US President Joe Biden last week issued an Executive Order titled “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern,” which may present new challenges for China-based life science companies operating in the United States. The order is designed to curb the misuse of data by ‘bad actors’ and ‘countries of concern,’ focusing on data types such as genomic, biometric, personal health, geolocation, financial, and other personally identifiable information.
The order mandates several actions to be taken by the Department of Justice (DoJ), Homeland Security, Health and Human Services (HHS), Veterans’ Affairs (VA), and other agencies within 12 months. The DoJ is tasked with creating regulations for the cross-border transfer of large-scale data in the mentioned fields, with an emphasis on preventing access through vendor, investment, and employment relationships.
The Departments of Defense, HHS, and VA are to ensure that Federal grants, contracts, and awards do not facilitate access to sensitive health data by countries of concern, including via companies within the United States. The measures are intended not to impede the flow of information vital for financial services or to initiate a broader decoupling of the substantial consumer, economic, scientific, and trade relationships the US shares with other nations.
The impact of this Executive Order on China-based pharmaceutical and device companies conducting clinical trials in the US will hinge on the regulations to be formulated by relevant departments. The Order highlights a focus on “bulk data sets,” especially those utilizable in the artificial intelligence (AI) field for espionage or AI technology development, including anonymized data sets derived from partnerships with US healthcare providers and research institutions. While relevant agencies currently views the Order’s wording as indicating a low direct risk to clinical trials, the full impact cannot be ascertained until formal regulations are published over the next 12 months.- Flcube.com
