China’s New Interim Generative AI Regulation will Likely Affect MedTech Companies

A few months ago, a number of Chinese organizations including the Ministry of Public Safety, the Ministry of Industry and Information and Technology, the Ministry of Science and Technology, and the Cyberspace Administration outlined interim measures on the field of AI. These interim measures were an update from similar draft regulations first outlined in the Spring.

Medical companies that lay out generative AI (GAI) services to the Chinese public will now face new regulations. For example, medical companies that introduce an app that helps patients and doctors interact via a question-and-answer format or input data that requires a response will likely need to meet these new Chinese AI requirements. On the other hand, apps that provide a preliminary fixed response in advance may not follow these new Chinese AI requirements.

Medical AI algorithms will likely fall into these new GAI regulations and will likely be subject to surveillance by the Chinese government. Overseas medical companies that provide GAI services to China are also likely to be regulated by these interim GAI measures. While some GAI internal use applications may not be subject to China’s GAI regulations, there are other Chinese regulations that will need to be followed, including the Personal Information Protection Law.

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.