In March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  Although the text has not yet been formally adopted by all the European institutions, a number of interesting points can already be highlighted.  This article focuses on the governance and enforcement of the EHDS; for an overview of the EHDS generally, see our first post in this series.

The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.Continue Reading EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data users; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.Continue Reading EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective

After nearly six months since the initial draft was issued for public comments on September 28, 2023 (see here for our previous alert on that development), on March 22, 2024, the Cyberspace Administration of China (“CAC”) issued the final version of the Provisions on Promoting and Standardizing Cross-Border Data Flows (促进和规范数据跨境流动规定) ( “Provisions”) (Chinese version available here).  The Provisions take effect immediately.  

The newly finalized Provisions introduce significant changes to China’s existing cross-border data transfer regime.  These changes primarily involve exemptions from the previously mandated transfer mechanisms outlined in the Personal Information Protection Law (“PIPL”) and its implementing regulations.  Such mechanisms included undergoing a government-led security assessment, entering into a standardized contract, or obtaining personal information protection certification.  As a result, many companies that previously faced these requirements may now be exempt, easing their compliance burden for cross-border data transfers.  Importantly, the Provisions take precedence over any conflicting provisions within PIPL’s implementing regulations, including the Measures on the Standard Contract for Cross-Border Transfer of Personal Information and the Measures for Security Assessment of Cross-Border Data Transfer.Continue Reading China Eases Restrictions on Cross-Border Data Flows

Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, published on February 21, 2024, a white paper with various proposals to update privacy protections for health data. In Part 1 of this blog series (see here), we discussed the first section of Senator Cassidy’s February 21, 2024, white paper. Specifically, we summarized Senator Cassidy’s proposals on how to update the existing framework of the Health Insurance Portability and Accountability Act, as amended, and its implementing regulations (collectively, “HIPAA”) without disrupting decades of case law and precedent. In this blog post, we discuss the other sections of the white paper, namely proposals to protect other sources of health data not currently covered by HIPAA.Continue Reading Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 2: Safeguarding Health Data Not Covered by HIPAA 

In late December 2023, the Federal Communications Commission (“FCC”) published a Report and Order (“Order”) expanding the scope of the data breach notification rules (“Rules”) applicable to telecommunications carriers and interconnected VoIP (“iVoIP”) providers.  The Order makes several notable changes to the prior rules, including broadening the definitions of a reportable “breach” and “covered data,” requiring covered entities to notify the FCC in addition to federal law enforcement of breaches, and modifying certain customer notification requirements.  The Rules are expected to become effective sometime in 2024, after they are reviewed by the Office of Management and Budget and the FCC’s Wireline Competition Bureau (“Bureau”) announces the effective dates by subsequent public notice.Continue Reading The FCC Expands Scope of Data Breach Notification Rules

Digital health apps are increasingly used in practice. They raise various questions under regulatory and data protection and data security laws. On November 6, 2023, the German Conference of the Independent Data Protection Supervisory Authorities (Datenschutzkonferenz, DSK), a national body which brings together Germany’s federal and regional data protection authorities, issued a paper about the GDPR’s application to cloud-based digital health applications (“health apps”) that are not subject to the German Digital Health Applications Ordinance (Digitale Gesundheitsanwendungen-Verordnung, the “DiGA Regulation”).Continue Reading German Data Protection Authorities Publish Paper on Cloud-Based Digital Health Applications

On October 11, 2023, the French data protection authority (“CNIL”) issued a set of “how-to” sheets on artificial intelligence (“AI”) training databases. The sheets are open to consultation until December 15, 2023, and all AI stakeholders (including companies, researchers, NGOs) are encouraged to provide comments.  Continue Reading French CNIL Opens Public Consultation On Guidance On The Creation Of AI Training Databases

EU advocate general Collins has reiterated that individuals’ right to claim compensation for harm caused by GDPR breaches requires proof of “actual damage suffered” as a result of the breach, and “clear and precise evidence” of such damage – mere hypothetical harms or discomfort are insufficient. The advocate general also found that unauthorised access to data does not amount to “identity theft” as that term is used in the GDPR.Continue Reading EU Advocate General Defines “Identity Theft” And Reaffirms GDPR Compensation Threshold

On October 10, 2023, California Governor Gavin Newsom signed S.B. 362, the Delete Act (the “Act”), into law.  The new law represents a substantive overhaul of California’s existing data broker statute, which requires data brokers to register with the California Attorney General annually.  The passage of the Act follows a renewed interest in data broker activity nationwide, including a request for comments from the Consumer Financial Protection Bureau and the introduction of similar legislation at the federal level.   Below, we outline a number of key provisions:Continue Reading California Amends Data Broker Law