China’s generative AI interim measures for service management have came into effect on August 15, 2023.
The National Internet Information Office introduced and approved (No.15-2023) the “Interim Measures for the Management of AI-Generated Content Services” in May 2023 during their 12th meeting this year. In this blog post, we will explore the implications of these new regulations and how they may impact medical device manufacturers as well as the steps to consider to ensure compliance.
Balancing innovation and security
In pursuit of encouraging innovation while upholding security, China’s regulatory approach prioritizes both elements. The regulations explicitly state that AI-generated content should not promote content that could harm national security, unity, or stability. Moreover, the regulations require generative AI service providers to implement algorithms that prevent any form of discrimination based on factors like nationality, religion, or gender. For medical device manufacturers, this means ensuring that any content related to their products does not inadvertently fall afoul of these guidelines.
Securing data and privacy
One of the central pillars of the regulations revolves around respecting intellectual property rights, safeguarding user privacy, and ensuring the accuracy and reliability of AI-generated content. Medical device manufacturers must take China’s Data Security Law and Personal Information Protection Law into account when dealing with AI-generated content. Any handling of personal information should be done in compliance with these laws, and manufacturers should be prepared to respond promptly to users’ requests for information access, correction, or deletion.
Protecting intellectual property
Respecting intellectual property rights is a key component of the regulations. Medical device manufacturers should ensure that their AI-generated content services do not infringe upon the intellectual property rights of others. This includes securing the necessary licenses for any content or technologies used in their AI applications.
Fostering transparency
Transparency is a critical element of the regulations. Medical device manufacturers should consider how they can make their AI-generated content services more transparent to users. This may involve providing clear explanations of how AI is used in their products, especially if it involves patient data. Being transparent about the ethical use of AI-generated content can help build trust with consumers and regulatory authorities.
Collaboration for AI development
The regulations encourage collaboration between various stakeholders, including industry organizations, enterprises, and research institutions. For medical device manufacturers, this could mean exploring partnerships or collaborations with AI experts and research institutions to enhance their AI-generated content capabilities while staying within the regulatory framework. This collaboration can also contribute to responsible AI development in the healthcare sector.
Ensuring compliance and accountability
While promoting innovation, the regulations underline the significance of legal compliance and accountability. Medical device manufacturers should establish agreements with users, outlining the scope of their services and their commitment to protecting user-generated content and personal information. In cases where illegal content or activities are identified, manufacturers must take corrective measures and report them to relevant authorities.
Further information
Read the original article on Interim Measures for the Management of Generative Artificial Intelligence Services.
By adhering to the outlined requirements, manufacturers can ensure their products meet the necessary safety and performance standards. Also, Cisema can assist manufacturers in navigating the registration process effectively. Discover our services for medical device registration, renewals and NMPA Legal Agent.
