Most drug and medical device executives know that getting Human Genetic Resources (HGR) from China is not an easy task. However, over the last year, China has implemented changes to make this a somewhat easier process. For example, data can be transferred across borders that are not on the “negative list.” Also, two free trade zones in Shanghai and Lingang have been set up to help facilitate data transfer.
However, in late February, the US signed an Executive Order that prevents access to sensitive US personal data by countries of concern including China. The US Executive Order aims to restrict the transfer of large volumes of government and sensitive personal data. The only issue is it does not define what large volumes are. This executive order may make it harder for US drug and medical device companies to share US data when they or their China partner apply for China product registration. It may also be more difficult for US firms to share clinical data (global trials), share safety data (pharmacovigilance), post-market sales information, and data collected by a customer relationship manager system (CRM) or via electronic health records (HER). In addition, medical device companies that store or network data or utilize AI device software (which continuously adds new data) may also be hindered by this Order. Since drug and device companies in both the US and China oftentimes need an easy flow of data, such companies will need to plan on healthcare data exports in advance.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.
Source used in the article: https://www.bloomberg.com/news/articles/2024-02-28/us-data-security-order-to-limit-china-s-access-to-americans-personal-data#:~:text=US%20Seeks%20to%20Limit%20China’s%20Access%20to%20Americans’%20Personal%20Data&text=President%20Joe%20Biden%20will%20sign,particularly%20by%20China%20and%20Russia.