Baig Mansoor Ali, Almuhaizea Mohamad A, Alshehri Jumanah, Bazarbashi Mohammad Shouki, Al-Shagathrh Fahad
King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia.
Department of Biostatistics Epidemiology & Scientific Computing, KFSHRC, KSA.
Stud Health Technol Inform. 2020 Jun 26;272:253-256. doi: 10.3233/SHTI200542.
Lately, the application or integration of Artificial Intelligence in various areas of the Healthcare domain has been a prime attraction; this includes diagnostics, medicine/drugs, medical devices, interventions/procedures, imaging, therapies as well as treatment regimes, and these areas are in direct relation with the patient care, which is the core subject of the improvements envisioned through the implementation of AI. Although carrying this practice with a focused objective of improvisation in providing quality care, the overall concept of such implementations misses the governance path which can comply with any available regulatory environment, which unfortunately at this stage does not exist. As these implementations would have a direct impact on patients care, there is an urgent need to institute a robust governance and compliance framework in order to ensure the efficacy, safety, privacy, and ethical considerations. The onus of pioneering this initiative of building a governance framework for the implementation of healthcare artificial intelligence primarily rests with the Food and Drug Authority of the respective country, it is also important for this authority to further organizing the governance framework in agreement or collaboration with other international authorities.
近来，人工智能在医疗保健领域各个方面的应用或整合一直备受关注；这包括诊断、医学/药物、医疗设备、干预措施/程序、成像、治疗以及治疗方案，而这些领域与患者护理直接相关，患者护理正是通过实施人工智能所设想的改进的核心主题。尽管开展这项实践的目标是专注于改善优质护理，但此类实施的总体概念却缺少能够符合任何现有监管环境的治理路径，而不幸的是现阶段这种路径并不存在。由于这些实施将直接影响患者护理，因此迫切需要建立一个强大的治理与合规框架，以确保有效性、安全性、隐私性以及伦理考量。为医疗保健人工智能的实施构建治理框架这一倡议的首要责任主要落在各个国家的食品药品管理局身上，该机构与其他国际机构达成一致或合作来进一步组织治理框架也很重要。
