ,
Cybersecurity ,
Data Protection ,
Department of Justice (DOJ) ,
Digital Health ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Personal Data ,
Pharmacies ,
Popular ,
Telemedicine
On 22 December 2023, the Regulation on harmonized rules on fair access to and use of data ("Data Act") was published in the EU's Official Journal. The Data Act lays down rules on fair access to and use of personal and...more
Beginning October 12, 2023, the UK-U.S. Data Bridge will allow UK companies to transfer personal data to the United States using the new EU-U.S. Data Privacy Framework....more
10/17/2023
/ Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
EU ,
EU Data Protection Laws ,
Information Technology ,
International Data Transfers ,
Personal Data ,
Personally Identifiable Information ,
UK
On May 30, 2023, the Cyberspace Administration of China ("CAC") issued the "Guidance on Filing the Standard Contract for the Cross-Border Transfer of Personal Information" ("Guidance"), which took effect on June 1, 2023....more
In Short -
The Situation: There has been uncertainty over the circumstances in which data subjects can claim compensation for "mere" infringement of their rights without specific evidence of harm. On May 4, 2023, the Court...more
On October 7, 2022, President Biden signed an executive order on "Enhancing Safeguards for United States Signals Intelligence Activities," outlining the measures that the United States will take to implement its commitments...more
On 31 January 2022, the English High Court delivered its judgment in Stadler v Currys Group Limited (EWHC 160 (QB)); the latest in a series of rulings which appear set to constrain the relatively nascent UK data breach claims...more
2/25/2022
/ Corporate Counsel ,
Cybersecurity ,
Damages ,
Data Breach ,
Data Protection ,
Emotional Distress Damages ,
General Data Protection Regulation (GDPR) ,
Personal Data ,
UK ,
UK Data Protection Act ,
UK Supreme Court
On February 23, 2022, the European Commission ("Commission") published a proposal for a Data Act which aims at enhancing data access and use within the European Union ("EU")....more
2/24/2022
/ Artificial Intelligence ,
Data Collection ,
Data Privacy ,
Data-Sharing ,
EU ,
European Commission ,
Information Governance ,
International Data Transfers ,
Internet of Things ,
Personal Data ,
Personally Identifiable Information ,
Proposed Regulation ,
Regulatory Agenda ,
Small and Medium-Sized Enterprises (SMEs)
EU and UK data protection rules each restrict transfers of personal data to third countries not regarded as having an adequate level of protection, such as the United States, China, Russia and India....more
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
The Background: On February 1, 2021, Singapore's Personal Data Protection (Amendment) Act 2020 ("PDPAA") came into effect.
The Situation: The PDPAA is the first comprehensive update to Singapore's Personal Data Protection...more
United States -
Regulatory—Policy, Best Practices, and Standard -
NIST Unveils Draft Guidance to Protect Critical Infrastructure -
On October 22, 2020, the National Institute of Standards and Technology ("NIST")...more
1/8/2021
/ CNIL ,
Consumer Privacy Rights ,
Court of Justice of the European Union (CJEU) ,
Cybersecurity ,
Cybersecurity Framework ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Protection Authority ,
Data Security ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
Information Commissioner's Office (ICO) ,
NIST ,
Personal Data ,
Popular ,
Risk Management
The Situation: After the invalidation of the EU-U.S. Privacy Shield by the Court of Justice of the European Union ("CJEU"), the conditions under which international data may flow from the European Union continue to remain...more
11/23/2020
/ Binding Corporate Rules ,
Court of Justice of the European Union (CJEU) ,
Cybersecurity ,
EU ,
EU-US Privacy Shield ,
European Data Protection Board (EDPB) ,
General Data Protection Regulation (GDPR) ,
International Data Transfers ,
Personal Data ,
Schrems I & Schrems II ,
Standard Contractual Clauses
The Situation: The United Kingdom is due to leave the European Union ("EU") on 31 October 2019. Negotiations between member states of the EU excluding the United Kingdom ("EU27") and the United Kingdom are ongoing, but it is...more
10/1/2019
/ Corporate Counsel ,
Data Protection ,
EU-US Privacy Shield ,
European Commission ,
Extraterritoriality Rules ,
General Data Protection Regulation (GDPR) ,
Information Commissioner's Office (ICO) ,
International Data Transfers ,
Member State ,
No-Deal Brexit ,
Personal Data ,
Standard Contractual Clauses ,
UK Brexit
The Situation: Fashion ID, a German online clothing retailer, embedded on its website the Facebook "Like" button. When a user consults the website of Fashion ID, that user's personal data are transmitted to Facebook Ireland....more
8/5/2019
/ Cookies ,
Corporate Counsel ,
Data Collection ,
Data Processors ,
EU ,
EU Data Protection Laws ,
European Court of Justice (ECJ) ,
Facebook ,
General Data Protection Regulation (GDPR) ,
Joint Liability ,
Personal Data ,
Social Media ,
Website Owner Liability ,
Websites
The Situation: The UK Parliament has not approved the draft Brexit Withdrawal Agreement and Political Declaration on the future relationship of the European Union and United Kingdom. The next steps in the Brexit process are...more
The Situation: The General Data Protection Regulation has a broad territorial scope and can apply to businesses based outside the European Union.
The Result: The European Data Protection Board has provided important...more
The Situation: The European Union's General Data Protection Regulation ("GDPR") has raised questions regarding the scope of coverage and protection afforded by current cyber policies, especially with respect to potential GDPR...more
The Situation: The European Court of Justice ("ECJ") is to rule on the validity of EU Standard Contractual Clauses used by companies to transfer personal data outside of the European Union, at the request of Ireland's High...more
10/17/2017
/ Binding Corporate Rules ,
Cybersecurity ,
Data Protection Authority ,
EU ,
EU Data Protection Laws ,
European Court of Justice (ECJ) ,
Facebook ,
General Data Protection Regulation (GDPR) ,
International Data Transfers ,
Ireland ,
Personal Data ,
Schrems I & Schrems II ,
Standard Contractual Clauses ,
US-EU Safe Harbor Framework
New York Attorney General Announces Record Number of Data Breach Notices in 2016 -
On March 21, 2017, the New York Attorney General's Office announced that it received 1,300 reported data breaches in 2016—a 60 percent...more
6/5/2017
/ Advertising ,
Argentina ,
Australia ,
Chile ,
CNIL ,
Cyber Crimes ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Data Privacy ,
Data Protection ,
Data Protection Authority ,
Data Security ,
De-Identification ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
DNA ,
DPA ,
e-Privacy Directive ,
EDPS ,
Encryption ,
Enforcement Actions ,
ENISA ,
EU ,
FACTA ,
FCC ,
Federal Aviation Administration (FAA) ,
Federal Trade Commission (FTC) ,
France ,
Fraud ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Hong Kong ,
Information Commissioner's Office (ICO) ,
Information Sharing ,
Israel ,
Italy ,
Japan ,
Medical Records ,
Metadata ,
Mexico ,
National Security ,
Netherlands ,
NIST ,
Online Safety for Children ,
Patient Privacy Rights ,
Payroll Records ,
Personal Data ,
Personal Data Privacy Comission (PDPC) ,
Personally Identifiable Information ,
Popular ,
Privacy Policy ,
Repeal ,
Robocalling ,
Securities and Exchange Commission (SEC) ,
Singapore ,
Social Media ,
Spain ,
SWIFT ,
Telecommunications ,
Transparency ,
UK ,
Unmanned Aircraft Systems ,
USTR ,
XBRL Filing Requirements