Regulatory Perspectives of AI as Medical Device: a scoping review

Abstract

The integration of artificial intelligence (AI) into medical devices presents significant regulatory challenges as well as opportunities for enhancing patient safety. This study employs a scoping review method to identify the regulatory views of the key authorities such as MDR of EU, FDA of USA and the HSA of Singapore. Some of the considerations include patient safety, ethical issues and the implementation of transparency in AI algorithms which are different from those of the conventional medical devices. The current trends of AI technologies require awareness of how these regulations address the issues such as data privacy, algorithmic bias, and cybersecurity. This study aims to identify gaps in current regulatory frameworks and provide foundations for better understanding existing regulations across jurisdictions. This study employs a scoping review method to identify the regulatory views of the key authorities such as MDR of EU, FDA of USA and the HSA of Singapore. Searches were performed in various databases including PubMed, ProQuest Central, and Science Direct to gather all the available publications concerning the regulatory documents for the AI as medical devices. Following the three-step search strategy recommended by JBI for scoping reviews, the process included an initial pilot search, the actual search, and a detailed analysis of the results at three levels: first by the title, followed by the abstract, and lastly from the full text. Furthermore, other sources were sought from some of the chosen articles. Research validation process have done by conducting interviews with four subject matter experts’ consultation to co-creation. As a result of executing a systematic search procedure, 15 research articles were identified and selected for detailed analysis based on this scoping review. The data for this review were examined utilizing inductive content analysis. Five themes arose from this examination that represent the factors influencing regulations, focusing on both patient safety and ethical considerations of AI as medical device. While AI holds great potential for improving healthcare, the current regulatory bodies adopted flexible, robust, and ethical frameworks to address safety, privacy, bias, and accountability concerns in these rapidly evolving technologies. The thesis revealed that the explored 15 regulatory guidelines and frameworks have been developed to ensure patients’ safety and well-being. Risk identification and mitigation are incorporated into these AI-MD regulations for diagnostic and treatment healthcare use. They also ensure a level of human intervention for autonomous AI-MD and regulatory oversight & accountability important discussions in this research domain area. However, these regulations are still very diverse and regulatory harmonization across jurisdictions is essential for usage of medical device in global market. From the practical needs of the healthcare related industries, in order to maintain best performance and accuracy of the medical device, responsible manufactures will need frequent periodic updates for post market surveillance and real time monitoring process of AI regulation developments. This study provided initial insights into the current regulatory landscape of AI as a medical device for use in healthcare industry. This works will need to be maintained also in the future, as regulations change frequently, and the idea of AI empowered medical devices impacts all types of such applications in healthcare.