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. 2024 May 24;4(6):100564. doi: 10.1016/j.xgen.2024.100564

Table 1.

Key legal requirements exerting influence on collaborative AI-based genomic research between the United States and China

China’s regulation of generative AI, export control law, and data protection laws US export control rules
  • Regulation of generative AI
    • The scope of application of the Provisional Measures (Article 2, Provisional Measures for the Administration of Generative Artificial Intelligence Services)
    • The respectful handling of intellectual property of datasets, privacy, data protection, the prevention of discrimination in algorithmic programming and training data selection, and the need for improving transparency of AI service provision (Articles 4 and 7, Provisional Measures for the Administration of Generative Artificial Intelligence Services)
    • The encouragement for participating international dialogue and proactive involvement of international rule making for AI development (Article 6, Provisional Measures for the Administration of Generative Artificial Intelligence Services)
  • Laws related to human genomic data
    • Restriction of foreign entities’ direct access and use of China’s human genetic resources including genetic data (Article 7, The Administrative Regulations on Human Genetic Resources)
    • Prohibition of purchase and sale of human genetic resources (Article 10, The Administrative Regulations on Human Genetic Resources)
    • Administrative approval procedures of international research collaborations using China’s genetic resources (Article 27, The Administrative Regulations on Human Genetic Resources)
    • Procedures of filing for record and submitting backup for providing open access to human genetic resources to foreign entities (Article 28, The Administrative Regulations on Human Genetic Resources)
    • Legal liability for providing genetic data to foreign entities without fulfilling the procedures of filing for records or obtaining administrative approval (Articles 41 and 42, The Administrative Regulations on Human Genetic Resources)
    • Legal regimes of personal information protection
    • Three approaches to conduct the cross-border data transfer, i.e., passing the security evaluation, gaining the certification of data protection capacity, and concluding the Standard Contract (Article 38, Personal Information Protection Law)
    • The mandatory adoption of security evaluation in cross-border data transfer activities (Article 4, Security Evaluation Measures for Data Provision Abroad)
  • Rules of healthcare data management
    • The data localization requirements and its wide applicability to medical institutions at all levels within China (Articles 2, 3 and 10, Notice of National Health and Family Planning Commission on Promulgation of the Measures for the Administration of Population Health Information)
  • Definitions of “technology” as used in the Export Administration Regulations (EAR) (15 CFR § 772.1 Definitions of terms as used in the EAR)

  • Application of Unverified List (UVL) to non-citizens
    • UVL statement required of entities listed in the UVL to export, reexport, or transfer (in country) items subject to the EAR (15 CFR § 744.15 [a] and [b] Restrictions on exports, reexports and transfers (in-country) to persons listed on the UVL)
    • Criteria for revising the UVL, including adding entities to and removing entities from the UVL (15 CFR § 744.15 [c] Restrictions on exports, reexports and transfers (in country) to persons listed on the UVL)
  • Application of the Entity List to non-citizens
    • Criteria for including entities into the Entity List and related license requirements for them (15 CFR § 744.16 [a] Entity List)