Recently, U.S. President Joe Biden officially signed the "Executive Order on Preventing Countries of Concern from Obtaining Extensive Sensitive Personal Data of U.S. Citizens and U.S. Government-Related Data," calling for measures to be taken to prevent "bad actors" and "countries of concern" from abusing data related to the United States. Various types of data about citizens, including genomic data, biometric data, personal health data, geolocation data, financial data and other types of personally identifiable information. The executive order may pose new challenges to Chinese life sciences companies operating in the United States.

The order requires the Departments of Justice, Homeland Security, Health and Human Services, Veterans Affairs and other agencies to take a variety of actions over the next 12 months, including:

Ministry of Justice:

Regulations will be enacted to govern cross-border transfers of large-scale data related to genomics, biometrics, personal health data, geolocation and the above areas, including a focus on preventing access to such data sets through relationships such as supplier, investment and employment relationships measures;

Ministry of Defense, etc.:

It will ensure that federal grants, contracts and awards are not used to "help countries, including U.S.-based companies, obtain sensitive health data of Americans."

Notably, the U.S. government claims:

"It will ensure that these measures do not block the flow of information needed for financial services activities or take steps that are designed to decouple the United States from a broader range of consumer, economic, scientific and trade relationships with other countries."

The potential impact of this executive order on Chinese pharmaceutical/device companies operating in the United States, such as conducting clinical trials, will depend on the regulations ultimately formulated by relevant authorities. The order specifically states that its focus is on "bulk data sets," particularly those that can be used in the field of artificial intelligence, whether for espionage or to develop artificial intelligence technology, or even anonymized data sets. This includes data obtained through partnerships and agreements with U.S. healthcare providers and research institutions.

At this time, the GBI believes the wording of the executive order indicates that the risk of direct impact on clinical trials is low. For example, it is unclear whether the large amounts of data generated in clinical trials will also be classified as "batch data," and everything will have to wait until the next 12 months. Domestic formal regulations will be studied and judged after they are promulgated.

http://www.phirda.com/artilce_34352.html?cId=1&module=trackingCodeGenerator