Proposed Framework for Modifications to Artificial Intelligence/Machine Learning (Ai/Ml)-Based Software as A Medical Device (SAMD)
Anurag Shrivastava, Upma Jain, Mohammed Al‐Farouni, Yogendra Kumar, R J Anandhi, Munugapati Bhavana · 2024
The rapid adoption of software as a medical device (SAMD) driven by artificial intelligence and machine learning has brought about a fundamental shift in the medical industry. This shift has the potential to greatly improve clinical outcomes and the quality of care provided to patients. This shift has been responsible for a number of key achievements made in recent times. When seen in this context, the proposed legal framework for revisions to the AI/ML-SAMD appears as an essential response to the malleability of these technologies. To successfully navigate the tough process of modifying AI/ML-SAMD with the assistance of this framework. It does this by taking into consideration the need for rapid regulatory scrutiny and making an attempt to combine the promotion of innovation with the simultaneous preservation of patient safety. In other words, it ensures that patient safety is protected while also encouraging innovation. This abstract provides a summary of the fundamental components of the framework, as well as a discussion of the significance of those components with regard to fostering the development of moral AI/ML-SAMD within the context of the healthcare ecosystem. The healthcare sector is undergoing a change as a direct result of artificial intelligence and machine learning, which are improving patient outcomes, diagnostic accuracy, and treatment options. The research emphasizes the significance of specific AI and ML applications as well as the sector’s embrace of this paradigm-shifting technology. In addition, the regulatory framework that has been presented is an important step towards guaranteeing the safe use of AI and ML in the medical field.