For almost a decade, the scientific research provisions of the General Data Protection Regulation (GDPR) have lacked authoritative, European Union (EU)-wide interpretation, leaving sponsors of clinical trials and research institutions alike to navigate a patchwork of national implementing laws. A 2019 study commissioned by the European Data Protection Board (EDPB) — the body comprising EU national data protection authorities — confirmed significant divergence among EU Member States, and interim guidance published in 2021 by the EDPB highlighted — but left unresolved — several key GDPR compliance issues facing organisations in the life sciences industry. In the years since, the COVID-19 pandemic and the United Kingdom’s post-Brexit departure from the EU framework have only sharpened the need for more specific guidance. Ropes & Gray attorneys co-authored an article published in Science magazine in October 2020 that provided a summary of the complexity in this space and potential solutions.
Continue Reading The European Data Protection Board Releases New Guidelines on the Processing of Personal Data for Scientific Research
In Bloomberg Law, David Peloquin Discusses Bulk Data Transfer Rule Enforcement
Ropes & Gray’s health care partner, David Peloquin, spoke with Bloomberg Law on the additional DOJ instructions regarding the Biden-era Executive Order 14117. DOJ has provided clarity surrounding the effective date for enforcement, with a promise to delay any enforcement efforts until July 8 for companies that show “good faith efforts to comply.” David
DOJ Releases FAQs and Compliance Guidance for Final Rule Restricting Flow of Bulk Sensitive Personal Data to China and other Countries of Concern
On April 11, 2025, the Department of Justice (“DOJ”) released additional detail regarding the Final Rule implementing former President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the “Final Rule”), which went into effect on April 8, 2025. The release included additional
DOJ Bulk Data Final Rule Update
Today, the Department of Justice’s (“DOJ”) Final Rule implementing former President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the “Final Rule”) took effect.
Earlier this year, Ropes & Gray published an alert providing an overview of the Final Rule, material changes
In IAPP Article, David Peloquin and Jake Barr Discuss DOJ Rule Limiting Sensitive Data Transfers
In an International Association of Privacy Professionals (IAPP) article, health care partner David Peloquin and data, privacy and cybersecurity associate Jake Barr along with Legend Biotech Chief Privacy Officer and Assistant General Counsel Corey Dennis discuss the landmark rule limiting sensitive data transfers to “countries of concern.” The article reviews key aspects for health care
DOJ Issues Final Rule Restricting Flow of Bulk Sensitive Personal Data to China and Other Countries of Concern
On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern” (the “Final Rule”). This follows the DOJ’s publication of its Notice of Proposed Rulemaking (“NPRM”) in October 2024
DOJ Issues Notice of Proposed Rulemaking to Restrict Flow of Bulk Sensitive Personal Data to China and other Countries of Concern
On October 29, 2024, the Department of Justice (“DOJ”) published its Notice of Proposed Rulemaking (“NPRM”) to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern.” This follows the DOJ’s publication of its Advance Notice of Proposed Rulemaking earlier this year.
U.S. Enacts Sweeping Legislation to Restrict Flows of Sensitive Data to the People’s Republic of China and Other Foreign Adversaries
On April 24, President Biden signed a sweeping foreign aid bill into law, which included a critical provision covering privacy and data transfers known as the Protecting Americans’ Data from Foreign Adversaries Act (“PADFA”). This Act is separate from the TikTok divestment portion of the legislation, which has received far greater attention in the press.
In Bloomberg Law Article, Attorneys Analyze Washington State’s New Privacy Law That Safeguards Consumer Health Data
In a Bloomberg Law article, attorneys examined Washington State’s comprehensive new privacy law, the My Health My Data Act, the first state law that specifically safeguards consumer health data.
The article discusses the new law’s scope, applicability, and ensuing company obligations. The Act will apply to many life sciences companies, pharmaceutical and device
New Executive Order Would Restrict Transfer of Certain Bulk Sensitive Personal Data and United States Government-Related Data to China and Other Countries of Concern
On February 28, 2024, President Biden announced an Executive Order directing the Department of Justice to promulgate regulations that restrict or prohibit transactions involving certain bulk sensitive personal data or United States Government-related data and countries of concern or covered persons. The DOJ’s initially identified countries are China (including Hong Kong and Macau), Russia, Iran