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...more
4/15/2025
/ China ,
Compliance ,
Corporate Counsel ,
Data Privacy ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Executive Orders ,
Final Rules ,
New Guidance ,
Personal Data ,
Sensitive Personal Information
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...more
On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
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...more
1/9/2025
/ Biometric Information ,
Broker-Dealer ,
CFIUS ,
Compliance ,
Cybersecurity ,
Cybersecurity Information Sharing Act (CISA) ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Justice (DOJ) ,
Enforcement ,
Executive Orders ,
Final Rules ,
Foreign Subsidiaries ,
Geolocation ,
Hong Kong ,
International Data Transfers ,
Life Sciences ,
Macau ,
National Security ,
PRC ,
Privacy Laws ,
Recordkeeping Requirements ,
Regulatory Requirements ,
Restricted Transactions ,
Risk Management ,
Sensitive Personal Information
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
1/7/2025
/ Classification ,
Clinical Trials ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Institutional Review Board (IRB) ,
International Harmonization ,
Investigations ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Office for Human Research Protections (OHRP) ,
Prescription Drugs ,
SACHRP
On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on...more
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...more
11/5/2024
/ Biometric Information ,
CFIUS ,
China ,
Cybersecurity Information Sharing Act (CISA) ,
Data Brokers ,
Data Transfers ,
Department of Justice (DOJ) ,
Employment Contract ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Financial Services Industry ,
Geolocation ,
Iran ,
National Security ,
North Korea ,
PRC ,
Prohibited Transactions ,
Proposed Rules ,
Recordkeeping Requirements ,
Risk Management ,
Russia ,
Sensitive Business Information