Legal Frameworks for the Integration of Artificial Intelligence


The rapid advancement of artificial intelligence (AI) and neural net-works has significantly impacted various industries, including biomedical engi-neering. These technologies promise to revolutionize healthcare by improving diagnostics, treatment planning, and personalized medicine. However, their inte-gration into the biomedical field also raises legal and ethical concerns. This study aims to investigate the existing legal frameworks governing AI and neural net-work applications in biomedical engineering and evaluate their effectiveness in addressing the challenges of technology integration. We conducted a comprehen-sive review of international, regional, and national legal frameworks and policies related to AI and neural networks in biomedical engineering. Our findings indi-cate that while current legal frameworks have made strides in addressing some challenges, gaps remain, particularly in terms of data privacy, algorithmic ac-countability, and ethical considerations. The article concludes by discussing po-tential improvements to existing legal frameworks and the need for ongoing eval-uation and adaptation to keep pace with technological advancements in AI and neural networks within biomedical engineering.



1. Xiao Y. Application of Neural Network Algorithm in Medical Artificial Intelligence Product Development. Comput Math Methods Med. 2022 Jun 8;2022:5413202. doi: 10.1155/2022/5413202. 2. European Commission. (2016). General Data Protection Regulation. Retrieved from 3. FDA. (2019). Proposed Regulatory Framework for Modifications to Artificial Intelli-gence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Retrieved from 4. Floridi, L., Cowls, J., Beltrametti, M., Chatila, R., Chazerand, P., Dignum, V., … & Schafer, B. (2018). AI4People—An ethical framework for a good AI society: opportunities, risks, principles, and recommendations. Minds and Machines, 28(4), 689-707. 5. Goodman, K. W., Adams, S., Berner, E. S., Embi, P. J., Hsiung, R., Hurdle, J., … & Sarkar, I. N. (2017). AMIA’s code of professional and ethical conduct. Journal of the American Medical Informatics Association, 24(1), 2-12. 6. ISO/IEC. (2018). ISO/IEC 27000 series of standards. Retrieved from 7. Mittelstadt, B., Allo, P., Taddeo, M., Wachter, S., & Floridi, L. (2018). The ethics of algo-rithms: Mapping the debate. Big Data & Society, 3(2), 1-21. DOI: 10.1177/2053951716679679 8. NHSA. (2020). Guidelines on the regulation of AI and neural networks in medical devices and digital health services. Retrieved from 9. Price, W. N., Gerke, S., & Cohen, I. G. (2019). Potential liability for physicians using arti-ficial intelligence. JAMA, 322(18), 1765-1766. 10. Yin, M. C. (2019, March). Biomedicine offers advanced medical findings. BioMedicine, 2(1), 1. 11. Huang, C. Y. (2013, December). Diagnosis and treatment trends in biomedicine. BioMedi-cine, 3(4), 147. 12. Tsai, F. J. (2021, December). Biomedicine brings the future nearer. BioMedicine, 1(1), 1. 13. Gulyamov Said Saidakhrorovich (2020). REGULATORY LEGAL FRAMEWORK FOR THE REGULATION